Clinical considerations for perioperative personnel

Linda McNeilly

In the healthcare environment, the appropriate use of personal protective equipment (PPE) is a key factor in the prevention of transmissible infection for both healthcare workers and patients. Medical gloves are among the most frequently used items of PPE and are one of the most important infection prevention products.

Years ago, there were basically two choices of medical glove materials: latex or vinyl. Today, with the development of new synthetic materials and technological advancements in glove manufacturing, there is a much wider variety of hand protection solutions from which to choose. Accordingly, glove selection for varying clinical tasks requires a careful review and understanding of key clinical considerations.

Glove selection in the perioperative setting is a subjective matter. To aid the selection process, the wearer must consider the material (natural rubber latex vs. synthetic), glove properties (length, size, thickness, strength, coatings) and regulatory and professional recommendations for glove usage from agencies and organizations such as the Food and Drug Administration (FDA), American Society of Testing and Materials (ASTM), Occupational Safety and Health Administration (OSHA), Centers for Disease Control (CDC) and the Association of periOperative Registered Nurses (AORN). And, because infection prevention is the top concern in all surgical practice settings, clinicians should consider only those gloves proven to provide optimal performance in terms of barrier protection.

Medical Gloves: A Highly Regulated Medical Device

Medical gloves are classified as a Class I medical device, so their manufacturing process is subject to rigorous FDA monitoring. Section 510(k) of the Food, Drug and Cosmetic Act also requires device manufacturers to notify the FDA of their intent to market a medical device in the U.S. market at least 90 days in advance. Once the FDA grants clearance, it requires manufacturers to perform batch testing—examining gloves for sterility, dimension consistency, physical properties and freedom from holes—prior to shipment of each manufacturing lot. And while the FDA requires compliance with its regulations, the Administration relies on voluntary consensus standards for gloves issued by ASTM and other regulatory and oversight agencies such as the CDC, OSHA and AORN.

Manufacturers of medical gloves are also required to meet Good Manufacturing Practices (GMP) for medical devices. Manufacturers are required to implement quality assurance (QA) programs and to test their gloves to make sure they meet the Acceptable Quality Level (AQL) and quality claims when delivered to customers. AQL refers to the barrier protection confidence level, and a lower AQL represents a higher quality product.

Key Glove Properties to Consider

While barrier properties such as AQL are the primary consideration for the selection of gloves, there are a number of other properties to consider:

• Length: Measured from the tip of the middle finger to the wrist cuff, surgical glove length can range from 12 to15 inches. When evaluating length, healthcare workers should consider the type of procedure, likelihood of splash and depth of immersion. Because glove lengths vary among glove manufacturers, it is important to make sure the cuffs are long enough to fit snugly over a surgical gown and provide a continuous barrier from hand to arm.
• Size: Glove size is determined by the circumference of the palm at its widest point. Surgical gloves are available in whole and half sizes, ranging from 5.5 to 9. Gloves that are too large can adversely affect dexterity, while gloves that are too small can cause hands to become fatigued.
• Thickness and gauge: Gloves must be 0.10mm thick at the finger, palm and cuff.
• Tensile strength: This refers to the force, measured in megapascals (MPa), required to stretch a glove until it breaks. A high number indicates a stronger glove film.
• Ultimate elongation: This measurement indicates how far a glove can stretch before it breaks. A higher number percentage reflects a stronger glove film.
• Modulus: Modulus is a measure related to comfort—articulating how much force, in MPa, is necessary to stretch a glove to twice its length. A lower number reflects a softer, more comfortable glove.

While length, size, thickness and comfort are primary considerations for the wearer, additional glove properties such as donning lubricants and glove hydration also require consideration in the glove selection process.

In the past, powder has been used to facilitate the release of gloves from their formers during the manufacturing process and also to facilitate glove donning. But advances in manufacturing and coating technologies have made the use and application of powder unnecessary. Coating technologies, such as hydrogel, polyurethane, acrylic, silicone and nitrile, can supplant or reduce the need for powder in the manufacturing process. As a result, glove manufacturers today are able to produce cleaner, low-allergen, powder-free surgical gloves that are equally comfortable to wear, effortless to don/remove and are versatile in both grip and tactile performance.

