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U.S. FDA’s Involvement in the Development and Utilization of D11.40’s Standards on Rubber Consumer Products

by Chiu S. Lin, Ph.D., and Carol Herman

The U.S. Food and Drug Administration ensures that medical devices are safe and effective before they are marketed in this country. The FDA division that regulates medical devices including medical gloves (patient examination gloves and surgeon’s gloves) is the Center for Devices and Radiological Health.

The use of medical gloves (especially patient examination gloves) has increased dramatically in the last decade due to concerns about the transmission of HIV and the hepatitis B and C viruses. Initially, the Centers for Disease Control and Prevention recommended “universal precaution” practices for all healthcare professionals. Medical gloves were to be worn in situations where exposure to blood or body fluids is expected. In 1991, the U.S. Occupational Safety and Health Administration of the Department of Labor published its blood-borne pathogen regulation, which mandates healthcare facilities to observe the practice of universal precautions. Today, medical gloves are used in almost every area of medical and dental practice in the United States.

As a result of this dramatic increase in the use of gloves, several new problems emerged. Gloves that had been worn occasionally were now being worn constantly. Allergic reactions increased among health care workers. These sometimes life threatening reactions were due to proteins contained in natural rubber latex as well as the chemicals used to manufacture gloves. There was also a perceived glove shortage and poor quality gloves began to dominate the market because of the increased demand. Quality issues included uncontrolled powder and protein in glove products, increased pinhole rates, and poor durability.

In the past, FDA would set mandatory regulatory performance standards to insure adequate glove regulations. FDA now believes it is advantageous to participate in the voluntary consensus standards process. ASTM Subcommittee D11.40 on Consumer Rubber Products, part of Committee D11 on Rubber, develops medical glove standards intended to reduce the allergic reactions and to improve the quality of the glove products. FDA believes that consensus standards offer many advantages.

• Consensus standards can be developed more efficiently by a collaborative effort among regulators, manufacturers, and users;
• Consensus standards can be more easily updated to reflect changes in technology or new product development; and
• Consensus standards can be easily modified to harmonize with other international standards.

Highlights of Current Regulatory Requirements for Medical Gloves

U.S. law requires FDA to classify devices into one of three regulatory classes: Class I, Class II, or Class III. FDA determines the classification of a device by the regulation necessary to provide a reasonable assurance of safety and effectiveness. FDA classifies devices into Class I (general controls) if there is information showing that the general controls of the act are sufficient to assure safety and effectiveness; into Class II (special controls) if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into Class III (premarket approval) if there is insufficient information to support classifying a device into Class I or Class II and the device is life-sustaining or life-supporting, or the device is for a use that is of substantial import in preventing the impairment of human health or unreasonable risk of illness or injury. FDA relies upon valid scientific evidence in the classification process to determine the limit of regulation for medical devices.

Based on information available during 1970s, FDA classified surgeon’s gloves (21 CFR 878.4460) and patient examination gloves (21 CFR 880.6250) into Class I, subject to general controls. Manufacturers of medical gloves are required to submit a 510(k) form and receive FDA’s clearance before they can market these devices in the United States. Medical device reporting is required after the gloves are marketed.

Recognition of Standards Under FDAMA

The Food and Drug Administration Modernization Act of 1997 exempts all Class I devices from the 510(k) requirements, with the exception of those devices of substantial importance in preventing impairment of health or a potentially unreasonable risk of illness or injury. These non-exempt Class I devices are referred to as “Class I Reserved.” All medical gloves are now regulated as Class I Reserved and require the submission of 510(k). The Modernization Act also gives FDA authority to create an alternate approach to the 510(k) process for Class II and Class I Reserved devices.

FDA now has the authority to recognize United States national and/or international consensus standards in the premarket submission review. Many consensus standards address aspects of safety and/or effectiveness relevant to medical gloves. Many of these standards have been developed with the participation of FDA staff. FDA may recognize all or part of an appropriate standard. About every six months a list of FDA recognized standards is published in the Federal Register with further information available on the standards program Web site. A manufacturer may reference the recognized standard in a declaration of conformity which can be used to satisfy premarket submission data requirements.

