Let's bring drug and medical device safety into the 21st century

February 19, 2007|By Kevin A. Schulman

DURHAM, N.C. -- Like a growing number of aging baby boomers, I recently had knee surgery. During a follow-up visit, my doctor showed me an X-ray of my knee, and I saw that a metal screw had been implanted during the surgery. I didn't know the screw was being placed there, and I knew nothing about who had made it, how well these devices had performed in long-term studies or whom I would tell if I had a problem with the device.

When I purchase an appliance these days, the manufacturer asks me to register the product by mail or over the Internet so it can match me with the product details. In health care, we don't do this. If there is a product recall, I won't know whether to be concerned about the screw in my knee because I don't know its make, model or lot number.

New devices and medications offer tremendous promise to America's aging population. However, with the increasing use of new technologies, it is remarkable how little we do to track their safety and effectiveness. The Food and Drug Administration monitors the safety of marketed drugs and devices by receiving spontaneous reports from physicians and patients or through follow-on clinical trials of products that have entered the market.

This system is facing increasing criticism in the medical community. The Institute of Medicine of the National Academies issued a report last fall that called for greater post-market safety assessment of prescription drugs. However, that report essentially recommended enhancements to the existing, passive FDA processes rather than pressing for new safety mechanisms. Congress will consider the recommendations this spring as part of a debate over the FDA User Fee Act, which is up for reauthorization.

Hospitals track information on medical devices by placing stickers with the product information in paper medical charts. For some devices, hospitals keep an electronic registry and send the information to the manufacturer, but the patient receives only a paper copy at discharge, if anything at all. A patient who has a problem with the device can't easily report this news in a way that would be helpful to the nation's safety monitoring system.

For example, after an FDA Advisory Committee meeting on the safety of drug-eluting coronary stents in December, cardiologists were urged to have patients continue taking blood-thinning medications for at least a year after the device was implanted. Patients, however, leave the hospital with this information on a paper card. If they lose the card, they might not know that the recommendations have changed and that they should call their physician.

True safety monitoring would provide every patient who receives a medical device with details about the make, model and lot or serial number, along with access to an online system with information about the device. The same system could be implemented for new prescription drugs. Upon leaving the hospital, the patient could be registered on a Web site that would allow for communication among the FDA, the manufacturer, the physician and the patient about potential problems with the product.

Active monitoring would match product with patient. If a patient has a problem but does not see the original physician or visit the same hospital, the new clinical team would have access to all of the information on the patient's device and other medical history. Moreover, the medical staff could report concerns back through the system to the FDA and the manufacturer. Such a system could also notify patients about product recalls and other developments, or be used to survey patients to study questions about medical devices.

Finally, the economics of a real-time safety monitoring system would be compelling. Patient-level, systematic data collection in the form of registries is far less expensive than new clinical trials. Most products withdrawn from the market are done so years after their launch, because it takes time to detect and study safety problems. With active monitoring, we would have information about new technologies today, rather than years after the technologies are approved for sale.

Until such a system is in place, I'll just have to hope the metal screw in my knee lasts at least as long as I do.

Dr. Kevin A. Schulman is a professor of medicine and business administration at Duke University. His e-mail is kevin.schulman@duke.edu.

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