Is Your Medical Device Under Warranty?

April 26th, 2010. By Hunter West

If you buy a car and it breaks down within the warranty period, the manufacturer fixes it. If your laptop goes wonky within the first year (usually under warranty), you ship it back and they’ll send you another one, or they undertake to fix it. 

That’s what warranties are for—to protect the consumer against substandard workmanship, faulty parts, or basically a lemon. Wear-and-tear is one thing. You can’t warrant against that. But when something fails well ahead of the best-before date, somebody is made to step up to the plate and extend some responsibility. 

Why does that not happen in the medical device industry? 

Back in January, William R. Morris had to have his artificial hip replaced after just three years. The replacement surgery cost about $50,000. Lucky for Morris, much of the bill was covered through his employer’s health insurance plan. But he figures, due to co-payments and other out-of-pocket expenses, he’s out about $10,000 for his initial replacement and two additional surgeries. 

That’s right—he’s had three replacements. The first operation in 2006 replaced the original hip his creator gave him. That one lasted less than a year—so the replacement was replaced. For a year, he told The New York Times, he felt good, but then THAT hip replacement went wonky. 

This year, he had another one. 

His first artificial hip lasted one year. His second, only three. 

They’re supposed to last 15. 

The April 3^rd edition of The New York Times reported that the manufacturer of the failed hip has been in communication with Morris’ doctor. However, no correspondences have made any reference or offer to cover replacement expenses for the failed hip. 

If that hip were a car, or a computer costing what hip devices cost, it would be fixed or replaced for free according to the warranty. However, where are the warranties for medical devices? Should there be? 

Part of the problem is that unlike a computer that you just ship back top the manufacturer, or a car that you ether drive or have towed to a dealer, remediating a substandard medical device implanted in the human body is a little more complicated. Subsequent hip replacement surgeries can be complex and can have an adverse affect on health, by way of various complications. 

Then there’s the expense. The New York Times says that an artificial joint can cost anywhere from $3,000 to $15,000. They are said to carry some of the highest profit margins anywhere. And that’s just the part. The service call can be $35,000 or more. 

Without warranties, the cost of both the part and the technician to install it is borne by insurance companies. No wonder health insurance is so expensive. 

What would happen if a manufacturer was to be made responsible for the first half, or the first two-thirds of the expected life span of an implanted medical device? That responsibility would include covering both the part AND the installation. Suddenly the profit from selling the device in the first place is instantly negated, and the manufacturer loses big time by having to pick up the tab on its replacement. 

Hmmmmmm… 

Some may argue that it would put medical device manufacturers out of business. 

Others may suggest that medical devices would suddenly become much more dependable…

Tags: Medical Device, Warranty

This was posted on Monday, April 26th, 2010 at 11:39 am and is filed under Defective Products, Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.