Even after selecting a glove based on other properties, a clinician may have concern with glove hydration. Glove hydration is the absorption of fluids into the interstitial areas of the glove polymer once wetted, which can result in dissolution of the glove. As a glove hydrates, it loses its resistivity and becomes more conductive over time, and this may be a concern when using electrosurgery devices.

All gloves, especially NRL, hydrate to some level. The amount of hydration is dependent on the material formulation and the glove manufacturing process.

Glove Materials: Advantages and Disadvantages 

Materials used in the manufacturing of gloves have unique qualities, which can serve as advantages or disadvantages in different clinical tasks. The following summary can help healthcare facilities determine how to provide optimal barrier protection while providing for clinician comfort and preference.

• Natural Rubber Latex (NRL)—Natural rubber latex has been considered the gold standard in gloves since the late 1890s and for many years was the only material used in the manufacture of medical gloves. Advantages of NRL include its barrier protection against bloodborne pathogens; its stretchability and elasticity during rigorous manipulation; durability; comfort; ease of movement and tactile sensitivity. However, the barrier properties of these gloves may deteriorate when the gloves are exposed to petroleum-based products, ozone, oxygen or ultraviolet light. And individuals who are allergic to natural rubber latex proteins cannot wear NRL gloves.

Protein levels in natural rubber latex gloves also are a consideration for healthcare workers with latex allergies. But the only protein level label claim that manufacturers can make is “these latex gloves contain 50 micrograms or less of water extractable protein per gram.” Because not all natural rubber latex proteins are allergens, allergen levels may be of greater clinical significance than total protein levels. Clinicians interested in those measurements should ask their glove manufacturer or supplier for the results of allergen testing.

• Polyisoprene (PIP)—Polyisoprene is a new synthetic material that has a chemical structure similar to NRL without the allergenic proteins. It offers healthcare workers an alternative solution that performs like latex in terms of comfort, fit and feel and is ideal for those with a known sensitivity or allergy to natural rubber latex.
• Neoprene—Neoprene was developed as a synthetic substitute for NRL. Although it is comparable in terms of strength, puncture resistance, fit and feel, it is less elastic than NRL. It is a suitable alternative for those allergic to natural rubber latex, offers excellent chemical barrier protection and is less permeable to alcohol than NRL.
• Styrene-Butadiene (SBR)—Another option for those allergic to NRL, SBR is a synthetic copolymer that does not require accelerators. It is ozone sensitive and requires the addition of antioxidant chemicals to control degradation. SBR has lower elasticity than NRL and disintegrates on contact with bone cement.
• Styrene Ethylene-Butadiene Styrene (SEBS)—This synthetic material is an option for those allergic to NRL; however, SEBS has a strong odor, low tensile strength and disintegrates upon contact with bone cement. It is, however, resistant to ozone.
• Polyurethane (PU)—Polyurethane, another synthetic polymer, has high tensile strength and is puncture resistant. PU is less comfortable to wear over time than other synthetic or NRL gloves, can be very slippery when wet and may dissolve when exposed to common alcohols such as ethyl and isopropyl.
• Nitrile—A synthetic polymer developed in response to a latex shortage during World War II, nitrile is a suitable alternative for those with NRL allergies. Other advantages include high resistance to punctures, abrasions, oil-based products, glutaraldehydes and many other chemicals.  Like NRL, this material is susceptible to deterioration from ozone, oxygen and ultraviolet light, and it tears easily once breached. It is most commonly used in the manufacture of examination gloves. 
• Vinyl—Polyvinyl chloride (PVC), or vinyl, is a synthetic material that has been used in glove manufacturing for many years.  It is not used as a surgical glove material due to its high in-use failure rates and poor fit and feel. It is primarily used in the manufacture of examination gloves. Vinyl gloves are suitable for food-service and other areas with low-risk tasks.

