News & Events
Regulation of Natural Rubber Latex Gloves
Elizabeth D. Jacobson, Ph.D.
Center for Devices and Radiological Health
Food and Drug Administration
Department of Health and Human Services
the Subcommittee on Oversight and Investigations
House Committee on Education and the Workforce
March 25, 1999
Mr. Chairman and Members of the Subcommittee, my name is Dr. Elizabeth Jacobson. I am Acting Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). With me today is Dr. Melvin Stratmeyer, Chief of the Health Sciences Branch, Office of Science and Technology, CDRH. We are happy to be here today to discuss issues related to the regulation of natural rubber latex gloves.
First, I would like to provide some brief, general background about the medical device regulatory process. I then will address the issue of natural rubber latex allergy and steps the Agency has taken to evaluate the magnitude and nature of the problem. I also will discuss FDA's efforts to assist manufacturers, health professionals and others in minimizing exposure and sensitization to natural rubber latex in medical devices. Finally, I will address our involvement with the Occupational Safety and Health Administration (OSHA), particularly in its development of a Technical Information Bulletin on natural rubber latex gloves.
Surgical and patient examination gloves are medical devices regulated by the FDA. The legal definition of "medical device" encompasses several thousand health products, from simple articles such as thermometers, tongue depressors, and heating pads, to sensitive and complex devices such as pacemakers, lasers, and imaging technologies. Prior to 1976, no specific Federal statutory program existed to regulate medical devices. The increasing sophistication and complexity of medical devices coupled with a growing number of safety concerns led to enactment of the Medical Device Amendments of 1976. This law amended the Federal Food, Drug, and, Cosmetic Act (the FD&C Act) to give FDA specific authority to regulate the safety and effectiveness of medical devices.
The FD&C Act provides several mechanisms to achieve this goal, including classification of medical devices, establishment registration, device listing, adherence to Good Manufacturing Practices (GMPs), and extensive control over market introduction of medical devices. Thus, any person engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for human use is subject to a regulatory scheme enforced by the FDA. Medical device regulation is based on the concept of risk. Devices on the market at the time the 1976 amendments were passed were assigned to one of three "classes." Devices presenting the least risk, such as elastic bandages, were placed in Class I, subject to the "general controls" already mentioned. Class II devices, presenting greater concern, are subject to additional "special controls" such as the performance of postmarket surveillance studies or adherence to performance standards. Class III devices, which include many implanted and life-supporting or life-sustaining devices, are subject to the most stringent controls and requirements, including a comprehensive premarket review.
The FD&C Act enables the Agency to reclassify a medical device to a higher or lower class as we gain more knowledge of its risks through actual use. Generally, reclassifications are to a lower class. Occasionally, changed circumstances require, or new information demonstrates, that a device risk profile has changed such that a higher classification is necessary to provide reasonable assurance of the device's safety and effectiveness.
THE CLASSIFICATION OF PATIENT EXAMINATION AND SURGEON'S GLOVES
In the 1980s, FDA promulgated regulations classifying surgeon's and patient examination gloves into Class I. At the time of classification, patient examination gloves were exempted from premarket notification and certain requirements of the GMP regulation. Following the emergence of AIDS as a major public health concern, FDA needed greater assurance that cross-contamination be prevented between health care workers and patients. FDA subsequently revoked the exemptions for patient examination gloves in order to obtain more information about gloves before they were marketed and to ensure that manufacturers complied with appropriate manufacturing practices. Thus, both surgeon's gloves and patient examination gloves must comply with all premarket notification and GMP requirements.
THE EMERGENCE OF LATEX ALLERGY
Since 1989, FDA has received reports of 15 deaths and numerous other severe allergic reactions associated with exposure to latex enema cuffs. These deaths were associated with anaphylactic reactions to the natural rubber latex cuff on the tip of barium enema catheters. To determine whether there was a connection between the deaths and latex, FDA initiated research that demonstrated that antibodies from latex sensitive individuals reacted to a number of natural latex proteins. FDA used this information to inform industry and users that natural latex proteins were the source of potentially life threatening reactions to natural rubber latex-containing products.
We developed advice for manufacturers to remove leachable proteins associated with these reactions from their finished devices. We also issued a Medical Alert to the medical community to alert health care workers to the problem of natural latex allergy, make recommendations for patient care and advice, and request health professionals to report adverse reactions to latex in medical devices.
Since the early 1990s, with increasing health care professional awareness of natural rubber sensitivity, FDA has received over 2000 adverse event reports describing allergic reactions to medical gloves containing natural rubber latex. These reports relate both to patients and users of natural rubber latex products. These reports include five deaths in addition to the fifteen noted above.
Scientific studies and case reports have documented sensitivity to natural latex proteins found in a wide range of medical devices. Based on this information, the Agency promulgated a rule which became effective September 30, 1998 to require labeling statements on medical devices and device packaging containing natural rubber with which people come into contact. The labeling information enables users who are already sensitized to natural latex proteins to avoid exposure to natural latex proteins. It also enables users to make informed choices about the gloves and other products they may use personally and as importantly, the products they use on patients who may have sensitivity to natural latex.
