The benefits of latex-free gloves in the operating room environment

Prevalence

Latex gloves have one major limiting factor, the potential for users to develop hypersensitivity to the latex itself, also known as latex allergy.

Since the exponential increase in the use of disposable powdered latex gloves after 1987 (Sussman et al, 2002), there is now sufficient evidence that health professionals as an occupational group have an increased risk of latex allergy (Bousquet et al, 2006), with a prevalence rate of type 1 mediated reaction of 17% (Turjanmaa et al, 2002). Internationally reported prevalence rates are between 2% and 22%, depending on the population and diagnostic methods used (Grzybowski et al, 1996; Douglas et al, 1997; Leung et al, 1997; Liss et al, 1997; Watts et al, 1998; Verna et al, 2003; Chaiear et al, 2006; Wan et al, 2007).

Impact and symptoms

An allergic reaction to latex typically results in discomfort and can potentially be life threatening. It also has an extended effect on the day-to-day lives of those affected, for example, not being able to eat food handled by workers wearing latex gloves (Bernardini et al, 2002; Beezhold et al, 2000; Lee et al, 2001; Schwartz, 1995).

The most common type of latex allergy is a type 4 reaction, presenting as contact dermatitis secondary to cumulative exposure, often appearing hours or days after contact with the allergen. This is a cell-mediated reaction, often to the chemical additives in rubber, rather than the latex proteins themselves (Conde-Salazar et al, 1993). Anaphylaxis is a rare but potentially fatal type 1 immunoglobulin E–mediated reaction that can also occur in individuals who have previously been sensitised to latex proteins (Seaton et al, 1988; Taylor et al, 1989; Aldlyami et al, 2010). In more common situations, this manifests with cutaneous, ocular, respiratory or systemic symptoms. These include contact urticaria, pruritis in the skin and eyes, sneezing, bronchospasm and asthma (Dreyfus et al, 2004).

Associated costs

Latex allergy poses not only a risk to the individual but also an economic burden for employers and wider society. An allergy may cause employees to underperform at work, no longer be able to carry out certain roles or have to take leaves of absence, resulting in lower productivity (Taylor, 1997). These employees may also require additional medical care and/or costly changes to the work environment and, if these are not sufficient, they may then seek litigation claims and claim early pension benefits (Horwitz et al, 2002; Tyler, 2002). This can all incur significant added costs for employers and, consequently, taxpayers.

For example, studies on latex-related compensation claims in the USA have shown that, between 1987 and 1998, the annual claim rate was 0.58 per 10 000 healthcare workers, constituting 0.29% of all worker claims, with an average cost per claim of US $8309 (Horwitz et al, 2002). Implementation of latex-sensitivity protocols has been an effective method of reducing the average cost per claim (Tyler, 2002).

Identifying risk factors

Identifying high-risk groups of patients allows the targeting of cost-effective preventive management strategies (Dakin and Yentis, 1998). Since numerous latex proteins have been portrayed, immunological testing is not dependable. Therefore, because of the occurrence of false negatives, patients suspected to have latex allergy based on their history should be managed in a latex-free environment, even if immunological tests state otherwise.

The most prudent test available to establish those at risk of latex allergy is history taking with knowledge of at-risk groups. The most reliable indicator of latex sensitivity is the appearance of symptoms, such as itching, swelling and redness, after contact with rubber products, such as rubber gloves, balloons and condoms, or swelling of the tongue and lips after dental examinations (Holzman, 1993; Porri et al, 1997). Other reported risk factors for developing a latex allergy include:

Cornstarch dusting powder

The cornstarch dusting powder used in latex gloves has been shown to increase the risk of sensitisation, because the latex proteins are carried and made airborne by the powder particles, thus contaminating operating theatre or ward environments (Palosuo et al, 1998; Barbara et al, 2003; Crippa et al, 2003). The frequency of latex glove use is a strong determinant of airborne latex allergen levels in the healthcare setting, which in turn correlate with the frequency of allergic symptoms in those exposed (Heilman et al, 1996). It is known that powdered gloves have higher latex allergen content than powder-free gloves (Koh et al, 2005) and are thus associated with higher prevalence rates of latex sensitisation (Allmers et al, 1998; Hermesch et al, 1999).

