Document 6458592

Transcription

Document 6458592

Operating Room Procedures And
Postoperative Care of Large Animals
Date Issued: September 27, 2006
Date Revised: March 31, 2009
Comparative Medicine Resources
I.
CMR Policy ..........................................................................................................2
II.
Compliance ..........................................................................................................4
III.
Personnel Training ...............................................................................................5
IV.
Modifications to Intra-Operative Plan.................................................................... 6
V.
Review of Surgical Program .................................................................................6
VI.
Reporting Deficiencies in Animal Care and Treatments ....................................... 7
VII.
General ................................................................................................................7
VIII.
CMR Surgical Facilities ........................................................................................8
IX.
Principles of Asepsis .......................................................................................... 10
X.
Expired Medical Materials .................................................................................. 15
XI.
Medical and Surgical Records ............................................................................ 17
XII.
Pre-Operative Approval ...................................................................................... 20
XIII.
Fasting ...............................................................................................................24
XIV. Surgeon Preparation .......................................................................................... 22
XV.
Anesthetist Responsibilities ................................................................................ 24
XVI. Patient Preparation ............................................................................................ 28
XVII. Operating Room Emergency Evacuation ........................................................... 30
XVIII. Loss of Electric Power: Emergency Procedures ................................................. 31
XIX. Post-Operative Recovery ................................................................................... 32
XX.
Assessing Pain and Distress .............................................................................. 36
XXI. Sanitation ........................................................................................................... 38
XXII. References......................................................................................................... 39
I. Approval for Research Staff to Provide Anesthesia Support.
1. CMR requires that all surgical procedures in USDA-regulated animals 1 are
attended by a CMR Veterinary Technician (VT) and that preoperative
USDA regulated large animals include but are not limited to nonhuman primates, dogs, cats, pigs, rabbits
and woodchucks. Others may be included. Not included are small USDA regulated rodents including
hamsters, guinea pigs, gerbils and rats NOT of the Genus Rattus and mice NOT of the Genus Mus. Note
that rats of the Genus Rattus and mice of the Genus Mus are not regulated by the USDA.
1
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CMR Operating Room Procedures and Postoperative Care 9/27/06 Revised: March 10, 2009
(preoperative) care, anesthesia and postoperative (postoperative) care is provided
by a CMR Veterinary Technician.
2. Exceptions may be made for investigators who can provide staff with training and
experience equivalent to a CMR VT to do the anesthesia including preoperative
and postoperative care.
3. An investigator who wishes to use their own staff for anesthesia support must
submit this person’s name and resume in writing to Director, CMR. The CMR
Director, Chief of Surgery and CMR VT staff will evaluate this individual by
observation during three major operative procedures in the species to be
authorized and write a comment evaluating the proposed individual. This
commentary will be sent to the PI within one week of the completion of the 3rd
surgical procedure and post-operative care with a copy to the Chair, IACUC and
the Institutional Official (IO).
4. Procedures as outlined in the document CMR Operating Room Requirements and
Postoperative Care must be observed.
5. In the interest of maintaining animal welfare and protect the institution’s
compliance with Federal Laws and Regulations the CMR Veterinary Staff and
members of the IACUC reserves the right to observe animal care and use at any
time without prior notification.
II. Scheduling and use of CMR surgical suites
1. The CMR maintains 3 sterile surgical suites as follows: A-level and MSB Glevel (G-level is an investigator’s exclusive surgical suite).
2.
Surgeries are scheduled through CMR VT office.
3.
Access to CMR surgical suites and maintenance of surgical suites remain the sole responsibility
of the CMR.
III. Charges
2
1.
CMR will charge for Operating room, supplies and maintenance. 2
2.
If Operating Room time is scheduled and then cancelled with less than 24
hours notice, the cancellation charge will apply.
3.
Pre-operative, anesthetic monitoring and postoperative care charges will not
be billed if provided by research staff.
4.
Any and all other billable charges will apply.
See CMR Technical Assistance billable charges
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IV. Noncompliance
1. Noncompliance constitutes not adhering to procedures, or omission of
procedures outlined in CMR Operating Room Requirements and
Postoperative Care, which jeopardizes animal welfare or Institutional
Compliance.
2. Approval of investigator research staff to perform anesthesia will be withdrawn
after three (3) or fewer noncompliance incidents as defined in IV.1.
3. Noncompliance will be reported to the IACUC, IO, USDA and OLAW as
required by Federal Policy.
4. Every attempt will be made to contact the PI before reporting to the IACUC,
the IO, USDA and OLAW.
5. The PI may contest noncompliance items by appealing to the IACUC.
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II. Compliance with Federal Regulations
UMDNJ utilizes animals in biomedical research, testing and education and has
recognizes an ethical responsibility for the humane care and use of such animals. The
IACUC along with the Institutional Official is charged with the responsibility for reviewing
the University’s program for humane care and use of animals; for reviewing concerns
involving the care and use of animals; for inspecting the University animal housing
facilities, study areas and satellite facilities; for reviewing and approving, requiring
modifications (to secure approval) or withholding approval of proposed activities or of
significant changes in activities relating to the care and use of animals; and, if
necessary, for suspending activities involving animals.
The purpose of compliance is to follow procedures in respect to the special cautions and
considerations, which must be exercised in the conduct of research. The special
cautions and consideration include procedures which may affect the welfare of the
employees, the welfare of animals, and the environment.
Since special precautions and considerations are to be followed, guidance on prompt
reporting of deficiencies to OLAW under the PHS Policy on Humane Care and Use of
Laboratory Animals can become a very challenging aspect of medical research. The
Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research requires
and gives guidance intended for IACUCs and Institutional Officials in determining what,
when, and how situations should be reported under IV.F.3 of the Policy, and to promote
greater uniformity in reporting. All institutions with Animal Welfare Assurances are
required to comply with the provisions of IV.F.3. The Institutional Official signing the
Assurance, in concert with the IACUC, is responsible for this reporting. Situations that
meet the provisions of IV.F.3 and are identified by external entities such as the USDA or
AAALAC, International, or by individuals outside the IACUC or outside the institution, are
not exempt from reporting under IV.F.3.
PHS Policy, IV.F.3 requires that:
“The IACUC, through the Institutional Official, shall provide OLAW with a full explanation
of circumstances and actions taken with respect to:
1. any serious or continuing noncompliance with the PHS Policy (OLAW)
2. any serious deviation from the provisions of the Guide3
3. any suspension of an activity by the IACUC”
Reporting to OLAW or USDA serves dual purposes. Foremost, it ensures that
institutions deliberately address and correct situations that affect animal welfare, PHSsupported research, and compliance with the Policy. In addition, it enables OLAW to
monitor the institution’s animal care and use program oversight under the Policy,
evaluate allegations of noncompliance, and assess the effectiveness of PHS policies
and procedures. OLAW will assist the reporting institution in developing definitive
corrective plans and schedules if necessary.
A comprehensive list of definitive examples of reportable situations is impractical.
Therefore, the examples below do not cover all instances, but demonstrate the threshold
at which OLAW expects to receive a report.
Examples of reportable situations, but are not limited to these situations
3
The Guide for the Care and Use of Laboratory Animals. NCR. National Academy of Sciences. 1996
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Conditions that jeopardize the health or well-being of animals, including
natural disasters, accidents, and mechanical failures, resulting in actual harm or
death of animals
Conduct of animal-related activities without appropriate IACUC review and
approval
Failure to adhere to IACUC-approved protocols
Implementation of any significant change to IACUC-approved protocols
without prior IACUC approval as required by PHS Policy IV.B.7.
Participation in animal-related activities by individuals who have not been
determined by the IACUC to be appropriately qualified and trained as required by
PHS Policy IV.C.1.f
Failure to monitor animals post-procedurally as necessary to ensure wellbeing (e.g. during recovery from anesthesia or during recuperation from invasive or
debilitating procedures)
Failure to maintain appropriate animal-related records (e.g. identification,
medical, husbandry)
Failure to ensure death of animals after euthanasia procedures (e.g. failed
euthanasia with carbon dioxide, anesthetic overdose)
Institutions should notify OLAW of matters falling under IV.F.3 promptly, i.e., without
delay. Since IV.F.3 requires a full explanation of circumstances and actions taken and
the time required to full investigate and devise corrective actions may be lengthy, OLAW
recommends that an authorized institutional representative provide a preliminary report
to OLAW as soon as possible and follow-up with a thorough report once action has been
taken. Preliminary reports may be in the form of a fax, email, or phone call. Reports
should be submitted as situations occur, and not collected and submitted in groups or
with the annual report to OLAW.4
III. Personnel Training
Personnel involved with anesthesia and surgery in a research setting often have a wide
range of educational backgrounds and may require various levels of training before
performing surgery on animals. Personnel trained to perform surgery in humans may
require additional training for interspecies variations in anatomy, physiology, and
response to anesthetics and analgesics.
Regardless of an individual's responsibility or educational background, all personnel
performing anesthesia and surgery must have thorough knowledge and understanding
of the approved IACUC protocol procedures and possess knowledge and familiarity with
the relevant anatomy of the species and the surgical site.
Personnel involved with any aspect of research projects must also be in compliance with
all of Institution‘s requirements and training. Several training courses are required either
annually or biannually. It is the responsibility of the investigative staff to be and remain
in compliance with the CMR policies and University policies.
At a minimum, training of anesthesia and surgical personnel must include:
• A thorough knowledge of aseptic technique, including sterile gowning techniques
• Administration and assessment of anesthesia
• Appropriate tissue handling (tissue trauma contributes to postoperative infections)
4
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html
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Familiarity with possible adverse events and when and how to manage properly
such events (e.g., cardiac arrhythmias, bradycardia, etc.) in each species used
Appropriate use of instruments
Effective methods of hemostasis
Correct use of sutures and/or skin staples
Postsurgical care and monitoring, including the ability to recognize and alleviate
pain and distress
IV. Modifications to Intra-Operative Plan
