In an unprecedented move, the medical device industry has tried to block a report that examines new regulations on the industry. They are using the usual arguments that there was bias in the scientific report, that industry was not represented, that regulation will slow innovation and kill jobs, and harm patients. Keep in mind that the pro-business group hasn’t even seen the report and yet they’re attacking it. I’ve looked at some of the issues with the medical device industry here and here. First, Do No Harm.
Update: Also, it is becoming increasingly difficult to seek redress if you are harmed by a product. See the film Hot Coffee.
July 27, 2011
Study of Medical Device Rules Is Attacked, Unseen
By BARRY MEIER
Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry.
The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.