The End User—Glove Selection Criteria

A greater understanding of glove manufacturing, regulation and glove properties will improve the glove selection process. End users, though, are often concerned with more practical, task-specific and subjective attributes such as easy removal from packaging, ease of donning, ease of movement, flexibility, good fit, secure grip and tactile sensitivity. For those reasons, it is important for healthcare facilities to offer staff trial opportunities and facilitate feedback on glove quality. Facilities should assist staff in evaluating gloves by asking them to consider these questions when considering various gloves:

• Does the glove material conform to the hand and not feel stiff?
• Does the glove cause any hand fatigue after long periods of time?
• Is there excess glove material—length, width, finger contour, thumb position?
• Does the glove allow for secure grasp of objects?

Healthcare professionals responsible for purchasing gloves need to be familiar with the support services provided by their suppliers. Some manufacturers offer a comprehensive program for glove standardization that can be customized to meet the unique needs of the facility. Others can help a facility analyze utilization patterns and provide comparisons to industry benchmarks. Suppliers can also design plans for optimal glove choices including standardized options defined by clinical procedure and job function.

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Surgical Gloves Do’s and Don’ts

Do’s:

• Inspect gloves for tears, pinholes or any breach after donning and change gloves if breach is suspected.
• Change exam gloves frequently and surgical gloves periodically during lengthy procedures.
• Change gloves between different tasks performed on the same patient.
• Always perform hand hygiene before and after glove removal.
• Ensure that gloves fit properly for the task at hand.
• When double gloving, change both gloves.
• Use only water soluble lotions and moisturizers.
• Use caution with tape or other adhesives that can stick to gloves and cause tears.
• Keep gloves in original packaging, store properly and rotate stock.

Don’ts:

• Wash or reuse single-use gloves.
• Use a glove that feels brittle, hard, weak or too soft.
• Use oil-based lotions.
• Wear gloves for tasks that do not involve contact with blood, body fluid of other potentially infectious material.

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Beyond Glove Selection—Reducing the Risk of Infection

After clinicians select a surgical glove, they must do their own part to promote sterility and prevent infection. Clinicians themselves can reduce bacteria on the skin beneath the surgical gloves by scrubbing with an antiseptic agent prior to donning gloves. Reducing bacteria under the gloves decreases the risk of infection if ever a glove were torn or punctured during the procedure. Failure to perform appropriate hand hygiene is the leading cause of healthcare-associated infection (HAI) and the spread of multi-drug resistant bacteria.

Glove Storage and Handling

Regardless of which gloves are ultimately selected, clinicians must be aware of factors that compromise glove barrier properties and take care to store gloves appropriately. Staff should never store gloves near heaters, air conditioners, sterilizers, x-ray units of any area exposed to ultraviolet light, sunlight or fluorescent light. They should also rotate gloves so that older gloves are used first.

Improved Glove Selection Protocol 

Medical gloves provide more than a crucial barrier of protection for patients, surgeons and nurses during operating procedures. They also supply comfort and tactile sensitivity for all clinicians in the important pursuit of treating and healing their patients. That’s why appropriate glove selection starts with accurate knowledge about the protective properties of glove materials and use considerations for the practical, task-specific and subjective needs of the staff who will be donning those gloves. Moreover, with the growing concern regarding the transmission of epidemically significant pathogens and increased use of medical gloves, healthcare facilities need to recognize that an improved glove selection protocol takes the facility one step closer to eliminating the spread of deadly infections.

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For information on presenting the “Appropriate Glove Selection and Use” continuing education activity to your perioperative team, request the activity via the Cardinal Health Continuing Education Opportunities webpage at http://161.244.186.129/education/ce/ or contact your local Cardinal Health representative. The intended audience is perioperative nurses, surgical technologists and other healthcare professionals who participate in surgical or invasive procedures and are interested in learning more about appropriate glove selection and use for the various patient care activities they encounter in the surgical practice setting. Pfiedler Enterprises is the sponsor of the continuing nursing education credits through the California Board of Registered Nursing. Participants can earn 2.0 contact hours/CE credits.

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Linda McNeilly is a director of marketing, clinical messaging and education for the Surgical Products category at Cardinal Health. For questions related to glove selection and use, contact her at linda.mcneilly@cardinalhealth.com.