Patients are experts in their conditions and offer valuable information to the U.S. Food and Drug Administration (FDA) about living with the condition and its treatments. Patient input can significantly impact the development, evaluation, and monitoring of medical devices.

Discover how the FDA’s Center for Devices and Radiological Health (CDRH) puts patients first with its Patient Science and Engagement Program.

Patients and Health Care Professional Organizations Give Feedback on Philips Respironics Recall

On November 12, 2021, the FDA updated its website on Philips Respironics recalled ventilators, BiPAP, and CPAP machines to further clarify recommendations for people who use affected devices. The update also addressed common questions and concerns from patients and health care providers. As the FDA continues to work diligently on this recall and consider solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers.

Following the recall, the FDA worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, Mended Hearts, Inc., and the American Academy of Sleep Medicine to include their feedback in the updated “Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions” web page. The FDA will continue to work with these groups as well as others to inform communications about the safety of the affected devices. Read more.

CDRH Released Video on Cybersecurity for Connected Medical Devices

The FDA launched a video focused on patient cybersecurity best practices, Cyber Vitals: Information for Patients’ Medical Device Health. The video offers steps patients can take to protect their medical devices and personal information.

In the video, the FDA encourages patients to protect their personal information, monitor their medical device for unusual behaviors, and get a medical device check-up from their health care provider or the device manufacturer. Watch the video.

New Abstract on Patient Preference Information and Prostate Cancer

CDRH, in collaboration with Stanford University and University of Maryland Baltimore, conducted a study to assess patients’ perspectives on the benefits and risks associated with high intensity focused ultrasound (HIFU), a minimally invasive tool that destroys prostate tissue and has minimal side effects.

The study results may help inform the FDA’s regulatory decision making for new prostate ablation devices. Read the abstract.

Webcast: Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices Public Workshop

Last October, the FDA hosted a workshop to explore the meaning of and best ways to promote transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, providers, and caregivers.

In our discussions, we identified unique considerations in achieving transparency for users of AI/ML-enabled medical devices and ways in which transparency might enhance the safety and effectiveness of these devices. We also gathered input from various stakeholders on the types of information that would be helpful for manufacturers to include in AI/ML-enabled medical device labeling, as well as other potential mechanisms for sharing information with the public.

Workshop participants included more than 3800 registrants representing industry, health care providers, patients, academia, government, consultants, and more. Watch the webcast recording and read the transcript.

Webcast: Patient Engagement Advisory Committee

On October 6, 2021, CDRH held its fifth Patient Engagement Advisory Committee (PEAC) meeting. The discussion focused on how the FDA can effectively communicate and share information about medical device recalls with patients.

The Committee considered concerns patients have about changes to their device in response to recalls and ways patient perspectives could be incorporated in the FDA’s and industry’s benefit-risk decision making related to recalls.