If you are looking for an example of what's wrong with the current system of regulating medical devices, have a look at the terrifying story posted on the Bioethics Forum by Dan Walter, whose wife, Pam, nearly died in a device study at Johns Hopkins in 2002. Pam underwent an ablation procedure for atrial fibrillation at Hopkins, where Dr. Hugh Calkins, a paid advisor to Johnson and Johnson, was testing a J&J device called a Lasso Mapping Catheter. Yet because Johnson and Johnson had claimed that the Lasso Mapping Catheter was "substantially equivalent" to earlier devices already on the market, the FDA did not require J&J to conduct clinical trials to prove that it was safe and effective. So the study in which Pam participated, which, according to Walter, enrolled at least 517 subjects, was not overseen by the Johns Hopkins IRB.
The results were disastrous. Here is the way Walter describes the procedure, which was performed by a Fellow in cardiology:
"Being new on the job and unfamiliar with the new catheter, the cardiology Fellow turned the catheter control knob to the left instead of the right, which transformed the lasso into a corkscrew that wound its way through the complex web of muscles of Pam’s mitral valve and became entangled there. The catheter was stuck. These and other details emerged in depositions and written statements as part of a lawsuit brought by my wife against the Hopkins doctors. After about 45 minutes, a colleague of Calkins’ was called in. With considerable difficulty, the catheter was finally removed, but in the process Pam’s mitral valve was damaged."
"The doctors took Pam down the hall to surgeons, who said that she might die if she did not have emergency open heart surgery to replace her valve. Shortly after the surgery, she suffered a stroke and hovered near death in a coma for the next three weeks."
In a case study published later, Calkins himself laid the blame for Pam's injuries on the design of the catheter. But the Lasso Mapping Catheter remains on the market; device studies like this one are still not subject to IRB oversight; and and Johns Hopkins has done nothing to compensate Pam Walter.
You can read the full story in Dan Walter's alarming new book, Collateral Damage.