Changes in the surgical procedure as approved by the IACUC protocol are only
permitted:
• In the event of an emergency AND
• With permission from CMR veterinarian. Request and Approval to be
submitted in writing within 24 hours of verbal approval.
This includes but is not limited to deviations from the protocol in terms of volume or
frequency of blood collections, drugs, doses, suture material, and suture patterns.
V. Review of Surgical Program
Every six months, as part of the Semiannual Review and Inspection of Facilities, the
IACUC along with the CMR veterinary staff will evaluate the comprehensive surgical
program including but not limited to the following:
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Evidence that an IACUC Approved Animal Protocol is being followed;
All animals are maintained in accordance with approved protocol;
Operating room sanitation is maintained according to CMR Standard
Operating Procedures.
Instruments and implants used for survival surgeries are being correctly
sterilized (e.g. steam autoclave, glass bead sterilizer, approved chemical
sterilant);
Appropriate anesthesia and euthanasia techniques are being utilized;
Proper medical records are maintained;
Compliance with all regulations and guidelines;
Controlled drugs are adequately secured and a drug usage log is being
maintained;
Volatile anesthetics are being vented or scavenged adequately;
Animal carcasses are being disposed of properly;
All lab personnel handling animals are appropriately trained and have
attended all required CMR Training;
All lab personnel have attended the University's basic laboratory training;
The PI must provide a list of staff who work with animals.
A summary of the findings will be presented as part of the Semiannual Review of
Program and Inspection of Facilities.
Disclaimer: Additions or deletions to the operating room requirement document can be
made with the approval of the CMR Director, CMR Veterinary Staff, and IACUC
committee.
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VI. Reporting Deficiencies in Animal Care &
Use
Deficiencies or concerns about laboratory animal care and use should be reported to the
Director of CMR, the Chairperson of the IACUC, the IACUC Administrator or any
member of the IACUC. Anyone reporting deficiencies or concerns about animal care
who wishes to remain anonymous can make the report through the Office of Business
Conduct (973-972-8093 or 800-215-9664). The concern will be documented and will be
investigated. If the concern is legitimate, actions will taken with the IACUC involved.
The IACUC and the CMR Director will take action to correct deficiencies to assure
humane care and use of animals and to protect the interests of the University.
VII. General
Animal surgical procedures must be conducted in accordance with the requirements of:
• The Guide for the Care and Use of Laboratory Animals [Institute of Laboratory
Animal Resources, National Research Council, 1996)
o The Guide classifies surgical procedures under the category Veterinary Medical Care. It
specifically states that: “appropriate attention to pre-surgical planning, personnel training,
aseptic and surgical technique, animal well-being, and animal physiologic status during all
phases of protocol will enhance the outcome of surgery.”
• Animal Welfare Regulations (AWR, CFR, 1985)
o The USDA's CFR, title 9 (Animal Welfare Act and Regulations) require that all major
operative procedures on non-rodent species are to be performed in a dedicated facility
that is operated and maintained under aseptic conditions. It is also required that no animal
is subjected to more than one major operative procedure unless, the procedure has been
justified for scientific reasons by the Principal Investigator and approved by the IACUC or
the procedure is required as routine veterinary care to protect the health or well- being of
the animal.
• Public Health Service Policy on Humane Care and Use of Laboratory Animals
(PHS Policy, 1985)
• UMDNJ-Comparative Medicine Resources Policies and IACUC
Surgery is defined as any procedure that exposes tissues normally covered by skin or
mucosa. Experimental surgery has great potential for causing pain or distress to
animals if not performed properly. Surgery can result in pain, damage to tissue and
post-operative infections. Therefore, stringent guidelines for training, surgical facilities,
asepsis, surgical preparation, anesthesia, intra-operative records, analgesia, surgical
technique, and post-operative monitoring have been established. There are different
requirements depending on the type of surgery, and activity being performed.
Terminology
o
o
Major surgery is any procedure that enters a body cavity (thorax, abdomen,
calvarium), or has the potential for having significant complications. Included
would be orthopedic procedures and extensive cannulation procedures.
Minor surgery is classified as any invasive operative procedure in which only
skin, mucous membrane and/or connective tissue is resected. Minor procedures
include peripheral vessel cannulations and skin incisions.
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o
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Survival surgery is any surgical procedure from which an animal recovers
consciousness. Aseptic technique must be used for all survival surgical
procedures.
Non-survival surgery (terminal) is a procedure which is conducted on animals
that are not allowed to regain consciousness following the anesthesia and surgical
procedures. Asepsis and sterility are not required for non-survival procedures,
unless the procedures are of sufficient duration to allow bacterial infections to
affect the outcome of the study.
Multiple survival surgery is generally discouraged on a single animal. However,
under special circumstances, more than one major surgical procedure on a single
animal may be permitted with the approval of the IACUC, provided both surgeries
are essential and related components of the research project. Occasionally,
unanticipated additional operative care may be necessary to correct complications
that arise following the primary surgical procedure. Such follow-up procedures
may be justified as long as the second procedure does not cause an inordinate
degree of distress to the animal.
Antimicrobial – An agent or action that kills or inhibits the growth of microorganisms.
Antiseptic - A chemical agent that is applied topically to inhibit the growth of
microorganisms.
Asepsis – Prevention of microbial contamination of living tissues or sterile
materials by excluding, removing or killing micro-organisms.
Bactericide – A chemical or physical agent that kills vegetative (non-spore
forming) bacteria.
Bacteriostat – An agent that prevents multiplication of bacteria.
Cleaning – The process by which any type of soil including organic material, is
removed. Cleaning is accomplished with detergent, water and scrubbing action.
Commensals – Nonpathogenic microorganisms that are living and reproducing
such as human or animal parasites.
Contamination – Introduction of microorganisms to sterile articles, materials or
tissues.
Distress – Distress occurs with stress, which in turn may be induced by pain,
among other stressors. Distress is an aversive state in which an animal cannot
adapt completely to stressors and, therefore, the animal shows maladaptive
behaviors.
Sanitization – A process that reduces microbial contamination to a low level by
the use of cleaning solutions, hot water or chemical disinfectants.
Sterilant – An agent that kills all types of micro-organisms
Sterile – Free from microorganisms.
Sterilization – The complete destruction of microorganisms.
VIII. CMR Surgical Facilities
Specific rooms within the CMR are approved for survival surgical procedures on nonrodent mammalian species. These include A-level and MSB G-level. These facilities are
constructed, maintained, and operated to ensure a level of cleanliness appropriate for
aseptic surgery. In addition, they are directed and staffed by trained personnel. The
following are basic procedures for the use of the surgical suites.
A. Scheduling
1) Principal Investigator (PI) or designated staff member must call or e-mail to
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schedule CMR surgical suite(s) with the supervising veterinary technician in as
much in advance as possible to reserve the operating room.
All requests will be accepted on first-come-first-serve basis.
2) Operating days and hours – Monday through Thursday 7:00am-4:00pm and
Friday 7:00am-12:00 noon.
a. Surgical Procedures are scheduled no earlier than 8:00 am and no
later than 1:00 pm Monday –Thursday.
b. Surgical Procedures are scheduled no earlier than 8:00 am and no
later 9:00 am on Friday.
3) A complete surgical request form must be completed 48 hours prior to the
surgical procedure to ensure proper care of the animal.
4) Investigators are required to use a CMR Veterinary Technician to provide surgical
support. The Veterinary Technician will provide services such as preoperative
preparation of animal, anesthetic induction and maintenance, perioperative
monitoring, record keeping and post-operative care depending on the
investigator’s and animal’s needs for a nominal fee. A clinical veterinarian is
available at no charge for professional consultation. Exceptions can be made
according to CMR Policy for Surgery in Large Animals.
a. If the PI or Research staff is doing part of the procedures and they
request CMR to be responsible for any portion of the pre-operative,
anesthesia, or post-operative care, whether it be all or part of the
procedure, the PI must make prior arrangements, so that animal care
and responsibilities can be appropriately addressed.
5) Any unique scenarios or situations not described above remain subject to
discussion and approval by CMR Director and/or veterinary staff.
B. Surgical Suite Procedures
1) Preparation of the animal (e.g. anesthetization, clipping and preliminary surgical
scrub) must be performed in the animal prep room separate from the operating
room. After the animal has been moved to the operating room, a final scrub
should be performed on the operating table.
2) Preparation of the surgeon must be performed in the surgeon prep room separate
from the operating room which must be contiguous with the operating room.
Instrument cleaning and pack preparation may also occur in this area but must
not occur in the operating room.
3) The operating room must be free of supplies and equipment that are not relevant
to the surgical procedures being performed. Long term storage and storage of
supplies not used in operative procedures are not permitted.
4) The number of people present in the operating room must be suited to the size of
the room and complexity of the procedure. CMR reserves the right to remove any
non-authorized or excessive authorized personnel if their presence interferes
with the procedure and/or compromises the safety of personnel or the research
animal.
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5) Eating and drinking is only permitted in the designated areas such as the break
room or library or other such designated area.
6) Maintenance of the gas anesthesia machine is the responsibility of the CMR
veterinary staff. When in use, if any problems occur, call any veterinary staff
member for immediate assistance.
7) Investigators who are approved to utilize a surgical suite without CMR technical
support will be provided with the following equipment:
a. Inhalation Anesthetic Machine with oxygen and Isoflurane
b. Ventilator
c. Pulse Oximetry Monitoring system
d. Heating pad(s) – circulating hot water pad
e. Thermometer – the monitoring version
f. Fluid pumps- for continuous rate infusion of fluids
8) Other equipment and supplies can be used for a usage fee and must be
requested at the time surgery is scheduled (Note: This is not a complete list):
e. Surgical Instruments
a. Suction unit with tubing
f. X-ray machine and
b. CMR’s Cautery Unit
developer
c. I-Stat Machine
g. Thermal Care Unit
d. Autoclave
IX. Principles of Asepsis
Individuals performing survival surgical procedures must be knowledgeable about
aseptic surgical techniques and have adequate training and skills to conduct the
procedure to be performed without causing undue post-surgical distress to the animal.
Aseptic procedures must be used for all survival surgical procedures.
Asepsis is defined as preventing exposure to microorganisms and prevention of
infection. Three things that are extremely important in achieving asepsis are the
reduction of time, trauma and trash.
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Time of surgical procedure is an important factor, as the longer a procedure
takes the greater the possibility of contamination and therefore infection.
Trauma that is sustained by the tissue as a result of rough handling, drying
out upon exposure to room air, excessive dead space, implants or foreign
bodies or non-optimal animal temperatures will contribute to infections.
Trash refers to contamination by bacteria or foreign matter.
According to The Guide, “aseptic technique is used to reduce microbial
contamination to the lowest possible practical level. No procedure, piece of
