Tracking recalled medical devices is surprisingly difficult

Tracking recalled medical devices is surprisingly difficult due to the lack of unique device codes.

When food is recalled, consumers are usually given enough information that they can check the UPC on their food or receipts to see if they have been affected. Likewise, if a part in their car has been recalled they will usually receive a letter from the car manufacturer notifying them about how to replace the part. What may surprise many people, however, is that no such system exists for tracking recalled medical devices. Difficulty in tracking those devices place patients in harm's way, according to many patient safety advocates. As the Minneapolis Star Tribune reports, while there have been repeated calls to include codes on Medicare and insurance forms, similar to a UPC or VIN, the plan has been met with resistance from medical device manufacturers and insurers.

Pacemakers recalled but not tracked

An example of the difficulty in tracking recalled health devices was highlighted by a 2011 report by the federal Government Accountability Office (GAO) into the 2005 recall of thousands of pacemakers made by former manufacturer Guidant Corp. The pacemakers were recalled because excess moisture could seep inside and cause them to stop functioning. The issues resulted in some patients suffering heart failure or cardiac arrest and one patient may have died because of the problems with the pacemaker.

However, the GAO report noted that 1,732 of those recalled pacemakers were never recovered because there was no way of tracking them down. As a result, regulators have no way of knowing how many of those patients still have a defective pacemaker in their bodies.

Making tracking easier

There are plans to make it easier to track medical devices. In 2007, for example, Congress mandated that a system of unique device identifiers (UDI) be implemented to help track individual medical devices. While the Food and Drug Administration (FDA) has been working on implementing those new UDI rules, there has been pushback.

As Bloomberg BNA reports, many patient safety advocates want the UDIs added to Medicare and private insurance claim forms. They point out that while the FDA can force medical devices to have a UDI, the FDA doesn't have the power to include those UDIs on claims forms. By including the UDIs on claims forms, it would be much easier to track down patients who may have recalled medical devices.

However, many medical device manufacturers and insurers have fought against adding UDIs to the forms. While they claim changing the forms would be cost-prohibitive and too complex, critics say the manufacturers and insurers are more worried about decreased sales and more litigation if the devices can be more easily tracked.

Medical malpractice help

Medical malpractice lawsuits tend to be extremely complex and they require a level of expertise that is different from other types of lawsuits. That's why anybody who has been the victim of potential medical malpractice should contact an attorney right away who has experience handling such cases. A medical malpractice attorney can help clients pursue whatever compensation they may ultimately be entitled to and show them how to go about making a claim.