I have blogged in the past about the fact that perhaps the FDA is taking too long to approve much needed life saving medical apparatuses, especially devices that are simply advancements of devices that are already in use. Well, it seems that most consumers don’t agree with me. In fact, according to a recent Consumer Reports Poll, more than 8 in 10 people surveyed allocated more importance to avoiding safety problems in devices, as opposed to encouraging innovation or to getting them to market faster.
Other highlights from the report include:
- 91 percent said each implant should be safety tested before being sold even when similar implants were in use.
- 71 percent said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
- 94 percent indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device.
- 95 percent said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
- 66 percent indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Frankly, I’m torn. I still believe that a lengthy and tedious FDA approval process can lead to lives being lost as people await life saving devices, some of which are actually already in use in other countries. I also understand the consumer’s concern for the highest safety standards possible on any kind of mechanism that could make the difference between life and death for its recipient.