equipment, or germicide alone can achieve that objective. Aseptic technique
requires the input and cooperation of everyone who enters the operating suite.
The contribution and importance of each practice varies with the procedure.”
Techniques include:
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Preparation of the patient; such as hair removal and disinfection of the
operating site(s).
Preparation of the surgeon such as the provision of decontaminated surgical
attire, surgical scrub, and sterile surgical gloves.
Sterilization of instruments, supplies, and implanted materials
The use of operative techniques to reduce the likelihood of infection
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•
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Antibiotic administration
Record keeping
In considering methods of sterilization procedures, it is important to differentiate
between sterilization and disinfection. Sterilization kills all viable microorganisms
while disinfection only reduces the number of viable microorganisms. High level
disinfection will kill most vegetative microorganisms, but will not kill the more
resistant bacterial spores. Commonly used disinfectants such as alcohol, iodophors,
quaternary ammonium, and phenolic compounds are not acceptable items intended
to be used in survival surgical procedures.
The purpose of the following guidelines is to assist the investigators in complying with
these requirements. In general, unless an exception is specifically justified as an
essential component of the research protocol and approved by the IACUC, the
investigators should follow these guidelines.
A. Principles of Surgical Techniques
1) All items used in any survival surgical procedure must be sterilized.
a. Items used in any non-survival surgical procedures must be “clean”.
2) Persons who have scrubbed should touch only sterile items. Persons who have
not scrubbed should touch only non-sterile items.
3) If the sterility of any items is in doubt it should be considered non-sterile.
a. If a non-scrubbed person touches a sterile table, re-drape the table.
b. If a scrubbed person touches a non-sterile table, the person should re-gown or
cover the contamination.
c. Any sterile table or sterile item left unguarded or uncovered should be
considered non-sterile.
d. If the autoclave tape is only partially changed in color the item should be
considered non-sterile.
4) When preparing for surgery, personnel should:
a. First put on a cap and then a mask.
b. Open gown and glove packs
c. Scrub from fingers to 2-3 inches above elbow.
d. Scrub for a minimum of five (5) – seven (7) minutes
e. Then put on gown and gloves.
5) Persons who have not scrubbed should avoid reaching over sterile fields and
those who have scrubbed should avoid leaning over non-sterile areas.
a. The scrubbed person should set fluid basins to be filled at the end of the table.
b. The non-sterile assist should stand at a distance from the sterile field when
adjusting the light.
c. The surgeon should turn away from the field to have his/her brow mopped.
d. The scrubbed person should drape the sterile tables nearest him/her first.
6) Tables are considered sterile only at tabletop level or above.
a. Linen or sutures falling below table level are considered non-sterile and
discarded.
b. When draping the table the part of the sheet that drops below the table surface
should not be brought up to table level again.
7) Gowns are considered sterile only from waist to shoulder level and in front or on
the sleeves.
8) While scrubbing, keep hands in sight above waist level, and away from the face.
9) When standing on stools, the area of the gown below the waist must not brush
against the sterile table.
10) Arms should never be folded; perspiration in the axillary region may lead to
contamination.
11) Articles dropped below waist level must be discarded.
12) Scrubbed persons should keep well within the sterile area. A wide margin of
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safety should be allowed when passing non-sterile areas.
a. Scrubbed persons should:
i. Keep a safe distance from the operating table when draping the
patient.
ii. Pass each other back to back.
iii. Turn their back to a non-sterile area when passing.
iv. Face a sterile area when passing it.
v. Ask a non-scrubbed person to step aside rather than trying crowding
past him/her.
vi. Stay near and facing the sterile tables if waiting for the animal to be
prepped.
13) Persons who have not scrubbed should avoid sterile areas.
a. If a person who has not scrubbed must pass a sterile area he/she should face
the area when passing to make certain it has not been touched.
14) Moisture allows bacteria to grow around the sterile area causing contamination.
15) Sterile packages should be laid only on dry areas.
a. If a sterile package becomes damp or wet, it should be re-sterilized or
discarded.
b. If a solution soaks through a sterile drape to a non-sterile area, the wet area
should be covered with another sterile drape.
16) When bacteria cannot be eliminated from a field, they should be kept to an
irreducible minimum. Patient skin cannot be sterilized and is a source of potential
contamination from both the patient and members of the operating team. To
minimize contamination potential:
a. The patient is shaved and scrubbed in the animal prep area and is given a final
sterile scrub in the operating room.
b. When draping, all skin should be covered except the site of incision, leaving a
large enough undraped scrubbed are for the surgeon to work.
c. All surgeons and assistants must scrub their hand and arms.
d. All surgeons and assistants must gown and glove without touching the outside
of the gown and gloves.
e. Hand towels should not touch scrub suits while drying hands after scrubbing.
f. The knife blade used for the skin incision should be considered contaminated
and should not be used deeper than the skin, so a new knife should be used
for internal incisions.
g. If a glove is contaminated during the procedure it must be changed at
once. If an instrument punctures the glove, the instrument must also be
handed off and either replaced or resterilized.
17) Ablate all "dead space" during closure- Any pockets or spaces remaining
between tissue layers will fill with extracellular fluid or blood and increase the risk
of developing seromas or abscesses. This is an abscess waiting to happen.
Tacking down tissue layers is an acceptable method used. If this is not possible,
use of a drain for 3 to 5 days following the procedure is recommended.
18) Be gentle when handling tissues
a. Do not use toothed or crushing instruments if it is not necessary.
b. Hold the cut edge rather than grasping in the middle of a tissue layer.
c. When tying off vessels include only a minimum of surrounding tissues.
d. Use electrocautery or electroscalpels sparingly. They cause significant
tissue necrosis.
19) Use appropriate suture techniques
a. Any suture that will be buried in tissues should be either absorbable or
monofilament (non-absorbable braided suture is irritating and can harbor
bacteria). Monofilament suture material such as Nylon is the
recommended suture material for skin closures
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b. Sutures should be placed evenly and as close to the tissue edge as
possible to prevent obstruction of blood flow - typically no more than 1 cm
from the edge is necessary in large animals and 0.2 cm in small animals.
c. Sutures should only be tightened enough to appose the tissue edges. Any
tighter will obstruct blood supply; retard wound healing and may result in
dehiscence.
d. They may cause the animal to chew or scratch at the incision site.
Alternatives include subcutaneous/intradermal closure techniques or
tissue adhesive.
e. Skin sutures should be a simple interrupted pattern. Continuous skin
sutures may be removed by the animal and the wound could dehisce.
B. Cleaning Instruments
Prior to sterilization, all instruments must be cleaned to remove debris, blood, oil,
etc. The two common methods of cleaning include:
Manual Cleaning
1) Rinse the instruments in tap water as soon as surgery is over. This prevents
blood from drying in serration and box locks.
2) Open all box locks and disassemble instruments.
3) Scrub each instrument with a soft brush in warm water with an instrument
detergent with a pH in the range 7.0-8.5. Wear gloves and be mindful of sharp
edges on instruments.
4) Inspect each instrument for proper function and cleanliness; particularly box
locks, grooved ends, and other areas not readily exposed.
a. Rinse the instruments with water (distilled if available) to ensure removal of
detergent. Distilled water is used to prevent mineral deposits on the
instrument surfaces. If distilled water is not available and tap water is used,
hand-dry the instruments to remove mineral deposits from the water.
5) Instrument "milk" can be used to lubricate instruments.
Ultrasonic Cleaning
Ultrasonic cleaning is a more effective cleaning method than manual cleaning. It
can penetrate areas that a hand brush cannot reach. Cleaning is accomplished
by the use of high frequency sound waves converted in the solution into
mechanical vibrations, which pull soil out of instruments. The ultrasonic method
typically removes about 90% of soil. However, it is important to recognize that it
does not sterilize, or eliminate the need for initial removal of obvious blood and
soil. Ultrasonic cleaning is most effective when it follows a preliminary manual
cleaning to remove accessible debris from the instruments. When using an
ultrasonic cleaner, always:
1) Follow manufacturer's instructions carefully.
2) Use the detergent solution recommended by the manufacturer.
3) Strictly adhere to the cleaning times and temperatures recommended by the
manufacturer.
4) Use distilled water or de-mineralized water.
5) Rinse instruments with box locks open and disassembled.
6) Do not overload cleaner.
7) Inspect instruments carefully on a regular basis; ultrasonic cleaning can
accelerate flaking of chrome-plated instruments and loosen small screws in
instruments.
C. Sterilizing Instruments and Supplies
Page 13 of 42
As described above, the use of sterilized instruments is a critical requirement of
sterile survival surgery techniques. The preferred methods of sterilization are
high pressure/temperature (autoclaves) for items that can withstand high
temperature, and ethylene oxide gas for items that cannot withstand high
temperature. Sterilization indicators need be used to identify materials that have
undergone proper sterilization.
Cold chemical sterilants may be used effectively for many items. The use of
liquid chemical sterilizing agents must be conducted in approved facilities with
adequate ventilation systems and should be used with adequate contact times.
Instruments should be rinsed with sterile water or saline before use. Note:
Alcohol is not a sterilizing agent.
D. Procedures for Instruments and Supplies
1) All articles to be sterilized must be clean.
2) All articles to be sterilized should be packaged in Heat-sealed paper and
transparent plastic pouches or Double wrapped muslin (each 2 layers) that
protect them from contamination.
3) Date (must include the sterilization date) and label the sterilized items. If
multiple sterilizers are used by a laboratory group, the specific sterilizer
should also be indicated on the package. The efficacy of the sterilizing
process should be measured at monthly intervals with a biological indicator.
Autoclaves not used frequently (less than once a month) will be tested before
each use.
4) Packs should not be too densely packed in the autoclave to allow for adequate
steam or gas penetration. Indicator test strips are to be placed deep within
the pack.
5) Store sterilized items in a clean, dust-proof and low-humidity area. Closed
storage cabinets prevent contamination more effectively. Storage under sinks
or in places likely to result in wetting is to be avoided.
6) Any sterilized package that is dropped or torn or has come in contact with
moisture is considered contaminated and must be cleaned, repackaged and
re-sterilized. All packages containing sterile items should be inspected before
use to verify package integrity and dryness.
7) If the package has remained intact and dry, items in Heat-sealed paper and
transparent plastic pouches may be considered sterile for 1 year regardless of
storage location. Items in dDouble -wrapped muslin (each 2 layers) are
considered sterile for 7 weeks, if stored in closed cabinets and 3 weeks if stored
on open shelves.
8) Veterinary surgical technicians will check sterile packs monthly and before
packs are used. Any package considered contaminated will be cleaned,
repackaged and re-sterilized.
E. Methods and Terminology
Page 14 of 42
 Autoclave- Relies on pressurized steam; is extremely reliable and cost effective.
However, surgical instruments must be durable (e.g., stainless steel) and the
process is relatively slow, from 15 to 60 minutes. Instruments are typically
wrapped or sealed in packs that are opened as needed on the day of surgery.
o Packs may be stored if they are kept away from moisture.
