Medical Device Approval Process Needs Overhaul

The New York Times has reported that a study commissioned by the Food and Drug Administration (FDA) has strongly recommended a complete revision of the approval process for certain medical devices. In particular, artificial metal-on-metal hip implants were cited in the article as an example of the kind of medical device which was approved through this process, but was also the center of recalls and reports of injuries.

The report’s stringency concerning the approval process and its need to be rebuilt came as a shock to the researchers themselves.

The Institute of Medicine (“one of the nation’s top scientific groups,” says the paper) was commissioned to conduct a study on how the FDA could strengthen a certain area of their approval process for medical devices. The report they handed back called for a complete overhaul of the entire approval system for moderate-risk devices. The criticisms are aimed at a supposed ability for new medical devices to “piggy-back” on the approval of similar devices that have come before them, leading to less rigorous testing and evaluation than may be necessary.

The study has met opposition from industry leaders and been embraced by patient groups and some members of the medical community. The New England Journal of Medicine, notably, vocalized support for the study and its conclusions. Of particular interest is the report’s suggestion that artificial joints, like hip replacements, should be subjected to the same thorough and rigorous testing that high-risk medical devices are required to undergo.

The report’s stringency concerning the approval process and its need to be rebuilt came as a shock to the researchers themselves, who had not planned on coming to such a severe conclusion. It remains to be seen what effect this research will have on the FDA’s methods, if any, but those who have been injured by defective hip replacement implants (such as the recalled DePuy ASR implants) may count this as a sizable victory for their cause.