Implantable Device Safety
Implantable devices are relatively common – some back of the envelope calculations show that in 2009, there were 46 million Medicare enrollees, about 7.3 million of whom had an MA plan. There were 1.6 million implantable medical device (IMD) procedures that year of people in fee for service Medicare plans, meaning about 4 percent of FFS Medicare beneficiaries had an IMD procedure in 2009. Additionally, there is a growing use of IMDs in cosmetic surgery.
Regardless, when I saw this story about a woman who had been told she had a different IUD than her records showed, I was shocked. For the record, IUDs are regulated as drugs, not devices, but because I worked on devices such as breast implants at the FDA, I wanted to round up some information about the existing safeguards to ensure that what happened to this woman doesn’t happen to anyone else.
As technology makes access to information about a person’s own medical records, the performance of their device and the identification of the device more accessible, ideally, these safeguards will become less important. However, for the time being, we are in a technological transition period. Oversight of implantable medical devices is not as stringent as many would like.
To start with, implantable medical devices are regulated by the FDA, under the device paradigm, which is risk-based. Some implantable devices are Class II (moderate risk) while others are Class III (high risk).
A manufacturer is required to report all adverse events to the FDA, which then analyzes these and looks for trends. Of note, some adverse events are not considered related to the device itself; failure to report these concerns has affected public health.
Devices have Unique Device Identifiers (UDI), which are meant to be incorporated into a patient’s electronic health record and insurance claims. UDI for implantable devices has been required for more than five years.
Some implantable devices use software or are connected to the internet; any that do are required to meet FDA’s cybersecurity provisions.
FDA requires some devices to come with patient device cards (eg, breast implants) while some companies (eg, Medtronic, BSC, Abbott) provide device cards to patients with at least one type of implantable device.
A study a few years ago showed that many patients were not familiar with these safeguards: “Participants overall lacked details on their implanted devices and had a lack of clarity on what information was available to them.”
While I hate to ask patients to take on one more burden, there are relatively simple ways to know what device they have. Knowing what implant a patient has can help when it comes to adverse events, recalls and knowing when the patient needs a replacement.