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Legislation Needs to Address Faulty Medical Devices

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Medical devices can be an important part of patient care-but only if they work properly. According to patient safety advocates, more needs to be done to ensure that medical devices do not malfunction and lawmakers need to pass legislation that will enable the Food and Drug Administration (FDA) to accomplish this. Unfortunately, current legislation does not make this possible.

“Our system for overseeing medical implants and other high risk devices is clearly broken and allows too many dangerous devices on the market,” Lisa McGiffert, Director of Consumers Union’s Safe Patient Project, said in a statement. “Tens of thousands of patients have been injured or died in recent years because current law fails to ensure medical devices are safe.”

Legislative Shortfalls

According to the Consumers Union, the following areas need to be addressed by lawmakers in order to ensure that medical devices are safe.

  • Medical device design. If a medical device was taken off the market by the FDA, the agency has the power to deny authorization of another product that uses a similar design. However, if the manufacturer takes the product off the market voluntarily, the FDA does not have this power -, which has led to patients being injured by products such as transvaginal mesh.
  • Unique Device Identifiers. Unique Device Identifiers (UDIs) would allow the FDA to track the progress of patients who have had implants and other high-risk devices put into their bodies. Although the Senate has addressed making improvements in this area, the House has neglected it.
  • Registries. Both the Senate and the House have not addressed the need for national registries, which would allow the FDA to easily find and notify patients when a medical device is being recalled because of safety risks.
  • Post-market research. The FDA does not have the authority to conduct post-market studies of devices that were approved for sale. The House and Senate have yet to draft legislation that would give the agency this authority.

Source: Market Watch, The Wall Street Journal, “Medical Device Bills Missing Critical Protections For Patients,” 4/19/2012.

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