The Agency also noted that manufacturers of many products, including latex gloves, increasingly were labeling their products as "hypoallergenic." FDA believes this term is interpreted by consumers to mean that the risk of allergic reactions to any component of the device would be minimal. This is not the case with devices containing natural rubber. The labeling regulation, therefore, prohibits use of the term "hypoallergenic" on medical devices that contain natural rubber because it incorrectly implies the device can be used safely by persons sensitive to natural latex proteins.
GLOVES AND POWDER
Glove powder contributes to a number of other adverse health effects for patients in whom the powder may get deposited, e.g. foreign body reactions, inflammation, granulomas and adhesions of peritoneal tissue after surgery. FDA also has significant concerns about the role of glove donning powder (typically cornstarch) in the sensitization and reaction to natural latex. Natural latex allergens have been shown to bind to cornstarch. The dispersal into the air of glove powder carrying latex proteins may be a significant agent for sensitizing non-allergic individuals who breathe in the powder. We believe that a decrease in levels of glove powder will decrease the prevalence of adverse health effects.
Natural rubber latex is recognized currently as the best overall material for barrier protection in health care settings. The use of powder as a lubricant is widespread. Increasing sensitivity to natural rubber latex and the concern that powder may play a role in this increasing sensitivity, however, are making alternative technologies more attractive and stimulating research into alternatives.
Some health care institutions already have discontinued use of latex gloves in favor of synthetic rubbers or other synthetic polymers. Alternative manufacturing processes exist, e.g., chlorination of natural rubber latex gloves, that can eliminate the need for donning powders. These processes must be highly controlled, however, to avoid deleterious effects on the properties of the natural rubber latex. It should be stressed that all alternatives to latex gloves are cleared by FDA only if they are as safe and effective for their intended use as other products on the market. The ability of such products to protect against blood-borne pathogens remains a primary concern.
ACTIVITIES TO ADDRESS THE PROBLEM OF LATEX ALLERGY
Since the problem of latex allergy emerged, FDA has undertaken numerous activities to understand and address this problem. We have:
- organized conferences and workshops on sensitivity to latex in medical devices;
- served as an information resource for consumers, health care professionals and others on matters concerning latex allergy;
- developed an improved assay which resulted in an American Society for Testing and Materials (ASTM) test that allows manufacturers to establish and label the protein content of their products;
- developed guidance to manufacturers for testing skin sensitization to chemicals in natural rubber products so their labeling may identify them as products with reduced potential for sensitization; and
- compiled and posted on the Internet a comprehensive "Medical Glove Powder Report."
Currently, we are collaborating with industry and ASTM to develop a consensus standard that would identify maximum protein and powder levels for medical gloves. We also are conducting research to determine the prevalence of natural latex allergy, identify and measure the natural latex allergens, and identify sensitized individuals.
Currently, FDA is considering a number of actions to further address this problem. We are considering regulatory options, including labeling requirements and recommendations for the amount of natural latex protein and glove powder on natural rubber latex gloves. We are working with industry toward development of a more sensitive method than previously developed to measure proteins in natural rubber.
COOPERATION WITH OTHER AGENCIES
FDA routinely collaborates with other federal agencies with jurisdiction in this area to ensure that actions taken are coordinated and complimentary. FDA, The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), CDC's National Center for Infectious Diseases, and OSHA have been working together on this public health problem using their appropriate expertise according to their respective mandates. These combined efforts are evidenced by the NIOSH Alert on Latex Allergy (1997), FDA's labeling regulation (September 1997) and the OSHA Technical Information Bulletin under development.
In addition, in recognition of the need for federal agencies to provide consistent, current regulatory and scientific information concerning natural rubber latex allergy to their constituencies, FDA held a live educational teleconference on May 5, 1998. The teleconference involved seven federal agencies, seven major US health professional and industry organizations, the Canadian Royal College of Physicians and Surgeons, and Health Canada. The goal was to provide important baseline information to health care professionals and others concerned with latex allergy. This teleconference reached the largest live audience of multidisciplinary health care professionals and others ever assembled. The program continues to serve as a consumer and industry resource due to its availability on videotape, CD-ROM and the Internet.
THE DRAFT OSHA TECHNICAL INFORMATION BULLETIN
Over the last several months, the Department of Health and Human Services (DHHS) and FDA have received numerous inquiries about OSHA's efforts to issue a Technical Information Bulletin on latex gloves. The inquiries reflect a concern that the recommendations contained in the draft Bulletin conflict with FDA regulations; that there is a perceived lack of coordination among federal agencies with an interest in natural rubber latex gloves; and that OSHA's actions may infringe upon FDA's regulatory jurisdiction over natural rubber latex gloves.
FDA and DHHS do not believe the recommendations contained in the draft bulletin conflict with FDA regulation. Further, FDA has been an active participant as the Bulletin has been developed.
The attached August 1998 report, entitled "Responses to Concerns Regarding Natural Rubber Latex Allergy," describes extensive interagency coordination on this subject. The attached December 18, 1998 letter from Dr. Michael Friedman, Deputy Commissioner for Operations, FDA, to Charles Jeffress, Assistant Secretary for Labor for Occupational Safety and Health, clearly states our intent to assert regulatory jurisdiction over these products.
I thank you for the opportunity to appear here today to discuss FDA's activities addressing the problem of natural rubber latex allergy caused by medical devices. FDA is committed to addressing this public health problem and will continue our efforts in a coordinated manner. I am happy to answer any questions you might have.