Natural rubber latex allergy is recognized as an important public health issue and continues to be addressed in both the public and private sectors through rule making, educational efforts, and research. (1) Coincident with the increased recognition of glove reactions in the late 1980s and clinical natural rubber latex allergy in the early 1990s, the US Food and Drug Administration (FDA) began to receive reports describing various health effects, such as contact dermatitis and allergic reactions, that were associated by the reporters with the use of medical gloves. (2) The term medical glove, from the FDA’s regulatory perspective, refers to a wide variety of glove products with specific barrier claims that are labeled and marketed for medical use as either surgeon’s gloves or patient examination gloves. (3) Currently, medical gloves are required to receive FDA premarket clearance under section 510(k) of the Food, Drug, and Cosmetic Act before they can be marketed legally in the United States. They also are subject to mandatory reporting requirements outlined under the FDA’s Medical Device Reporting (MDR) regulations. (4) Gloves that are not labeled for medical use, such as cleaning gloves, painter’s gloves, and hobby gloves, are not covered under the FDA’s jurisdiction. The FDA’s reporting system does not capture problems directly associated with the use of consumer glove products. The aim of this study was to provide a descriptive analysis and summary of health effects reported to the FDA in association with the use of medical gloves made from either natural rubber latex formulations or synthetic materials.

THE FDA’S REPORTING SYSTEM

Since 1973, the FDA has maintained a nationwide voluntary reporting program for adverse events associated with medical devices. Currently administered as part of the FDA’s MedWatch program, the program accepts information voluntarily submitted to the FDA by health care providers and consumers. Beginning in 1984, the FDA’s MDR regulations require device manufacturers and importers to submit reports to the FDA concerning medical device-related deaths, serious injuries, and device malfunctions. Since 1991, facilities that use medical devices also have been required to report device-related deaths and serious injuries to either the manufacturer or the FDA. Facilities that use medical devices subject to mandatory reporting include hospitals, nursing homes, outpatient diagnostic and treatment facilities, ambulatory surgery centers, ambulance services, and home health care service providers. Private offices of physicians, dentists, or other health care professionals are exempt from the FDA’s mandatory reporting requirements, but practitioners can report problems voluntarily to the FDA. From 1990 to 1996, medical device distributors also were required to report certain types of events. Both the mandatory and voluntary reporting systems continue to capture information about medical device-related adverse events, and the FDA’s adverse event databases currently contain more than one million reports. The FDA uses the information reported through these programs to assist in the early identification and characterization of emerging medical device problems and related public health issues.

METHODS

The FDA’s medical device adverse event databases were searched via computer using text search criteria (eg, red, rash, allergic, anaphylaxis, asthma, wheezing, reaction, swollen, swell, itch, passed out) developed to identify reports describing local or systemic reactions associated with the use of any type of medical glove. The search covered information submitted from the inception of the database in 1973 through March 31, 1999. Duplicate reports describing the same event were identified and merged into a single adverse event report, yielding a total of 2,639 candidate reports. A secondary manual review of the candidate reports resulted in the identification of a subset of 2,396 unique reports of glove-associated reactions that served as the subject of the study.

Certain prescribed information (eg, patient age, gender, location of event) must be included in mandatory adverse event reports submitted to the FDA unless it cannot be obtained by the reporter. Since 1993, voluntary reporters have been asked to supply basic data elements as part of a standard adverse event report format developed by the FDA, but voluntary reports are accepted regardless of whether the minimal requested information is provided by the reporter. Narrative information is requested for all adverse event reports; however, the FDA’s adverse event databases are not designed to capture and code detailed clinical information associated with an individual device-related event, and there are no specific content requirements for the narrative sections of the report form. When supplied, the quality of narrative information varies substantially between reports.

This study required the use of a secondary database and the development of a unique coding scheme that allowed for manual abstraction and organization of the coded narrative and information of interest. The coding system entailed the creation of dichotomous and nominal variables to represent the information of interest in the reports for entry into the secondary database. The computerized database was created with checks to assume the correct entry of values for the variables. The manual abstraction was intended to identify, categorize, and record demographic and clinical information contained in the selected reports, particularly when such information was provided exclusively in the narrative sections of a report. Clinical information included symptoms, physical findings, or diagnostic terms that were reported in association with a specific glove reaction. This information then was used to assign each report to one or more of the following clinical response categories: