Maintenance, Cleaning, and Reprocessing
Tourniquet instruments, tourniquet cuffs, tubings and connectors should be inspected and maintained after every use in order to maintain good tourniquet safety, performance and reliability. Accordingly, the 2015 Recommended Practices for the Use of the Pneumatic Tourniquet in the Perioperative Practice Settings (RPs) of the (US) Association of periOperative Nurses (AORN) recommend that the pneumatic tourniquet and accessories should be cleaned after each use according to the manufacturer’s written instructions [1].
For reusable tourniquet cuffs, it is important that they are cleaned according to manufacturer’s guidelines or discarded if they are unable to be cleaned adequately. For disposable tourniquet cuffs, it is important that they are used as single-use products. Reprocessing disposable tourniquet cuffs may result in hazards for the surgical patient on whom such cuffs are subsequently used. For tourniquet instruments, it is important to have a comprehensive pneumatic tourniquet management program to identify problems that may adversely affect patient safety. Finally, it is important to check the entire tourniquet system for pneumatic leakage.
Reusable tourniquet cuffs
Reusable tourniquet cuffs are supplied as non-sterile products, and are intended to be used for multiple surgical procedures. Reusable tourniquet cuffs can be reused with confidence and safety if they are cleaned and inspected properly between each surgical procedure. Each tourniquet manufacturer and 2015 AORN Recommended Practices for the Use of the Pneumatic Tourniquet in the Perioperative Practice Setting [1] provide guidelines for cleaning and inspection of reusable tourniquet cuffs prior and after use.
In general, a reusable tourniquet cuff may be cleaned in lukewarm water and an US Environmental Protection Agency (EPA) registered, intermediate-level, tuberculocidal disinfectant. . The cuff should then be rinsed thoroughly because cleaning solution residue may cause skin irritation, increase the chance of allergic reaction, and decrease the life of the cuff and bladder. A soft hand brush may be used to remove encrusted material. The cuff may also be wiped with isopropyl alcohol.
All tubing should be cleaned, rinsed, and dried between patients and before storage, using an EPA-registered, detergent/intermediate-level disinfectant. Care must be taken to prevent introduction of solution into the ports. Water in the ports contributes to microbial growth. Subsequent deflation of wet bladders may cause minute droplets of solution to be forced into the tourniquet regulating mechanism, causing damage.
The cleaned cuff and tubing should be allowed to drip dry at room temperature. Any increased temperature during cleaning may cause unevenness or rippling in the cuff material, rendering it unsuitable and unsafe for further use.
It is important to note that if a cuff is unable to be cleaned adequately, it should be discarded in an appropriate receptacle.
Finally, before a cuff can be used, it must be thoroughly inspected. For example, the following is a list of items that can be used for cuff inspection prior to use:
- Has the cuff been cleaned thoroughly after the previous use?
- After cleaning, is there any obvious discoloration remaining due to blood or residue remaining from previous use that could be a potential source of contamination?
- Is there any physical damage to the cuff (for example, rips, tears, holes, unevenness or rippling along the length of the cuff when laid flat)?
- Is (are) the positive-locking hose connector(s) on the valve stem(s) bent, broken or worn, or does the black o-ring on each connector appear to be cracked, damaged or missing?
- Is the colored ribbon torn or the ribbon stitching broken?
- Is the hook and loop (Velcro) material torn or is any of the stitching around the material broken or fraying?
- After cleaning, is more than 25% of the (Velcro) contact closure material embedded with fibers that cannot be removed?
- Connect the cuff to a tourniquet instrument, wrap the cuff onto itself, and inflate the cuff. Are there any leaks in the cuff or connectors? Some recent tourniquet instruments have advanced leak detection for automatically detecting leaks in cuffs during and after surgical operations.
- Is there any other physical change or damage to the cuff that would compromise the cuff’s ability to maintain pressure and stop blood flow during a surgical procedure?
- If any of the above conditions are present the cuff is no longer usable and should be discarded. Possible consequences of using a damaged cuff include the possibility of serious to the patient due to the release of blood into the surgical site.
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.
