FDA Announcement on New Patient Engagement Initiative
Today the FDA is announcing the establishment of the Patient Engagement Advisory Committee (PEAC) to help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues relating to the regulation of medical devices and their use by patients.
While patient representatives participate in many FDA advisory committee meetings, the FDA has never had a committee that was wholly focused on patients. Rather than focusing on a product or specific disease, the new committee will be asked to weigh in on a variety of important patient-related issues. The FDA is asking the public to comment on which issues the committee should focus on first.
The FDA is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. For information about how to nominate yourself or another candidate to participate in the Committee please see the Federal Register notice.
For more information about additional ways that CDRH is engaging patients, see the CDRH Patient Engagement webpage.
For more information about the Patient Engagement Advisory Committee, see the Patient Engagement Advisory Committee webpage.
Food and Drug Administration
Center for Devices and Radiological Health
If you are struggling with your own stroke recovery you must read this post and watch this video
Read: A Lesson in Learning from a Skateboarding Physics Professor
by David Dansereau,MSPT
PFO Closure vs. Medical Therapy
Published Sept. 8 2015
The authors of this report wanted to compare the safety and effectiveness of transcatheter device closure (TDC) versus medical therapy in people with a patent foramen ovale (PFO) who have suffered a stroke of unknown cause in order to prevent strokes or similar events occurring again.
Key results: The Cochrane Report found that, “when compared with medical therapy, TDC failed to show any significant benefit in reducing the risk of recurrent stroke or similar events. However, there was a possible protective effect on recurrent strokes in those participants for whom an Amplatzer device was used compared with medical therapy. We did not find evidence that TDC increased the rate of serious adverse events overall. However, TDC increased the risk of new-onset atrial fibrillation (where there is a problem with the rate or rhythm of the heartbeat) and may be associated with the type of device used.”
Read the full Cochrane Report on PFO closure vs. medical therapy
Li J, Liu J, Liu M, Zhang S, Hao Z, Zhang J, Zhang C
Have You Had PFO Closure? Take Our Quick Poll:
Many patient’s report improvement in symptoms and sometimes even complete resolution of symptoms after PFO closure, while other patients report mixed results. If this applies to you, I hope you’ll chime in here how you feel after closure in this very unscientific anonymous poll:
See Our Previous PFO Poll:
Want to tell Us More about Your PFO Story?
Keynote Presentation: The Future of Home Stroke Recovery and Prevention: Where will Connected Health Tools Fit?
Announcing the 22nd Annual Stroke Rehabilitation Conference for 2015
Southern New England Rehabilitation Center
I am honored to be presenting as a keynote lecturer for this exciting event on October 9th at the Crowne Plaza Hotel in Warwick Rhode Island. My topic is one that I am passionate about and have spent many years actively involved in both as a stroke survivor and advocate for better community awareness and preventative engagement outcomes for patients. My topic will be : The Future of Home Stroke Recovery and Prevention: Where will Connected Health Tools Fit? Below please find link to full announcement of the event with resources to learn more about attending as well as how to become a sponsor. Please mark your calendar and share the news of this event. I hope to see you there!
Read the Full Announcement Here and Learn More