Clinician preferences

In a study of clinicians' preferences by Mylon et al (2014), most surgeons preferred using latex gloves, and they only used latex-free alternatives if the patient had an allergy or sensitivity to latex. Participants reported that latex-free gloves provided less tactile sensitivity, comfort and flexibility, and that they were comparatively ill-fitting, slippery and felt thicker, despite being the same thickness according to manufacturer data and laboratory measurements. The clinicians provided mixed feedback in terms of how the glove material affected their performance. Some thought that non-latex gloves were less safe, because they lacked elasticity, which led to poor fit, and that they were less efficient, because they tore more easily, which led to more frequent changes. Others thought that the material had no negative effect on performance that could not be compensated for by user adaptation.

Failure rates

A study comparing latex and latex-free gloves by Newsom et al (1998) found puncture rates to be comparable. However, latex-free gloves were associated with lower tearing resistance and larger punctures, which were more readily noticed by the surgeon. Some of the surgeons found this to be unacceptable, and it was also reflected in the number of gloves discarded while donning.

The barrier protection provided by both latex and latex-free gloves can break down over time, and therefore they should be changed after 2–3 hours of use (NHS Plus and RCP, 2008). This is supported by Newsom et al (1998), who found that the puncture rate increased by 40% after 100 minutes of use.

According to guidance from the NHS Plus and RCP (2008), latex-free gloves ‘have higher failure rates in use and lower user satisfaction than latex gloves’. Therefore, the guidance generally recommends the use of powder-free, low-protein latex gloves instead of entirely latex-free substitutes. However, exception is made for individuals who are allergic or sensitive to latex, with whom the guidance advises the use of latex-free gloves.

Overall cost

Philips et al (1999) conducted a cost analysis of three healthcare institutions in the USA. This showed that, despite latex counterparts gloves being cheaper than latex-free counterparts, 1% or fewer of those at risk would have to become fully disabled or fewer than 2% would have to become partially disabled for the continued cost of latex gloves to exceed the cost of a latex-safe approach. Thus, it was concluded that, despite latex-related disability rates being relatively low, healthcare institutions regardless of size would benefit financially from becoming latex safe. A business case can therefore be made for the use of non-latex gloves in hospitals, particularly in the operating theatre, not only to protect patients and healthcare workers, but also to cut costs for institutions and the health service overall.

Local protocols

Although latex-free gloves are now readily available in all hospitals in the UK, at present, there are no mandatory requirements for hospitals to be completely latex free. However, there are protocols for managing risk should a patient have a latex allergy, which are often enforced on a local level, with slight national variations.

In surgical environments, this typically begins with taking patient history to identify at-risk groups before they enter the operating theatre. Then, to ensure that at-risk patients are operated on in a latex-free environment, they are either put first on the operating list or taken to a theatre that has been unused or latex-free for 1 hour, in order to reduce the level of latex particles in the atmosphere. A laminar-flow theatre is ideal for this. Since latex gloves are the main source of NRL proteins in the atmosphere and can therefore contaminate other equipment, the latex-free gloves should be used when preparing the theatre. All latex objects should be removed from the theatre itself or made inaccessible. Health professionals should wash their hands after touching latex objects and change theatre scrubs if they have previously used latex-containing items earlier. Finally, theatre doors should always display ‘latex allergy’ warning signs (Royal Cornwall Hospitals NHS Trust, 2019).

National guidance in Ireland

In Ireland, the Health Service Executive (HSE) recommends that employers must carry out a suitable and sufficient assessment of the risks to health caused by the exposure to latex proteins. Employers must prevent or adequately control exposure and implement suitable health surveillance for employees exposed or likely to be exposed to latex proteins. They should also provide information, instructions and training for people who may be exposed to these proteins. Employers should carefully consider the risks when selecting gloves in the workplace, because of the importance of latex gloves as a source of exposure to latex. Control measures should therefore be put in place, such as the use of latex-free products where reasonably possible and the implementation of guidelines on latex use (HSE, 2011; HSE (Republic of Ireland), 2017).

