James R. Ravitz and James H. Hartten09.11.07
FDA Focuses Enforcement on Medical Device Adverse Event Reporting
By James R. Ravitz and James H. Hartten
Last year, this column addressed the FDA’s plans to improve the postmarket safety of medical devices. In January 2006, the agency announced a major initiative to improve device safety by implementing a program called the “Postmarket Transformation Initiative.” This program was aimed at ensuring that marketed devices are appropriately monitored by both the agency and device manufacturer. As part of the initiative, the FDA proposed focusing more attention on device establishment inspections and adverse event reporting. The device safety report issued by the FDA, in conjunction with the announcement of the Postmarket Transformation Initiative, stated:
“The submission of adverse event reports is essential for CDRH to be able to identify existing and potential risk factors of medical devices. Reports submitted by manufacturers and health care practitioners are used to assess the underlying cause and seriousness of an adverse event. The data from these reports are used by staff to conduct health hazard evaluations and product assessments, and as a basis for compliance actions and recall classifications. It is also used for trend analysis such as detecting safety profile discrepancies across various manufacturers within a product class.”
Indeed, the FDA appears to be implementing the Postmarket Transformation Initiative with fervor. Over the past few months, the agency has taken enforcement action against a number of device manufacturers due to their failure to report adverse events in the manner required by the Federal Food, Drug and Cosmetic Act as well as the FDA’s regulations covering medical device reporting (MDR). Its enforcement strategy also may signal a tougher stance by the agency compared to the relative quiet that has been seen over the past several years.
FDA Issues Warning Letters
Since January 2007, the FDA has issued the following warning letters relating to adverse event reporting:
• A letter to Medtronic on July 3, citing the company, in part, for (a) not evaluating adverse events referenced in several scientific journal articles collected by the company to determine whether such adverse events needed to be reported to the FDA; and (b) not reporting adverse events to the FDA within the required 30-day timeframe. The agency also clarified that “consumer self-reported events do not have to be confirmed by a health-care provider in order for a manufacturer to determine whether an event must be reported to FDA.” According to the warning letter, Medtronic responded to the FDA’s findings by implementing a new standard operating procedure to determine whether adverse events reported in journal articles constitute an “MDR reportable event.” Medtronic also revised its internal MDR procedures to include requirements for assessing consumer-reported events to determine MDR reportability.
• A letter to Staar Surgical on June 26, citing the company, in part, for not immediately evaluating three adverse device effects that occurred during a clinical trial to determine if they were expected or unexpected events. Ac-cording to the warning letter, Staar responded to the FDA by stating that its adverse event reporting procedure was being revised.
• A letter to Rhytec on April 24, citing the company, in part, for not submitting MDR reports to the FDA within the required 30-day timeframe after the company “received or became aware” of a reportable incident.
• A letter to Abbott Laboratories on March 13, citing the company, in part, for not submitting MDR reports to the FDA within the required 30-day timeframe for reporting adverse events.
MDR Reporting Legal Background
The FDA monitors postmarket device-related adverse events through both voluntary and mandatory reporting mechanisms. The voluntary reporting of adverse events to the FDA began in the 1970s and continues today under the “MEDWatch” program, which was created by the agency in 1993 to encourage voluntary reporting by all interested parties. Further, in 1984, the agency promulgated its MDR regulation, which requires manufacturers and importers to submit reports of device-related deaths, serious injuries and malfunctions. Under the MDR regulation, a “serious injury” is defined as (a) a life-threatening event; (b) an event that results in permanent impairment of a body function or permanent damage to a body structure; and (c) an event requiring medical or surgical intervention to preclude permanent impairment or damage.
The MDR program was expanded under the Safe Medical Device Act (SMDA) in 1990, in part by requiring mandatory universal reporting of adverse events by device user facilities. Since enactment of the SMDA, reports from industry and user facilities have been collected in a database that currently houses more than 1.8 million reports. In sum, roughly 95% of these reports are from industry, with the remaining from healthcare facilities and providers.
Under MDR regulations, a device “malfunction” is defined as the “failure of a device to meet its performance specifications or otherwise not perform as intended.” The term “device-related" means that “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-related error.”
In addition, the FDA’s quality system regulations require device manufacturers to maintain complaint files and establish procedures for receiving, reviewing and evaluating complaints in a uniform and timely manner to determine whether a complaint represents an event that is required to be reported under the MDR reporting requirements.
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Based on its recent enforcement activity, the FDA’s warning letters should signal three alarms for device firms. First, the agency appears to be instituting more aggressive enforcement measures to ensure that device companies are meeting their device reporting obligations. Second, device firms must ensure that they have effective procedures as part of the quality system regulation for identifying an adverse event that triggers a reporting requirement. Finally, device firms must ensure that reportable events are filed within the requisite 30-day period. Given the public relations battering it has taken during the past couple of years and the FDA’s commitment to re-establishing its mandate to protect public health, the device industry should expect more enforcement going forward.