Consumers Union calls for improved medical device safety
In a Nov. 15 letter to members of Congress, Consumers Union urged reauthorization of the Medical Device User Fee Act—currently set to expire Sept. 30, 2012—and outlined ways to improve oversight of medical device clearance processes. The letter appeared Tuesday morning prior to a meeting of the Senate Health, Education, Labor and Pensions Committee on medical devices.
Taking a position in the ongoing debate surrounding the medical device review process, Consumers Union called for a more rigorous review by the FDA, as well as better tracking of implantable and life-sustaining medical devices.
“Lax medical device approval standards are putting patient lives at risk,” said Lisa McGiffert, manager of Consumers Union’s Safe Patient Project, in a statement. “The current system has allowed the FDA to fast track approval of more than 90 percent of new medical devices based on whether they are similar to other devices already on the market without clinical trials that show the devices are safe and effective. It’s time to strengthen the federal law on medical devices, not scale back oversight at the expense of patient safety.”
The letter pointed out that the medical device industry is “far less regulated” than the drug industry, citing weaker standards for clinical trials. Providing a high-profile example of a medical device failure, the consumer group noted metal-on-metal hip implants that were cleared through the 510(k) process caused considerable harm to patients and cost to the healthcare system.
“When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device,” the authors wrote. “Some patients are permanently disabled or die due to complications from a device.”
Consumers Union made the following recommendations:
Taking a position in the ongoing debate surrounding the medical device review process, Consumers Union called for a more rigorous review by the FDA, as well as better tracking of implantable and life-sustaining medical devices.
“Lax medical device approval standards are putting patient lives at risk,” said Lisa McGiffert, manager of Consumers Union’s Safe Patient Project, in a statement. “The current system has allowed the FDA to fast track approval of more than 90 percent of new medical devices based on whether they are similar to other devices already on the market without clinical trials that show the devices are safe and effective. It’s time to strengthen the federal law on medical devices, not scale back oversight at the expense of patient safety.”
The letter pointed out that the medical device industry is “far less regulated” than the drug industry, citing weaker standards for clinical trials. Providing a high-profile example of a medical device failure, the consumer group noted metal-on-metal hip implants that were cleared through the 510(k) process caused considerable harm to patients and cost to the healthcare system.
“When an implanted device is recalled or removed from the market, patients cannot simply stop using them. Removal of the device requires surgery, sometimes multiple surgeries, and it may take months or years to repair the damage done by the device,” the authors wrote. “Some patients are permanently disabled or die due to complications from a device.”
Consumers Union made the following recommendations:
- Raise standards of approval for devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
- Ensure that implantable and life-sustaining devices do not go through the 510(k) process, and require them to go through the full pre-market approval process, which requires clinical trials.
- Remove recalled devices from the list of predicates upon which other devices may seek to be cleared and require that devices approved based on a recalled device be automatically reviewed for safety.
- Require the FDA to implement a national unique identifier system for devices so that patients and healthcare providers can be contacted when problems with that device are identified.
- Ensure that the FDA has adequate resources to fully implement existing patient protection programs for monitoring and reporting adverse events.
- Enable the FDA to use its recall authority more effectively and provide the FDA with authority to call for longer-term post-market studies.
- Retain current conflict of interest standards for federal advisory committees.