National guidance in the UK

The national guidance (NHS Plus and RCP, 2008) is based on the literature on the use of NRL products, and the authors' recommendation is to remain in line with this. The key findings and recommendations are:

The guidance concludes that the evidence does not support a complete ban on the use of latex gloves, but that institutions should consider whether latex-free gloves, powder-free low-protein latex gloves, or both, would better meet their needs, depending on the setting, the required properties of the gloves and the relative drawbacks of each material (NHS Plus and RCP, 2008).

Case study 1

Steve Jeffery, Consultant Burns and Plastic Surgeon, University Hospitals Birmingham, NHS Foundation Trust

The senior author wore the size 8.5 Protexis PI Micro latex-free gloves for five consecutive plastic surgery cases during a routine elective operating list. The operating list consisted of one scar revision with direct closure; one scar revision with local flap closure; one contracture release with a local flap; one excision of lesion with application of a split-thickness skin graft; and one wound debridement with the subsequent application of negative-pressure wound therapy. He was not allergic to latex and had been routinely wearing latex gloves for over 35 years. He had previously worn latex-free gloves on the occasion when the patient was thought or known to be allergic to latex, during which the whole theatre team were told to wear latex-free gloves.

He trialled the gloves at the request of the manufacturer. He found them to be easy to put on and comfortable to both wear and remove. The feel and grip of the gloves were good, and the appearance of the gloves and their packaging was satisfactory. The durability of the gloves seemed satisfactory, and he had no problems with ripping, despite this being something he had experienced with his hospital's current gloves. Surgeon safety, therefore, should not have been an issue. He had no issues with the performance of the gloves and would gladly wear them in the future, if permitted. There was no redness or irritation of his skin on removing the gloves.

His previous experience of latex-free gloves was that they were inferior to standard latex gloves, being more prone to ripping and not contouring as well. He was, therefore, pleasantly surprised with the performance of these latex-free gloves. Because these latex-free gloves were just as good in terms of feel, comfort, appearance, packaging and grip as standard latex gloves, he could not see why they are not used more frequently.

Case study 2

Amir Hamid, Consultant Ophthalmic Surgeon, Optegra Eye, Hospital Central London

A 58-year-old woman presented for cataract surgery and implantation of a multifocal intraocular lens for both eyes at a hospital in central London. The surgery would remove her cataract and simultaneously remove her dependency on a spectacle correction. Following a full assessment and informed consent, she was listed for the procedure to be performed on both eyes. A latex allergy was identified at her pre-operative assessment. She would develop a rash whenever exposed to latex, but no previous symptoms of respiratory distress or anaphylaxis were noted.

As was standard policy, the patient was first on the morning theatre list, having ensured the previous day that a latex-free environment had been established in both the theatre and pre-operative ward, and sufficient time was allowed for a complete cycle of air exchange. Her latex allergy was clearly identified on the theatre operating list; she had a red allergy patient identification band applied to her wrist; the allergy was further discussed with all team members at the pre-operative team brief.

Surgery was performed as standard, with no complications to either eye. Both the operating surgeon and the scrub nurse used latex-free operating gloves. For this particular case, they used latex-free gloves from Cardinal Healthcare. The surgeon found it an excellent substitute for their normal latex microsurgical gloves, so much so that they could barely tell the difference. He said that he would, in all honesty, be happy to use these gloves even in non-latex allergy cases, and that they would be an excellent choice for health professionals with latex allergies to use routinely.

Latex allergy is a common occurrence in this patient population; it also frequently affects members of the ophthalmic team. The correct policies can both mitigate risk and ensure excellent patient outcomes. Surgical-glove technology and quality have improved significantly in the past few years, and there is little difference in performance intraoperatively.

