Medical Device Tracking Needed to Protect Consumers

December 4, 2017 | Crandall & Pera Law
Medical Device Tracking Needed to Protect Consumers

When your car has a recall, you might get a letter in the mail, or an email, or even a personal phone call from the dealership where you purchased it. If a food in your fridge is recalled, you can check your receipt and the tracking information on the product itself to see if it is a concern. But what happens when your implanted hip replacement or pacemaker has an issue?

That is the basis of a new effort by consumer advocates who wish to know the serial numbers on medical implants. The laws exist already to move forward with unique device identifiers, or UDIs – but no one seems to know just how to start implementing those laws.

Growing population, urgent need

Implanted medical devices go far beyond joints and hearts, into nearly every category of medicine available, including:

  • Sensory and brain implants, such as cochlear implants and neurostimulators

  • Heart and circulatory implants, like stents, artificial hearts, and pacemakers

  • Bone and joint implants, including pins, rods, plates, joints, and screws

  • Contraceptive implants, both intrauterine and placed elsewhere in the body

  • Cosmetic and prosthetic implants

  • Urological implants, for issues such as bladder or fecal incontinence, including transvaginal mesh

According to the American Joint Replacement Registry, nearly half a million joint replacement surgeries alone were done in the US between 2012 and 2015. The number of Americans walking around with an unregistered, untraceable, and potentially defective medical implant or device is staggering. 

Consumer protection and accountability

If automotive dealers can implement infrastructure, paperwork, and fees associated with VIN’s, then it seems entirely feasible for the healthcare and insurance industries to do the same. The problem, however, is twofold: first patient privacy laws, to start, may prohibit the transmission of information about patients to manufactures. This means the collection work would have to be done by someone else.

Manufacturers do support a detailed data collection record. The Executive Vice President of device manufacturer AdvaMed, a man named Don May, told the Star Tribune "We support the collection of the UDI in the electronic health record, where it can actually be used to really help track patient outcomes and be used in a more proactive way around postmarket surveillance. If we are really concerned about patient safety, then let's go to the tool that makes the most sense."

This leads us to point number two: the “someone else” in charge of data collection – Medicare. This will be a time-consuming and costly process, and Medicare may not be sufficient for the task. The funds will need to come from somewhere, but this federal program may not be able to supply them.

The best possible outcome for patients would be a threefold responsibility process. Manufacturers of all medical devices need to use the same format and issue alerts through a nationwide system accessible to both medical professionals and individuals; doctors and healthcare facilities practitioners need to conscientiously track patients’ implants throughout their lives; and insurance companies need to assist in maintaining accurate patient contact records for each implant.

At Crandall & Pera Law, our defective medical device attorneys make sure your voice is heard when health care companies sell dangerous products.  If you need considerate, yet tenacious legal representation, please contact our Ohio lawyers at 877-686-8879, our Kentucky attorneys at 877-686-8879, or use our contact form to make an appointment.