Getting a Grasp on the Surgical Glove Market
By Carolyn L. Twomey
In 1890, Dr. William S. Halstead acquired rubber gloves for his nurse who had hand issues related to carbolic acid use in the perioperative arena.1 The adaptation of gloves as a component of surgical attire followed quickly as the reduction in surgical infections was noted. Today surgical gloves are just that--an item worn in every case when an aseptic environment is essential. Historically, practitioners took gloves off the shelf without much thought to the material from which they are made, the impact to the patient and the practitioner from the materials used in the glove manufacturing process, the glove performance characteristics, or the quality of the protective barrier.
Today, more and more practitioners are educated on the issues of dermatitis, chemical allergy and latex protein allergy associated with the use of latex gloves.2 Nevertheless, the ongoing education of healthcare practitioners remains an essential component of risk reduction for both practitioners and patients alike. In a recent paper published in The American Journal of Infection Control, researchers found that although education was provided regarding latex allergies and powder, and alternative products were offered, practitioners failed to make the "right choice."3 Today, as in 1997 when the National Institute of Occupational Safety and Health (NIOSH) Alert4 was released, many experts in the field of allergy and immunology continue to stress the importance of choosing low protein powder-free gloves.5
Latex glove manufacturers have made significant strides in addressing these issues. Latex protein levels have dropped across the board and the powder-free latex glove has made its presence known.6 Today, the market has a number of powder-free latex gloves, made donnable either through the use of an alternative donning agent, such as a polymer coating, or through a finishing process which creates a surface that allows for ease of donning.7
It is helpful to understand what is happening in the glove market overall. As awareness and understanding of the latex allergy and powder associated issues have increased, the shift in the market has become quite clear. As of third quarter 2002, approximately one-third of the surgical glove market is powder free. The powder-free sector of the surgical glove market is growing at a double-digit pace while the surgical glove market overall is growing at a single-digit pace.8 In addition, while synthetic gloves became available when an alternative to latex was needed, in the last two years there has also been an explosion in the synthetic (latex-free) market, not only in volume growth (33 percent) but also in technology available.9 Today a number of synthetic compounds from which the gloves are manufactured are available with a broad spectrum of performance characteristics. There has also been the introduction of a synthetic double gloving system and a synthetic puncture indication system--two key risk management tools. Some believe that within a few years, powder-free and synthetic gloves will be the predominant technologies.10 The significance of this market shift makes it imperative that those involved in product selection or value analysis committees understand the performance characteristics of both powder-free latex products as well as the plethora of synthetic technologies. Keep in mind that glove selection at the practitioner level is dependent upon:
- Length of the procedure
- Type of procedure
- The ability to double glove, as necessary
- Stresses to which the glove is exposed
- Wearer and patient sensitivity
- Individual preference
At the committee level, the key to a successful glove selection process is the determination of glove selection criteria to include such items as:
- Powdered, powder-free, or synthetic
- Low latex protein levels
- Low residual chemical levels
- Quality assurance measures taken by the manufacturer
- Availability of test data for handling hazardous drugs
- Breadth of product line (to meet the needs of all specialties)
To complicate decision making, it is also important to understand the interplay between the surgical glove selected and hand hygiene products as well as surgical gowns, because indeed there are differences. The majority of gowns used today are manufactured with special coatings or proprietary fabrics to prevent strikethrough. However, these barrier characteristics of gowns may lead to a more slippery outer surface. Couple this with a glove that has a smooth inner surface to facilitate donning, and you may have an interface issue (often considered the most vulnerable area of our surgical attire11). This interface issue and the potential for cuff slide down leads to the potential for contamination and quality practice issues. Another interesting issue, addressed in a study by Dr. Kenneth Meyers and William Beck, found that the design of the gown sleeve (fullness gathered at the stockinette cuff) can compromise the sterile barrier. This design creates channels in the gathers of the gown that allow blood and body fluids to run into the glove, soaking the stockinette--the critical interface in the gown-glove interface.
Myers and Beck reported: "From these studies, we conclude that prevention of liquid penetration of gown and glove requires sealing their interface. The exact nature of the sealant, specifics of manufacture, and maintenance of sterility will need to be developed by industry, but it should not be technically difficult once the two industries work in concert."12
Interestingly enough, anecdotal reports have also included the running of sweat from inside the glove out through these same channels, soaking the stockinette cuff leading to barrier compromise.
Today, hand hygiene products for use as a surgical scrub include those that are brushless and/or waterless. Anecdotally, some practitioners have reported greater drag on the hands and arms from some emollients or other components of the surgical scrub that remain on the hands and arms. Yet practitioners working in sync with the industry have been able to overcome many of these difficulties.
It is critical that those involved in the purchase of surgical attire components consider the relationship between the elements and explore these issues with the vendors involved. Some glove manufacturers are responding to issues such as cuff slide down with changes in glove design so the cuff remains more securely on the gown. It is important to work with your manufacturers to address these issues because in all of the above mentioned situations, practitioners and manufacturers working together have been able to work through the issues.
As we go forward in healthcare, it is important to realize that our knowledge must encompass the understanding of new technologies, not only in our areas of expertise, but also clearly understanding products that we evaluate and use. We need to ask about and understand product features, benefits, performance characteristics, challenges (issues) as they relate to product interaction with other medical devices or products, and solutions
Manufacturers that truly want to partner with you for the long term will be just as interested in assuring your in-depth knowledge about their products as they are in responding to your needs long after the product is implemented.
Carolyn L. Twomey is a clinical nurse consultant for Regent Medical.