More than 500 people attended a special webinar to discuss the FDA’s proposed rule regarding medical device service setting a new 2016 attendance record for TechNation’s Webinar Wednesday series.
The webinar followed MD Publishing’s immediate response to the FDA’s announcement of the proposed rule that resulted in an interview with the FDA’s Valerie Flournoy for the April cover story in Medical Dealer magazine. MD Publishing President and Founder John Krieg contacted industry insiders and thought leaders to develop a steering committee, organized a conference call to share ideas and set into motion planning for the special webinar.
A panel of experts was assembled to address the proposed rule and answer questions from webinar attendees. The panel of experts included AAMI President Mary Logan, Jonathan Gaev from the ECRI Institute, Dave Francoeur from Sodexo, Ryan Klebba of IMS Steris, industry veteran Manny Roman, consultant Binseng Wang, Matt Tomory from Conquest Imaging, Jason Crawford from Block Imaging and Wayne Webster from IAMERS. Chris Nowak and Doug Dreps also served on the panel representing health care systems. Additionally, at least five FDA officials joined the webinar as attendees and were invited to make comments.
Each panelist gave a brief statement regarding their unique perspective and shared an opinion as to what they believe to be the FDA’s goal regarding this action. The consensus is that this is an opportunity to educate the FDA and further promote patient safety.
The FDA is seeking information regarding seven questions as well additional data that will be helpful in its mission to promote patient safety. The webinar’s panelists weighed in on the seven questions, which are:
1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?
2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities?
3. What are the potential risks to patients/users and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices?
4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs them?
5. Are these activities more difficult or riskier to perform on certain devices versus others.
6. What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device?
7. What additional challenges do stakeholders encounter with devices that result from these activities?
The panelists were able to address these questions and those asked by webinar attendees. The goal is to encourage the submission of comments to the FDA to help educate it about the work and practices of third-party professionals and OEMs of medical devices, especially in regards to patient safety.
Attendees praised the special webinar and MD Publishing’s efforts to share valuable information regarding this potentially industry-altering FDA request.
“I appreciate MD Publishing taking a lead role and the effort to bring industry contributors together. It was good to hear the level of consensus among the varied panel members,” Christopher B. wrote in his post-webinar survey.
“It is only through MD Publishing that I personally became aware of the FDA’s docket. Listening is beneficial for me so I hear and understand the perspective and challenges of those whom I serve in dealing with the products that we build,” Keith B. wrote.
“Best webinar I’ve attended yet. The expert panel’s insight, candor, and experience focused on a common goal of patient safety elevates the biomedical industry,” Michael D. wrote.
“I would like to reaffirm the call to action. While many other issues have had the attention of HTM leaders — service manuals, parts, and Right to Repair have not had the attention it should. If we don’t get out in front on this, we may become coat holders and packers and shippers for the OEMs. Let’s all work together to get the message out,” Scot McKeil wrote.
For more information about the proposed rule, please see the April issue of Medical Dealer magazine. Also, AAMI has posted talking points regarding the proposed rule on its website.
MD Expo Dallas, being held April 21-23, will host a FDA panel discussion on Friday, April 22 from 9-11 a.m. The session is open to all registered attendees.
