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People, Places, Processes & Products that Influence the Supply Chain

 

INSIDE THE CURRENT ISSUE

February 2009

Infection Protection

From patient transport to food service:

Glove selection is critical across the care continuum

by Judson Boothe, marketing director of medical supplies, Kimberly-Clark Health Care

In the healthcare setting, gloving is an important component in preventing microbial transmission as hands are the primary means by which microorganisms are passed between patients and healthcare workers (HCWs). Physicians, nurses, and other clinical specialists are often the focus of barrier protection; however, ALL staff across the healthcare continuum may be vulnerable to contracting and spreading transmissible diseases. Therefore, it is critical that all personnel select and use appropriate glove protection for the task to be performed. Considerations for glove selection include the barrier protection afforded by the glove material, potential for glove-associated reactions and cost per use.

The Centers for Disease Control and Prevention (CDC) noted in the "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007 (2007 Isolation Guideline) that "there is considerable variability among gloves" and that "both the quality of the manufacturing process and type of material influence their barrier effectiveness."1 The protection a glove offers depends on the base material used in manufacturing, formulation of the materials used in its production, tasks performed by the glove wearer, and stresses and chemicals to which it will be exposed. How each factor is weighted in importance is critical to selecting the right glove for the right activities and exposure levels. The protective ability of a medical glove is dependent upon the molecular structure of the material from which it is made as this can lead to dramatic differences in barrier performance.

Nurse suffering irritation due to a latex allergy

With the allergenic concerns for patients and staff exposed to natural rubber latex in clinical settings, gloves made from vinyl and nitrile materials are increasingly chosen as alternatives to latex gloves. Vinyl, or polyvinyl chloride (PVC), is the same material used in a range of products, from pipes to credit cards. To transform PVC from its rigid, brittle form to a very thin and flexible material for use in glove production, a number of plasticizers and softeners must be added. Some of these additives can amount to 50 percent of the finished product.2 Even after compounding, "vinyl lacks the ability to stretch when stressed or snagged and readily fractures, tears or separates at the molecular level resulting in barrier loss."2 As the CDC noted in the 2007 Isolation Guideline, "studies have shown repeatedly that vinyl gloves have higher failure rates than latex or nitrile gloves when tested under simulated and actual clinical conditions" and does not recommend using vinyl gloves for procedures requiring manual dexterity or more than brief patient contact.1 Still another concern with some vinyl gloves is the uncertain fit with bagginess in the body of the glove and loose cuffs that can impede performance and compromise safety. The protective capacity of vinyl gloves can also be weakened by commonly used liquids and chemicals used in the healthcare setting such as alcohols and glutaraldehydes, thus placing the wearer at risk for exposure to potential toxins.3

The U.S. Food and Drug Administration (FDA) as well as health agencies in a number of other countries have also warned against the use of vinyl gloves containing an additive called diethylhexylphthalate, commonly abbreviated DEHP.4 These warnings are due to studies which show that DEHP may be harmful to infants, young boys, and pregnant women.5,6

By comparison, nitrile-based gloves offer more consistent protection and durability with a greatly reduced risk of punctures or tears. The molecular structure of nitrile provides greater flexibility, conformity and in-use durability than vinyl.6 When tested for chemical permeation resistance, studies show nitrile performs as well as or better than natural rubber latex against penetration by oil-based products, glutaraldehydes, and many other chemicals.2,7,8 Certain nitrile glove products have been cleared by the FDA for use in chemotherapy administration, having performed well when tested with chemotherapeutic drugs to assess breakthrough times.

Vinyl is often thought of as suitable from a cost standpoint for staff that perform ancillary or indirect patient care activities such as patient transportation, housekeeping, or food service delivery. However, those responsible for choosing and purchasing personal protective equipment (PPE) should be aware that employees performing these functions are still at risk for potentially infectious exposures and also require reliable barrier protection which vinyl may not provide. Cost will always be a consideration when determining which glove product to purchase. It should be remembered, however, that the cost factor must be evaluated within the context of product use. Because of the increased risk of barrier failure with vinyl gloves, more gloves per task may be used by the employee. Conversely, because of wearer dissatisfaction with product characteristics (i.e., fit, feel), non-compliance with PPE use may result in increased infectious exposure risk to the worker and resultant financial risk to the facility. Either scenario demonstrates that solely considering the purchase price of vinyl gloves may reflect a false cost savings.

In summary, the wearing of gloves is essential for all HCWs across the continuum of care. However, not all gloves are created equal in their inherent protective characteristics. Understanding the barrier protection provided by the different glove materials is critical to making an informed and appropriate choice.

References

1. Siegel JD, Rhinehart E, Jackson Nm Chiarello L, and the Healthcare Infection Control Practices Advisory Committee. 2007 Jun. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. Online: http://www.cdc.gov/ncidod/dhap/pdf/isolation2007.pdf

2. Rego A, Roley L. 1999 Oct. In-Use Barrier Integrity of Gloves: Latex and Nitrile Superior to Vinyl. American Journal of Infection Control 27(5): 405-410.

3. Association for the Advancement of Medical Instrumentation (AAMI). 2005 Dec. ANSI/AAMI ST58-2005 Chemical Sterilization and High-Level Disinfection in Health Care Facilities. Approved 6 Dec 2005.

4. U. S. Food and Drug Administration (FDA). 2001 Sep. Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices. Online: http://www.fda.gov/cdrh/ost/dehp-pvc.pdf.

5. Rosander P, Malkan S. 2003 Feb. Children, Pregnant Women Need Immediate Protection from DEHP, Says Sweeping New European Union Proposal. HCWH News Release Online: http://www.noharm.org/us/pvcDehp/reducingPVC, accessed January 7, 2009.

6. Brody C. 2002 Dec 4. RE: Medical Devices Made with Polyvinylchloride (PVC) Using the Plasticizer Di-(2-Ethylhexyl) Phthalate (DEHP); Draft Guidance for Industry and FDA. Docket No. 02D-0325. Online: www.fda.gov and www.noharm.org.

7. Infection Control Nurses Association. 2002 May. A Comprehensive Glove Choice. Infection Control Nurses Association.

8. Ghosal K, Szymanski R. 2000 Jan/Feb. Nitriles - Versatile Glove Materials. Rubber Asia 14(1): 27-30.