August 18, 2011
Jeffrey Shuren, Director
Center for Devices and Radiological Health
Food and Drug Administration
Silver Spring, MD 20993
Dear Dr. Shuren,
The Patient, Consumer, and Public Health Coalition strongly supports the implementation of the Unique Device Identification (UDI) system, which was part of the Center for Devices and Radiological Health’s (CDRH) 510(k) and Science Report Recommendations issued earlier this year.
We had hoped that a UDI system would already be up and running given that MDUFA 2007 required the Secretary of Health and Human Services “to promulgate regulations establishing a unique identification system for medical devices” in order “to help reduce medical errors, facilitate recalls…and reduce product counterfeiting.”
We realize that it would be next to impossible to assign and implement UDIs for all medical devices at once, so we recommend that CDRH prioritize implantable devices, whether they are Class III or Class II. We do not recommend focusing first just on Class III devices, because so many implantable Class II devices, such as artificial joints and cardiac devices, have also seriously harmed patients in recent years.
A UDI system that includes a federal device registry would save lives. It would immediately and accurately identify defective medical products so patients and doctors could be notified when those devices are recalled, and it would help CDRH flag safety signals such as the recent problems with metal-on-metal hips. If the problems with the metal-on-metal hips had been caught sooner, it would have saved government programs such as Medicare and Medicaid billions of dollars, and it would have spared patients the pain, debilitation, and enormous costs of revision surgery and rehabilitation therapy.
Medical device registries in other countries already help to improve health and save money by reducing the need for revision surgeries. In Sweden, the percentage of surgeries that are revisions is half that in the U.S. A UDI system and registry in the U.S. could reduce revision rates by more quickly identifying device failures and determining if the failures are due to a bad batch or a systemic flaw.
For many years, the medical device industry has complained that U.S. regulation of medical devices should be more like Europe and other countries. In the EU, it is somewhat easier for the highest-risk medical devices to get on the market, but much more difficult to get the national health plans to pay for them. In addition, Sweden, Denmark, Germany, Norway, Australia, and Canada all have national registries to track and monitor medical devices, making their post-market surveillance far superior to ours. Since more than 90% of medical devices are allowed on the U.S. market without clinical trials, it is past time that the United States strengthens its post-market safety and effectiveness systems, as so many other countries have done. A UDI system would be an important step in the right direction. The FDA’s Sentinel project has the potential to serve a similar function as a national registry, but without a UDI system, it is impossible to gather meaningful data on the safety record of medical devices.
A UDI system and national device registry would also benefit the device industry. In addition to helping reduce counterfeit products, it would reduce the number of recalled devices. For example, if certain models or lot numbers of medical devices such as hips need to be recalled, a UDI system would be able to target those devices, which would avoid complete recalls.
As the editors of two of America’s most prestigious medical journals wrote on August 10th, “As was recommended by the IOM committee, a formal system of post marketing surveillance for medical devices should be put in place. Strong, mandatory, and transparent post marketing data, in registries, allow rapid identification of serious problems that may emerge after approval. Careful tracking of every patient with a high-risk device is a crucial step for ensuring patient safety and avoiding nightmare scenarios.”
For the above reasons, we urge CDRH to establish a UDI system for medical devices without further delay to permit post marketing surveillance. The UDI and registry would help protect patients by early identification of defective devices, it would improve public health by helping to assess revision rates, tracking recalls and advisories, assisting in post market surveillance (especially of new technologies and long term outcomes), and determining which devices work best.
As baby boomers age, Medicare and Medicaid will spend hundreds of billions on implantable devices. An effective UDI system will help to ensure that the money is well spent on safe and effective devices.
Annie Appleseed Project
Breast Cancer Action
Community Access National Network
National Consumers League
National Physicians Alliance
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
THE TMJ Association
cc: FDA Commissioner Margaret A. Hamburg, M.D.
For more information, contact Paul Brown at (202) 223-4000 or email@example.com