By: Michelle Tarver, M.D., Ph.D., Deputy Director, Office of Strategic Partnerships and Technology Innovation; Program Director for Patient Science, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH) and Angela Calman, M.P.A., Director, Office of Communication and Education, CDRH
Thirty-five years ago, the U.S. Food and Drug Administration issued an alert that warned health care providers how certain electrically powered hospital beds could harm and even kill children. That was one of our earliest communications about medical device safety. Since then, communicating about medical device safety has been one of our core responsibilities for the 190,000 medical devices that we regulate at the FDA. These public communications, many of which are about medical device recalls, are critical to protecting patients from problems related to medical devices, and to ensuring the safety and effectiveness of medical devices.
At the Center for Devices and Radiological Health, we partner with many different people in industry, health care facilities, and professional societies to help ensure safety issues related to medical devices are quickly identified, assessed, and communicated appropriately. We engage with patients, caregivers and health care providers when solving communication challenges, using a human-centric approach which combines empathy, creativity and critical thinking. This approach helps us better understand the needs of our audiences and helps inform and improve the ways we communicate. These groups, along with members of the media, play a key role in helping to share safety information with the public as well as advocating for continued transparency about safety signals and potential risks of medical devices.
As part of our ongoing commitment to assure patients receive the right information at the right time to inform their decisions about medical device safety, the FDA is hosting a Patient Engagement Advisory Committee (PEAC) meeting on October 6, 2021. This meeting will address factors that the FDA and industry should consider to effectively communicate medical device recall information to patients and the public. This committee, comprised solely of patients, caregivers, and patient advocates, will provide recommendations to the FDA on this important topic. This advisory committee meeting follows the November 2020 public meeting on the FDA’s Communications About the Safety of Medical Devices, which included important dialogue with our key stakeholders on improving the ways we communicate.
There is a lot for us to consider when it comes to the challenges of communicating about medical device safety. First, there are many different types of communications, including safety communications, recall notices, and letters to health care providers, among others. These communications appear in different forms and different channels, ranging from the FDA’s website posts to database entries to email notices, to social media posts, and more.
When we communicate about medical device safety, we first consider patients’ needs and the information that will be most beneficial to them. We provide useful information to clinicians and health care providers to ensure they have the technical information necessary to provide the most relevant guidance to the patient’s condition or medical status. Additionally, our communications typically support or amplify existing publicly available information, and we offer resources if further clarification is needed.
There are many steps we can take to achieve this balance and to improve our communications to ensure our stakeholders receive the information they need in a timely, clear, and consistent manner. We have already taken several of these steps, and intend to keep accelerating these efforts, which include:
- Messaging and Communications: Continuing to study and adopt best practices in messaging, including new insights and techniques in clear, effective communications, and expanding our access to expertise in the field; enlisting the latest techniques in testing and measuring communications effectiveness which includes expanding our ability to reach and seek feedback from a wide group of people; and, exploring new forms and channels of communications, in ways that reach patients, caregivers and health care providers with tailored content that is most useful to them.
- Social Media and Media: Strengthening our presence on social media, which is becoming an ever-more-important source of information for patients, caregivers and others; and, improving how we communicate with the media, keeping them fully informed and responding to their inquiries effectively.
- Stakeholders: Improving the ways we share responsibility for communications with the medical device industry — including providing the industry with more input and guidance about when an FDA communication may be more effective; and, partnering with patient advocacy groups to help disseminate our communications.
The FDA’s communications on medical device safety are often critical to patients, caregivers and health care providers. Over the past 35 years, we have issued thousands of communications that protect patients and promote public health. Collectively, with industry, health care facilities, professional societies and patients, we can continue to enhance the safety of patients whose health, independence and well-being depend on beneficial medical devices.