Hazards of Hemaclear Elastic Ring Tourniquets

Posted on September 18, 2012. Filed under: Silicone Ring Tourniquets, Tourniquet Safety | Tags: , , , , , , , , , , , |

This article discusses hazards and limitations associated with the use of a Hemaclear elastic ring as a tourniquet.

The Hemaclear elastic ring has been shown to apply high pressure levels and high pressure gradients to the underlying limb and soft tissues [1, 2].  Such high pressure levels and high pressure gradients produced by this elastic ring have resulted in reports of high levels of pain [3, 4, 5].  In addition to pain, evidence in the published literature has shown that higher pressure gradients and higher pressure levels in tourniquets are associated with higher probabilities of injuries to underlying nerves and soft tissues [2,6].

Elastic tourniquets were used as tourniquets in the nineteenth century.  However, their use was abandoned early in the twentieth century because of many recurring reports of serious nerve and soft tissue injuries resulting from elastic tourniquets, including permanent limb paralysis.  They were replaced by pneumatic tourniquet systems which safely and reliably stop arterial blood flow at much lower tourniquet pressures and lower tourniquet pressure gradients [2,6].

Related hazards and limitations associated with recent efforts to re-introduce a non-pneumatic elastic ring as a tourniquet include the following.

1. The Hemaclear elastic ring does not measure the actual tourniquet pressure applied to the limb, nor does it measure the pressure gradient applied to the patient’s limb.

2. Thus a Hemaclear ring cannot provide the user with an accurate indication of the actual tourniquet pressure and pressure gradient applied to the patient’s limb.

3. There is no documented evidence of the actual pressure levels and pressure gradients applied to limbs by each size of Hemaclear elastic rings.

4. It is not possible to control the pressure applied by the Hemaclear elastic ring to the patient’s limb during a surgical procedure.

5. The surgical user is left with no practical contingency plan in the event of arterial bleeding in the limb distal to the Hemaclear ring during surgery, other than finding and cutting off the ring, and then using a pneumatic tourniquet.

6. Use of a Hemaclear elastic ring is impractical if there is a need for reperfusion of the limb during a long procedure that is typical of revision surgery.

7. Although the Hemaclear elastic ring has had very limited usage in the US to date, problems and hazards associated with this limited usage have already been reported to the FDA. For example: Report of Severe Pain and Report of Skin Tearing.

References (VIEW DETAILS)

[1] McEwen JA, Casey V. “Measurement of hazardous pressure levels and gradients produced on human limbs by non-pneumatic tourniquets.”  Proc 32nd Can Med Biol Eng Conf. 2009, pp 1-4.

[2] Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. “Current Concepts Review: Surgical Tourniquets in Orthopaedics.” J Bone Joint Surg Am. 2009; 91:2958-67.

[3] Smith OJ, Heasley R, Eastwood G, Royle SG. “Comparison of pain perceived when using pneumatic or silicone ring tourniquets for local anaesthetic procedures in the upper limb.” J Hand Surg Eur. 19 June 2012. DOI: 10.1177/1753193412449116

[4] FDA Report 1, FDA Report 2

[5] Report to FDA MedWatch on the Hemaclear elastic ring tourniquet, 2009

[6] McEwen JA. “Complications of and improvements in pneumatic tourniquets used in surgery.” Medical Instrumentation. 1981;14(4):253-7.

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