Since 2013, the FDA has required manufacturers to label implanted medical devices with a unique device identifier (UDI) that includes the manufacturer name, model and, as available, the lot number, serial number and expiration date. UDIs can be scanned during a patient procedure and documented in electronic health records.
A study known as UDI2Claims is developing a process to transmit UDIs to insurance claims. As part of that work, Brigham and Women’s Hospital’s Joel Weissman, PhD, deputy director and chief scientific officer of the Center for Surgery and Public Health, Amanda J. Reich, PhD, MPH, a research scientist in the Center for Surgery and Public Health, Deepak L. Bhatt, MD, MPH, executive director of the Interventional Cardiovascular Program at the Heart and Vascular Center, and Louis L. Nguyen, MD, MPH, MBA, vice chair for digital health systems in the Department of Surgery; and Natalia A. Wilson, MD, MPH, a faculty member in the College of Health Solutions, & the Center for Healthcare Delivery and Policy, at Arizona State University; and Jove Graham, PhD, assistant professor at Geisinger Health, studied whether patients who receive implanted devices are aware of UDIs and want their implanted device information shared.
In Health Expectations, the team reports that patients were unaware of the availability of UDIs for documentation and tracking of their device, and they mistrust having their implanted device information shared outside the health care system.
At the Brigham and Geisinger Health (Danville, PA), the researchers held focus group meetings with a total of twenty-four patients who had received a cardiac or vascular implanted device within the past six months. Two groups were held in June 2017, and two in April 2019.
Based on the iterative review of focus group transcripts, the researchers identified several key themes:
Lack of awareness of identifying information on implanted devices—Some patients had a card that listed information such as the manufacturer and model of their device, but others had never received one and didn’t know it was available. No participant was aware of UDIs. Patients seemed to assume the identifying information was documented somewhere within the health care system and could be accessed as needed.
Identifying information considered valuable—Participants endorsed the value of having identifying information for their personal clinical care. They acknowledged UDIs are important in case a patient must find a different health care provider. Some considered device tracking beneficial in general, including for clinical research.
Perceived risks of sharing device information—Patients were most comfortable about sharing device information with their clinicians and hospital. They perceived risk in sharing it with insurers and the federal government, remarking on the potential for denial of insurance coverage and loss of privacy. Patients seemed unaware insurers may already receive their procedural information and the FDA has responsibility for medical device oversight. Trust in manufacturers was mixed, and participants were unsure whether manufacturers keep records of their device.
Lack of consensus on a systematic process to track implanted devices—Patients desired a systematic way for device information to be stored and a clear method to be notified of problems. There was no consensus on how to do this or who should be responsible: clinicians, manufacturers, the FDA, and/or a national registry. Patients expressed surprise and frustration that no comprehensive system already exists.
Implications for Patient Counseling
Many outcomes of this study are discordant with the goals of shared decision-making and patient-centered communication. After implantation of a medical device, clinicians can improve care by:
- Giving the patient information about the device, including the UDI, how long-term tracking will be supported, and the process for notifying the patient in case a problem occurs with the device
- Ensuring the patient receives a wallet card or e-version of their implant information, including the UDI
- Communicating where the device information is documented (e.g., electronic health record) and where it is shared for device tracking, post-market safety surveillance, and research (e.g., clinical registry, FDA)
- Explaining how sharing of device information supports patients’ long-term care (e.g., post-market safety surveillance and research)
- Repeating education provided after the procedure during the first post-discharge office visit