University Policy on Performing Non-Rodent Survival Surgery

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CONTENTS

A. Scope of Policy
B. Definitions
C. Training and Supervision
D. Anesthetics, Anaglesics and Tranquilizers
E. Aseptic Surgery Techniques
F. Animal Preparation
G. Animal Preparation - Farm Animal Species
H. Surgeon
I. Post-Operative Care
J. Records
K. Deviations From this Policy
L. Suggestions, Comments and Feedback
M. References
N Preparation for a Lab Inspection
O. Equipment Vendors

A. Scope of Policy

This policy applies to all major survival surgical procedures performed on animals at Rutgers on non-rodent mammalian species. It includes such animals as rabbits, cats, dogs, non-human primates, and livestock. It excludes rodents and guinea pigs (gp’s have recently been placed in a separate order from rodents).
This policy does not apply to surgical procedures on university animals performed by a New Jersey licensed veterinarian in the performance of his/her regular clinical practice. Private veterinarians may use the type of records normally used in the practice and generally accepted in the profession as adequate.

B. Definitions

Major surgical procedure: a surgical operation that involves penetrating or opening a body cavity or any surgical procedure which produces permanent physical or physiologic impairment. (e.g. abdominal, thoracic, and cranial surgery. Jugular catheterization in swine is included because of the depth of the vessel.)

Postoperative Period: the period of time after recovery from anesthesia and prior to removal of surgical sutures and or wound healing. Generally, the period will be no less than five days.

C. Training and Supervision

"It is important that persons have had appropriate training to ensure that good surgical technique is practiced,... The PHS Policy and the [Animal Welfare Act regulations] place responsibility with the IACUC [the ACFC at Rutgers] for determining that personnel performing surgical procedures are appropriately qualified and trained in the procedures to be performed." [p. 61, Guide, 1996]

In order to perform surgery, each researcher must be certified for that procedure by a Laboratory Animal Services veterinarian. Generally, this will require the veterinarian to observe the researcher perform the surgical procedure.

Non-certified people may assist and be trained by a certified surgeon. The certified "trainer" is responsible for the proper performance of the surgery, must be physically present throughout the procedure and must "scrub in". An uncertified researcher may not perform surgery alone without being certified by an LAS veterinarian.

Certification is for an individual researcher performing a specified procedure. New procedures, and/or different species may require separate certification.

LAS veterinarians will provide training in general surgery technique and in specific procedures. Researchers may also obtain training from others, but all surgery done at Rutgers must be done by a certified surgeon under an approved animal use protocol.

D. Anesthetics, Anaglesics and Tranquilizers

"An integral component of veterinary medical care is prevention or alleviation of pain associated with procedural and surgical protocols." [p. 64, Guide, 1996]

The use of anesthetics, analgesics and tranquilizers is required. An appropriate method of preventing and/or alleviating pain must be used. Agents should be selected in consultation with an experienced veterinarian. This is part of the protocol review process. Agents, routes, and doses must be listed in the protocol and other agents cannot be used without approval. A change in the method of anesthesia is a "significant change" and requires an amendment to an animal use protocol before the change is made.

Physical facilities

"The design of a surgical facility should accommodate the species to be operated on and the complexity of the procedures to be performed. ... For most surgical programs, functional components of aseptic surgery include surgical support, animal preparation, surgeon’s scrub, operating room, and postoperative recovery." [p. 78, Guide, 1996]

Nonrodent survival surgery must be done in a facility approved by the ACFC. There is an approved facility on each of the Busch, Cook and Newark campuses. Because these facilities are not always used regularly, the following procedures must be followed.

The surgery suite floor should be mopped with an appropriate disinfectant prior to use. If the surgery has not been used in the last 7 days, it should be mopped before the next surgery. This may be done the day before.  The surgery suite should be cleaned following the last procedure of the day. (Empty wastebaskets, clean all surfaces, move all equipment and mop floor, clean and store all instruments, etc.) The surgery should be left in a condition so that it is ready for use by the next researcher.

E. Aseptic Surgery Techniques

"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. Aseptic technique includes preparation of the patient, such as hair removal and disinfection of the operative site; 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; and the use of operative techniques to reduce the likelihood of infection." [p. 62, Guide, 1996]

Instruments

Steam autoclaving or ethylene oxide gas sterilization are recommended. Both methods provide dry instruments at the time of surgery. Instruments should be wrapped in such a way that they can be introduced to the surgical field in a sterile manner. Larger surgical packs can be wrapped with fabric wraps, or paper wraps. Smaller packs and individual items can be sterilized in see-through, peel-apart envelopes. Laboratory Animal Services (LAS) can help you obtain these supplies. LAS has steam autoclaves. (Ethylene oxide is not readily available at Rutgers).

