Medical devices: More oversight or less?

There is competing federal legislation - and views, of course - on whether the country needs more or less regulation of medical devices, such as replacement hip parts or vaginal mesh implants.

This debate spins out of the often-competing need for safety and jobs.....or greater profit.

Pennsylvania Sen. Bob Casey (D) and his Arizona colleague John McCain (R) have sponsored a bill that would remove one hurdle for device companies seeking approval from the U.S. Food and Drug Administration.

The senators argue that it makes no sense for manufacturers to prove, and the FDA to certify, that a new product doesn't already exist on the market, even if it is already known that a similar device does not exist. Of course, the existence of a device - safe or not - is hard to know unless someone does such a review.

On the other hand, Bloomberg News reported that legislation put forth by House Democrats, led by Ed. Markey (D., Mass.), would allow U.S. regulators to block medical devices based on past products with safety issues.

In the case of the problematic vaginal mesh implants, the devices were cleared by the FDA's 510(k) system, which allowed them to be sold without human testing once the FDA rules they are similar to existing products. The Bloomberg story is here.

Meanwhile, the Wall Street Journal reported Friday morning that the General Accounting Office will release a report that shows hospitals pay varying amounts for the same medical device. The variance is often due to confidential negotiations between hospitals and device makers.

Consumers are used to seeing a price on an item in a store. But a normal part of many private business deals is the competition to get the best price, whether your business is the seller or the buyer.

But hospital costs and medical devices are not normal private business deals because those hospitals costs are often passed on the taxpayers, who fund Medicare, which insures seniors and disabled people.

The Journal noted Medicare spent $19.8 billion on procedures involving implantable devices in 2009, up from $16.1 billion in 2004. The Journal story is here.

Beyond costs, there is the issue of safety.

As The Inquirer has reported, Synthes Inc., the medical device manufacturer with operations in Chester County, pleaded guilty to charges for illegally testing bone cement on humans in clinical trials.

Without seeking FDA approval of the bone cement for the specific procedure or the clinical trial, Synthes trained surgeons and provided the cement to them for the use in spinal surgeries. Three patients died on the operating table, before the FDA learned enough of the situation to step in. Four Synthes executives are serving prison terms.