Case study 3

Matthew Camilleri, CT2 in Anaesthesia, North West Anglia NHS Foundation Trust

A 74-year-old man undergoing general anaesthesia for a laparotomy had a four-lumen central venous catheter inserted after induction for central venous access and monitoring of central venous pressure. It was placed in the right internal jugular vein, using an ultrasound-guided Seldinger technique, under full aseptic conditions. A risk assessment showed no risk of latex allergy in the patient or staff. However, the operator used latex-free sterile gloves in order to compare them with standard available latex gloves for education and training purposes.

This demonstrated that the latex-free gloves were paler in colour, but otherwise presented in the same way as latex gloves, in a sterile paper packet with folded cuffs arranged for left- and right-hand application, with both the outer and inner packet clearly marked with the latex-free symbol. On opening the packet, there was a distinctive but not unpleasant smell that was not present with latex gloves. The latex-free gloves were easy to put on and felt comfortable; their texture was smoother than that of latex counterparts. However, this did not affect grip, and passing of the guide wire was easy, even when wet, with the gloves providing good grip on the equipment used. The latex-free gloves did not affect dexterity, nor hinder the use of small pieces of equipment. Their tactile sensation was equal to that of latex counterparts, giving the ability to palpate landmarks confidently. The latex-free gloves were easy to remove and, after testing the fingertips by stretching, they did not tear with the application of moderate force.

The latex-free gloves used on this occasion appeared to be of equal quality and utility for this procedure as the latex-containing counterparts used previously. While this was a single use by a single operator, the equal efficacy when using latex-free gloves would suggest that routine use in theatre would not be unreasonable to reduce risk of latent latex allergy. The cost-effectiveness of this change would need to be examined and further opinions sought by other members of the anaesthetic department, but the operator will be considering routine use of latex-free gloves in the future.

Case study 4

Alexander Zargaran, Academic Foundation Doctor, Guy's and St Thomas' NHS Foundation Trust, David Zargaran, Core Surgical Trainee, Guy's and St Thomas' NHS Foundation Trust, and Maxim D Horwitz, Consultant Hand and Wrist Surgeon, Chelsea and Westminster Hospital NHS Trust

A 24-year-old woman sustained an injury to the flexor tendon (flexor digitorum profundus) of her right little finger. She was noted to have a latex allergy, and the theatre staff ensured that no latex-based gloves were used. The procedure requires very careful manipulation and handling of tissues to ensure surrounding structures are not adversely affected and dexterity is, therefore, a critical component of hand surgery.

The non-latex gloves used were donned in accordance with the non-touch sterile approach and had the look and feel of the usual latex-based gloves. The tactile feedback of the gloves enabled the tying of suture knots with relative ease, ensuring the application of appropriate tension. Given the relatively fine nature of the sutures used, sutures are at risk of fracturing inappropriately when the application of tension is not evenly distributed. Furthermore, the delivery and interpretation of tactile feedback is also critical in operations where access is restricted, although, in hand surgery, it is often the case that good access can be achieved. Intraoperatively, the gloves did not restrict dexterity and allowed for supple manipulation of tissues, sutures and instruments. The entire procedure lasted 45 minutes, and no perforations of the gloves were noted.

Upon completion of the operation, the gloves were removed with appropriate ease. In summary, the difference in comfort, application, intraoperative use and removal were comparable with latex-based gloves. From a business perspective, there was evidence of cost savings arising from a switch to latex-free gloves; however, formal cost effectiveness analyses would inform future decisions. Furthermore, comfort and reducing the chances of allergic reactions through removing the offending allergen all represent benefits of switching to latex-free gloves.

However, these are not the only considerations when weighing up a potential switch to latex-free gloves. In medicine, the primary concern should be patient safety. Given the reports of perforation when operating with latex-free gloves, there would need to be an evaluation of the safety-profile of the gloves, as well as an assessment of whether there is any difference in surgeons' technical abilities when operating, before any transition.