o A preparation date must be put on each prepared pack.
o CMR can provide the service of autoclaving instruments and surgical packs
for a nominal charge.
 Ethylene oxide- A gaseous sterilant that requires specialized containment
equipment. This is a good sterilization method for supplies that cannot tolerate
high heat such as plastics and catheters. It is more costly than autoclaving and
typically is performed overnight. The pack requires airing inside a fume hood for
24 hours after exposure to ethylene oxide. UMDNJ Hospital provides this service
at a nominal charge.
 Cold sterilant solutions (hypochlorite, glutaraldehyde, etc.)- Generally, cold
sterilants must have prolonged contact time (15 - 60 minutes) to sterilize surgical
equipment. Only products classified as sterilants are to be used for sterilizing
instruments and implants for surgery and they must be used according to the
manufacturer’s recommendations for sterilization. In addition, the instruments
must be rinsed completely with a sterile solution like saline to prevent tissue
irritation. Note: Alcohol is not a sterilant.
o Exposure
o The physical properties of the item being sterilized must be relatively
smooth, impervious to moisture, and be of a shape that permits all surfaces
to be exposed to the sterilant.
o All surfaces, both interior and exterior, must be exposed to the sterilant.
Tubing must be completely filled and the materials to be sterilized must be
clean and arranged in the sterilant to assure total immersion.
o The items being sterilized must be exposed to the sterilant for the prescribed
period of time.
 Hot bead sterilizer- This device is a small tabletop unit, approximately 6 x 6 x 8
inches. The appliance heats a small container of Pyrex beads to approximately
250o C and can sterilize the tips of metal surgical instruments in 10-20 seconds.
However, only the tips of the instruments are sterilized. It is also necessary to
allow the instruments to cool before handling tissue to prevent thermal injury. It is
very useful for sterilizing instruments between rodents when performing multiple
surgeries.
 Pre-sterilized items- Many instruments and supplies can be purchased in
sterilized packaging. Such items must be used prior to the label expiration date.
X. Expired Medical Materials
Expired medical materials such as drugs, fluids, and sutures may not be used on any
research animal that is to recover from an anesthetic procedure or in a terminal
procedure if it will adversely affect research results. The use of such materials under
these conditions constitutes inadequate veterinary care under the Animal Welfare Act,
USDA Policy #3.5 Note that any compounds administered to animals are covered.
Please refer to CMR Policy on Expired materials on the CMR Home page.
1) Expired medical materials such as drugs, fluids and sutures may not be used on any
Page 15 of 42
research animal. This includes but is not limited to include IV fluid solutions, nonemergency drugs (diuretics, contrast material, antibiotics), IV catheters, bandage
materials, surgery gloves and suture materials.
5
USDA Animal Care Resource Guide Policy #3 Veterinary Care: Expired Medical
materials, Pharmaceutical-Grade Compounds in Research, Surgery, Pre- and Postprocedural Care; Program Veterinary Care; health Records, Euthanasia
2) Expired materials are only to be used on anesthetized animals in terminal studies
(non-survival surgical procedures) if the use does not adversely affect the animal’s wellbeing or compromises the validity of the scientific study.
a) Injectable drugs or anesthetics when expired may not be used to induce or
maintain the animal.
b) Any saved expired materials must be clearly and individually labeled as “Expired.
For acute use only” and kept together in an area physically separate from all other
medical materials and drugs.
3) Inventory of medical materials documentation
a) The investigator’s laboratory, surgical/procedure cart, or anywhere an animal
is going to undergo a survival surgical procedure will be required to
reproduce documentation of inventory of when items expire, thus, ensuring
expired items are not used during survival surgery.
b) The purpose of the written documentation is in the interest of maintaining
animal welfare and to protect the institution’s compliance with Federal Laws
and Regulations.
c) The CMR Veterinary Staff and members of the IACUC reserve the right to
request the documentation of inventory at any time without prior notification.
4) Pharmaceutical Grade Compounds
a) Investigators are expected to use pharmaceutical-grade medications wherever
they are available, even in acute procedures.
b) Non-pharmaceutical-grade chemical compounds should only be used in
regulated animals after specific review and approval by the IACUC for
reasons such as scientific necessity or non-availability of an acceptable
veterinary or human pharmaceutical-grade product.
Page 16 of 42
XI. Medical and Surgical Records
Surgical records are both helpful and required by animal welfare regulations. Accurate
records allow one to monitor trends and they can be helpful in refining and improving
research projects. Complete records also assure compliance with accepted care
standards and agreed-upon procedures approved by the IACUC. Records can also be
helpful in interpreting research data.
1. Individual medical records are maintained for:
•
•
•
•
•
•
Woodchucks
Rabbits
Dogs
Cats
Swine
Non-Human-Primates
2. Types of medical record forms:
Name of Form
Daily
ObservationProcedure Form
Color
Blue
Staff Use
CMR and
Research Staff
Daily
ObservationProcedure Form
Green
CMR and
Research Staff
Appetite Watch or
Monitoring Forms
White
CMR and
Research Staff
Laboratory
Animal
Examination
Form
Anesthesia
Record
Yellow
CMR staff only
White
CMR and
Research Staff
SurgicalProcedureObservation
Tan
Surgeon/person
completing the
procedure
Care of Long
Term Non-rodent
Laboratory
Animals
ImmunizationParasite Chart
Purple
CMR staff
Pink
CMR staff
Indications for Form
All medical observations
and research procedures
EXCEPT the following as
listed below
All medical observations
and research procedures
EXCEPT the following as
listed below:
To document how the
animal is eating and/or what
it is eating or specific
research information
needed to assess an animal
At time of receipt of animals
only
Upon administration of
premed/preop drugs until
the wound is closed
To be completed before the
surgeon/technician leaves
the operating or procedure
room
At time of completion of
care e/g/ physical exam,
bath, grooming, pedicure
At time of fecal exam,
change of food regimen,
immunization, all body
weights
Page 17 of 42
3. All heading on paperwork must be filled out completely for each individual
sheet and side.
4. Keep the medical records with the animal including during laboratory
procedures. There are extra blank sheets in the folder or in the animal room. Contact
CMR veterinary staff if you need more blank sheets or a photocopy of the medical
record.
5. All research and CMR staff must document all handling of the research
animals including but not limited to:
•
•
•
•
•
•
•
•
•
•
Drug or fluid administration. Controlled, non-controlled and over-thecounter drugs are included. Include the date, time, dose (mg/kg?, volume
and route of administration.
Imaging 9x-rays, MRI, ultrasound)
Fluid collection (blood, CSF, urine collection)
Physical restraint, or transport to the laboratory
IV catheter placement (location, gauge, and reason for placement)
Observation: include subjective (e.g. behavioral) and objective (e.g. rectal
temperature) assessment and plan treatment of relevance.
Food or water deprivation (including pre-anesthetic fasting)
Suture removal, bandaging
Any post-operative complication encountered – e.g. delayed recovery from
anesthesia, bleeding from incision site, etc.
Itemization of all care and monitoring provided to the animal such as
wound cleaning, bandage changes, flushing of indwelling catheters, body
temperature, heart rate, etc. as described in the approved IACUC protocol.
6. Date, note the time and initial all entries.
7. Required information is to be provided in SOAP format (Subjective, Objective,
Assessment, and Plan/Treatment) (See chart below)
S = Subjective
Demeanor
BAR = bright, alert,
responsive; means the
Appetite (A)
animal is acting like his/her
usual self
QAR = quiet, alert,
responsive; means the
animal is quiet, is not like
itself. It usually does not
move about much, however
s/he is alert and sees and
responds to the
environment
Feces (F)
can be indicated
with + or - sign;
amount eaten or left
is required if animal
did not eat all
offered
can be indicated
with + or - sign;
explanatory notes
should be added if
anything is
abnormal
Page 18 of 42
Depressed = means
Urine
U = can be
indicated with + or sign, if doubt occurs
about urine
production the
following
observations must
be made →
Incision
Site/Area
CDI = clean, dry,
intact; any other
condition must be
noted in the records
and possibly treated
animal is quiet, does not
move about much, may be
guarded and usually does
not eat and is either painful
or not feeling well. S/he
may also be in an altered
state of consciousness
*Other Behaviors not
normally seen in the
species
Other Info
Hydration =
within normal
limits (WNL)
or
dehydration.
*If animal is
dehydrated,
steps must be
taken in
consultation
with CMR
Veterinary
Staff
Abdomen
If urinary
retention is
suspected,
a full
bladder
may be
palpated
Note: Any bandages, patches, or other visible items if they are CDI or if they have any
problems and how they are rectified.
Any exercising of animals should also be documented for enrichment purposes and to state
that the animal has had an opportunity to stretch their legs. This also gives the animal the
opportunity, during postoperative recovery via removing the animal from cage, to urinate or
defecate.
O = Objective
SPO2
Indicates oxygen
saturation of tissues
Pulse or
Heart Rate
(P or HR)
are measured pos-op
until WNL; RS should
be checked during
days post-op,
especially if animal is
not recovering as
expected can indicate
pain or distress
(RS =
respiratory
system)
Mucous
Membranes
(MM)
Temperature
(T)
must be measured
post-op until WNL
Respiratory
Rate (RR)
*Dogs and rabbits
check for 7 days
*Pigs and cats
check for 3 days
Capillary Refill
Time (CRT)
*Aggressive animals
check day of
recovery and only if
possible without
injuring yourself or
the animal (NHP,
woodchucks)
can
indicate
pain or
distress
Use of < or
> signs
with time
designation
- Indicates
the time
frame of
how fast
the blood is
reperfusing
through the
tissues
indicates the
healthiness of tissues
including perfusion
and hydration also the
moisture content of
the mouth can be an
indication of the
hydration level of the
animal
A = Assessment
This is where notes are made indicating the condition of the animal: example: painful?,
comfortable, good recover, stable, anorexic/poor appetite
P/TX = Plan/Treatment
Page 19 of 42
Here is where noted administration of any treatments such as analgesia or antibiotics. Any
medication administered should include notes on dose, route, and frequency of
administration. Treatments must be administered according to IACUC protocol, however, if
for any reason that does not seem appropriate, consult with CMR Veterinary Staff.
Records are required for all animals undergoing terminal or survival surgery. The CMR
will provide the anesthesia record along with a “cheat-sheet”, which contains the
anesthetic drugs for induction and antibiotics according to investigator’s protocol and
CMR Standard Operating Procedures (SOP).
• Surgical anesthesia monitoring sheet must have all heading s filled out. This
includes: animal identification, current body weight, estimated body weight, drugs
administered, brief description of surgical procedure, surgeon, and any other
information listed in the heading.
•
Surgical records and postoperative records can be maintained in the investigators
laboratory notebooks. However, surgical and post-surgical records must also be kept in
patient’s record and accompany the animal in the vivarium to all veterinary staff to
oversee any animal.
XII. Pre-Operative Approval
Successful surgery includes proper surgical planning. Proper planning means adequate
assessment of patient and experimental needs, discussion of the surgical plan with the
surgical team prior to initiating anesthesia, and preparation of the surgery room and
instruments.
1) Animals should be allowed to stabilize in weight, temperature, eating, behavior,
and physical state before chronic survival surgery. Usually, this occurs during the
quarantine or acclimation period. The physical status of an animal (observation,
TPR, blood work, radiography) should be evaluated to ascertain whether the
animal is a good surgical candidate and appropriate for surgery. These
parameters of well-being or (if abnormal) of distress include:
Behavioral
Observation
Physiologic
Measures
Grooming
Appetite
Activity
Facial expression
Temperature
Pulse/heart rate
Respiration
Weight loss
Cardiac
output/perfusion
Blood gas levels
Hematology and
Serum Chemistry
Serum chemistry
(Superchem)
CBC, differential
Clotting parameters
Vocalization
