Potential Risks and Hazards of Reprocessing Single-use Disposable Tourniquet Cuffs

Single-use disposable tourniquet cuffs are generally supplied as sterile products and are intended for disposal after use. The design characteristics and choice of materials for these disposable cuffs are intended to allow them to be applied and used safely and reliably within a sterile surgical field during a single surgical procedure. These various materials and components have been chosen to be sufficiently inexpensive to allow the cuff to be economically discarded after use, and also to be capable of sterilization by exposure to a specific sterilizing agent specified by the manufacturer, without deterioration or change of properties in the cuffs.

Some institutions have reprocessed and reused tourniquet cuffs that were originally supplied by their manufacturers as sterile products limited to a single use. Reprocessing efforts typically involve saving rather than discarding a disposable tourniquet cuff after surgery, visually examining the cuff to identify any obvious deterioration that might suggest reprocessing is not appropriate, attempting to remove any blood and other surgical debris by washing and disinfecting the cuffs with water combined with a variety of detergents, cleaning liquids and disinfecting agents prior to re-sterilization.
Some disposable cuffs are reused as non-sterile cuffs after only cleaning, or after cleaning and disinfection, with no functional testing and with no attempt to re-sterilize the cuff. In other situations, cleaned cuffs may be repackaged and then re-sterilized by exposure to a sterilization agent within a sterilization process that may be different from that determined by the original manufacturer to be safe and effective.

Reprocessing of disposable tourniquet cuffs, with or without re-sterilization, may be carried out within a hospital or a surgery center or by a third-party reprocessor, with the quality and methods of reprocessing highly variable.

Reprocessing of a disposable tourniquet cuff may result in hazards for the surgical patients. For example, one such hazard arises from deterioration of cuff materials due to exposure to chemical or physical agents during reprocessing, cleaning, disinfection and re-sterilization. Exposure of a cuff to liquids during cleaning and disinfection may allow liquids to enter and partially or completely block the pneumatic passageways within the port and inflatable portion of the cuff. If the cuff is re-sterilized as part of the reprocessing, any water remaining within the pneumatic passageway after cleaning may subsequently react chemically with ethylene oxide, a sterilizing agent commonly used in reprocessing, to form ethylene glycol, a sticky substance that may completely or partially block the pneumatic passageway.

A single or repeated exposure of cuffs containing flexible thermoplastic materials to elevated temperatures during drying after cleaning or disinfection with liquids, or during re-sterilization, may soften materials and components, increasing the likelihood of hazardous deformation of some components such as tubing, connectors, ports, stiffener etc. Substantial deformation of the stiffener may impair the application of pressure to an underlying limb upon subsequent use during surgery. Partial or complete blockage of a pneumatic passageway within port may affect regulation of pressure within a tourniquet cuff during use. Deformation of the connector may lead to separation of the cuff to the tourniquet instrument, resulting in instantaneous deflation of the cuff and loss of limb occlusion.

In general, repeated reuse of a disposable tourniquet cuff beyond the limit of usage specified by the manufacturer, including exposure to cleaning and disinfection agents and processes not anticipated by the manufacturer if reused as non-sterile cuffs, and including exposure to re-sterilization agents and processes if reused as sterile cuffs, may progressively increase the hazards for the surgical patient.

References for educational viewing only

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AORN. Recommended Practices for the Use of the Pneumatic Tourniquet in the Perioperative Practice Setting, Ass’n of periOperative Registered Nurses, 2009.