AST Guidelines for Best Practices for Safe Use of Pneumatic Tourniquets

24 the patient from experiencing an allergic reaction and avoid decreasing the life of the cuff. 97 3. The tubing and pressure device should be cleaned with an EPA-registered intermediate-level tuberculocidal disinfectant solution in lukewarm water. 97 The open end of the tubing should not be immersed in the water/disinfection solution; introduction of the solution into the ports can damage the tubing and contribute to microbial growth. 25,97 Additionally, the solution from the tubing can enter the cuff and upon cuff deflation droplets of the solution are forced into the tourniquet regulator ultimately damaging the system. 97 4. The clean cuff and tubing should be dried according to manufacturer’s instructions. The instructions may require the cuff and tubing to drip dry at room temperature or wiped dry with a clean, non-linting cloth to prevent the tubing from drying out and cracking. 25,97 5. After cleaning and drying the cuff and tubing both should be immediately connected to the tourniquet system and tested for pneumatic leakage. 97 6. The tourniquet system with components should be placed in a storage area of the surgery department that is dust-free and clean, and the storage area meets the temperature and humidity requirements of manufacturer. Additionally, it is recommended that the tourniquet system is covered such as with a reusable clear, plastic cover. The manufacturer’s operating guide should be included with the tourniquet system in the storage area. The majority of tourniquet systems are electrical that contain a backup battery that charges while the unit is plugged in; therefore, when the unit is in storage it should be plugged in. Guideline VI The surgery department should involve a multi-disciplinary team in the selection and purchase of tourniquet systems to ensure that the systems meet the demands of the surgical specialties that require the use of a tourniquet during specific procedures. The team should include surgeon(s), anesthesia provider(s), risk management, purchasing department, biomedical department, OR manager, CST(s), and RN(s). 1. In the U.S., pneumatic tourniquet systems are FDA regulated devices; they are regulated as a Class I medical device under 21 CFR 878.5910 Pneumatic Tourniquet (Title 21 Food and Drugs; Part 878 General and Plastic Surgery Devices; Section 5910 Pneumatic Tourniquet). 98 The following are recommended questions to forward to a vendor prior to purchasing a tourniquet system. A thru C are questions taken directly from McEwen (2018), FDA Requirements for Pneumatic Tourniquets in the United States . A. Is the pneumatic tourniquet’s manufacturer registered as an establishment with the FDA and has the manufacturer device listed the pneumatic tourniquet product with the FDA? 1) The manufacturer should provide the Establishment Registration Number and description and the Device Listing Number.