Published: Friday 4 May 2012
The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

 

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn't track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA's minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s ...

Published: Monday 30 January 2012
“Caroline is one of more than 50 million men, women and children who do not have health insurance in the United States.”

“It shouldn’t be this way,” read the subject line of an email I received Friday morning from a conservative friend and fellow Southerner. “People shouldn’t have to beg for money to pay for medical care.”

At first, I thought he was referring to my column last week in which I wrote about the fundraising effort to cover the bills, totaling hundreds of thousands of dollars, that the husband of Canadian skier Sarah Burke is now facing. Burke died on January 19, nine days after sustaining severe head injuries in a skiing accident in Park City, Utah. I noted that had the accident occurred in Burke’s native Canada, which has a system of universal coverage, the fundraiser would not have been necessary.

But my friend was not writing about Sarah Burke. He wanted to alert me to another fundraiser, this one on Alabama’s Gulf Coast, to help pay for the mounting medical expenses for a beautiful 13-year-old girl fighting for her life at USA Children’s & Women’s Hospital in Mobile, Ala.

In late November, Caroline Richmond was rushed to the hospital after collapsing on the way home from school. Doctors quickly determined she’d had a stroke and required immediate surgery. The bad news just kept coming. The ...

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