The Use of Non-Sterile Pneumatic Tourniquets in Limb Operations

Submitted by

Noam Gavriely MD, DSc and Larry Murdock, RRT

Synopsis

Despite multiple peer-reviewed clinical studies showing 100% of non-sterile reusable pneumatic tourniquet cuffs being contaminated with the same pathogens that cause surgical site infection (SSI), many hospitals and surgical centers continue to use them. The purpose of this position paper is to review the literature and set the stage for a mid-term change in the AORN Standards of Care recommendation on the use of tourniquets to mandate that all tourniquets used on patients for limb surgery be sterile.

Conflicts of Interest:

Both authors are employees and stakeholders of OHK Medical Devices, the manufacturer of HemaClear Exsanguination Tourniquet (www.hemaclear.com).

Background

?Devices to exsanguinate a limb and block the re-entry of blood into it have been in routine use for >140 years. Initially it was the Esmarch bandage, originally described by Friedrich von Esmarch in 1873, used alone to both exsanguinate the limb and for arterial blocking. The pneumatic tourniquet followed shortly thereafter with its invention by Harvey Cushing in 1908. Both devices are still in broad use in the operating theatre. Since 2003 the sterile elastic exsanguination tourniquet (HemaClear?) is being used in hospitals in the US and around the world.

?Data

Starting in 2006 a series of papers appeared in the peer-reviewed literature where bacterial colonization of non-sterile pneumatic tourniquets had been analyzed. Table 1 shows the main findings of each of these studies.

Title: Microbial colonization of tourniquets used in orthopedic surgery. Authors: Walsh EF1, Ben-David D, Ritter M, Mechrefe A, Mermel LA, DiGiovanni C. Journal: Orthopedics. Date and page: 2006 Aug; 29(8):709 -13.

Main findings: coagulase-negative staphylococci, Bacillus, and Staphylococcus aureus were present in 100%, of non-sterile OR tourniquets.

Authors Comment: Tourniquet contamination may be a risk factor for the development of surgical site infection in orthopedic surgery.

Title: A study of microbial colonization of orthopedic tourniquets. Authors: Ahmed SM1, Ahmad R, Case R, Spencer RF. Journal: Ann R Coll Surg Engl. Date and page: 2009 Mar;91(2): 131-4

Main findings: All sampled (n=20) tourniquets were contaminated with colony counts varying from 9 to >385. Coagulase-negative Staphylococcus spp. were the most commonly grown organisms from the tourniquets (96%). Some tourniquets had growths of important pathogens including methicillin- resistant Staphylococcus aureus (MRSA), Pseudomonas spp., and S. aureus.

Authors Comment: In addition to the manufacturers' guidelines, we recommend the cleaning of tourniquets with a disinfectant wipe before every case.

Title: Tourniquets and exsanguinator s: a potential source of infection in the orthopedic operating theater? Authors: Brennan SA1, Walls RJ, Smyth E, Al Mulla T, O'Byrne JM. Journal: Acta Orthop. Date and page: 2009 Apr; 80(2):251-5.

Main findings: Bacteria commonly implicated in surgical site infections such as coagulase-negative staphylococci, Staphylococcus aureus and Proteus spp. were prevalent. We also found a resistant strain of Acinetobacter and Candida.

Authors Comment: Infectious organisms reside on the tourniquets and exsanguinators presently used in the orthopedic theater. These fomites may possibly be a source of surgical site infection.

Title: The effect of sterile versus non-sterile tourniquets on microbiological colonization in lower limb surgery. Authors: SM Thompson, M Middleton, M Farook, A Cameron- Smith, S Bone, and A Hassan. Journal: Ann R Coll Surg Engl. Date and page: 2011 Nov; 93(8): 589–590.

Main findings: Thirty-four (34) non-sterile tourniquets were sampled prior to surgical application, twenty- three of which were contaminated with several different organisms including coagulase-negative Staphylococcus spp Staphylococcus aureus, Sphingomonas paucimobilis, Bacillus spp, and coliforms. Thirty-six sterile tourniquets were used, with no associated contamination.

Authors Comment: There was significant contamination of 68% of orthopaedic surgical tourniquets. These are used regularly in procedures involving the placement of prosthesis and metalwork, and can act as a potential source of infection. We recommend the use of sterile single- use disposable tourniquets where possible. The availability of an alternative should now set the new standard of care and we recommend adopting this as a current NICE guideline for control of surgical site infection.

Title: Microbial colonization of orthopedic tourniquets: A potential risk for surgical site infection. Authors: SK Sahu1, B Tudu, PK Mall. Journal: Indian J Med Microbiol. Date and page: 2015: 33: 115-118.

Main findings: It was observed that the tourniquets were colonized with coagulase-negative staphylococci, Staphylococcus aureus, Bacillus, diphtheroids, Pseudomonas, Acinetobacter, enterococci, enterobacteria, and Candida.

Authors Comment: All the tourniquets were colonized with microorganisms. Colony counts from different spots of the untreated tourniquets ranged from 15 to 68 colonies per spot. The inner surfaces of the tourniquets were more contaminated than the outer surfaces (1459 against 1030 colony counts). Proximal aspects were more contaminated than the distal aspects (1382 against 1107 colony counts).

It is clear from the above literature review that nearly all non-sterile tourniquets are contaminated with pathogens.

Methods that are currently used to mitigate the risk of contaminating the surgical site

The most commonly used method is to place the pneumatic tourniquet as far away as possible from the incision site. For example, the tourniquet is placed on the thigh for a foot case or on the upper arm for a hand case. The tourniquet is wrapped or covered by a sterile drape which creates a bacterial barrier when intact. The recommendation to clean the tourniquet between cases with a bacteriocidic solution is seldom adhered to in most ORs.