Appearance
Posture
Response to
handling
Aggression
Water intake
Hydration
Urine and fecal
output
2) Criteria for approval for surgery include:
a. Completing and submission of the Surgical Scheduling form.
Page 20 of 42
b. Availability of all necessary personnel and satisfactory preparation of their
roles.
c. Equipment and supplies required for the planned procedures must be
available.
d. Location and nature of surgical facility.
e. Preoperative animal health assessment criteria.
f. A “Cheat-Sheet’ with the description of pre- and post-surgical medications
i. Received after the processing of the surgical scheduling form.
g. Expected postoperative care and identification of all needed supplies.
h. Any required training and/or acclimatization to restraining devices has
been completed.
i. Patient evaluation – Does the animal appear healthy enough to undergo
the surgical procedure (see above chart for complete list)
i. Current body weight
1. Swine are estimated based upon 10% per week increase
in body weight
2. Non-Human primates are estimated 0.1-0.3kg higher than
most recent weight
3. All other species can be weighed prior to surgery.
ii. Evaluate mucus membranes, capillary refill time.
iii. Evaluate temperature, pulse and respiration rate.
iv. Evaluate RBC, WBC, hematocrit, kidney and liver function tests,
when possible
v. All documentation must be in the medical record 48 hours prior to
approved surgery.
XII. Fasting
Pre-Operative Fasting
It is recommended that most animals be fasted prior to the induction of anesthesia in
order to minimize the possibility that vomiting will occur during induction and to decrease
abdominal distention, which can compromise respiratory function when excessive.
Fasting animals should still have free access to water. Restricting water results in
dehydration and more difficult anesthesia. Recommended time periods for fasting
animals are listed below:
Dog, cat, pig, nonhuman primate, rabbit, woodchuck: Overnight (12-16 hours)
for AM surgery or fasting at 7am for same day afternoon surgery (the
animal must have a minimum of 4 hours fasting time)
Ruminant: 24-48 hours
Rodents: no fasting required6
CMR will provide blank red fasting cards when investigative staff is responsible
for fasting.
6
Generally, rodents do not have a vomit reflex, and therefore cannot regurgitate during surgery. Rabbits and
woodchucks do not vomit, but experience has shown that they recover better post-operatively when fasted prior to
surgery.
When gastrointestinal surgeries are performed on rodents, it is often desirable to fast these animals prior to surgery in
order to reduce the volume of ingesta. Consult the veterinary staff for advice regarding the length of time feed should be
withheld from rodents.
Page 21 of 42
XIV. Surgeon Preparation
 Each member must develop a surgical conscience, a willingness to supervise
and be supervised by other regarding the adherence to standards. Without this
cooperative and vigilant effort, a break in sterile technique may go unnoticed or
not be corrected, and an otherwise successful surgical procedure may result in
failure because of complications due to infection.
 The patient must be protected from organisms that can be carried and shed by
the surgeon. These organisms reside on the surgeon’s skin, hair, in the nose or
mouth, or may be carried on dust particle from the floor or room surfaces. This
route of contamination is minor compared to the patient’s own flora; however, it is
a significant source of contamination in some types or forgery.
 Those personnel having cold, sore throats, open sores, and/or other infections
should not be permitted in the operating room, especially during virus injections
and primate surgical procedures.
 Surgery must be performed or directly supervised by trained, experienced
personnel
A. Survival Surgery
1. Required garb for a survival surgery, including dental procedures where
the soft tissue is manipulated (cut and sutured) are clean surgical scrubs
(pants and shirt), shoe covers, face mask and bouffant or surgical hat.
Eye protection must be used where aerosolized material is generated.
PAPR or N95 respirator must be used when viral or allergenic
contamination, or rDNA material are part of the procedure.
a. Head covers and face masks should cover all facial hair.
b. Remove all rings, jewelry and wrist watches before scrubbing.
Fingernails should be trimmed short and cleaned with a
disposable nail cleaner.
2. All members of the surgical team having direct contact with the surgical
site must perform the surgical hand scrub before the operation. The
hands and arms should be scrubbed for 5-7 minutes with a disinfectant
such as povidone iodine or chlorhexidine, rinsed with water and dried with
a sterile towel prior to gloving.
a. Note: As much as 30% of the time, gloves become perforated
during surgery, exposing the animal’s tissues directly to the
surgeon’s skin. In such a case, gloves must be replaced.
b. A complete surgical scrub and reqowning must be done for each
patient. 7
c. All materials and instruments used in contact with the site must be
sterile.
d. Non-sterile articles must not come in contact with sterile articles.
3. After using proper hand scrubbing technique, the surgeon steps into the
surgical suite to be assisted in putting on a sterile surgical gown and
sterile gloves.
a. Operating room attire (which includes scrub suits, gowns, head
coverings, show covers and face masks) should not be worn
outside the operating room suite. If such occurs, change all attire
__________________________________________________
7
For rodents, with the exception of woodchucks, it is sufficient to change gloves only between
patients
Page 22 of 42
4.
5.
6.
7.
before re-entering the clean area. (The operating room and adjacent
supporting areas are classified as “clean areas”.)
The surgeon and surgical assistants must wear sterile gowns and sterile
gloves for all survival surgery. They must not touch anything that is not
sterile.
a. The gowns worn by surgeons and scrubs assistant(s) are
considered sterile from shoulder to waist (in the front only),
including the gown sleeves.
b. If sterile surgical gloves are torn, punctured, or have touched an
unsterile surface or item, they are considered contaminated.
Surgical assistant(s) who do not directly participate in a survival surgery
must wear a face mask, bouffant or surgical hat, shoe covers, and use
either clean gloves to hand non-sterile supplies or sterile surgical gloves
for sterile supplies. Eye protection must be used where aerosolized
material is generated. PAPR respirator or N95 respirator must be used
when viral vectors, rDNA or other airborne hazardous agents are used.
All disposable supplies and garb must be removed and disposed of into
the designated garbage can/basket after leaving the operating room.
All materials exposed to blood must be disposed of in red biohazard
plastic bags.
B. Non-Survival Surgery
1. Required garb for a non-survival surgery or dental procedure where the
soft tissue is not manipulated (cut and sutured); only – clean long-sleeved
surgical gowns, bouffant or surgical hats, masks, shoe covers and gloves.
Eye protection must be used where aerosolized material is generated.
PAPR or N95 respirator must be used as above.
C. Non-Human Primate Surgery
•
All portions of surgeon preparation must be followed to ensure
the safety of the surgeon, surgeon assistant, non-sterile
assistants, and the NHP.
1. Required garb for a primate survival surgery, including dental procedures
where the soft tissue is manipulated (cut and sutured), are clean surgical
scrubs (pants and shirt), shoe covers, face mask and bouffant or surgical
hat, shoe covers, plus mandatory eye protection (goggles, face shields).
a. Head covers and face masks should cover all facial hair.
b. Remove all rings, jewelry and wrist watches before scrubbing.
Fingernails should be trimmed short and cleaned with a
disposable nail cleaner.
2. All members of the surgical team having direct contact with the surgical
site must perform the surgical hand scrub before the operation. The
hands and arms should be scrubbed for 5-7 minutes with a disinfectant
such as povidone iodine or chlorhexidine, rinsed with water and dried with
a sterile towel prior to gloving.
a. It is recommended to wear two pairs of surgical gloves, although
not required.
Page 23 of 42
3.
4.
5.
6.
7.
8.
9.
b. Note: As much as 30% of the time, gloves become perforated
during surgery, exposing the animal’s tissues directly to the
surgeon’s skin. In such a case, gloves must be replaced.
c. A complete surgical scrub and reqowning must be done for each
patient.
After using proper hand scrubbing technique, the surgeon steps into the
surgical suite to be assisted in putting on a sterile surgical gown and
sterile gloves.
a. Operating room attire (which includes scrub suits, gowns, head
coverings, show covers and face masks) should not be worn
outside the operating room suite. If such occurs, change all attire
before re-entering the clean area. (The operating room and
adjacent supporting areas are classified as “clean areas”.)
The surgeon and surgical assistants must wear sterile gowns and sterile
gloves for all survival surgery. They must not touch anything that is not
sterile.
a. The gowns worn by surgeons and scrubs assistant(s) are
considered sterile from shoulder to waist (in the front only),
including the gown sleeves.
b. If sterile surgical gloves are torn, punctured, or have touched an
unsterile surface or item, they are considered contaminated.
Surgical assistant who does not directly participate in a survival surgery
must be dressed in a clean long-sleeved gown or Tyvec suit, face mask,
bouffant, show covers, plus mandatory eye protection (goggles, face
shields) and use either clean gloves to handle non-sterile supplies or
sterile surgical gloves for sterile supplies.
Required garb for a primate non-survival surgery consists of long-sleeved
surgical gowns or disposable coveralls (lab coats are not acceptable),
face masks, bouffant hats, shoe covers, plus mandatory eye protection
(goggles, face shields).
In case of accidental bite, scratch, cut, needle stick or any injury where
operator may have been exposed to NHP body fluids (saliva, sputum,
blood, urine, semen or vaginal secretions) when working on a primate of
the genus Macaca, follow CMRSOP for Herpes B exposure. This SOP is
present in a bite kit (Tupperware container) in the surgical suites and in
animal housing rooms.
All disposable supplies and garb must be removed and disposed of into
the designated garbage basket lined with red biohazard plastic bags
when leaving the operating room.
Generally, as long as any non-human primate remains in the surgical
suite, all human operators must remain gowned up (for details, refer to
CMR SOP on Non-Human Primates).
Page 24 of 42
XV. Anesthetist Responsibilities
Anesthesia and intra-operative monitoring
The anesthetic agent, dose, and route of administration must be described in the
approved IACUC protocol. Personnel involved with surgical procedures must be
competent in administering and monitoring anesthetic depth in the animals and in the
particular species with which they are working. If needed, additional doses of
anesthetic may be required during a surgical procedure.
General signs of inadequate surgical anesthesia include:
•
Movement in response to painful stimuli (toe pinch, needle prick)
•
Reflex activity: corneal reflex, foot/leg movement in response to toe pinch, etc.
•
Increase in muscle tone, e.g. increased jaw tone as surgery progresses
•
Increase in respiratory or heart rate, increase in blood pressure
•
Movement, and/or vocalization during the surgery
1. Anesthetic and patient monitoring must be the only role of the
anesthetist during the surgery.
a. The animal must be attended at all times
b. If the anesthetist must leave operating room for any reason,
another certified/approved anesthetist must be present in their
absence.
2. The “cheat-sheet” is to be followed in administration of any sedative,
tranquilizers, anticholingergics (atropine), analgesic antibiotic and other
anesthetic treatments.
a. All drugs should be calculated and drawn-up prior to surgical
procedure.
b. Any changes on the “cheat-sheet” must be made prior to
surgical procedure.
c. All syringes must be labeled clearly with contents and animal
identification.
d. The date and initials of preparation of drugs must be present
either on the syringe or on the bag the drugs are stored in.
e. In case of surgical cancellation, drugs that have been drawn up
are only good for 24 hours to a maximum of one week
depending upon the manufacturer’s set shelf life as directed on
the bottle or the insert.
3. All anesthetists are to be ready in time to anesthetize their patients.
a. Machines are to be checked, equipment prepared, IV fluids
checked, etc., before this time.
b. Anesthesia machine must be pressure checked.
c. If CMR provided equipment fails, contact the CMR veterinary
technicians for assistant.
4. The patient must not remain on the table for more than 60 minutes prior
to the start of surgery. If the surgeon is delays and has not entered the
