New regulations focus on strengthening safety and reliability for examination gloves.
The heightened awareness of the potential risk for disease transmission and/or contamination through the contact with bloodborne pathogens and/or contaminated material with bodily fluids has given rise to the needed and mandated use of high-quality patient examination gloves. Thin film examination gloves are effective protective devices that offer barrier protection against exposure to contaminated or infected materials.
The quality of examination gloves is being scrutinized by the Food and Drug Administration (FDA) more today than ever before. The FDA recently announced its intent to raise the bar on the quality requirements for examination glove products and on the manufacturers who produce them.
In recent years, the National Institute for Occupational Safety and Health (NIOSH) issued an alert suggesting that appropriate measures be taken to reduce the incidence of latex sensitivity in the workplace. In addition, the American Society for Testing and Materials (ASTM) has been very active in developing and revising examination glove performance standards to serve as guidelines to manufacturers in the development and manufacture of their products.
In July 1999, the FDA released its draft proposal calling for additional mandatory information to be made available for all examination gloves. The FDA will be asking for a maximum protein quantity label, a maximum powder quantity label, an expiration date, and an optional residual chemical content label.
The FDA has released preliminary and draft compliance guidance information, including the following:
* A maximum upper protein quantity limit of 200µg/g of glove or 200µg/dm2 of glove (dm2 = decimeters squared, a surface area measurement) has been proposed. In addition, a maximum total water extractable protein limit of 1,200µg/glove has been suggested. The protein quantity labels would become mandatory.
* A proposed maximum total powder content or quantity limit for powdered medical gloves was set at 120mg/glove. The powder quantity statement would become mandatory.
* In addition, expiration dating has been suggested. Studies to measure and predict expiration dates (shelf life) would also become mandatory. Real-time data to support the product expiration date recommendations would also become mandatory, as would accelerated aging data that correlates with the real-time data. These efforts will better ensure the predictable effectiveness, via expiration date, of the protective device.
Medical gloves are among the tools that have been mandated for the prevention of the transmission of disease through exposure to bloodborne pathogens and contaminated bodily fluids. The selection of appropriate medical gloves requires an informed decision. It is imperative that the barrier integrity of the various materials used to manufacture thin film medical gloves be evaluated thoroughly.
Test studies have shown that all medical gloves do not offer the same barrier protective qualities. Studies have been published, for example, during the last decade comparing vinyl medical gloves with latex medical gloves. The studies show consistently that latex gloves are superior in barrier protection and performance ratings, as measured by failure rates and resistance to leakage.
In 1995, Heller and Greer wrote an article on glove safety where they summarized studies that have evaluated the integrity of gloves before and after use. The studies indicate that latex gloves provide the best available protection from biohazardous substances.
Some observations from the studies include:
* Korniewicz DM, et al., showed that regardless of the level of stress and the duration worn that used vinyl gloves had a leakage rate of 85.3 percent compared to used latex gloves which had a leakage rate of 18.4 percent.
* Robert C. Klein, et al., in an article titled OVirus Penetration of Examination GlovesO found that polyvinyl gloves had failure rates of 22 percent, and that following exposure to the common disinfectant, 70 percent ethanol, this failure rate was found to have increased to 56 percent. It was also found that latex, although permeable to ethanol exhibited viral penetration less than 1 percent of the time, regardless of whether the latex was pre-exposed to disinfectant.
* Korniewicz DM, et al., showed through the use of a dye-penetration test that there was a statistically significant difference between vinyl and latex procedure gloves. These tests yielded failure rates of 53 percent for the vinyl gloves and 3 percent for the latex gloves.
In addition, the American Society for Testing and Materials (ASTM) has recently reported on its heightened level of activity in revising performance standards for examination gloves made of various thin film materials ? including vinyl, nitrile (proposed), and natural rubber latex (latex), and on its efforts to develop new testing methodologies. ASTM reports that revisions to the Modified Lowry protein test methodology are expected to be final later this year, and that development of a total particulate test methodology for powdered gloves is near completion. The table depicts the various examination glove standard requirements.
ASTM has also been very active in revising the performance standards for medical gloves to include tighter acceptable quality levels (AQL) and more demanding inspection levels.
Because of these new developments, it is becoming increasingly important that glove users and glove purchasers build a strong relationship with a reputable and well-informed medical glove supplier. The medical glove industry is becoming ever so dynamic and is experiencing diverse challenges anywhere from regulatory changes to performance standard changes. As a result, glove purchasers and glove users will begin to rely heavily on a strong medical glove supplier to keep them well-informed and in compliance with appropriate mandated personal protective equipment ? medical gloves.
Tito Aldape is vice president of QA/RA and scientific affairs at Microflex Corp.
Y International Glove Conference. FDA Report. March 29, 1999.
Y NIOSH Alert. June 1997.
Y International Glove Conference. ASTM Report. March 29, 1999.
Y Heller, Eric T. and C. Russ Greer: Glove Safety: Summary of Recent Findings and Recommendations From Health Care Regulators. Southern Medical Journal, Vol. 88, No. 11: 1093-1098, November 1995.
Y Korniewicz DM, et. al.: Leakage of latex and vinyl exam gloves in high and low risk clinical settings. Am Ind Hyg Assoc, Vol. 54, No. 1: 22-26, January 1993.
Y Klein RC, et.al.: Virus Penetration of Examination Gloves. BioTechniques, Vol. 9, No. 2: 196-199, 1990.
Y Korniewicz DM, et.al.: Integrity of vinyl and latex procedure gloves. Nursing Research, Vol. 38, No. 3: 144-146, May/June 1989.
Y ASTM D 5250-92 OStandard Specification for Poly (vinyl chloride) Gloves for Medical Application.O
Y ASTM D 6319-99. OSpecification for Nitrile Examination Gloves for Medical ApplicationO.
Y ASTM D 3578-95 OStandard Specification for Rubber Examination Gloves.O