Institutional Animal Care & Use Committee, Yale University

Yale University
Institutional Animal Care
& Use Committee
New Haven CT
USA 06510

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Survival Surgery Standards for Non-Rodent Mammals

Federal Animal Welfare Regulations require appropriate surgical standards in accordance with established veterinary and nursing care.

I. General Considerations:

	Facilities for aseptic surgery should include surgical support, animal preparation, surgeon's scrub, operating room and postoperative recovery as stated in the Guide for the Care and Use of Laboratory Animals. The areas that support these functions should be designed to minimize traffic flow and separate the related, non-surgical activities from the surgical procedure in the operating room to decrease the potential for contamination. This separation is best achieved by physical barriers but may be achieved by separation of space or by the timing of appropriate cleaning and disinfection between activities.
	Major survival surgery must be conducted in facilities intended for that purpose. These facilities must be approved by the Yale Institutional Animal Care and Use Committee (IACUC) and inspected by the YARC Regulatory and Safety Services and VCS. In addition to initial inspection and approval, the surgical area is inspected semi-annually by the IACUC, Regulatory and Safety Services and VCS. All surgery areas are subject to unannounced inspections.
	Surgery must be performed only by qualified personnel. "It is important that persons have had appropriate training to ensure that good surgical technique is practiced, that is asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis and correct use of suture materials and patterns." As stated in the Guide for the Care and Use of Laboratory Animals.
	A start up meeting between Veterinary Clinical Services (VCS) and the researcher is held prior to the surgical procedure.
	All survival surgery must be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, aseptic technique.
	An Intent to Perform Survival Surgery form must be filed with VCS, LSOG B15 or fax 7-1943, 48 hours in advance with all information completed.

II. Definitions:

	Survival Surgery:
		Survival surgery is defined as a surgical intervention in which it is anticipated that the animal will recover from anesthesia, regardless of the survival time. Survival surgery is further defined as either major or minor.
	Major Survival Surgery:
		The PHS Guide for the Care and Use of Laboratory Animals defines major survival surgery as "penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement, and limb amputation).
		The USDA 9CFR defines a major operative procedure as any surgical intervention that penetrates and exposes a body cavity or any procedure which produces impairment of physical or physiological functions.
		Multiple major survival surgical procedures on a single animal are not permitted unless scientifically justified, in writing, by the user and approved by the IACUC or required as a routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian.
	Minor Survival Surgery:
		The PHS Guide for the Care and Use of Laboratory Animals defines minor survival surgery as "does not expose a body cavity and causes little or no physical impairment (such as wound suturing, peripheral vessel cannulation…)."
		Minor procedures are often performed under less stringent conditions than major procedures but still require aseptic technique, sterile instruments and appropriate anesthesia.
	Emergency Surgery:
		Emergency situations sometimes require immediate surgical correction under less than ideal conditions. The appropriate course of action requires veterinary medical consultation.

III. Drugs:

		Reconstituted drugs must be dated when mixed and the expiration date included on the bottle (nearest expiration date of either the medium or drug).
		Expired drugs must be labeled as such and may not be used on live vertebrate animals.
		Sterile saline, sterile water, or drugs without preservative must be in date and discarded after each procedure.
		Use of non-pharmaceutical grade drugs are not permitted unless approved by the IACUC (i.e. p pharmaceutical grade drugs are not available or there is scientific justification for the use of a chemical grade drug). All infused compounds must be sterile.
		Controlled substances must be in a locked cabinet/safe. A controlled substance log must be maintained.

	A. Antibiotic Therapy:
		May be instituted or changed following veterinary recommendation at the start-up meeting. If the plan finalized at the start-up meeting is different from that listed in the approved IACUC protocol, a copy of the new plan (signed by a veterinarian) must be sent to the IACUC Office for approval before proceeding.
	B. Analgesic Therapy:
		Must be given post-operatively following the approved protocol or the plan formalized with the veterinary staff at the start-up meeting. If the plan finalized at the start-up meeting is different from that listed in the approved IACUC protocol, a copy of the new plan (signed by a veterinarian) must be sent to the IACUC Office for approval before proceeding.

IV. Fluids:

	A. Therapy:
		Fluids must be dated when opened and discarded after each procedure.
		When IV fluids are connected to an administration set, the end cap must be left in place or a capped needle placed on the end of the tubing to maintain the integrity of the system.
		Fluids should be warmed to body temperature prior to use, unless there is a need to maintain body at subnormal temperature or to cool the body (i.e., nature of the surgical procedure, elevated temperature).
	B. Irrigation:
		Sterile saline used for irrigation:
		Must be dated when opened.
		Should be warmed to body to body temperature prior to use, unless there is a need to maintain body at subnormal temperature or to cool the body (i.e., nature of the surgical procedure, elevated temperature).
		Must be discarded after each procedure.
		Must have the cap replaced after pouring.

