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BEGIN:VEVENT
DTSTAMP:20240325T185835Z
LOCATION:Continental Ballroom\, Lobby Level
DTSTART;TZID=America/Chicago:20240326T143500
DTEND;TZID=America/Chicago:20240326T150000
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess132_INDLEC138@linklings.com
SUMMARY:Human factors activities in response to adverse events and custome
 r complaints: Sharing experiences from post-market case studies
DESCRIPTION:Oral Presentations\n\nTricia Gibo and Eline Hooijman (Philips 
 Medical Systems)\n\nWhile much focus is often placed on the design and dev
 elopment of new products and next releases, post-market activities are equ
 ally important, both from a regulatory perspective as well as to maintain 
 a customer-first approach. Even the most comprehensive human factors plans
  and activities are unlikely to capture all potential use-related issues p
 rior to a product’s market release, especially for complex systems. Additi
 onally, some parts of the user interface might have been designed and deve
 loped prior to the implementation of a human factors program in accordance
  with the guidances and standards we adhere to today. The incorporation of
  human factors engineering into post-market activities can help ensure tha
 t use-related adverse events and customer complaints are properly addresse
 d, and any modifications to the user interface are safe, effective, and al
 igned with user needs.\n\nDuring this presentation, we will discuss a few 
 case studies involving post-market activities that the usability team with
 in Image Guided Therapy Systems at Philips Medical Systems has recently co
 nducted. In these case studies, adverse events were reported from the fiel
 d and, although risk assessments determined that the residual risk was acc
 eptable, additional activities were conducted to see whether the risk coul
 d be reduced further. We will share the human factors activities conducted
 , special considerations given the limited scope of these post-market acti
 vities (compared to developing a complete new product), and lessons learne
 d with considerations to how human factors can effectively collaborate wit
 h other stakeholders (e.g., system designers, clinical development, risk m
 anagement).\n\nSome case studies involve user interface components that ar
 e of unknown provenance and, therefore, had been originally designed witho
 ut the application of human factors engineering. For these case studies, w
 e will discuss our experiences of how we brought forward the value of post
 -market usability activities to other stakeholders, who (in some cases) mi
 ght need some extra convincing to consider modifying system components tha
 t have already been in the field for many years. In one example, we applie
 d our root cause analysis expertise to re-evaluate data collected during c
 ustomer interviews to help educate development teams about how to get to t
 he real underlying cause of adverse events in the field. In another exampl
 e, we conducted interviews with customers (including some of whom had prev
 iously submitted related customer complaints) to re-evaluate user needs an
 d organized a hands-on workshop with other stakeholders to help demonstrat
 e and convince them of the issue at hand.\n\nOther case studies involve de
 sign modifications made to the user interface in response to non-use-relat
 ed issues (e.g., technical causes). For these case studies, we will discus
 s the unique considerations we took for these usability tests, given their
  limited scope. While the main goal of these evaluations was similar to th
 at of a “standard” pre-market usability test – namely, demonstrating the s
 afety and effectiveness of (new) risk control mitigations and the (modifie
 d) user interface – we also needed to consider how to design and conduct e
 valuations that focused on one specific component of a highly complex syst
 em and/or a particular worst-case scenario.\n\nTrack: Medical and Drug Del
 ivery Devices\n\nSession Chair: Sarah Burleton (GE HealthCare)
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