Medical devices – an ‘exemplary’ safety record.

Last week I wrote on how CMS can save big bucks on Medicare expenditures – negotiate directly with pharma for drug prices for Part D, and base reimbursement for devices on effectiveness and efficacy.
Add ‘safety’ to the list of reimbursement standards.
A post on Care and Cost reinforces the importance of the device issue; contributor Merrill Goozner reports on the ‘recall rate’ exhibited by devices that passed the FDA’s safety review. For the superficial statistician, the figures touted by industry backers sound reasonable – 0.4%, or 4 out of every thousand devices are recalled.
Here’s Merrill…
“Put another way, for every million people who get those devices, 4,000 people are subjected to a faulty product whose failure could put their health at risk.
Now let’s compare that to the “Six Sigma” quality standards used by manufacturers of cell phones and flat-screen televisions. Six-sigma, for those not familiar with the concept, was adopted by Motorola in 1986 so it could compete with its Japanese competitors. Such firms aim to make products 99.99966 percent defect free. That’s 3.4 defective products per million made.”
Here’s how a researcher stated his case in written testimony: “(Recalls are an indicator of major device problems that have the potential to negatively affect patient safety and/or device effectiveness.) Such results demonstrate that serious device-related safety problems are extremely rare. [emphasis added]
So. A quality rate that is dramatically lower than that deemed acceptable in the cell phone, mail-order pharmacy, or electronics industry is somehow acceptable, even ‘exemplary’, by medical device manufacturers.
Why?