Coming soon: IDs to track medical devices

Congressional hearings on health care can be contentious, but the story will be different today (November 19), when the bipartisan House Medical Technology Caucus convenes a forum with representatives from the U.S. Food and Drug Administration , manufacturers, and hospitals to discuss how new tracking codes for medical devices can enhance recalls and assessments of heart stents, glucose monitors, and other products patients need.

Unlike breakfast cereal or auto parts with scannable barcodes, medical devices were one of the few products on the market in our country that lacked a national identification system—until now. After years of delay, the federal government has issued new rules that require the makers of medical devices—artificial hips, implanted stents, and other technologies—to use unique identifying codes to track these products from the manufacturer to the patient.

ADVERTISEMENT
The FDA has issued guidelines for the new codes, which will begin appearing on product packaging, and sometimes on the product itself, within a year. The new FDA codes will make sure doctors and patients know which devices have been used, help identify defective products more quickly, and speed product recalls when problems arise.

The majority of medical devices perform as intended, but when something goes wrong the consequences can be serious or even deadly. In recent years, hundreds of thousands of Americans have suffered terrible reactions due to failed medical devices, including hip implants that released metal debris into patients’ bloodstreams and defibrillator leads that delivered unnecessary heart shocks.

Yet putting a number on a product is just the first step. Hospitals, clinicians, health plans, and other federal agencies now have to do their part and make sure that identifying codes are recorded in patients’ electronic health records and in insurance claims forms. This will create new databases with enormous potential for assessing the performance of these devices over time. That data will help locate faulty products and improve the quality of health care by discovering which medical devices improve patient outcomes and lower costs.

Insurance claims data are already being used to detect drug safety problems through FDA’s Sentinel program, and they can be used in the same way to find flawed medical devices. Claims data, for example, could reveal that a certain type of hip replacement is associated with a high rate of corrective surgeries, or that a newly invented cardiac stent results in fewer complications. Ultimately, this will mean that patients stay healthier, Medicare and other insurers will save money, and consumers will have more faith in health care providers and manufacturers who supply the millions of medical products that help keep all of us healthy and productive.

The new FDA codes are long overdue, but the agency has recently done its job by establishing this identification system. Now it’s incumbent on manufacturers to comply promptly with the new regulations, and clinicians, hospitals, and health insurance plans to incorporate these codes in patients’ health records and insurance claims.

We all have a stake in improving the safety of medical devices and the quality of care provided to us and our loved ones. These identifiers hold great promise to achieve significant strides in both those areas. Tuesday’s briefing, cosponsored by the Medical Technology Caucus and The Pew Charitable Trusts, will bring together the stakeholders to discuss how the healthcare system can best adopt the codes to evaluate the long-term effects of artificial hips, pacemakers, and other implants that can prolong and improve our lives.

Rising s the director of The Pew Charitable Trusts’ medical device initiative, which seeks to facilitate innovation of new medical devices and to improve the tracking of the safety of devices once they are on the market.