Methods to avoid transmission of pathogens from one patient to another

Reusable pneumatic cuffs are padded with an absorptive soft material (e.g. Web Roll) and/or cuff covers. No data are available on the effectiveness of such pads in blocking the spread of pathogens from one patient to another.

Methods to protect the OR staff against contamination by tourniquets.

Given the fact that almost all non-sterile pneumatic tourniquets are contaminated and typically stored in an open basket (photo), it is advisable that the OR personnel handling them and place them on the patient will do so with sufficient protection. Unfortunately, this is not always the case.

Critique and Discussion

The incidence of Surgical Site Infection continues to be high, ranging from 0.72% to 1.4% in 3 recent clinical-epidemiological studies of SSI in TKA ( ). This translates to between 7 and 14 deep SSI cases per thousand TKA patients. Unfortunately there are no studies that looked at the incidence of SSI post TKA with sterile vs. non-sterile tourniquets. There is one study in bilateral TKA (Demirkale et Al, J. Arthroplasty, 2014 Volume 29, Issue 5, Pages 993–997 ) that showed a drop from 1.3% to 0.4% in post TKA Deep SSI (p=0.11) when non-sterile pneumatic tourniquet was replaced by a sterile elastic exsanguination tourniquet. Clearly, additional studies are needed in order to determine if using non-sterile pneumatic tourniquets are safe to use.

SSI is debilitating and very expensive with the cost coming to be $50,000 - $70,000 per patient. If the incidence of SSI is reduced by only one case per 1000, it is easy to see that the saving can be

$50 - $70 per case which is roughly the cost of each sterile single-patient use tourniquet.

Conclusion

Based on the literature published in the last few years reusable pneumatic tourniquets are contaminated with pathogens which may cause surgical site infection. These publications are not cited in the current AORN Guidelines on safe tourniquet use and should be considered new evidence that justify a mid-term evaluation of the subject matter. We recommend that the committee will act to consider these new evidence-based data and move to amend its guidelines to include a requirement that tourniquets used in the OR for limb surgical procedures will always be sterile.

Bibliography

?Incidence of Surgical Site Infection

?1.????Levent T1, Vandevelde D, Delobelle JM, Labourdette P, Létendard J, Lesage P, Lecocq P, Dufour M. Infection risk prevention following total knee arthroplasty. Orthop Traumatol Surg Res. 2010 Feb;96(1):49-56.

The incidence of infection was 1.4%...?

2.????Sewick A1, Makani A, Wu C, O'Donnell J, Baldwin KD, Lee GC. Does dual antibiotic prophylaxis better prevent surgical site infections in total joint arthroplasty? Clin Orthop Relat Res. 2012 Oct; 470(10):2702-7.

?During this period, there were 22 SSIs (1.2%)…

3.??????Robert S. Namba, MD, Maria C.S. Inacio, MS, and Elizabeth W. Paxton, MA Investigation performed at the Department of Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, California. Risk Factors Associated with Deep Surgical Site Infections After Primary Total Knee Arthroplasty An Analysis of 56,216 Knees. J Bone Joint Surg Am. 2013;95:775-82

Incidence of deep surgical site infection was 0.72% (404/56,216).

?Tourniquet guidelines

4.????https://www.guideline.gov/content.aspx?id=47825&search=tourniquet+single+use+clea ning+2014

?Tourniquet colonization studies

1.??????Walsh EF1, Ben-David D, Ritter M, Mechrefe A, Mermel LA, DiGiovanni C. Microbial colonization of tourniquets used in orthopedic surgery. Orthopedics. 2006 Aug; 29(8):709-13.

“Tourniquet contamination may be a risk factor for the development of surgical site infection in orthopedic surgery.”

2.??????Ahmed SM1, Ahmad R, Case R, Spencer RF. A study of microbial colonisation of orthopaedic tourniquets. Ann R Coll Surg Engl. 2009 Mar;91(2):131-4

“All sampled tourniquets were contaminated with colony counts varying from 9 to > 385. Coagulase-negative Staphylococcus spp. were the most commonly grown organisms from the tourniquets (96%). Some tourniquets had growths of important pathogens including methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas spp., and S. aureus.”

3.??????Brennan SA1, Walls RJ, Smyth E, Al Mulla T, O'Byrne JM. Tourniquets and exsanguinators: a potential source of infection in the orthopedic operating theater? Acta Orthop. 2009 Apr; 80(2):251-5.

“Bacteria commonly implicated in surgical site infections such as coagulase-negative staphylococci, Staphylococcus aureus and Proteus spp. were prevalent. We also found a resistant strain of Acinetobacter and Candida.”

4.??????SM Thompson, M Middleton, M Farook, A Cameron-Smith, S Bone, and A Hassan The effect of sterile versus non-sterile tourniquets on microbiological colonisation in lower limb surgery. Ann R Coll Surg Engl. 2011 Nov; 93(8): 589–590.

“Thirty-four non-sterile tourniquets were sampled prior to surgical application, twenty-three of which were contaminated with several different organisms including coagulase-negative Staphylococcus spp, Staphylococcus aureus, Sphingomonas pau-cimobilis, Bacillus spp, and coliforms. Thirty-six sterile tourniquets were used, with no associated contamination.”

5.??????SK Sahu1, B Tudu2, PK Mall2 Microbial colonisation of orthopaedic tourniquets: A potential risk for surgical site infection. Indian J Med Microbiol 2015: 33: 115-118

“It was observed that the tourniquets were colonised with coagulase-negative staphylococci, Staphylococcus aureus, Bacillus, diphtheroids, Pseudomonas, Acinetobacter, enterococci, enterobacteria, and Candida.”

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