Medical Devices — where are the regulators?


Corruption 101:  medical device makers.  It’s unbelievable that in the same week we get reports of device makers paying physicians billions of dollars to use their products while the FDA approves devices with skimpy rules and secret files.

To pay cardiologists to “research” how a pacemaker works after the device is mass produced is like giving a coupon to a housewife to “research” a new laundry detergent.  Except, the laundry detergent costs $5 whereas the pacemaker costs $30,000.  This is a kickback and it is unethical (because the doctor gets the money and the patient gets no benefit).

The idea the FDA can and does approve new models of pacemakers without proof they are safe is beyond comprehension.  Many of the recent recalls involve defective pacemaker electrical leads — new models are OKed without materials testing or prolonged flexion testing that most engineers would expect.  Even Consumer Reports lab could do a better job.  A car recall is one thing, but cutting a patient open and jerking out a defective pacemaker wire from the heart is something hugely different.

Self policing of device makers has failed — we need regulations with teeth.  In addition to safety regulation a limitation on device profit is badly needed.

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