Sustainable Hospitals - Using MedWatch to Report Allergic Reactions to Latex

Using MedWatch to Report Allergic Reactions to Latex

If you have an allergic reaction to latex medical products, the U.S. Food and Drug Administration (FDA) MedWatch program is a viable avenue for reporting your reaction. MedWatch, a program for reporting problems with medical products, should also be considered for reporting other medical device related problems such as allergic reactions to glove additives, glove failures (e.g. finding blood inside a glove with no visible holes), surgical adhesions and granulomas caused by glove powder, and even needlesticks. Why should you report these?

Reporting failures and problems provides a cumulative accounting of product performance and provides a driving force for safer products.
Since FDA governs medical devices, they are in a key position for influencing product development and improvement.
Healthcare professionals who work in a healthcare facility and have a device-related illness or injury are considered "patients" of that facility and any health outcomes are reportable just as if it had happened to a patient in that facility.

The U.S. Food and Drug Administration (FDA) has the responsibility for assuring the safety and effectiveness of medical products. The FDA relies on healthcare professionals and medical facilities to report serious problems with medical devices. FDA considers the following outcomes "serious" if the product caused:

death,
a life-threatening situation,
admission to a hospital or a longer than expected hospital stay,
a permanent disability,
a birth defect, or
the need for medical or surgical care to prevent permanent damage.

The FDA offers two avenues for reporting problems with medical products: Medical Device Reporting (MDR) and MedWatch. (See a summary of these two options in the table below).

MDR is a mandatory program for user facilities (e.g. hospitals), manufacturers, or distributors to report the most serious problems with devices that they identify. These include incidents which may have caused or contributed to a death, serious illness, or serious injury.
MedWatch is a voluntary program which encourages individual health professionals or consumers to notify FDA and/or the manufacturer about serious adverse events and product problems. Reporting is done by using MedWatch FDA Form 3500.

Each year, FDA receives approximately 100,000 reports through the MDR route and 5,000 reports through the voluntary MedWatch route.

According to the FDA, "While voluntary MedWatch reporting with Form 3500 is designed for serious reports only, you are welcome to report even if your case does not meet any of these specific criteria and you feel strongly that FDA should review the report." In this case, just check the "other" box to describe "Outcomes attributed to adverse event".

To provide feedback to the FDA, you may fill out Form 3500 to report problems with or reactions to medical products you use. To get a copy of the most current MedWatch FDA Form 3500 and instructions for filling it out, call the FDA at 800-FDA-1088 or find the materials online at:

MedWatch home page of general information:
http://www.fda.gov/medwatch/index.html
MedWatch FDA Form 3500:
http://www.fda.gov/medwatch/safety/3500.pdf
(this is a postage paid MedWatch Form)
Instructions for Completing MedWatch FDA Form 3500:
http://www.fda.gov/medwatch/report/consumer/instruct.htm

Information for this fact sheet was taken from the following sources:

"Improving Patient Care by Reporting Problems with Medical Devices" (September, 1997), a MedWatch Continuing Education Article provided by the Uniformed Services University of the Health Sciences, Bethesda, MD, and the Food and Drug Administration, Rockville, MD

"Instructions for Completing MedWatch FDA Form 3500", (April, 2000), U.S. Food and Drug Administration, Rockville, MD

"MedWatch FDA Form 3500", U.S. Food and Drug Administration, Rockville, MD

Adverse Event Reporting - Program Summary

	Medical Device Reporting (MDR) Program	MedWatch Program
Reporting is:	Required	Voluntary
Who reports:	User facilities (e.g. hospitals), Manufacturers, or Distributors	Individual health professionals
What prompts a report:	When user facility becomes aware of information that reasonably suggests: That a device has or may have caused or contributed to the death, serious illness, or serious injury of a patient in the facility. Device malfunctions and/or user error which results in death or serious injury of a patient	Observation of a serious adverse event associated with any medical product, including any patient* outcome that results in: death a life-threatening event hospitalization disability congenital anomaly the need for medical or surgical intervention to prevent permanent damage or impairment FDA is also interested in product problems, including: inaccurate or unreadable labeling packaging or product mix-up suspected contamination questionable stability defective devices therapeutic failures product confusion (caused by name, labeling, design or packaging). *"Healthcare professionals who work in user facilities and sustain a device-related illness/injury (or death) are considered "patients" of that user facility and any serious adverse event reportable uner the law would be reported as if it had happened to a patient in that facility".
Does one have to establish causality?	User facility has the responsibility for determining if the device-related event is reportable based on the facts and circumstances observed by its medical or nursing personnel.	Health professionals do not need to prove causality; a suspected possible association between a product and an adverse patient outcome is sufficient reason to report.

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