there is no such thing as user error

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Medical device design necessitates an assessment of risk. The need is prudent given their ecosystem of use, but also mandated by regulatory agencies. Risk management uses analysis protocols to identify and predict situations where a device may fail and assess the consequences. Common techniques, like Failure Mode and Effects Analysis (FMEA) must expand to go beyond engineering and material failure to identify hazard risks due to user-device interactions or “use errors.” During this webinar, we will discuss the practice of the FMEA with added upgrades, such as a Task Analysis and how integration with simulated use labs can help you and your design team be more successful at reducing patient risk.

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  • 1. There is no such thing asUser ErrorPRESENTER:Gavin LewKorey JohnsonManaging DirectorAssociate DirectorUser Centric, Inc. User Centric, Inc.MODERATOR:#uxlunch Pamela Stoffregen-Gay Sr. Marketing Mgr. Join the discussion! User Centric, Inc. @UserCentricInc

2. Company Overview: Snapshot Profile Founded in 1999; privately held firm with over 50 full time UXresearch and design consultants Most have graduate degrees in psychology, human factors /ergonomics, ethnography, design and human computerinteraction In 2007, 2008, 2009, 2010, 2011 User Centric was included on theInc. 5000 List of the fastest growing companies in the U.S. UC is arguably the strongest user experience firm in the US Healthcare (medical devices and HIT: EHRs) 2011 Proprietary and Confidential 2 3. Introduction: In Search of Use Errors July 31, 2012 Proprietary and Confidential 3 4. IntroductionNo One Wants to Make a Device that Causes Errors July 31, 2012 Proprietary and Confidential4 5. IntroductionUsual Suspects When Use Errors Are Committed Designers cannot ever think that being highly trainedsolves a medical device that is poorly designed July 31, 2012 Proprietary and Confidential5 6. IntroductionIncreased Vulnerability While it is true that HCPs are highly educated, often the tasksperformed puts them into an automatic mode which makesthem more vulnerable to use errors** Guenter, et al (2008). Enteral Feeding Misconnections: A Consortium PositionStatement, The Joint Commission Journal on Quality and Patient Safety, 34(5):282-292. July 31, 2012 Proprietary and Confidential6 7. IntroductionDont Forget Other Users Originally, pharmacists were not considered to be a relevantuser group for use errors, but Flynn, et al. (2003) estimated51.5 million errors occur per year (4 per day per pharmacy) Moreover, a human factors-related recall with pharmacists asthe user as recent as September 23, 2011 July 31, 2012 Proprietary and Confidential7 8. IntroductionWhat About Patients? Especially when a medical device used by HCPs isrepurposed for use with patients! July 31, 2012 Proprietary and Confidential8 9. IntroductionPatients Are incredibly diverse Literacy, education, experience Receive a wide range of training Skewed towards no training Have different perspective and context Live in varied environments i.e., uncontrolled environments Consider: dogs, younger children Do research long enough and patients resemble July 31, 2012 Proprietary and Confidential9 10. IntroductionA Truly Diverse User Group July 31, 2012 Proprietary and Confidential10 11. IntroductionMust Users Really Shoulder the Blame? July 31, 2012 Proprietary and Confidential11 12. IntroductionDefinition of a Use Error Use errors are made by humans and can often beattributed to the design itself Use as opposed to human error or user errorremoves blame from the user as the cause of the failure Targeting design deficiencies of the design itself linksremedy to design changes (earlier the better) Often, we focus on the device itself, but Interaction with other devices, connections (things) and Instructions also contribute to use errors July 31, 2012 Proprietary and Confidential12 13. IntroductionFocus Towards Improved Risk Management In an effort to improvepatient safety The healthcare industry has focused more attention on risk management tools Awareness of the important role that human factors plays in the design process By driving more human factors into the design process sooner, rather than later, results in more positive change July 31, 2012 Proprietary and Confidential13 14. What is FMEA? July 31, 2012 Proprietary and Confidential 14 15. What is FMEA?FMEA: Failure Modes and Effects Analysis Answers the simple question: If a system component fails, what is the effect onsystem performance or safety? Usage dates back to the 1940s to evaluate military M&Pto identify risks using a bottom-up assessment As technology advanced into areas, such as spaceexploration and nuclear power, the need to identify,prioritize and manage risk amplified At that time, assessment of risk in the design of systems tended to involve engineering and material failure. July 31, 2012 Proprietary and Confidential 15 16. What is FMEA?Engineers: Two types of FMEA Risk Analyses1. DESIGN FMEA. A design FMEA is used to examine the components of a product to identify potential failures. For example, in the automotive industry, a design FMEA isconducted on all components and subsystems of a newcar during the design and