operating room and has not been scrubbed and gowned within60 minutes
after the patient has been ready on the table, the anesthetist will stop the
anesthesia, recover the patient and return the patient to the recovery
room.
5. Monitor anesthesia continuously and record physiological parameters in
the medical record or the anesthesia record every 5-10 minutes.
Page 25 of 42
Documentation of the following should be noted on the anesthesia record,
but not limited to the following:
o = Respiration (when not on ventilation)
• = Heart Rate
− = SPO2
6. Monitoring of anesthetic levels/depths should be checked and
documented every 15 minutes such as:
a. Reflexes – They are to be absent and muscle tone is relaxed
during surgical anesthesia
i. The pedal withdrawal reflex, eyelid/eyelash reflex,
palpebral reflex, and the tone of jaw and anal sphincter
muscles can be readily evaluated in larger mammals.
ii. Ocular position and papillary size are unreliable
indicators of dept of anesthesia. However, a widely
dilated pupil, with little or no iris visible, should always
cause concern, since it may be the result of an
excessively deep plane of anesthesia or hypoxia.
b. Respiratory signs –
SPONTANEOUS BREATHING:
i.
Anesthetists should monitor the rate, rhythm, and depth
of respiration and mucus membrane color.
ii. An increase in respiratory depth, regular rhythm, and
decrease in respiratory rate signifies surgical anesthesia.
iii. Cyanotic mucus membranes indicate hypoxemia from
inadequate lung ventilation.
ANIMALS ON VENTILATOR:
i.
If an animal is fighting or bucking the ventilator, the
animal may have a partly collapsed lung, increase in
carbon dioxide build-up, and/or may not have adequate
anesthesia.
ii. Respiratory arrest usually precedes cardiovascular
collapse.
c. Cardiovascular signs – A slowing heart rate indicates surgical
anesthesia depth.
i. An increase in rate (tachycardia) during the performance
of a surgical procedure often indicates that the depth of
anesthesia is not adequate and or insufficient amount of
oxygen.
ii. A decrease of rate (bradycardia) during surgery may
signify an excessive depth of anesthetic.
iii. Blood Pressure (BP) must be documented on the
anesthesia record, when made available, to document
the maintenance of the blood volume and adequate
perfusion.
d. Body Temperature (T) – Anesthetics usually cause a
depression of body temperature. Body temperature can be
measured rectally. Maintaining of body temperature at normal
levels allows more rapid metabolism of anesthetic agents. To
avoid hypothermia, body temperature should be monitored and
Page 26 of 42
maintained throughout the anesthetic process and postoperative period. Conservation of body heat is an integral part
of anesthetic management. Core body temperature can fall
precipitously during general anesthesia, especially in small
animals.
i. To avoid burns, heating pads should be wrapped or
covered to prevent direct contact with the animal.
ii. If the heat source is inadequate, immediate steps must be
taken. These steps may include, but are not limited to,
additional sources of heat such as heat lamps, heat packs
and warmed IV fluids.
7. Documentation on the anesthesia sheet must also include the following:
a. Drug or fluid administration. Controlled, non-controlled and
over-the-counter drugs are included. Include the dose (mg/kg),
volume and route of administration, and changes in rates.
b. Observations. Include complications encountered, ties when
various procedures and other relevant sequence of procedures.
8. Supplemental fluids- Prolonged surgeries, procedures longer than 30
minutes, require placement of an IV catheter and intraoperative fluid
supplementation.
a. Fluid administration may be continued into the postoperative
recovery period.
b. A calculation of 24 hour percent fluid maintenance requirement
should be made PRIOR TO surgery for each patient.8
c. A calculation and notation on the anesthesia sheet of the total
24 hours percent requirement fluid administered should be
calculated and noted on the anesthesia sheet after surgery is
completed.
9. The surgical-procedure-observation chart must be completed in order to
document the surgeon’s presence and the surgical procedure.
10. The anesthetist should not leave the patient in the Post-Operative
Recovery Room until satisfied with the patient’s stability (which is
outlined in the pos-operative recovery portion of the document), or
until patient care responsibly has been transferred.
______________________________________________________________________
8
Total fluid requirements for animals with body weight of less than 10 kg = 44ml/kg X body
weight (kg)
Total fluid requirements for animals with body weight of more than 10 kg = 66ml/kg X body
weight (kg)
Page 27 of 42
Indications of Anesthetic Overdose
Monitoring vital signs continuously during anesthesia will provide early warning of
potential problems and emergencies that may be averted by appropriate and quick
corrective actions. Do not rely on a single parameter to assess the animal’s condition. All
parameters should be evaluated prior to initiating any corrective actions.
The following indicators of overdose, which may lead to cardiac or respiratory failure, are
helpful in assessing the animal’s status during anesthesia.
− Heart Rate may be rapid or slow, depending on the state of physiological
decompensation.
− Remember anticholingergics cause the heart rate to increase.
− Pulses may be weak, slow, irregular, or even imperceptible.
− Blood pressure will be reduced if blood loss is significant, patient is in shock, or
pending cardiac arrest.
− Capillary refill time progressively slows to 3 or more seconds indicating blood
pressure is inadequate to perfuse peripheral tissues.
− Respiration may be slow, irregular, shallow, often become diaphragmatic, and may
eventually cease. Paradoxically, respirations may increase in response to low blood
oxygen and high blood carbon dioxide during deep anesthesia.
− Mucus membrane and skin color, depending on the animal’s skin pigmentation, may
be pale to cyanotic from poor perfusion of capillary beds and low blood oxygen.
− Low blood oxygen from hypoventilation causes cyanosis, although tissue perfusion
may be normal.
− Significant hypothermia requiring immediate action is defined as equal to or lower
than 95oF.
Anesthetic Overdose Corrective Actions
See Cardiopulmonary-Arrest Emergency Manual located in the Animal Prep Room.
XVI. Patient Preparation
The majority of post-procedural infections are the result of contamination of the surgical
site with resident or transient skin bacteria from the patient. Therefore, decontamination
of the surgical site and prevention of contamination from other areas is the best means
of preventing post-procedural infections.
ANIMAL IDENTIFICATION
1. Verify animal’s identification with animal's medical record, cage card, and at least one
of the following prior to administering anesthesia:
a.
b.
c.
d.
ear tag
tattoo
grease mark
ear notch
PREMEDICATION
Premedication, usually composed of a tranquilizer and an anticholinergic, is
frequently administered in the animal’s home cage. After this has taken effect (15 – 30
minutes) the animal is transported to the appropriate room for induction of anesthesia.
Page 28 of 42
PLACEMENT OF IV CATHETER
This can easily be done in some species before they are anesthetized (cats,
dogs, rabbits); however, other species require to be anesthetized before they can be
safely or easily handled (pigs, monkeys and woodchucks).
INDUCTION
Induction may also be performed in the animal’s home cage, or, if the animal is
easily manageable, in the CMR lab/pharmacy or in the animal prep room next to the
surgery. Induction is induced by an agent which causes the animal to loose
consciousness and be amenable for endotracheal intubation prior to placing the animal
on the gas anesthesia machine. It may be accomplished either by an injectable agent or
by masking the animal down with the anesthesia gas.
1. Preparation is facilitated by first inducing anesthesia via injectable anesthetic or
gas anesthetic.
2. After the animal has been anesthetized, the eyes should be lubricated with a
sterile ophthalmic ointment (Paralube®) to prevent corneal drying.
3. Lube the penis of male rabbits and cats with lubricating K-Y jelly (the penis
relaxes out of its sheath during surgery, which may dry the penis out causing
painful urination later on.
4. Intravenous catheter placement
a. This area should then be prepared by performing a surgical scrub. This
consists of three cycles of scrubbing the area with Betadine or Nolvasan
scrub solutions; wiping the area after the scrub with 70% isopropyl
alcohol and then re-scrubbing. Always scrub from the intended vascular
puncture site, outward in a circular pattern.
b. Use of an ear splint must be used when placing intravenous catheters in
pig and rabbit ears. This is to give added support to the ear.
5.
Blood withdrawal
a. Alcohol swab
i. Once blood is obtained, apply pressure to prevent hematoma
ii. Blood may be collected at the time of surgery for preoperative
CBC, Differential and Serum Chemistry. However, it is preferred
to collect blood for above tests in sufficient time prior to surgery
to have these data available prior to scheduling patient for
surgery.
7. Endotracheal Intubation
a. Carefully observe the animal for signs of anesthetic depth and that the
appropriate level has been achieved to allow endotracheal intubation,
i. Use of gas anesthesia requires turning off the anesthetic gas, and
remove nose mask.
ii. Use of injectable anesthesia requires careful induction of
anesthesia; it is given to effect within a specific range documented
on the cheat sheet.
b. Intubate the animal with a sterile endotracheal tube (ETT).
i. Proper ETT preparation i.e. Cuff inflates, tighten end of tip
Page 29 of 42
c. Check to ensure proper placement of the tube via stethoscope and
condensation in the ETT.
d. Listen to both sides of the chest using a stethoscope to ensure that ETT
is placed to provide ventilation bilaterally
e. Tie the ETT to the upper jaw or behind ears using muzzle gauze
f. Inflate the cuff.
g. To maintain an Isoflurane surgical anesthetic plane, connect ETT to
connection hosing on the anesthetic machine and administer
approximately 1-2 liters/minute of oxygen in conjunction with Isoflurane at
0.5-3% or to effect.
h. To maintain oxygenation only, connect ETT to connection hosing and
administer approximately 1-2 liters/min of oxygen.
PATIENT PREP
8. The patient's hair should be removed from the surgical site.
a. This should be completed with an electric clipper (#10, #40 or #50 blade)
or depilatory rather than a razor.
b. Depilatory creams may be applied to the surgical site, but they may cause
contact dermatitis which may interfere with the healing process.
c. Hair removal should be performed immediately prior to the surgery.
d. In the current survival surgical suites, the clippers are attached to a
vacuum system to remove the hair as one shaves.
e. The surgical area to be prepared should be approximately 2-3 times the
size needed for the incision.
9.
While in the animal prep, the patient's skin should be scrubbed with a disinfectant
such as povidone iodine or chlorhexidine scrub.
a. Scrubbing should start at the center of the surgical site and move to the
outside in a linear or circular manner.
b. Typically two- three scrubs with a disinfectant and then two-three with
70% alcohol or sterile water to remove debris are used.9
10. When the animal is moved to the operating area, it should be positioned on a
heating pad on the surgical table. To avoid burns, heating pads should be
wrapped or covered to prevent direct contact with the animal.
11. The surgical approach will dictate actual animal position; however, some
guidelines to consider are:
a. The animal's respiratory function should not be compromised by
overextension of forelegs stretched towards the head, or by excessive
body tilt which causes pressure from the abdominal organs on the
diaphragm.
b. Limbs should not be extended beyond their normal range of motion and
restraint straps should be padded as needed to prevent impaired venous
return in extremities.
c. Placement of animals placed in special equipment such as a stereotaxic
unit must have frequent checks to make sure head is stabilized and air
way via ETT is clear/open.
______________________________________________________________________
Page 30 of 42
9
It may not be appropriate to scrub the site of some patients. Scrubbing the skin of a fish or
amphibian will remove the protective bacterial slime layer, and may actually increase the risk of
infection.
12. Ruminants are frequently positioned on a slight incline with the head dependent
to minimize the potential for aspiration of rumen fluids. After intubation with an
endotracheal tube, a large bore stomach tube is also frequently placed down the
esophagus to remove rumen fluids and gas.
13. After the animal has been secured, any monitoring devices such as ECG
electrodes, monitoring thermometer, blood pressure cuffs, and esophageal
stethoscopes should be placed and their function tested.
14. Starting of intravenous fluids at the appropriate rate as per cheat sheet to surgery
