AST Guidelines for Best Practices for Safe Use of Pneumatic Tourniquets

25 B. Does the labeling and packaging of the pneumatic tourniquet product comply with all relevant requirements specified by the FDA? 1) The manufacturer should provide a copy of the labeling that includes the contraindications, IFU, precautions, prescription device statement and warnings. C. Does the pneumatic tourniquet’s manufacturer have an appropriate and certified quality system for the design, manufacture, installation and servicing of its pneumatic tourniquet products, and management and control of these processes? 1) The manufacturer should provide a copy of the quality system certificate or equivalent evidence of quality system compliance with 21 CFR 820. D. Does the pneumatic tourniquet system contain the following features: 1) Embedded automatic cuff leak detection. 2) Embedded automatic LOP measurement. 3) Embedded automatic cuff testing capability. 4) Releasable application handles rather than tie ribbons. 5) Safety interlock to prevent inadvertent deflation of both cuffs during a procedure involving IVRA. E. Will the surgery department be allowed to use a “loaner” pneumatic tourniquet system to test as well as use during surgical procedures for a prescribed period of time? Guideline VII The surgery department should review the policies and procedures (P&P) regarding safe use of pneumatic tourniquets on an annual basis. 1. The surgery department should include members of the surgical team and administration when reviewing the P&Ps, including CSTs, surgeons, RNs, risk management and infection control officer. A. The surgery department should document when the P&Ps were reviewed, revision completed (if necessary) and who participated in the review process. B. Tourniquets should be included in a routine documented equipment inspection program and preventative maintenance. 6,25,50 Procedures should be established addressing documentation and record keeping at regular intervals of the biomedical inspection and preventive maintenance of the tourniquet system(s) that are in the surgical suite; a 6-month inspection interval is recommended. 50 Documentation of each tourniquet system should include the assigned biomedical or HDO identification number, manufacturer’s serial number, date of inspection and preventive maintenance and comments as to the effectiveness level of the equipment. 97 Additionally, every month, a designated individual, CST or RN, should test the tourniquet systems by connecting the controller to a gauge to verify the pressure accuracy at 300 mm Hg. 50 The pneumatic system(s) should be listed on the facility’s inventory of biomedical equipment to facilitate identification and location