Thousands of people around the world have been exposed to toxic chemicals generated by their metal hip implants. Similarly, many patients have contracted infections from pieces of implanted mesh used in hernia-repair surgery, even though materials less prone to causing complications were available.
In these cases, and many more like them, experts say the health care system is failing to quickly detect and react to problematic medical devices. It's all the more puzzling because the health care system is generating more data than ever on patients, and the safety gaps in the system have long been recognized by Congress and health care researchers.
Quicker detection and communication could spare scores of patients from suffering complications, if researchers could tap the vast troves of health data that doctors and hospitals have begun to collect on their patients.
That's why harnessing the potential of data on patients is one of the main goals of a national device surveillance system proposal being unveiled Monday by the health care arm of the Brookings Institution, the Washington think tank.
The report, "Strengthening Patient Care," written at the behest of the Food and Drug Administration's device-safety division, lays out an ambitious seven-year, $250 million proposal to study and then launch the National Medical Device Postmarket Surveillance System.
"Interactions with the health care system are generating new insights every day," said Yale cardiologist and health care outcomes expert Dr. Harlan Krumholz. "If a million people have had a device, we should have the benefit, as a society and as the next patient, of what you could learn from the experience of a million people."
The system would track each medical device through its life cycle with patients on a mass scale, offering insights not possible with clinical trials that might only track a few thousand patients over the course of one or two years.
Besides securing funding from Congress, one of the biggest hurdles will be figuring out the best way to securely access electronic medical records without exposing personal health information. Study authors say several different models may work, which is why they're recommending two years of pilot studies before a five-year rollout of the program.
Krumholz, who served on the study's planning board, said the goal is for the industry to design a voluntary public-private partnership model with input from devicemakers, health care providers, insurance companies and patients. It's intended to avoid a cumbersome top-down regulatory mandate that could follow in the wake of Congress' 2012 order to the FDA to begin including medical devices in its new Sentinel System for monitoring medical safety.
The Sentinel system tracks drugs and vaccines, but not devices. Although Congress' mandate to include devices is now three years old, the FDA hasn't been able to implement it because medical gadgets still lack a universal system for product numbering like the familiar VIN on a car.
The agency has since unveiled rules for how it plans to have companies put unique device identifiers, giving product-safety advocates a way to track the safety of each device.
"That is something that we do not have today. And it is something that we absolutely need in health care," said Greg Daniel, managing director of the Engelberg Center for Health Care Reform at Brookings, which is publishing the plan.
So far, medical-device industry officials say they are supporting the effort, though they're still parsing the details of the Brookings report.
Janet Trunzo, senior executive vice president with industry trade group AdvaMed in Washington, said device makers agree that input from all stakeholders in the system can be harnessed to promote public health. Companies also support using unique device identifiers in a national device-safety surveillance system.
"Any National Medical Device Postmarket Surveillance System should promote optimal patient care by leveraging the input of patients, physicians, industry and other stakeholders to inform decisions about medical technology safety, effectiveness, and quality," Trunzo said in an e-mail.