is started and documented on the anesthesia monitoring sheet
15. The animal should be ready for final preparation of surgical site with disinfectant.
One to two sets of scrubs should be completed, then, a disinfectant solution like
povidone iodine is painted onto the surgical site and left to dry.
16. Following the final preparation of surgical site, see Section A under Principles of
Asepsis for proper surgical preparation of surgical site.
XVII. Operating Room Emergency
Evacuation10
Fire alarms are intermittent in the Medical Science Building and occur approximately
once monthly. Depending on the location of the suspected fire, all personnel are
requested to evacuate the building. Evacuation of operating staff during a surgery poses
a dilemma as to either rapidly conclude the procedure or alternatively euthanize the
patient. An anesthetized animal cannot be left unattended. Because the animal usually
represents a considerable expenditure in time and money, and it would be inadvisable to
euthanize an animal unnecessarily. The following procedures are in place to exempt
surgical staff from prompt evacuation in response to a fire alarm.
Response to Fire Alarm
1. When a fire alarm sounds, the CMR Contact Person (Director, Assistant Director,
Chief Clinical Veterinarian or most senior CMR staff) will listen to the
announcement indicating action to be taken and floors required to be evacuated
and contact the staff in the surgery suite(s) and Procedure Rooms to inform staff
that a fire alarm is being investigated.
2. The CMR Designated Contact Person will monitor the situation. If the fire alarm is
part of a scheduled drill or a false alarm the surgery team(s) will not be required to
evacuate.
3. If not due to a scheduled drill or false alarm and while the alarm is being
investigated surgery teams will not be required to interrupt surgery or leave the
surgery suite.
4. If the fire alarm does not appear to be due to a drill or false alarm the CMR
Contact will:
a. Decide if the situation merits immediate evacuation of the surgical team.
b. Call the surgery suite(s) and Procedure rooms or walk to the surgery
suite(s) and update the team on the fire alarm status every 5 minutes.
c. The CMR contact person will also relay their status to the CMR
designated contact person on the outside, which is scheduled to be
completed every 10-15 minutes.
Page 31 of 42
5. While waiting for confirmation of fire alarm, a member of the surgery team will
prepare to euthanize the animal if this should be required.
10
CMR Emergency Procedures for Escape and Evacuation in Response to Fire or Fire alarm
6. If evacuation of building is deemed necessary or if a fire or smoke condition is
noticed in the area:
a. The animal on the table will be humanly euthanized.
b. The surgery team will evacuate the building via
i. A-level evacuation: Door SA24 which is to the left of the janitor’s
closet.
ii. G-level evacuation: Either use the stairs next to the regular
elevators or the entrance into the hospital, which is on the
orthopedic section of MSB G-level
XVIII. Loss of Electric Power
Please note that the G-level surgery suite does not have emergency electric power
outlets in the operating suite.
A. If the MSB or part of it loses electric power, emergency lighting comes on within a
few seconds as follows:
a. A-level
i. Every third light in the corridor on A-level comes on.
ii. No lights in the animal rooms come on, but flashlights are present
in the animal rooms.
iii. Ceiling lights in the A-level surgery suite comes on.
iv. Any machines or instruments connected to the RED
EMERGENCY OUTLETS continue to receive electric current and
to function. If the emergency outlets fail follow the procedure
under b. MSB G-level section 2.
b. MSB G-level
i. The surgical suite does not have emergency power, because
there are windows in this surgery suite, loss of light is not
disastrous.
ii. Emergency procedures when animal are connected to gas
anesthesia machine and/or ventilator.
1. Turn the ventilator off
2. Remove the conducting tube which connects the ventilator
to where the rebreathing bag attaches
3. Connect the rebreathing bag back onto the machine
4. Open up the ALP valve (pop-off valve) ½ way
5. Resuscitate using the rebreathing bag (this will ensure that
the gas anesthesia and/or oxygen is getting into the
patient)
Page 32 of 42
XIX. Post-Operative Recovery
"Appropriate facilities and equipment should be available for postsurgical care. Postsurgical care
should include observing the animal to ensure uneventful recovery from anesthesia and surgery;
administering supportive fluids, analgesics and other drugs as required; providing adequate care
for surgical incisions; and maintaining appropriate medical records. Equipment and supply items
that can be helpful for intensive care include heating pads, vaporizers, vacuum equipment,
respirator, cardiac monitor, and oxygen. Proper monitoring by trained personnel should be
provided during recovery." Guide for the Care and Use of Laboratory Animals
Post-surgical care begins with completion of the surgery to recovery from anesthesia to
post recovery. The period may extend for days to weeks depending on post-surgical
outcome and study design. Post-surgical care includes after-hours and weekend care
and is the responsibility of the Principal Investigator and the CMR Veterinary Technical
Staff. Technical services are available as fee for service. Research staff desiring to
provide their own postop care must be approved as outlined in CMR Policy for Surgery
in Large Animals.
A. RECORD KEEPING REQUIREMENTS
1) Maintaining records of care given via medical records: These records must
include at least a twice daily (BID) assessments and treatments given. Other items that
are included in the record are any pharmaceutical or other agents and time
administered, nursing care provided and a BID SOAP summary (See XVI. Medical
Records). Post-operative records are required by the USDA on all species covered
under the AWA and must be readily available for review in the same room with the
animal.
2) Administration of fluids, analgesics, antibiotics, and other medications
as indicated in the approved IACUC protocol and/or consultation with CMR veterinary
staff
3) All proper PPE is to be worn when posted for recovery rooms requiring such
materials.
B. Post-surgical care includes the following:
1) Adequate Acute Post-procedural Monitoring:
1. All postoperative animals are to be closely observed for the initial 24-72 hours
post-surgical procedure period. It is important to assess whether or not the animal
has returned to normal behavior. Animals, which do not return to normal, often
have surgical-related infections/complications and require re-evaluation.
2. Surgical incision sites must be observed for the first 24-72hours post-surgery for
clinical signs of infection or suture breakdown.
3. Temperature monitoring and support provided during recovery period.
a. Provision of supplemental heat during anesthetic recovery, as needed.
b. Provisions of cooling during anesthetic recovery, as needed.
4. Endotracheal tubes should be kept in place as long as possible; they must be
removed when the animal begins to chew or swallow. An animal with an ET in
place must not be left alone and unobserved.
Page 33 of 42
5. The animal must be monitored and data collected every 10-15 minutes until the:
a. vital signs are stable
b. animal has regained consciousness
c. animal can maintain sternal recumbancy
d. the need for analgesia has been thoroughly assessed.
6. Parameters which are to be monitored and recorded 10-15 minutes until stable.
Body Temperature
CRT
Heart Rate
Behavior/Character
Respiratory Rate
(RR)
Pattern of RR
MM
Jaw tone
Palpebral
reflex
Incision area
If any discharge is noted
(blood, fluids)
Body's position in cage (left or
right lateral recumbancy,
sternal) *see note below
If on fluid drip, note that it is
still working
7. Reference Ranges for the parameters per species. If the range is above or
below the parameters for longer than 60 minutes, report the situation to the
CMR veterinary staff.
Heart
Rate
(bpm)
RR
(breaths/
min)
90-100%
60-135
Oct-48
90-100%
110-140
15-40
90-100%
120-180
35-50
90-100%
90-100%
90-100%
90-100%
130-250
60-80
60-80
60-120
120-150
Summer
12-60
Winter
30-620-Oct
18-20
Aug-40
30-50
Summer
4-12
Winter
Species
SPO
Dog
Cat
Primate
(Cyno)
Rabbits
Goats
Sheep
Pigs
Woodchuck
2
90-100%
Body
o
Temp ( F)
100.4102.5
100.4102.5
98.6103.1
100.4-103
101.3-103
101-103
101-103
96.8100.4
MM
(color)
CRT
(sec)
Pink
<2
Pink
<2
Pink
<2
Pink
Pink
Pink
Pink
<2
<2
<2
<2
Pink
<2
8. Once stable parameters are met, every 30-60 minutes checks can be
conducted.
9. If an animal is unable to move into different positions, the animal must be
repositioned into another position every 30 min to 1 hour. Alternating
between placing the animal in Left Lateral Recumbency (LLR) and Right
Lateral Recumbency (RLL) is frequently best. This change in position must
be noted in the Medical Records. Request help for larger animals to
decrease the opportunity for personal and animal injury. If moving the
Page 34 of 42
animal will cause personal injury or injury to the animal, do not move
animal and inform CMR veterinary staff of situation.
10. Food or water should not be available in the cage until the animal is fully
recovered or considered stable for the night.
11. Ability of animal to maintain normal physiology such as body
temperature and fluid balance must be assured before leaving the animal
for the night.
12. IV catheters are to remain only up to 3 days maximum.
a. If it is required longer, the original catheter is removed and a
second catheter is placed.
b. If the catheter is not needed or required, it can be taken out earlier,
but is recommended to be removed the next morning after surgery
in case it is required for the administration of emergency drugs
C. Adequate Analgesic Support:
1. Administer post-operative analgesics as required.
2. All animals subjected to surgery must have analgesic agents (painkillers)
available to them for at least the initial 24-48 hours post-surgery.
3. The analgesic that should be used depends upon on species and “severity”
of surgical manipulation. If the use of analgesic interferes with the
experimental design, prior IACUC approval must be obtained.
D. Adequate Antibiotic Support:
1. Administer post-operative antibiotics as required.
2. Depending upon several factors perioperative and postoperative antibiotics
are administered for a shorter or longer time postop. These factors include
but are not limited to:
a. Duration and invasiveness of surgery,
b. Whether instrumentation was implanted during surgery
c. Whether indwelling catheters or cannulas were implanted
d. Age and immune status of animal
e. Body system operated on (orthopaedic procedures usually require
longer term administration of antibiotics)
3. Several antibiotics are available for a variety of species. The antibiotics that
should be used depend upon on species and “severity” of surgical
manipulation.
4. If the use of antibiotics interferes with the experimental design, prior IACUC
approval must be obtained.
Page 35 of 42
5. If antibiotics are being used, they should be administered before surgery,
so that they are in tissues when the surgeon is performing surgery.
6. An appropriate antibiotic should be administered at an adequate dose at the
recommended frequency to minimize the development of resistance.
7. Antibiotics should not be used in place of surgical asepsis and good tissue
handling techniques.
E. Adequate Chronic Post-procedural Monitoring:
1. Monitoring post-procedural complications
a. Provide analgesia for any procedures with potential for pain or distress
b. Administer antibiotics to prevent post-procedural infections
c. Monitor incisions for swelling, exudates, pain or dehiscence
d. Monitor catheters & devices
e. Monitor for procedure-related complications such as organ failure,
thrombosis, ischemia.
2. Monitoring and management of chronic indwelling devices such as catheters or
implants. For example, indwelling catheters typically require flushing with
anticoagulant solutions and chronic electrodes may require daily wound cleaning
and debridement. Skin suture / staple removal: Generally speaking, all sutures /
staples MUST be removed 14 days following the procedure.
a. Most sutures can be removed by 10 days.
b. It may be appropriate to remove some sutures / staples as early as 3-5
days, leaving the required ones for a longer period of time for complete
closure.
c. The goal of the staples/sutures are to keep the skin margins closed
(thereby discouraging infection, or the risk of infection), while not allowing
the staples / sutures to become a nidus for infection or distress to the
animal.
d. Sutures/staples do have a defined life span, after which they are not
needed, and can only serve to cause problems for the patient and the
research data.
e. Absorbable sutures are left in place and are gradually absorbed by the
tissue.
f.
If there are any questions concerning the removal of the sutures/staples
consult the veterinarian.
F. Species Specific Post-operative/Post-procedural Documentation Guidelines

