BEGIN:VCALENDAR
VERSION:2.0
PRODID:Linklings LLC
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTAMP:20260715T161119Z
LOCATION:Murray Hill East
DTSTART;TZID=America/New_York:20260325T085200
DTEND;TZID=America/New_York:20260325T091500
UID:HFESHCS_2026 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess139_LEC251@linklings.com
SUMMARY:Impacting Patient Outcomes Beyond the Minimum Requirements Set by 
 Global Regulatory Standards for Medical Devices
DESCRIPTION:Varun Nair (Tufts University)\n\nThe medical device industry i
 s constantly innovating, with new devices designed years in advance to pos
 itively impact patient lives. However, despite these advancements, medical
  device use-errors remain a major global health challenge. Over the past 1
 2 years, such errors have contributed to nearly 1.7 million injuries and a
 lmost 83,000 recorded deaths worldwide, and in the United States, they are
  the third leading cause of death. Despite this, many companies still perc
 eive Human Factors (HF) primarily as a regulatory hurdle for approval, rat
 her than a vital element of device safety and effectiveness. \n\nThe insig
 hts of this presentation involves examination of the commonalities and dif
 ferences between the FDA, EU, and NMPA requirements, highlighting areas wh
 ere these regulatory frameworks overlap and diverge. Building on this anal
 ysis, I propose a set of processes and methods that could be integrated in
 to all three guidelines. These recommendations aim to standardize Human Fa
 ctors assessment globally, ensuring a more consistent and thorough evaluat
 ion of device usability, safety, and patient impact. These insights are su
 pported by contributions from industry professionals and regulatory expert
 s, further emphasizing the notion of improving the existing standards.\n\n
 Additionally, I analyze post-market surveillance data from a variety of so
 urces (including FDA Recalls, MAUDE, BfArM, MHRA, PubMed, Europe PMC, and 
 ClinicalTrials.gov) focusing on multiple approved medical devices that lat
 er faced recalls due to patient harm or death. This comprehensive review a
 ims to identify common patterns and root causes behind these incidents. By
  examining the specific factors that contributed to these recalls, I explo
 re how many of these issues could have been mitigated or avoided altogethe
 r with a proactive and refined approach to Human Factors during the design
  and development stages. The analysis emphasizes the importance of integra
 ting Human Factors insights early on, illustrating how small shifts in met
 hodology can significantly enhance device safety, reduce costly recalls, a
 nd ultimately protect and preserve patient health.\n\nThe key takeaway fro
 m this presentation is that industry professionals should view regulatory 
 guidelines not as the maximum achievable standard of safety, but as the mi
 nimum standard requirement. Companies are encouraged to go beyond these ba
 seline standards by leveraging the expertise of experienced and creative H
 uman Factors practitioners, whose insights and innovative approaches can s
 ignificantly enhance device safety and patient outcomes.\n\nTrack: Patient
  Safety Research and Initiatives\n\nSession Chairs: Tosin Akintunde (Unive
 rsity of Toronto) and Hongchen Liu (University of Toronto)\n\n
END:VEVENT
END:VCALENDAR