The Role of Shared Information in Preventing Medical Device Injuries
By Meaghan Olson
While many would agree that the health care system in place in the United States is less than desirable for many broad, sweeping reasons, they can easily forget that these larger reasons are often related to specific, tangible factors that create hassles and even physical pain for many Americans on a daily basis.
Many Americans have dealt with the hassle of insurance refusing coverage, or the difficulty finding help in an emergency because of HMO health plan regulations; but how many have thought of the real consequences of the lack of a national artificial joint registry for American hospitals and doctors?
A recent article by the New York Times highlights the chronic problems caused by the inability of doctors to share information effectively about prosthetics and artificial internal joints. Now, more than ever, artificial joints are becoming booming business: sales of knee and hip implants have more than tripled to a giant $7 billion industry.
The United States alone used more than one million hips and knees, more than half of the world's total. And the FDA, the government agency responsible for regulating the safety of medical devices, has had too many products flooding this hot market to keep the level of precision necessary over their regulatory responsibilities.
The primary example used in the Times article was a Durom cup metal hip socket manufactured by Zimmer Holdings, a device that caused pain in potentially hundreds of the nearly 13,000 patients who received the implantation. It took a group of doctors meeting at a professional association corroborating their experiences to finally raise the alert that the device might be causing widespread problems in patients.
It's true that these doctors should have been reporting their observations to the FDA; however, when it comes to medical treatments, it's not easy to identify a pattern among patients until the problematic drug or device has become widespread, due to the particularity of the bodily reception and the symptoms involved with a defective medical device.
A common database, on the other hand, would have allowed doctors to double-check for any problems before implanting a device through surgery, a significant operation that can be difficult to reverse without adverse problems. Not only would this have been in the best interest of patients, according to medical experts, but could have saved potentially billions in dollars that are wasted each year on treatments that may not work.
The article points to successful joint registry databases in other countries for a model of how such a registry would save lives and potentially billions in dollars. Australia's registry is touted as a model of effective regulation, as the accountability brought by the database forced manufacturing companies to remove several damaging or ineffective products from the market.
However, for now, it may be that medical companies are willing to hedge their bets, that is, until an inevitable class-action lawsuit can allow market competition to weed out the companies cutting corners. That is, if a product liability lawsuit can even be brought against a company: earlier this spring, the U.S. Supreme Court ruled to provide medical device manufacturers with immunity from liability under state laws if a medical device had been approved by the FDA.
With manufacturers insulated from having to pay damages for injuries caused by their products after FDA approval, perhaps we shouldn't be surprised that they aren't too willing to pull them off the market after reports of adverse effects.