Medical Device Defects Held to Go Unreported
Manufacturers of medical devices ranging from pacemakers to pediatric cribs are failing to notify federal officials of potentially dangerous defects and deciding for themselves whether to recall the faulty equipment, according to two new congressional studies.
In nearly half of the highest-risk equipment recalls of the past five years, the Food and Drug Administration was not aware that manufacturers had begun removing them from the market until after the process had begun, the General Accounting Office found.
Although manufacturers are not required to report recalls to the FDA, a 1984 law requires them to notify the agency when devices may have contributed to a death or serious injury or when a malfunction could prove extremely hazardous.
The GAO, a research arm of Congress, found in its analysis of 1,635 medical device recalls from 1983 through 1988 that manufacturers had provided the required notifications in only 16 of 31 high-risk recalls since the law took effect.
In 17 cases, involving replacement heart valves, dialysis units, anesthesia machines and other devices, the products were pulled from the market after their shortcomings were linked to patient deaths. Six of the companies involved in the most serious recalls are located in Southern California.
Copies of the GAO’s companion reports, one of which contains an overview of the issue while the other looks at specific recalls in detail, were obtained by The Times in advance of their scheduled release today.
“FDA became aware of the great majority of device problems associated with a recall in some other way than through (reports from the manufacturers),” the GAO said. “This suggests that the reports have not served as an effective ‘early warning’ of device problems serious enough to warrant a recall,” the agency concluded.
The FDA learned of the majority of recalls through inspections of company records and notification by users or competitors, the GAO reported.
The GAO also found that the FDA has failed to establish performance standards, as required under a 1976 law, for devices involved in nearly three-quarters of the recalls.
That law established three categories of medical devices based on their potential safety risks. Manufacturers are required to submit pre-marketing documentation to prove the safety and effectiveness of devices deemed to be high-risk.
The FDA is supposed to establish performance standards for medium-risk devices, while less stringent safety requirements apply to the least risky devices. Ironically, moderate-risk devices were responsible for a majority of the recall-related defects that the FDA said posed the greatest danger.
The medical equipment industry generates sales of nearly $14 billion a year and produces more than 1,700 products, including virtually every device used by health care professionals to diagnose and treat illnesses and injuries, excluding medications.
Although the FDA had not yet seen the GAO reports, spokesmen said Thursday that the agency believes that the information it is receiving from medical device producers is sufficient to safeguard consumers.
“We think manufacturers are complying with the reporting requirements and we’re looking at the incidents that happen with the products and coming to our own conclusions about when something needs to be done,” said Walter Gundaker, acting deputy director of the FDA’s Center for Devices and Radiological Health.
The center is receiving 15,000 reports annually about malfunctioning medical devices, FDA spokesman Bill Grigg said. In about 15% of the cases, the products are ultimately determined to have caused serious injury or death.
Gundaker said that no performance standards have been adopted for 800 devices deemed of medium risk when they entered the market because the formulation process is lengthy and “we don’t have the people to put on that project.”
He said that the only performance standard being developed is for apnea monitors, respiratory devices intended to prevent crib deaths. A number of infant deaths, possibly caused by failures of the machines, have attracted widespread attention.
The GAO studies, which were based on FDA computer records and interviews with agency officials and staff, are expected to provide new ammunition for congressional critics who are seeking to strengthen the medical devices law and FDA oversight.
The reviews were requested by Rep. Henry A. Waxman (D-Los Angeles), chairman of the subcommittee on health and the environment of the House Energy and Commerce Committee. Waxman’s panel has scheduled a hearing Monday on the FDA’s regulation of medical devices.
The reports “show that manufacturers who profit from the sale of these products often act without FDA oversight in deciding whether to keep their products on the market when problems begin to surface,” Waxman said.
“When FDA doesn’t even know about deaths and injuries from products that the manufacturers recall, how can the FDA even pretend to know about the safety of the thousands of other medical devices that remain on the market?”
He said that the agency is hamstrung by budget cuts and its desire to accommodate the industry.
Waxman and Rep. John D. Dingell (D-Mich.), chairman of the Energy and Commerce Committee, have introduced legislation to toughen the 1976 medical devices law. A similar measure passed the House in 1987 but died in the Senate in the face of industry opposition.
The bill would require hospitals and other health-care providers to begin informing the FDA of deaths or serious injuries that may have been caused by medical device malfunctions. The measure would also streamline the process under which the FDA can initiate recalls.
The FDA already has the authority to seek court-ordered recalls of medical devices. But the agency must show that, in addition to being dangerous, the devices fail to meet “the state of the art as it existed at the time of design and manufacture.” The FDA has never initiated such a recall, agency officials said.
“There’s no need to force a company to recall a product because the company has liability problems and wants to get the product off the market as well, once a problem has been discovered,” FDA spokesman Grigg said. He said that the public is best served by persuading the company to undertake a voluntary recall.
Eddie Allen, general counsel for the Health Industry Manufacturers Assn., which represents the device makers, said that the FDA’s reporting requirements are ambiguous.
“There is a certain amount of discretion that is given to a company,” he said. “The problem with the (medical device reporting) regulation is that well-intentioned companies interpret the same facts and the same regulatory requirements differently than the FDA does.”
Overall, the GAO reports found that cardiovascular and anesthesiology devices accounted for more than a quarter of all medical device recalls. Suntanning booths, beds and lamps were recalled 33 times, more than any other single product category. Problems with design and production were the cause of nearly three-fourths of all recalls.
The six Southern California companies and the products they recalled are Pacesetter Systems Inc., of Sylmar, cardiac pulse generators; Shiley Inc., of Irvine, replacement heart valves and aortic valves; Cooper Vision Inc., of Irvine, silicone tubing used in anesthesia; Primary Medical Products of Los Angeles, vaporizers; Intermedics Intraocular Inc., of Pasadena, intraocular lenses, and Bear Medical Systems Inc., of Riverside, ventilators.
Under the FDA classification system, 1,203 of the recalls, or 74%, involved devices considered medium risks. Another 278, or 17%, were considered least serious risks. A total of 153, or 9%, were in the high-risk category.
But the GAO said, “Our analysis showed that all classes of devices--including some devices that are considered relatively innocuous--can be associated with problems potentially leading to serious health consequences or death.”
MOST FREQUENTLY RECALLED MEDICAL DEVICES
Study covers 1983 through 1988
Product Recalls Problem Tanning beds, lamps 33 Timer Ventilators 31 Transformer IV administration sets 28 Wrong plastic Infusion pumps 23 Software Anesthesia equipment 21 Defective plastic Mobile X-rays 20 Beam filtration Anesthesia gas machines 15 Valve, pump Pacemakers 15 Sudden interruptions Defibrillators 15 Battery packs Laser surgery instruments 13 Safety features
Product Health Hazard Tanning beds, lamps Severe burns Ventilators Suffocation IV administration sets Loss of IV fluid Infusion pumps Air embolism Anesthesia equipment Suffocation Mobile X-rays Overexposure Anesthesia gas machines Overdose, other risks Pacemakers Death Defibrillators Delay in treatment Laser surgery instruments Accidental exposure
Source: General Accounting Office