manufacturing phases. The FMEA tool is used to evaluate the correctness of thematerials, accuracy of specifications, and all otherelements of design required to make a safe automobile.1. PROCESS FMEA. A process FMEA is used to analyze the processes used to make a product. July 31, 2012 Proprietary and Confidential 16 17. What is FMEA?Wait Where is the User in the FMEA? July 31, 2012 Proprietary and Confidential 17 18. How toNeed to Focus on the User in the FMEA If a system component fails, what is the effect on system performance or safety? Severity of Harm(S) If a user commits anerror, what is the effect Probability (P) on system performance or safety? (S x P) July 31, 2012 Proprietary and Confidential18 19. How to Conduct an FMEA July 31, 2012 Proprietary and Confidential 19 20. How toTowards a More UseError Focused-FMEA Expanding upon a chapter entitled Risk managementin medical products by Ed Israelski and Bill Muto In Pascale Carayons recently published textbook, Handbook of Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition Ed and Bill describe a step-by-step process to identifyhazards and integrate it into the medical productdevelopment process They advocate one major addition to the FMEAprocedure which adds the user into the process Perform a Task Analysis as this can predict user behaviorsthat relate to design interaction July 31, 2012 Proprietary and Confidential 20 21. How toBut First, Here is an Example FMEA FMEA appears in many different styles Ultimately, it is really a worksheet (table) Used by the team to document and work through issues Often has color to pull attention to specific rows July 31, 2012 Proprietary and Confidential 21 22. How to12-Step Process (Israelski & Muto, 2012)1.Form a Team2.Perform a Task Analysis3.Start a Worksheet4.Brainstorm Potential Use Errors (failure modes)5.List potential Effects of each Failure Mode / operator error6.Assign Severity ratings (S)7.Estimate the Probability of occurrence ratings (P)8.Derive a Risk Index (S x P)9.Prioritize Risks by risk index values10. Take Actions to eliminate or reduce the high priority failure modes11. Estimate Effectiveness of action ratings12. Revise the Risk PrioritiesIsraelski, E., & Muto. W. (2012). Risk management in medical products. In P. Carayon (Ed.), Handbookof Human Factors and Ergonomics in Health Care and Patient Safety, Second Edition. CRC Press. July 31, 2012 Proprietary and Confidential 22 23. How toStep 1: Form a Team Team composition includes representatives from: Product team Regulatory Human Factors Engineering (Development) Medical Affairs Quality Assurance Training User Group representatives Agree upon goals and procedures to conduct the FMEA July 31, 2012 Proprietary and Confidential 23 24. How toStep 2: Conduct a Task AnalysisBack to EntryJust-browsing... PointSeeing whats available...Just Browsingfor Info by:- Act- Venue- Date- Genre User may be first-time or repeat visitor - Geographic Area User is just browsing for information on upcoming events - Upcoming Events"I want to see whats coming soon""Whats"What would"What is"What dealsplaying at the be fun to do available thisare available?"Metro?"with the weekend?" family?" Try to limit browse to 3-4 stepsBrowse by Name Browsing by GenreBrowsing by DateBrowse by Deals (Event / Venue) Show me whats coming upShow Genre Show me latest dealsthis weekendSearch by Name Promo on Home Select GenreShow search resultsSearch by DateList of Acts: MetroList of Venues: MetroLink to Promose.g., Amazon.com Show sub-category lisitng Show Genre AlphaNumeric Jum Search by full listing? Select PromoSelect Act or Select sub- VenuecategoriesShow Conduct a formal task analysisEvents Show Events Show List of Acts ShowShow List of Events EventsSort by StateSort by Venue AlphaNumeric JumpJump to Date Closest to Zip Dont get lured into well do theSearch by full listing? Search by Price Sort by StateTM.com should help Show AnythingNo- Try another venue? Events interesting?- List headlinerstask analysis AND brainstormYes TM.com should offer help - Email new dates TixNoDepression - Avail ticketsAvail? - Next Concert - etc.Yes Select Provide team with tasks, userPerformance Go to Exit BuyTicketmaster.comprofiles, use environment, andexamples of use errors Save brainstorming for identifying use errors July 31, 2012 Proprietary and Confidential24 25. How toStep 3: Start a Worksheet Settle on the format and columns Consider using large sheets of paper (11 x 17 or larger)with gridlines Documenting electronically via MS Excel and projectingscreen to a wall can facilitate group interactions anddiscussions July 31, 2012 Proprietary and Confidential 25 26. How toStep 4: Brainstorm Potential Use Errors (Failure Modes) Follow typical brainstorming rules (i.e., facilitateideation over debate over merit discussions) Recognize efficiencies of breaking into sub-groups to reduce tangent takeover Actually helps to have the device (sounds silly) Use data from customer complaints or MDRs July 31, 2012 Proprietary and Confidential 26 27. How toStep 5: List Potential Effects of Each Failure Mode For each use error, describe the potential harmresulting from the Potential Effect When multiple harms can occur List harms and elevate worst-case scenarios to the top, so they can be addressed first July 31, 2012 Proprietary and Confidential