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 Post subject: Medical Device Adverse Events Reporting
PostPosted: Wed Aug 16, 2006 2:06 pm 

Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080

August 2006

Inside the FDA
Reporting of medical device-related adverse events
by Malvina Eydelman, M.D.

I have written several columns about how the Food and Drug Administration (FDA) regulates the routing of ophthalmic devices to market. FDA?s involvement in the medical devices, however, is not limited to the pre-market arena.
FDA monitors post-market reports of device-related adverse events/product problems (AEs). This is done to detect "signals" of potential public health safety issues, and it is an important aspect of FDA?s role.
Primary responsibility for this function is carried out by the Center?s Office of Surveillance and Biometrics. The interdisciplinary staff of clinicians and engineers that reviews these reports is headed by Tom Gross M.D., M.P.H. He provided his expertise in writing this column.
FDA?s ability to take appropriate and timely actions, where warranted, is inherently tied to its knowledge of the existence and the extent of a device-related problem shortly after it occurs. For this very important task FDA relies on the users of the devices (eye care practitioners in the case of ophthalmic devices).
Thus, it is of utmost importance that the ophthalmic community understands how, when, and where it should report potential problems. FDA relies on these reports to maintain safety surveillance of all FDA-regulated devices. Your reports may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the device, and leads to increased patient safety.

Monitoring and understanding AEs

The FDA monitors post-market AEs through both voluntary and mandatory reporting. Voluntary reporting to the FDA began in 1973. It was not until 1984 that the FDA implemented mandatory reporting, per the Medical Device Reporting (MDR) regulation.
This regulation required device manufacturers and importers, as they still do today, to report device-related deaths, serious injuries, and malfunctions to the FDA. Additional legislative initiatives have resulted in significant changes to mandatory reporting. User facilities (hospitals, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities, ambulance services, and health care entities) are required to report deaths to the FDA and deaths and serious injuries to the manufacturer. These requirements are summarized below in Tables 1 and 2.

The FDA recently established a network of 350 user facilities (primarily hospitals) to enhance our understanding of AEs in the clinical environment in which they occur. This Medical Product Safety Network (MedSun) provides enhanced reports of AEs and a platform for discourse and resolution of important safety issues (e.g., via periodic audio conferences).1
To better understand reporting of AEs under the current MDR regulations governing mandatory reporting, I will define some of the key terms:

? Serious injuries: Life-threatening events that result in permanent impairment of a body function or permanent damage to a body structure; events that require medical or surgical intervention to preclude permanent impairment or damage.
? Malfunctions: Failure of a device to meet its performance specifications or otherwise perform as intended.
?Device-related: The event was or may have been attributable to a medical device, or that a device was or may have been a factor in an event, including those occurring as a result of device failure, malfunction, improper or inadequate design, poor manufacture, inadequate labeling, or use error.
There are several guidances currently available about Medical Device Reporting (MDR) which can be found at http://www.accessdata.fda.gov/scripts/c ... s/cfTopic/

Voluntary reporting

Voluntary reporting to FDA of device-related problems is a critical professional and public health responsibility. Currently, voluntary reporting takes place under MedWatch, a program created in 1993 to encourage voluntary reporting by all interested parties.2
MedWatch allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense, or use. Reporting can be done on line at http://www.fda.gov/medwatch/getforms.htm, by phone (1-800-FDA-1088), or by submitting the MedWatch 3500 form by mail or fax.
Since its inception in 1973, the FDA's database of voluntary and mandatory reports of device AEs has received approximately 1.5 million reports and currently averages about 180,000 per year. Mandatory reports account for close to 95% of the total.
The reports capture information on device specifics (e.g. brand name, model number), event description, pertinent dates (e.g. event date), and patient characteristics. Manufacturers also supply methods, results, and conclusion codes relevant to their report investigation.
The staff of clinicians and engineers review the individual reports from a variety of perspectives: the potential for device failure (e.g. poor design, manufacturing defect); use error (e.g. device misassembly, incorrect clinical use, misreading instructions); packaging error; support system failure; adverse environmental factors; underlying patient disease or co-morbid conditions; idiosyncratic patient reactions (e.g. allergy); maintenance error; and adverse device interaction (e.g., electromagnetic interference).
Several immediate actions, aside from routine requests for follow-up information, may be taken by the staff. These include:

Recommending directed inspections of manufacturers. These may lead to: (a) label changes, including those affecting device instructions or training materials, (b) product modification/recall, and (c) product seizure or injunction (rarely).
Recommending internal expert safety meetings. These may lead to public notifications, recommendations for additional post-market study, or meetings with the company to explore issues further.
Alerting regulatory authorities outside the United States through the international vigilance program (a program that allows for sharing AE information among regulatory authorities).
Other internal uses of the AE data are widespread and include: input into pre-market review (by providing human factor insights and information on product experience in the general population); input into recall classifications (involving a hazard evaluation based on AE data); monitoring of recalls (and assessing reports in similar products); input into product reclassifications and exemptions from pre-market notifications (based, in part, on a product's safety profile); use in, and initiating of, standards efforts that establish device performance; educating the clinical community through newsletters, literature articles (peer-reviewed and professional and trade journals), and teleconferences; and as a general information resource for healthcare providers and the general public.
I hope that this column gives EyeWorld subscribers a strong appreciation of the importance of reporting medical device-related adverse events in support of FDA?s mission to protect public health. I look forward to thorough reporting by my ophthalmic colleagues.


2.Kessler DA. Introducing MeDWatch: A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269:2765-8.


Malvina Eydelman, M.D., is an ophthalmologist. She is director of the Division of Ophthalmic and ENT Devices (DOED) in the Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)/Office of Device Evaluation (ODE). Contact her at Malvina.Eydelman@fda.hhs.gov.

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