Tourniquet instruments
A comprehensive pneumatic tourniquet management program helps identify equipment problems that may adversely affect patient safety. Regular maintenance checks by the biomedical engineering department should include calibration of the pressure regulator and display with a calibrated pressure standard and regular inspection of the regulator on every mechanical tourniquet. Refer to the tourniquet controller operator’s manual for information on the appropriate frequency, method, and criteria for pneumatic tourniquet testing. Document the date of inspection, preventive maintenance performed, and status of all equipment. Review records of equipment failure and preventive maintenance to help identify equipment performance problems or hazards.
It is the nurse’s responsibility to calibrate a mechanical tourniquet prior to each patient use. If the pressure indicated by the mercury manometer is different from the set pressure by more than 10%, pull it out of service and send it to biomedical engineering.
Store pneumatic tourniquet components as a unit in an environment that is dust-free, clean, and cool; cover with a reusable or disposable fabric. Along with the equipment, store the manufacturer’s guide to troubleshooting and use. Prominently display the manufacturer’s name, model number, and serial number. Depending on hospital policy, tagging each tourniquet with the date of its most recent maintenance check may be required. Notation of date of most recent use is valuable for facilitating rotation among stored units.
Tourniquets that use battery power may have additional storage requirements, such as leaving the tourniquet’s electrical power cord plugged into an electrical outlet. Refer to your tourniquet system’s operating manual for specific storage instructions.
Pneumatic leakage
Pneumatic leakage in tourniquet systems that is not detected by routine inspections and checking is undesirable in surgery and may be hazardous. Undetected pneumatic leakage may lead users to set tourniquet pressures at levels that are substantially higher than required physiologically, to compensate for intraoperative reductions in cuff pressure that users had observed but had not been able to attribute to obvious leakage. However, setting tourniquet pressures to unnecessarily high levels is hazardous because, in the medical literature, higher tourniquet pressure levels have been associated with higher probabilities of patient injuries to nerves and soft tissues [2-4].
Some surgical tourniquet systems have attempted to compensate for undetected levels of pneumatic leakage in the design of their pressure regulators. In typical systems, the pressure regulator is designed to maintain cuff pressure within a predetermined pressure range from a reference pressure, and any fluctuations beyond that range are offset by actuation of a pump, reservoir, or valve in an effort to bring the cuff pressure back within the range. If there is pneumatic leakage sufficient to cause the cuff pressure to decrease beyond the predetermined pressure range, actuation of the pressure regulator may bring it back within range, and if not a pressure-regulation alarm is produced. In some cases, such systems may compensate for significant levels of sustained, undetected leakage without producing any indication of leakage or alarm for the user. Further, sustained leakage may produce an error in the indicated tourniquet cuff pressure in single-port tourniquet systems which estimate cuff pressure by measuring pneumatic pressure within the tourniquet instrument
For typical surgical tourniquet systems, three limitations in the performance and reliability of their pressure regulators exist in the presence of undetected pneumatic leakage. First, tourniquet cuff pressure fluctuates unnecessarily as decreases in cuff pressure are offset by the actuations of the pressure regulator. Second, unnecessarily frequent actuation of the pressure regulator reduces the operational life and reliability of its mechanical components, increases the cost of maintaining and replacing those components, and may increase capital costs by necessitating early replacement of the entire tourniquet instrument. Third, operation of tourniquet systems on battery power is impaired. Typical tourniquet systems may be powered either by external AC power or by an internal battery, so that they can continue to operate safely in the event of a sudden interruption of external power, and independently of external AC power for a prolonged period of time, for example during transportation of a patient from a preoperative room to the operating room, or to facilitate surgery under emergency or battlefield conditions. However, in the presence of sustained leakage pneumatic leakage, the operational time of a tourniquet system when powered by an internal battery for surgery may be substantially reduced due to unnecessary actuations of the pressure regulator. Additionally, the overall life of the internal battery may be significantly reduced, reducing the performance and reliability of the tourniquet system and thereby increasing costs and hazards.
In an effort to overcome these limitations, some of the most modern surgical tourniquet systems have included technology to automatically check the integrity of all pneumatic components prior to each use, or after each use, and to alert users to possible hazards identified by such checking [5].