FDA Wants Data on Older Medical Devices – Hip joints, dental implants and spinal surgery screws
Posted Apr 12 2009 11:51pm
This is probably a good idea, as most device makers are probably already doing this to some degree. Once analyzed, it could give patients an idea of how the devices are standing up and if there’s a possibility of needing a replacement at any time. Recently in the news with Medtronic and recalls were the defibrillators and wires connecting them to device in need of replacement or repair.
New device technology has improved dramatically in the last few years, but for those with old devices having a compiled area of information for reference could not hurt to help in any decision making process. BD
WASHINGTON (Reuters) – U.S. regulators on Wednesday ordered makers of 25 types of medical devices to supply safety and effectiveness data so the government can decide whether the products must undergo the most stringent review process.
The order addresses complaints that the Food and Drug Administration had allowed some devices that were sold before 1976 without agency approval to remain on sale without a thorough evaluation.
The devices include metal hip joints, dental implants and screws used for spinal surgery, an FDA notice said.
The FDA oversees medical devices ranging from simple bandages and tongue depressors to the most complex products such as pacemakers and heart-valve replacements. Each is classified based on the level of risk to patients. The most dangerous are labeled "Class III" and subject to the most rigorous level of review.