Why Standards Are Needed by FDA

As stated previously, FDA believes that conformance with FDA-recognized consensus standards can provide a reasonable assurance of safety and effectiveness for many applicable characteristics of medical devices. Under the new alternative process, a declaration of conformity with FDA-recognized standards can replace entire premarket data requirements or portions of them, and will eliminate the need to review the actual data by FDA reviewers. This reduces the time needed for approval or clearance of premarket submissions. Therefore, the standards can provide manufacturers the least burdensome approaches for design, development, and receiving FDA premarket clearance or approval. The use of recognized standards will result in thinner submissions, faster review, and move FDA toward global harmonization.

Since its creation in the 1980s, ASTM Subcommittee D11.40 has published many performance standards related to medical gloves. The FDA has participated and has voted on almost all medical glove standards. These ASTM standards are useful in the following areas: (1) new glove product development, (2) setting manufacturing specifications for glove products, (3) development of quality systems (good manufacturing practices) in the manufacture of the products, and (4) premarket submission review of these products. FDA uses standards for regulatory compliance enforcement. Health providers use ASTM standards for product selection and procurement.

Use of Standards in Premarket Submission to FDA

A medical glove 510(k) submission is a perfect example of how consensus standards are used in premarket submission. Manufacturers may declare conformity to several standards depending on the chemical nature of the material of the subject medical glove:

D 3578, Specification for Rubber Examination Gloves;
D 6319, Specification for Nitrile Examination Gloves for Medical Application;
D 5250, Specification for Poly (Vinyl Chloride) Gloves for Medical Application;
D 5151, Test Method for Detection of Holes in Medical Gloves; and
D 3577, Specification for Rubber Surgical Gloves.
In addition to the above, there are standards that further define labeling claims:
D 6124, Test Method for Residual Powder on Medical Gloves, to generate test data to support a powder-free labeling claim for medical gloves;
D 5712, Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method, to generate test data to support a claim of protein content; and
D 6355, Test Method for Human Repeat Insult Patch Testing of Medical Gloves, to generate the test data to support a claim that a glove product is devoid of the manufacturing chemicals that can cause skin allergic reactions.

Manufacturers of medical gloves may use any or all of the standards and each declaration of conformity simplifies the submission and thus reduces the time for review.

Current FDA Participation in ASTM D11.40 Standard Activities
FDA is a full participant in the ongoing work of D11.40. FDA staffs are members at the committee and subcommittee level. Work items currently under consideration include:

• Developing a standard test method for evaluating the durability of medical gloves;
• Revising a new standard test method for measuring latex protein antigens in latex gloves (ELISA test);
• Developing a test method for measuring latex allergenic proteins in latex gloves (IEMA test);
• Developing a standard for assessing the skin care products/ latex compatibility of medical gloves;
• Developing a standard test method for stability or shelf life testing of medical gloves;
• Developing a standard practice for assessing the resistance of medical gloves from permeation by chemotherapy drugs; and
w Developing a standard test method for measuring endotoxin levels in medical gloves.

Conclusion

ASTM D11.40 medical glove standards have a significant role in the premarket clearance of medical gloves. FDA’s recognition of all ASTM D11.40 medical glove standards gives manufacturers the potential to use these standards in premarket submissions. FDA strongly believes that standards developed under consensus processes will meet the relevant premarket submission requirements to ensure the safety and effectiveness of medical gloves marketed in this country. Using consensus standards simplifies and expedites the substantial equivalence process. FDA’s involvement in the development, recognition and utilization of standards indicates our commitment to the continued role of consensus standards. //

Further information regarding the use of consensus standards by the Center for Medical Devices and Radiological Health can be found at its Web site.

Copyright 2003, ASTM

Chiu S. Lin, Ph.D., is chief, Infection Control Devices Branch, Office of Device Evaluation, Center for Devices and Radiological Health, U.S. FDA, and serves as FDA primary liaison to ASTM Subcommittee D11.40. He is also a co-chair of the ASTM D11.40.09 Chemotherapy Glove Working Group.

Carol L. Herman is the director of the Standards Program in the Office of Science and Technology, Center for Devices and Radiological Health, in the Food and Drug Administration. She joined the radiological health laboratories of the Center in 1978. Herman has been involved in the internal administration of medical device standards since 1997 and took the directorship of the program in December 2000.