The minimum frequency of observation and care of patient and documentation in
the patient’s medical record is twice daily including weekends and holidays for
the first seven days postop.

More than twice daily may be required based upon the patient’s condition.

Documentation can be changed based upon the recovery of the patient. The
frequency can increase if the animal requires to be monitored more closely.
Page 36 of 42
G. Exceptions

ALL Pacing Animals are monitored BID until humane endpoint has been
reached.

All animals on antibiotic treatment are monitored BID and temperature taken as
needed.

All animals on analgesics are monitored BID.

Major surgical procedures NHP’s are monitored BID until humane endpoint

Minor surgical procedures on NHP’s are monitored BID for 7 days.

Simple procedures requiring anesthesia for health checks or procedural
examinations require monitoring until the animal is stable and next morning
monitoring.
XX. Assessing Pain and Distress
A fundamental approach to assessment of pain in laboratory animals does not begin
with chemical or biological evaluations. The key to adequate assessment lies in the
hands of the animal care personnel, technicians, laboratory specialists, and researchers.
It is here that clinical observations and abnormal behavior should be recognized as
possible identifying factors of pain in animals. It is, therefore, essential that all personnel
involved in the care of animals are well versed in normal animal behavior patterns and
even with the individual animal and that they recognize any deviation form the normal or
usual pattern. The conscientious laboratory animal personnel performing daily routine
functions should identify changes in personality, eating habits, physiological functions,
etc. Such observations should be reported quickly to the clinical veterinarian or
appropriate animal health care official. Good communication among all animal health
care personnel is essential. Early recognition of abnormal signs or any deviation from
usual daily animal performance can mean the difference between mild, moderate, or
severe pain.
Anticipating when signs of pain may occur is an important part of minimizing and
preventing unintended suffering in animals. This can be accomplished by a thorough
knowledge of expected results of all experiments which are known or are likely to
produce pain and distress. Clinical veterinarians should review each protocol for
assessment of research which may cause pain, stress, distress, discomfort, or suffering
to animals. This review also will reveal proposed drug usage which could interfere with
or react with post-procedural pain medications. Review of protocols prior to performance
and review of drug literature and analgesics known not to interfere with the experimental
design or protocol can enhance treatment of post-procedural pain. Knowledge of the
general responses of animals to a given procedure is important in the assessment and
management of pain.
Knowledge of an animal’s disposition and normal physiological functions prior to
execution of experimental protocols is extremely helpful in determining whether an
animal is in pain. Aggressiveness, attempting to bite, hissing, and/or withdrawal can be
Page 37 of 42
interpreted as signs of pain. However, if such behavior was present prior to manipulation
and is characteristic of the individual animal in question, then these indices are not
necessarily indicative of pain or suffering. It cannot, however, be assumed that the
animal is not in pain, and a thorough assessment for post-procedural pain should be
performed. Comparison of pre- and post-procedural behavior may indicate that the
animal is still growling, hissing, or attempting to bite, but movements or attempts to
escape may be minimal to none. The importance of being aware of pre-procedural traits
cannot be over-emphasized.
A. Signs of Acute Pain







Guarding (of affected area) – protect or move away
Crying or vocalizing on movement or palpation
Mutilation – excessive licking, biting scratching
Heavy breathing
Restlessness – pacing, lying down, getting up
Sweating, Lacrimation
Recumbancy – lying down for a long period
B. Signs of Chronic Pain or Illness









Limping or carrying limb
Licking area of body
Reluctance to move
Loss of appetite
Change in personality
Dysuria (painful urination)
Bowel lassitude (ileus)
Animals not mobile 24 hours post-surgery
Not eating or drinking
C. Species-Specific Behavioral Signs of Pain
Species
Vocalizing
Posture
Locomotion
Temperament
Other
Signs
Dog
Whimpers, howls,
growls
Cowers,
crouches,
recumbent
Reluctant to
move; awkward,
shuffles
Varies from
chronic to acute,
can be subdued
or vicious, quiet or
restless
Panting,
biting, licking
or scratching
Cat
Generally silent,
may growl or hiss
Stiff, hunched in
sternal
recumbancy,
limsb tucked
under body
Reluctant to
move limb, carry
limb
Reclusive
Unkempt
appearance,
papillary
dilation
Primate
Screams, grunts,
moans
Head forward,
arms across
body; huddled
and crouching
Favors area in
pain
Docile to
aggressive,
decreased activity
Decrease in
food and
water intake
Page 38 of 42
Rabbits
Goats
Apprehensive,
dull, sometimes
aggressive
depending on
severity of pain,
Postparturient
female may eat
neonates
Ocular
discharge,
protruding
nictating
membrane,
constipation
or diarrhea
Piercing squeal on
acute pain or
fright; Teeth
grinding
Hunched, faces
back of cage
Inactive, drags
hind legs
Grunting, teeth
grinding
Rigid, head
lowered, back
humped
Limps, reluctant
to move the
painful area
Dull, depressed
Rolling,
frequently
looking at or
kicking at
abdomen
Disinterested in
surroundings, dull,
depressed
Rolling,
frequently
looking at or
kicking at
abdomen
From passive to
aggressive
depending on
severity of pain
Anorexia
Sheep
Grunting, teeth
grinding
Rigid, head down
Limps, reluctant
to move the
painful area
Pigs
From excessive
squealing (fright
and/or pain) to no
sound at all
All four feet close
together under
body, changes in
gain or posture
Unwilling to
move, unable to
stand
Woodchucks
Page 39 of 42
XXI. Sanitation11
Sharps Container – A red container with a controlled opening for safe and proper
disposal of needles, syringes, scalpel blades, and opened ampules. Do not overstuff the
container. If a new container is needed, contact the CMR supervisor.
Red Trash Bags – Used for biohazard trash articles including any material with blood.
Black Trash Bags – Used for non-contaminated trash articles.
Blue Trash Bags –Used radioactive trash articles
Glass – Any glass item, broken or unbroken, should be disposed of in the properly
designed disposable glass box.
Infectious materials. Infectious materials must be rendered safe by sterilization,
decontamination, or other appropriate measure before disposal as described in the IBC
or EOHSS generated and approved document.
Radioactive waste. The removal and disposal of all radioactive waste must be handled
according to the Office of Radiation Safety Services (ORSS) as described in the ORSSgenerated protocol document.
Chemical waste. Proper disposal of hazardous chemical waste is very expensive. Thus,
researched are urged to minimize generation of hazardous chemical waste. For detailed
information refer to the current annual revised Notification of hazardous Materials
Program available through Environmental Heath and Safety. Chemicals and carcinogens
in animals are reviewed by EOHSS at the time of the review of the IACUC protocol and
handled according to the EOHSS-generated documents.
Infectious or biohazardous waste. Hazardous biological waste must be bagged and
properly autoclaved or chemically sterilized, if appropriate. Autoclaved bags should be
labeled to avoid alarming uninformed employees or the public. Place bags in special
designated containers near autoclave. Broken glassware and sharps must be disposed
of in proper containers and securely packaged by lab personnel before disposal.
Questions concerning the disposal of hazardous agents must be directed to the
Environment Health and Safety Department. Protocol specific procedures are reviewed
and approved at the time of the review of the IACUC protocol.
A. Operating Room Sanitation Procedure: 12
CMR will be responsible for the sanitation of the surgical suites and proper maintenance.
11
CMR SOP on Surgery and Procedure Room Sanitation and Maintenance
12
Please refer to CMR SOP on Surgery and Procedure Room Sanitation and Maintenance
Page 40 of 42
XXII. References
Animal Welfare Act: Code of Federal Regulations: 9 CFR Chapter 1 Subchapter A, Parts 1, 2 and 3
Guide for the Care and Use of Laboratory Animals, NRC, National Academy Press, 1996
Johns Hopkins University: http://www.jhu.edu/animalcare/committee_surgicalsuites.html
Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy, 1985).
University of Illinois Medical Center
University of Michigan, ULAM
Michigan State University, MSU
http://web.uccs.edu/osp/compliance/animalsubjects/guidelines.html
http://www.iacuc.ucsf.edu/Policies/awGlAsepSurg.asp
http://www.ahc.umn.edu/rar/surgery.html
http://vetmed.duhs.duke.edu/guidelines_for_general_surgery_in_animals.html
http://www.rgs.uci.edu/ora/rp/acup/policies/surgerypolicy.html
http://www.utmem.edu/compmed/Surgery.html
http://research.uiowa.edu/animal/?get=esasept
http://www.iacuc.uconn.edu/
XXIII. COMPILED BY
Douglas Larsen, DVM,
Kelly Conway, BS, LATG
Peter Condobery, MS, BVSC&AH
Eva B. Ryden, PhD, DVM, DACLAM
Page 41 of 42

Document 6458592

Transcription

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