Device safety has been a hot topic lately, with industry and patient safety groups weighing in. Now, the agency is fighting back as it works on a system for detecting malfunctions using medical and billing records from hospitals and insurance companies.
The FDA's proposed system would use a bar code-like number to search record databases. The goal is to allow the agency to determine the rate at which a device is failing. And the FDA could provide more details about the proposed system as early as today, The Wall Street Journal notes.
FDA officials are expressing enthusiasm about the proposed system. "The unique identifier is the real game changer," said William Maisel, deputy director for science of the agency's device center, the WSJ notes. "With that number and a medical database, you could see, for example, if the re-operation rate for a certain defibrillator has become statistically a high outlier."
Similarly, at least one hospital group is ready to allow the FDA to use its database. "We will definitely cooperate and do whatever we can with the FDA once the UDI goes into effect," Blair Childs, Premier Hospital Alliance senior VP, said, as quoted by the WSJ.
The White House Office of Management and Budget has received flak because it hasn't taken action on the unique identifier system for roughly 10 months. Although a group of senators has taken the OMB to task for the delay, the group has declined to comment.
The news is especially timely in the wake of the St. Jude Medical ($STJ) Riata lead brouhaha, as well as a breast implant scandal in Europe and the metal-on-metal hip recall.
Separately, as groups have increasingly pressured the FDA to speed device review times, the Senate's Health, Education, Labor and Pensions Committee took a step by agreeing on a bill covering medical device and drug user fee agreements. The goals of the bill are to decrease device review time and improve communication between the agency and companies. The legislation builds upon the current user fee programs, which will expire in September.
Panel members congratulated themselves on the bipartisan effort. "I'm riding side saddle with [Al Franken, (D-MN)]" said Sen. Pat Roberts, (R-KS), as quoted by the National Journal. "This has gone swimmingly." The House's Energy and Commerce Committee is slated to vote next month on its version of the FDA reauthorization, The Hill notes.
But Consumer Reports, which recently took the FDA to task in a big report over device safety and oversight, does not like what it sees. Consumers Union, Consumer Reports' advocacy arm, said the legislation as proposed doesn't improve the FDA's current medical device oversight system. "Unfortunately, this bill doesn't fix some of the most serious flaws in our current system and leaves patients at risk," said Lisa McGiffert, director of Consumers Union's Safe Patient Project.
"The FDA's current fast track review process has allowed too many dangerous and defective devices onto the market," she added. "To make matters worse, the FDA doesn't have the tools it needs to react quickly when safety problems with medical devices arise."
- read the HELP Committee's release
- see the WSJ report
- check out more from Consumer Reports
- see the National Journal report
- check out the story from The Hill