FDA Safety Tip: Pneumatic Tourniquet Cuffs,With a Tourniquet System
MedSun: Newsletter #11, January 2007

Device Description: The pneumatic tourniquet system consists of a pressure-regulated control unit, tubing, and an inflatable tourniquet cuff. The cuffs inflate with air, oxygen, or nitrogen to a preset pressure to compress the patient’s blood vessels during surgical procedures, thus ensuring a bloodless operative field. Qualified medical professionals, such as surgeons or anesthetists, use the tourniquet systems. Tourniquet systems are contraindicated for use in neonates and patients with peripheral vascular disease, thrombosis, or embolism. Both disposable and reusable tourniquet cuffs are available. Disposable cuffs are intended for single use only, and reusable cuffs are intended to be cleaned and inspected prior to their multi-use.

Crinkling, folding, and bending of pneumatic tourniquet cuffs are common occurrences whether it is a disposable single-use tourniquet or one that was intended for multiple uses. Reported Incident: A patient undergoing a total knee replacement had a pneumatic tourniquet cuff in use. Cast padding was applied to the patient’s upper thigh, beneath the tourniquet cuff, prior to covering the patient with a surgical drape. During the surgical procedure, the patient’s bleeding became uncontrolled and the pressure of the tourniquet cuff was inflated to 300 mmHg, and then to 350 mmHg. The inflation source appeared to be working properly, without any active alarms. At the end of the surgical procedure, the drapes were removed and the tourniquet cuff was noted to be crinkled and appeared to have a defect on the inside. The cuff’s rigid bladder was bent, folded, and crushed down the wrong way, thus preventing the appropriate pressures from being applied to the thigh and controlling the patient’s blood flow. The patient experienced subsequent blood loss as a result of this event.

Recommended Actions for All Pneumatic Tourniquet Cuffs:
• Tourniquet cuffs are subject to wear, tear, and deterioration, and should be inspected routinely for integrity and potential safety hazards prior to each use. The pneumatic cuff’s VELCRO® cuff closures, bladder, seams, and tubing should be inspected before applying the cuff to the patient. Physical damage to the cuff, such as rips, tears, or holes, as well as kinked or occluded tubing connecting the cuff to the instrument, may prevent the instrument from displaying the correct pressures.
• Tourniquet control units and cuffs should be checked, disassembled, and cleaned in accordance with the manufacturer’s written instructions with documentation per internal policy.
• Caution should be taken with the placement of tourniquet cuffs. The cuffs should be applied smoothly, with no wrinkles or tunneling effect, to prevent damage to the underlying skin and soft tissue. The skin should be protected by wrapping padding, with interlocking fibers that will not come apart, prior to tourniquet application.
• Inflation pressure and times are to be determined by the patient’s physician. It is important to remember that when a patient is experiencing uncontrolled bleeding at the operative site, increasing the pressure might not be the most appropriate action. Attention should be given to the tourniquet cuff to see if anything looks unusual, such as the crinkled cuff in this case.

References:
AORN (February 2002). Recommended Practices for Use of the Pneumatic Tourniquet. AORN Journal. 75 (2).
Food and Drug Administration (April 2001). Enforcement of FDA Requirements on Reprocessing of Single Use Devices.
McEwen J., Inkpen K. (August 2002). Safety Preventing Skin Injuries. The Surgical Technologist. 218 (1):7-14. Tourniquet.org (November 2005). Tourniquet Overview.

Additional Information:

Enforcement of FDA Requirements on Reprocessing of Single Use Devices.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121970.htm

Tourniquet Overview
http://tourniquet.org/


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