U.S. health officials on Tuesday proposed measures to improve the state system for medical devices, which was criticized for years for failing to catch problems with risky implants and medical instruments.
Plan from the food and drug administration includes a few changes, but contains a number of ideas and suggestions to improve safeguards for pacemakers, artificial joints, medical scanners, and other devices.
Among other measures, FDA will consider requiring additional training for doctors, implantation of certain devices of increased danger. But this step, like other sailed by the Agency, may require new guidelines or rules. Other proposals might require additional money from Congress.
The FDA has repeatedly been forced to issue warnings about unexpected problems with devices, which only appeared years after they were approved for use in patients. In the last decade, those involved the hip joint, which is out of order, faulty wiring in implanted defibrillators, surgical mesh is associated with pain and bleeding and a surgical instrument which is inadvertently spread cancer from the uterus.
“We want to have the best tools to identify issues that arise after approval,” FDA Commissioner Scott Gottlieb said on Tuesday. “But we also want to have the best policy in order to intervene quickly and to better inform patients and providers, if we see negative events that happen.”
One critic of the Agency says that the report contains a number of specific changes.
“The security strategy the FDA for medical devices are still years away from effective implementation,” said Diana Zuckerman, President National research center of health, group for the protection of the rights of consumers.
Ben Muscovite, medical device expert with the Pew charitable trusts, welcomed the Agency is looking “better and more data on the safety and quality”, including from large medical databases.
Fundamentals of FDA regulatory device belongs to the mid-1970s and was criticized in the reports of the state inspectors and independent medical experts. New devices are being tested in patients, while the vast majority of them would be good based on the similarity of the products already on the market.
In 2011, the report the influential Institute of medicine said that FDA should abandon its system, because it gives little confidence that most devices are really safe. The group is now known as the national Academy of medicine — consists of medical experts who advise the Federal government.
Employees of the FDA rejected the report’s findings, saying that the system works well for most devices.
The Tuesday report recognizes the shortcomings of the current system, the FDA to identify problems that officials of the Agency characterized as “passive”. The Agency relies on reports of problems from doctors, patients and manufacturers, but electronic documents often contain incomplete or inaccurate information. And most of the problems the device is not reported, according to government estimates.
This means that it can take a long time to determine if the problem “is a real security threat,” the FDA paper States.
Among other proposals set forth in the “medical action plan FHWA safety devices,” the FDA will consider:
— How fast you want the Additional safety requirements for certain devices, including the training of doctors who work with complex equipment.
— Additional testing devices for women, after the recent problems with vaginal mesh, birth control Essure implants and surgical instruments.
— New ways to stimulate producers to improve safety, including a fast approval for devices that appear safer than what is available.
— Requiring functions of cybersecurity for electronic devices, such as implantable pacemakers and defibrillators.
The Agency also will ask Congress for more money for public-Private system for monitoring insurance claims, electronic medical records and other data sources for early signs of problems with the device. The project is estimated at more than five years $ 250 million to become operational; currently intends to obtain $30 million from device manufacturers.
AdvaMed, the chief lobbying group for the industry, said in a statement that the applicable rules of the device are working fine, “but we believe that every process can be improved and welcome discussion of any proposals that will have a positive impact on patient safety and access.”
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Sourse: abcnews.go.com
