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By Pamela Werner, RN, BSN, CNOR, MBA
Another day begins in the busy operating room of a large community hospital. Today more than 60 procedures will be completed requiring the use of gloves. Surgical gloves, both latex and nonlatex, will be required for the surgery personnel that will be scrubbed in. Examination gloves will be necessary for the anesthesia team, environmental services, and other OR personnel involved in direct patient care, and for the Central Sterile Processing personnel to clean and decontaminate the instruments used during the day. Each has a need for a glove that will stand up to the task at hand. According to recent IMS data, approximately 6.6 million units of gloves were used in the hospital setting in the last year.
Prior to the mandate of universal precautions in 1987, gloves attracted little attention from any regulatory agencies. That is no longer true in today's healthcare environment. And it's a wonder that healthcare workers (HCWs) are able to do the work of caring for patients when they are so overwhelmed with regulations. However, these very standards and regulations provide the assurances HCWs need to provide the very best care for their patients. The following is a brief summary of the two agencies, that have a direct influence on medical glove standards in the US.
Food and Drug Administration (FDA)
Until 1976 the Food and Drug Administration (FDA), by statute, only had the authority to regulate drugs. This changed with the May 28, 1976 introduction of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. The FDA now regulates all medical devices. The FDA rules and regulations were established to assure the public of the safety, effectiveness, and proper use of all medical devices, including gloves.
The FDA does not actually write standards but it does recognize standards that are written by national and international standard-setting bodies, such as the American Association of Medical Instrumentation (AAMI), the American Society of Testing and Materials (ASTM) and United States Pharmacopoeia (USP). Representatives from the FDA often sit on standard-writing committees. The FDA, in determining the acceptability of medical devices for the marketplace, will often use these established standards as baseline requirements. For example, the FDA requires all medical glove manufacturers to meet the requirements in ASTM D 5151 for detection of holes. In response to growing concerns among HCWs and industry experts, new research information, and the development of new barrier materials, there have been many standards developed by ASTM for medical gloves over the years. And the FDA requirements for market entry have changed accordingly.
American Society for Testing and Materials (ASTM)
ASTM is a not-for-profit organization that provides a forum for consumers, manufacturers, citizens, organizations, government representatives, and academia, to meet and write standards for variety of products, services, and materials. Gloves, both surgical and examination, manufactured from natural rubber latex (NRL) were some of the first products forwhich ASTM developed standards. The list of current ASTM standards that relate to gloves (see Table 1) provides standards for test methods that are applicable to all medical gloves as well as standards for specific types of medical gloves. The FDA recognizes the ASTM standards in Table 1 and they are listed in the US Federal Register. Glove manufacturers must conform to these consensus standards in order to meet the requirements set forth by the FDA for the particular type(s) of medical gloves that they market. Numerous companies, manufacturers, laboratories and agencies also use ASTM standards.
Once ASTM has developed a standard, the responsible committee may revise it at any time in response to an industry, consumer or regulatory need. Every five yearsthe standard must be reviewed, at that time it may be either re-approved or withdrawn. The public may submit comments to the committee by addressing their concerns to ASTM headquarters. The ASTM book of standards is published annually and approximately 30% of the standards are new or revised. The standards are organized in alphanumeric sequence by their ASTM number. Each standard has a fixed number, i.e., D3577, followed by the date the standard originated or the date of the last revision, i.e., 00. As ASTM standards evolve, manufacturers will respond, in kind, to provide the best barrier protection materials to meet the needs of the healthcare environment.
Pamela Werner, RN, BSN, CNOR, MBA, is a clinical and educational affairs manager with Ansell Healthcare.
|Title of Standard||Performance Requirements|
|Â||Â||AQL for holes in Mpa||Minimum Unaged Tensile Strength||Minimum Unaged Elongation Percent|
|D 3577-00||Standard Specification for Rubber Surgical Gloves||1.5%||24 (3480 psi)||750|
|D 3578-00||Standard Specification for Rubber Examination Gloves||2.5%||14 (2030 psi)||700|
|D 5250-00||Standard Specification for Poly(vinyl chloride) Gloves for Medical Application||2.5%||9 (1305 psi)||300|
|D 6319-00||Standard Specification for Nitrile Examination Gloves for Medical Application||2.5%||12.5 (1813 psi)||500|
|D 5151-99||Standard Test Method for Detection of Holes in Medical Gloves||NA||NA||NA|
|D 6355-98||Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves||NA||NA||NA|
|D 6124-00||Standard Test Method for Residual Powder on Medical Gloves||NA||NA||NA|
|D 6499-00||Standard Test Methods for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products||NA||NA||NA|