medical devices under scrutiny

Overtreatment, overmarketing, conflicts-of-interest and all the trappings of disease-mongering pertain not just to medical treatments, education, publishing, screening and drugs, but, increasingly, to medical devices, both the kind that are used IN the body and ON the body. It is clear from current scandals and investigations in the US and UK that the device approval and oversight systems are, according to the BMJ, “fragmented, poorly regulated [and] market driven,” and that, shockingly, “financial incentives prioritize manufacturers’ interests over those of patients, with no requirement for clinical evaluation of a devices’s safety or effectiveness.”

Digging into the background of medical devices is eye-opening for someone already familiar with medicines and their scientific and regulatory problems. It’s a whole new world of engineering and chemistry, radiation and plastics, chips and tags, etc.

What isn’t new is the revelation of a patchwork and antiquated approval and regulatory system based on levels of risk that seems more appropriate to tongue depressors than hip implants. We’ll be sure to take a look at this topic next February at “Selling Sickness, 2013.”