The General Accounting Office has put the spotlight on the Food and Drug Administration's surveillance system for deaths and injuries involving medical devices and concluded it isn't working.
Among a laundry list of problems, Congress' nonpartisan investigative arm singled out underreporting of device-related problems to the FDA by user facilities, such as hospitals.
In theory, those reports, plus others made by manufacturers and distributors, should serve as an early warning system for device problems. That was the rationale behind changes in the medical-device law in 1990 to boost field data at the FDA's disposal by making user reporting mandatory instead of voluntary.
But critics note those changes have already led to data overload, a development that threatens to overshadow the problem of underreporting the regulations were supposed to solve.
"FDA is drowning in the volume of data," said Jeffrey Gibbs, a Washington attorney specializing in FDA law. "Fuller reporting by user facilities is only going to exacerbate the problem."
Released in late January, the GAO's analysis also criticized the FDA for failing to adequately analyze the reports it receives. That finding casts doubt on how the FDA would keep up with a heavier load if users conscientiously fulfill their reporting obligations. In fiscal 1996, the FDA received about 100,000 device reports.
One thing the FDA and the GAO do agree on is there is vast underreporting by users. All told, the GAO estimates the FDA received an average of 3,200 user reports each fiscal year between 1992 and 1995, well less than 10% of those filed by manufacturers.
During the current fiscal year, the FDA could receive as many as 150,000 reports of device problems from all sources with even a modest uptick in user reports, the GAO report said.
The FDA, however, has termed the GAO's critique "significantly flawed." In its defense, the health agency countered that it is properly processing reports received and analyzing all death and serious-injury reports within a week. Safety alerts concerning faulty bed rails and patient restraints, for example, were brought to light through user reports, the FDA said, showing the system works.
"Right now I'd say we're keeping up" with device reports, said Susan Gardner, deputy director of the office of biometrics and surveillance within the FDA's devices branch. "But our resources aren't growing," she conceded.
In the recent past, squabbling between the FDA and the GAO might have been of only passing interest to healthcare providers. While the FDA has wielded a big stick with manufacturers, the agency has generally kept out of providers' hair, with relatively few exceptions such as blood banking.
But last summer, the FDA finalized a regulation that makes user reporting mandatory. For now, the FDA is emphasizing training, including a series of seminars to "train the trainers" at healthcare facilities.
"The first year is primarily an educational year," the FDA's Gardner emphasized. "It's new to all of us, and the chief aim is not to run around and be the big policemen."
But the law allows the agency to levy criminal and civil penalties as high as
$1 million to punish violators of reporting rules. And the FDA is looking to enlist the Joint Commission on Accreditation of Healthcare Organizations and HCFA in educating healthcare facilities and possibly inspecting them for compliance later on.
Users are defined as personnel at practically all healthcare enterprises bigger than physician offices, which are explicitly excluded.
Under the regulation, required by a medical-device law passed in 1990, users are required to report deaths related to device use within 10 days directly to the FDA and separately to devicemakers. Users must also report serious injuries to devicemakers, although not to the FDA, and make semi-annual summary reports on those events to the FDA.
The regulations were finalized last summer after being released in preliminary form in 1991. Technically, users were to have begun reporting then, but the regulation only took full effect last year.
In any event, users trying to comply face a number of challenges.
Attributing a patient problem involving a device even partially to user error, for instance, can make hospital risk managers nervous. "Over 50% of medical device accidents involve user error to some degree," said Ronni Solomon, vice president for legal affairs at ECRI, Plymouth Meeting, Pa.
By way of guidance, Solomon suggested that "sometimes the design of the device invites the error, and in those cases it's wise to report so the manufacturer can make a better device."
Even though the FDA keeps the identity of filers confidential, the agency concedes that user reports at hospitals or other sites might have to be turned over to plaintiffs during litigation. While that may compound healthcare executives' concerns, the FDA expects users to do their duty.
"In terms of feeling uncomfortable reporting, the fact is the law's the law now," the FDA's Gardner said. "Is that scary in terms of liability? Probably so, but we have the law behind us."
Users must also grapple with what constitutes a serious injury to determine what's reportable. While unfortunate, some device-related problems are also statistically expected. For example, occasional infection following an orthopedic implant isn't unusual, but whether it should always be reported is unclear.
And the regulations seem to require reports on some incidents not typically captured by existing hospital or healthcare risk management systems, ECRI's Solomon said. Removal and replacement of unsuccessful orthopedic implants is one area that is particularly confusing, she said.
"If the purpose of this law is to improve the health of the public, then one needs to keep a practical approach to all of that," Solomon advised.
To that end, the FDA will do a pilot test of a "sentinel" system that would rely on a sample of hospitals and other facilities to collect data on users' experience with devices. The GAO recommended this as one possible solution to current problems.