"Liquid chemical sterilants should be used with adequate contact times, and instruments should be rinsed with sterile water or saline before use. Alcohol is neither a sterilant nor a high-level disinfectant." [p. 62, Guide, 1996]

Acceptable methods of sterilization

  • Steam autoclave
  • Gas sterilization (ethylene oxide)
  • Gamma irradiation
  • Material supplied as sterile by the manufacturer (by any technique) in such a way that it can be introduced to the surgical field in a sterile manner.
  • Chemical "sterilants" with adequate contact time (e.g. "Cidex" glutaraldehyde)

 

Unacceptable methods of sterilization

  • Non-sporocidal disinfectants (e.g. alcohol)
  •  

F. Animal Preparation

The animal’s skin is a weak link in aseptic technique. The incision site cannot be "sterilized". Proper preparation can minimize contamination of the surgical field with skin microorganisms. Hair around the surgical site should be removed with a surgical clipper using a #40 blade (clip "against the grain"). Shaving with a razor or use of a depilatory cream is generally not necessary. A common mistake is to not clip a sufficient area, only to find yourself looking at unsterile hair poking through your drapes during the surgery.

Scrub the surgical site with a surgical soap. Scrub in a spiral pattern starting over the intended incision site and moving outward. A typical scrub would involve use of a povidone-iodine (sudsing) soap (e.g. Betadine®), a rinse with alcohol or water and then alcohol, and final application of povidone-iodine (non-sudsing) solution.

The surgical site should be covered with a sterile surgical drape. Paper drapes are convenient because you can customize the hole to fit the surgical site. Any material can be used. Disposable surgical drape material is resistant to tearing when wet, and the blue/green color helps reduce glare from surgery lights.

A common mistake is to make the drape too small. The larger the sterile field you create, the easier you will find it to avoid "breaks" in sterile technique. "Beginners" should err on the side of a too-large drape.

 

Minimal Animal Preparation

  • Clip hair with an animal clipper with a #40 blade.
  • Scrub the skin with surgical soap.
  • Surgical drape

G. Animal Preparation - Farm Animal Species

Farm animal species require some special procedures to maintain an aseptic environment. The following procedures should be followed in working with farm animal species.

Unless contraindicated by the research protocol, sheep should be closely shorn prior to surgery.

Where possible, large animals (e.g. sheep, goats, swine, etc.) should be brushed or combed to remove bedding, feces, dirt, etc. before being brought to the surgery area. This can be done the day before if animals are placed in a raised floor pen until surgery.

The surgery site, peripheral vein sites, etc. should be clipped with a #40 blade. This should be performed outside the surgery room. This can be done the day before or immediately prior to inducing anesthesia if the animal’s temperament permits it, or it can be done in the animal prep room following induction of anesthesia. Hair should not be clipped in the surgery room.

Hooves of large animals should be covered before the animal is brought into surgery. This can be done with exam gloves, small bags, paper, etc.

Animals should be anesthetized in the animal prep area, and carried into surgery or moved on a cart. Animals should not be allowed to walk on the surgery room floor.

H. Surgeon

The surgeon and sterile assistants must scrub their hands and arms with surgical soap and a hand brush. This requires short sleeves, hence the recommendation for surgical scrubs. This should be done in an area away from the surgery table (all surgical suites at Rutgers have a separate room for this purpose).

Shoe covers are recommended for all persons in the surgery, at all times. Shoe covers should be changed if worn outside the surgery suite.

Surgical scrubs (i.e. a change from street clothes) are recommended. This protects your clothes from stains, the short sleeves are essential for doing an adequate scrub, scrubs are cool under surgery gowns, and they look "cool".

Other personnel in the surgery room during surgery must wear a cap and mask. Shoe covers should be worn if being worn by the surgery team.

Minimal Surgeon Preparation

  • Thorough hand scrub with a surgical scrub brush and antiseptic soap
  • Sterile gloves
  • Cap, gown and mask
  • Recommended Additional Surgeon Preparation
  • Changing into surgical scrubs from street clothes
  • Shoe covers

I. Post-Operative Care

Sec. 2.33 (b)] "Each research facility shall establish and maintain programs of adequate veterinary care that include: [Sec. 2.33 (b) (5)] Adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures." [Animal Welfare Act regulations]

"During the anesthetic recovery period, the animal should be in a clean, dry area where it can be observed often by trained personnel. Particular attention should be given to thermoregulation, cardiovascular and respiratory function, and postoperative pain or discomfort during recovery from anesthesia. Additional care might be warranted, including administration of parenteral fluids for maintenance of water and electrolyte balance, analgesics, and other drugs; care for surgical incisions; and maintenance of appropriate medical records." [p. 63-64, Guide, 1996]

