User Facility Reporting Bulletin Spring 1997


By Sharon F. Dillard, M.S., A.A.R.T. (N), C.N.M.T.

It is not always easy to identify medical device issues that have significant public health implications. That is why the Food and Drug Administration (FDA) maintains the voluntary MedWatch reporting system and relies on healthcare professionals to help identify emerging medical device problems. The easiest medical device problems to identify are simple mechanical failures that occur many times in one location. The hardest problems to recognize are patient problems that are unusual, occur infrequently at many different user sites, and cannot be easily linked to a specific product. The latter was the case with allergic and anaphylactic reactions to medical devices with components made from natural latex/natural rubber (NLNR).

FDA investigations, which ultimately identified NLNR allergy as an emerging public health concern, were started in response to VOLUNTARY reports submitted by physicians, nurses, and technologists. The first reports described patient deaths that occurred during barium enema procedures, before the administration of barium. These initial voluntary reports from vigilant and concerned healthcare professionals provided critical information that resulted in the identification of NLNR allergy as the probable cause of the reported events. Additional reports received from healthcare professionals in response to a special FDA request for any information related to NLNR problems provided enough information for FDA to issue a Medical Alert to raise clinical awareness of NLNR allergy issues. FDA has proposed a NLNR labeling regulation, participates in voluntary standards activities for medical gloves, has begun collaborative research on NLNR allergy-related issues, and has co-sponsored an international conference on latex sensitivity.

FDA continues to receive many calls from healthcare professionals requesting information on NLNR allergic and anaphylactic incidents. Since FDA began efforts to inform healthcare professionals about reactions to NLNR, we have received numerous reports from a number of sources about reactions to various other NLNR-containing medical devices.

FDA has received over 1,000 allergic and anaphylactic reaction reports on NLNR patient examination and surgeon’s gloves. These reports are unique because most are from healthcare professionals reporting their own reactions. In response, FDA conducted research and published two articles entitled “Prevalence of Latex-Specific IgE Antibodies in Hospital Personnel”(1) and “Short Analytical Review: Latex-Associated Allergies and Anaphylactic Reactions.”(2) FDA continues to work with device manufacturers and other Federal agencies responsible for occupational health concerns regarding latex sensitivity. On June 23, 1997, the National Institute for Occupational Safety and Health (NIOSH) released an alert entitled “Preventing Allergic Reactions to Natural Rubber Latex in the Workplace.” You can obtain copies of this document by calling 1-800-356-4674 or by visiting the NIOSH home page on the World Wide Web at:

Remember that your observations regarding device problems are critical to FDA’s mission to protect the public health. Your voluntary and mandatory MedWatch reports do make a difference. Keep up the good work.

(1) Kaczmarek, R.G., Silverman, B.G., Gross, T.P., et al., Annals of Allergy, Asthma, and Immunology, 1996, 76: 51–56.

(2) Tomazic, V.J., Withrow, T.J., Fisher, B.R. and Dillard, S.F., Clinical Immunology and Immunopathology, 1992, 64 (2): 89–97.

Sharon Dillard is a biologist and senior analyst in the Division of Postmarket Surveillance in CDRH’s Office of Surveillance and Biometrics.

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