Rationale:

According to the Animal Welfare Regulations (9 CFR Ch.1) §2.31, d., ix., “activities that involve surgery must include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices.  All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques.  Surgical procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions.”  

Policy:  

Non-rodent surgery must be performed using aseptic procedures consistent with the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Regulations, in dedicated surgical suites.  Animal recovery must be carried out in a designated post operative recovery area.

Applicability:

This policy applies to the following mammals: goats, sheep, pigs, cats, dogs, and rabbits.

This policy does not apply to the following mammals: guinea pigs, chinchillas, hamsters, gerbils, rats, and mice.

Exceptions:

Exceptions to this policy may be granted by the IACUC.

Instructions:

A.  Space requirements:

Separate spaces must be used for the following activities:

1) animal preparation,
2) sterile surgical area, and
3) postoperative recovery.

An IACUC approved dedicated surgical suite must be used for all surgical procedures on non-rodent animals. The designated surgical suites must be maintained in an aseptic manner (proper surgical attire, limited access, and proper disinfection before and following all surgeries).  If animals leave the ARC facilities to be transported to surgery, please refer to the Internal Animal Transport policy at http://www8.utsouthwestern.edu/utsw/cda/dept238828/files/265612.html .

B.  Sterilization of Instruments:

All instruments, supplies, fluids, or implants that are placed in the surgical field must be properly sterilized prior to surgery.  Instruments must be cleaned prior to sterilization to remove organic material and surface contamination.  Instruments to be sterilized by autoclave must be wrapped or placed in peel packs.  Surgical instrument packs must include a sterilization indicator inside and autoclave tape placed on the outside of the pack to demonstrate adequate sterilization has taken place.  Packs must be dated when sterilized and used within six months of that date. Sterilized instruments must be stored in enclosed cabinets or drawers until used.

Sterilization can be achieved by several methods:

1.  Steam: 250° F., 15 psi., for 30 minutes either wrapped in cloth or in a peel pack.
2.  Gas-Ethylene oxide: As required by the facility responsible for the sterilization.  Plastic implantable materials must be aerated according to manufacturer’s recommendations. 
3.  Laparoscopic cameras and instruments must be sterilized according to the manufacturer’s recommendations.

C.  Preparation of the Surgeon:

• Surgeons must have appropriate training to develop tissue-handling skills and avoid complications.  Training in proper scrub technique is required. It is available from the veterinary technical staff upon appointment. Good surgical technique requires knowledge of relevant surgical anatomy, asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis, and correct use of suture material. 
• For survival surgery, the surgeon and surgical assistants must wear a sterile gown, shoe covers, mask, bonnet, and sterilized gloves. Those in the room but not within the sterile surgical field must wear clean scrubs, gloves, shoe covers, mask, and bonnet.
• For non-survival surgery, the surgeon and those in the room must wear a mask, gloves, and a clean gown or clean scrubs. 
• The surgical suite must be properly disinfected after non-survival procedures before resuming aseptic surgeries.

D.  Animal Preparation:

• Except for rabbits, food must be withheld for at least eight hours prior to the surgery.  The investigator must post a blue fasting card on the animal’s cage and on the cage room door, remove the animal’s food bowl or feeder, and zip the cage door shut with cable tie (out of the animals reach) to assure the animal is not fed inadvertantly.  For more information, please refer to ARC standard operating procedure #382.00 “PostOp Recovery SOP,” #380.00 “Fasting Large Animals,” and #381.00 “Scheduling Surgery SOP.”
• All animals must have a preoperative exam by a veterinarian within 24 hrs prior to surgery.  Contact the ARC to arrange a preoperative exam. The anesthesia/surgery log sheet kept by the PI must be signed by the veterinarian after completing the preoperative physical examination.
• Animals must be properly anesthetized according to the IACUC approved protocol prior to surgical preparation.  Please request ARC surgical or anesthesia equipment as needed by filling out the Request for Surgery Reservation Form.
• Animals must be prepared for surgery in a designated surgical preparation room away from the surgical area.
• An ophthalmic ointment must be applied to each eye to prevent drying and damage to the cornea for all procedures.
• An area twice the size of the expected surgical field must be prepared.
• Hair must be removed from the incision area.  All loose hair and debris must be removed from the animal.
• The skin must be scrubbed three times with a standard surgical scrub such as an iodophor (Betadine) or a chlorhexidine (Nolvalsan, Hibiclens).  Alcohol alone is not sufficient. 
• After the skin has been prepared, the animal must be kept warm preferably by use of a water circulating heating pad.  A clean drape must be placed between the animal and the heating pad. Close monitoring is essential to ensure that the animal will not sustain a thermal injury from the heating pad or heat lamp.
• The animal must be draped with sterile covering to isolate the sterile incision area and create a sterile field.
• There must be no unanesthetized animals in the surgery room during surgery.

E.  Intra Operative Care

• Aseptic conditions must be maintained for survival procedures.  Clean conditions must be maintained for non-survival procedures.
• Animals must be carefully and continuously monitored. Use of a pulse oximeter and temperature monitor is required.  For animals larger than rabbits, an IV catheter for emergency access is required.
• For thoracic surgeries, mechanical ventilation must be provided.
• Documentation of heart rate, blood oxygen saturation, respiratory rates, and body temperature, must be recorded at least every fifteen minutes.
• The animal must be continuously warmed to maintain suitable body temperature.
• Animals anesthetized longer than 30 minutes must be properly hydrated.
• Surgical wounds must be closed according to the PI’s approved protocol.

F.  Postoperative Care:

• Animals must be continuously monitored during recovery from anesthesia until they can maintain sternal recumbency. Emergency airway equipment must be maintained near the recovery area (e.g. proper sized endotracheal tubes, laryngoscopes).
• Hydraulic lift tables shall be used to move an animal over 50 lbs. from the operating room to and from the recovery and/or induction areas.
• Animals must be recovered in the ARC ICU or IACUC approved recovery area or placed in a transport cage in the recovery room with equipment for supportive therapy until capable of standing. 
• Goats, pigs, and dogs must be recovered in transport cages in the ICU or in an IACUC approved recovery area.
• Animals may not be recovered in an animal housing room.
• Once the animal can maintain sternal recumbency, it must be monitored frequently (every 15 minutes) until capable of standing. 
• To prevent animals and humans from injuring themselves, two people are required to move animals over 50 lbs.
• Animals must be kept warm and dry to prevent hypothermia.  Water circulating pads should be removed when the animal is sternal. Once the animal is returned to its cage heating lamps can be directed on the animal until fully recovered.
• Recovered animals must not be kept in the same cage as anesthetized animals. 
• PI staff must immediately contact veterinary staff if any complications are suspected.
• Postoperative analgesia and antibiotics must be given in accordance with the approved IACUC protocol. 
• During the postoperative period, an animal’s normal hydration, nutrition, and behavior, must be assured and documented.
• Surgical sites must be monitored for infection and the animals monitored for any evidence of behavioral or physical changes. Surgical clips or sutures must be removed in a timely manner. 
• Due to occupational health concerns, all sheep procedures must be performed in the J9 sheep suite.

G.  Record Keeping:

The surgeon or assistant must keep records with the following information including signatures:

• IACUC approved protocol number;
• Animal(s) identification;
• Type of procedure;
• Type of anesthetic including dose and route;
• Type of analgesic, if given, including dose and route;
• Type of antibiotic, if given, including dose and route;
• Postoperative monitoring (time, observations, date of clip removal, etc.);
• Complications;
• Date of surgery;
• Observations of adverse events made by anesthetists must be recorded on the anesthesia/surgery log sheet;
• All reports of morbidity must be followed up by the veterinarian and documented in the animal health record; and
• A copy of each animal’s health record must be kept in the animal holding room or in an ARC accessible location.  The animal health record includes all treatment records, all anesthesia records, surgical records, and records of pre and post-op care.

Contact Information:

For any additional questions please contact the IACUC Manager at 5-6420.