V. Pack Sterilization:

	A. Steam:
	Indicators must be used:
		Inside the pack to confirm sterilization conditions of time, temperature and penetration (i.e., ATI Sterilometer Plus from Schein).
		Heat sensitive tape must be used on the outside of the pack to readily identify a pack as sterile (i.e. Autoclave indicator tape by 3M) with the date of sterilization recorded on the tape.
	B. Ethylene Oxide:
	1. Sterilization Indicators:
		Use sterilization indicators (AN 75ET02 by Anderson) in each load to confirm both the length of time as well as penetration.
		Use tape (i.e., Indox by 3M) on the outside of the pack with the date of sterilization recorded on the tape.
	2. Aeration:
		Permeable materials, sterilized with ethylene oxide, whether implantable or in close contact with mucous membranes or body parts (urinary catheters, endotracheal tubes, osmotic mini pumps, or silastic tubing) may require up to seven (7) days aeration time berfore use.
	C. Packaging:
		Paper/plastic sterilization pouches are good for one year as long as the integrity of the packaging is not compromised (punctures, gaps, package wicking).
		Cloth (double wrapped) is good only for one month. The shelf life increases to six months if the pack is enclosed in a sealed plastic bag after drying completely.
	D. Cold Sterilization:
		Liquid chemical sterilants (e.g., Cidex, Cidex Plus, Metricide 28, available from Schein) must be: Maintained without date of expiration. Diluted per manufacturer recommendations. Utilized for the appropriate duration. Labeled and dated with the date to be changed.
		Items must be: Clean and free of proteinaceous/extraneous material (i.e., blood). Completely immersed for the process to be effective. Rinsed with sterile saline or sterile water before use.

VI. Cleaning:

	A. The Surgery Area:
		The surgical suite must be properly sanitized prior to the surgical procedure. A dedicated mop and germicidal solution (e.g., LPH, Clorox, or equivalent) must be used for mopping the floor. All surfaces (e.g., counter tops, tables, equipment) must be wiped down with a germicidal solution (e.g., Nolvasan, Alcohol) on the day of surgery. If the room is unoccupied or used for another reason, then it should be sanitized.
	B. Anesthetic Equipment:
		Vaporizers must be serviced yearly.
		Patient connection tubing must be disinfected between animals (washed in dilute bleach, rinsed and hung to dry between surgeries).
		Sodasorb granules must be changed when they change colors during machine use. It is important to change the granules even if they return to white when the machine is turned off.
		F/air canisters used for scavenging must be dated and changed according to manufacturer instructions.
		Endotracheal tubes must be cleaned and sterilized after use. They must remain clean during storage.
	C. Air Vents:
		Must be cleaned on a monthly basis or more frequently if necessary.
		Change air filters semiannually or more frequently if necessary based on visual inspection or if a change in ventilation is noticed. (Note: the Heating, Ventillation and Air Conditioning system for the surgical facility must be monitored annually to ensure the appropriate directional airflow and pressure. This is accomplished through the Yale Buildings and Service Organization).
	D. Walls:
		Must be cleaned with a disinfectant as needed or a minimum of twice a year depending on facility usage.

VII. Appearance of the Surgery Area:

	A. Shelves:
		Open shelves, in general, are discouraged. If open shelving is necessary, it should be organized to facilitate cleaning.
		Must be constructed of an impermeable, easily sanitizable material.
		Supplies stored on shelves should be stored in non-permeable containers with lids and arranged in a safe manner.
	B. Cabinets:
		Supply cabinets should be labeled to reflect chronic and acute procedures if the area is used for both.
		Must be constructed of an impermeable, easily sanitizable material.
	C. Equipment:
		Extraneous equipment should be removed from the area, to facilitate ease of cleaning.
		Equipment that is needed should be covered with a sanitizable material to prevent dust buildup. The cloths should be washed monthly and the equipment wiped down with a germicidal solution before each surgery.
	D. Supplies:
		Inspect all supplies monthly for expiration (e.g., suture, ointment, cold sterilant solution, Betadine®, Gelfoam®, saline, Betadine® scrub brushes, pharmacologic agents, etc).

VIII. Surgical Prepping:

	A. Prepping of the patient:
	Animals must be:
		Clipped and then cleaned with appropriate detergent based antiseptic solutions (dilute Betadine Surgical Scrub® followed by isopropyl alcohol) after positioning on the operating table. A two-stage (Betadine®, alcohol) scrub is ideal (see handout for proper scrub technique). The prepping of the animal should be done by the non-sterile individual.
	B. Surgeon prep and attire:
		Attire worn by the surgical team consists of scrub suits, caps, masks, as well as sterile gowns and sterile gloves by the surgeon and assistant. The surgeon and assistant must scrub before gowning and gloving (see handouts). v Shoe covers may be used to decrease contamination of the O.R.
		Scrub suits or cover gowns, caps, and masks are worn by all others in the room.

IX. Anesthesia Record: (refer to examples provided)

	Must be utilized for each procedure and contain the following information:
		Principal investigator
		Protocol number
		Animal number
		Date of procedure
		Type of procedure
		Surgeon
		Anesthetist
		Drugs given (pre-anesthetic, anesthetic, antibiotics etc.,), doses in milligrams, route of administration, and times administered.
		Heart rate and respiratory rate, recorded every 15 minutes. If the animal is on a respirator, record the initial setting and any changes.
		Body temperature, initially and any fluctuations.
		Total fluids given during surgery IV, and immediately post-op SQ and IV.
		Response to noxious stimuli must be assessed and recorded every 30 minutes when paralytics are used.
		Complications, if any.
	Records must be maintained for three years following the expiration of the protocol.

References: USDA, 9CFR 1992, Animal Welfare regulations, Public Health Service Guide for the Care and Use of Laboratory Animals

REVIEWED & APPROVED BY THE IACUC: November 9, 1999