"After anesthetic recovery, monitoring is often less intense but should include attention to basic biologic functions of intake and elimination and behavioral signs of postoperative pain, monitoring for post-surgical infections, monitoring of the surgical incision, bandaging as appropriate, and timely removal of skin sutures, clips, or staples." [p. 64, Guide, 1996]

Properly performed aseptic surgery should not require the routine use of post-operative antibiotics. If post-operative infections become a problem, the first step should be to evaluate the aseptic technique of the operator. If antibiotics are used prophylactically, they should be started at the time of surgery and be continued for at least three days. Clinical infections should always be reported to the Laboratory Animal Services veterinarians so that specific, individual guidance may be obtained.

The use of post-operative antibiotics, analgesics or other medications should follow the procedures described in the approved protocol.

J. Records

Records for each surgical procedure: Laboratory Animal Services' Form 005, Surgical/Anesthetic Record, and Laboratory Animal Services' Form 006, Postoperative Care Record, shall be used to record information required by this policy. Forms may be obtained from Laboratory Animal Services.

Log of Surgical Activity: A log must be kept of all surgeries performed under each protocol. This log must include the following information: Surgical procedure; date of surgery; person performing the surgery; an indication of complications resulting in anesthetic death, unexpected death after surgery, post-op infections, or inability to collect data on the animal. Forms may be obtained from Laboratory Animal Services.

Maintaining records

During the surgical and postoperative periods the records described in this SOP shall remain with the animal. Facility managers should be consulted to select a place near or within the animal room to store the records. Records should be protected from damage but be available to Laboratory Animal Services and other reviewing individuals.

At the completion of the postoperative period records required by this policy shall be kept in an easily retrievable manner at the site of surgery or at the investigator's office or laboratory and should be made available for review by Laboratory Animal Services, the ACFC, and other authorized persons. Records for an individual protocol shall be maintained for 3 years from the date of termination of the protocol. Laboratory Animal Services may request a copy of the record for their files.

Surgery logs should be available to Laboratory Animal Services veterinarians, managers and supervisors, to the ACFC during facility inspections, to USDA, AAALAC or other authorized site visitors; and may be requested as part of periodic review of the protocol approval.

K. Deviations From This Policy

Deviations from this policy must be approved by the Animal Care and Facilities Committee as part of an approved animal use protocol. Changes requested after approval must be requested as an amendment to the protocol.

L. Suggestions Comments and Feedback

Investigators are encouraged to contact the Animal Care and Facilities Committee (Sponsored Programs Administrator, 445-2883) or Laboratory Animal Services (445-4168) with questions or comments about this policy.

M. References
(Copies Available From LAS)

Hicks, NJ. Reuse of biomedical implants in animals: a method for safe and effective chemical sterilization. Lab Animal, Feb., 40-43, 1995.

Smith, Alison C. Post Surgical Care. SCAW Newsletter, 16(2): 3-5, year?

Brown, MJ, Pearson, PT and Thompson, FN. Guidelines for animal surgery in research and teaching. Am J Vet Res 54(9): 1544-1559, 1993.

Also see the extensive bibliography on page 83 of the Guide.

N. Preparation for a Lab Inspection.

The Animal Care and Facilities Committee inspects all animal use areas every six months. This includes investigator labs where surgery or other animal procedures are performed. The American Association for the Accreditation of Laboratory Animal Care (AAALAC) also visits investigator labs during its accreditation site visits, which occur every three years. Inspections may be unannounced. Whether or not surgery is taking place at the time of the inspection, site visitors can determine much about surgery practices by asking appropriate questions of faculty and their laboratory staff. Here are some things you can do to demonstrate compliance. These are suggestions only.

Preparation for a Lab Inspection

  1. Perform only surgeries for which you have an active, approved animal use protocol.
  2. Train your staff in proper surgical technique. Familiarize them with these guidelines.
  3. Post these guidelines prominently in your lab.
  4. Have written standard operating procedures for each surgical procedure, and for instrument preparation, animal prep, etc.
  5. Maintain a list of people trained to perform each procedure. These should be included on your animal use protocol.
  6. Keep a surgery log. Document surgical complications, or better, the lack of them. Have post-up records available for review.
  7. Convey to the site visitor that you know what acceptable procedures are, that all surgeons are trained in acceptable procedures, and that you follow them.
  8. Emphasize those procedures you use to insure sterility in difficult situations.
  9. Prepare for inspections with a mock inspection. A common question will be "Take me through a typical surgery."



Home | Our Offices | Animal Care Program | Working Safely with Animals | Reporting Animal Care Concerns | ORSP | Links

Contact email: harris@orsp.rutgers.edu
07/13/02