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Audit Faults Gaps In FDA Process For Medical Device Recalls | Ormond Beach Personal Injury Lawyer

Audit Faults Gaps In FDA Process For Medical Device Recalls

The Food and Drug Administration is not using its recall data to proactively address the risks from unsafe medical devices, according to a new federal audit.

The Government Accountability Office (GAO) found 21 high-risk recalls between 2005 and 2009 where companies were unable to correct or remove faulty devices in a report dated June 14.

Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device.

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device–class I recalls present the highest risk (including death), followed by class II and class III. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated.

“The FDA can’t tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn’t routinely review recall data,” said U.S. Senator Charles Grassley in a statement. “It looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.”

High profile recalls include last year’s massive recall of artificial hips from Johnson & Johnson’s DePuy unit. Some 93,000 patients worldwide had that line of hip implant. .Medtronic had to recall heart defibrillator leads several years ago, while the FDA recently expanded a recall of coronary imaging catheters from Boston Scientific Corp. The FDA issued seven high-risk device recalls in June.

GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA’s documentation for a sample of 53 (40 percent) of class I recalls initiated during this period.

From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority — nearly 83 percent — as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote.

Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls.

Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.

FDA’s procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective.

FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices.

Additionally, FDA’s decisions to terminate completed recalls – that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls — were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls.

“If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market,” the report states.

To enhance FDA’s oversight of medical device recalls, and in particular, those medical device recalls that pose the highest risk, GAO suggests the Commissioner of FDA should:

  • Create a program to routinely and systematically assess medical device recall information, and use this information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. This assessment should be designed, at a minimum, to identify trends in the numbers and types of recalls, devices most frequently being recalled, and underlying causes of recalls.
  • Clarify procedures for conducting medical device recall audit checks to improve the ability of investigators to perform these checks in a consistent manner.
  • Develop explicit criteria for assessing whether recalling firms have performed an effective correction or removal action.
  • Document the agency’s basis for terminating individual recalls.

According to HHS officials, FDA plans to convene a working group to both evaluate improvements to the recall process and to develop strategies to implement the GAO recommendations. According to HHS, FDA recognizes that standardized guidance will strengthen the management of the recall process.

“We are greatly encouraged by the agency’s response, and believe its expeditious implementation of the recommendations will serve to enhance the safety of medical devices used by millions of Americans each day,” GAO officials said in a release.

For more on medical safety issues, see the library of articles by Daytona Beach medical malpractice attorney.



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