Watch the Sterile Field! Conducting Research in the OR

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Beth Loring and James Rudolph's presentation on conducting research in the operating room. From the UXPA Boston 2013 conference.

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Watch the Sterile Field! Conducting Research in the OR

  1. 1. Farm Design, Inc. Prepared for UXPA 2013 Page 1
  2. 2. Farm Design, Inc. Prepared for UXPA 2013 Page 2IntroductionPlanning and LogisticsOperating Room EtiquetteDocumenting the ExperienceGlobal InsightsVisualize Your DataConducting Research in the ORcontentsDemonstration:Credentialing servicesDemonstration:Video clips from an ORobservation
  3. 3. Farm Design, Inc. Prepared for UXPA 2013 Page 3INTRODUCTION
  4. 4. Farm Design, Inc. Prepared for UXPA 2013 Page 4IntroductionConducting research in the OR is more important than ever to ensure patientsafety as medical devices become more complex and integrated.Device manufacturers are seeing the enormous value in observing anddocumenting first-hand how their products are actually used.In competitive markets, identifying unmet needs helps to differentiate.User needs research provides inputs to required Usability Engineeringdocumentation for FDA and CE Mark.why this topic?
  5. 5. Farm Design, Inc. Prepared for UXPA 2013 Page 5IntroductionpresenterBeth LoringCertified Human Factors Professional with 25 years ofexperience.Extensive experience in the medical, consumer,software, and web industries.Has observed 25+ surgeries including orthopedic,cardiothoracic, ENT, and laparoscopic cases.
  6. 6. Farm Design, Inc. Prepared for UXPA 2013 Page 6James RudolphSenior Industrial designer with experience researchingand designing products for the consumer, medical andlab industries.Master’s degree in Human Factors.Has observed 60+ surgical procedures, and performedethnographic research in 10 different countries.Introductionpresenter
  7. 7. Farm Design, Inc. Prepared for UXPA 2013 Page 7PLANNING AND LOGISTICS
  8. 8. Farm Design, Inc. Prepared for UXPA 2013 Page 8Getting into the OR can be one of the biggest and mosttime consuming hurdles.There are three common routes that we have taken:1. Rely on the device manufacturer’ssales representatives.Sales reps have relationships with OR managersand surgeons.But: You may end up with all “friendly” surgeons.Or: You may end up with mostly key opinionleaders.Manufacturers provide a list of surgeons who maybe interested in participating.Often, results are similar to cold calling.Hire a professional recruiter.Cold calling, advertising online, flyers.Compile and maintain a list of surgeons fromonline sources.Planning and Logisticsgetting into the OR2. Recruit from leads provided by thedevice manufacturer.3. Standard recruiting methods.
  9. 9. Farm Design, Inc. Prepared for UXPA 2013 Page 9You will need to provide credentials proving that you aretrained and immunized in order to enter theperioperative area. Our colleagues have been turnedaway at the door for not having adequate credentials.Planning and Logisticscredentialing servicesTypical training includes:- HIPAA- Bloodborne pathogens- OR etiquetteImmunizations include:- Hepatitis B- TB- Chicken pox and MMR- Flu shot- Additional shots may be required when traveling todifferent countries (Tetanus, Yellow Fever)
  10. 10. Farm Design, Inc. Prepared for UXPA 2013 Page 10Documenting the experience is extremely important, but inthe hospital environment it can be difficult or sometimesimpossible.- Obtain permission from the institution ahead of timeand confirm several times during the recruitingprocess that you will be taking photos or videos.- Patient consent:Planning and Logisticsgetting permissionsYou need to get patient consent.Often the institution will handle this for you.Consider bringing your own consent forms just incase.- Surgeons in teaching hospitals are moreaccustomed to photos and videos.- You should be trained in patient confidentiality andnever take photos of the patient or his/her identifyinginformation.
  11. 11. Farm Design, Inc. Prepared for UXPA 2013 Page 11Planning and LogisticsIf using a credentialing service, you often sign in and print yourbadge in the hospital lobby.You will need to check in at the OR front desk.You may be asked to sign a visitors sheet, and/or a HIPAAagreement before you are allowed to observe.You will need to change into OR attire.when you arrive at the hospital
  12. 12. Farm Design, Inc. Prepared for UXPA 2013 Page 12Planning and LogisticsOR attireIncludes: scrub top, scrub pants, hat, mask, andshoe covers.Some institutions require eye protection now.Additional considerations:Operating rooms are cold – you may want ashirt underneath.Be sure to wear comfortable shoes! You willbe standing for a long time on a hardfloor.If the procedure uses X-ray, be sure to weara lead apron and thyroid shield.
  13. 13. Farm Design, Inc. Prepared for UXPA 2013 Page 13Planning and Logisticspractical considerationsDays in the hospital can be very long…up to 12 hoursif you observe multiple cases.Expect to wait around. Sometimes surgeries don’tstart at their appointed time.Often the number of observers allowed in the OR islimited.Sometimes the number of observers allowed in theOR should be limited…. because getting a good viewof the surgery can be challenging.You may be allowed in the OR as they are setting up,or you may be asked to wait outside until the patientis transferred and draped.Ask what you are allowed to bring into the OR, forexample, a camera bag or briefcase.
  14. 14. Farm Design, Inc. Prepared for UXPA 2013 Page 14OPERATING ROOM ETIQUETTE
  15. 15. Farm Design, Inc. Prepared for UXPA 2013 Page 15Introduce yourself to the circulator and others and explain why you’re there.Don’t assume that the OR staff know who you are!Act respectfully toward every member of the surgical team, regardless of hisor her role.You may be asked for your name or to provide a business card – theydocument who is in the room for every operation.Operating Room EtiquettecommunicationCirculatorResident/AssistantScrub Nurse/TechSurgeonAnesthesiologist
  16. 16. Farm Design, Inc. Prepared for UXPA 2013 Page 16There are some basic rules you should know regarding sterility:4 Never, under any circumstances, brush up againstthe surgical table, draped equipment, or anyonesterile.Operating Room Etiquettesterility2 Anything draped in clear plastic is also sterile (forexample, the C-arm X-ray machine).1 If its blue, dont touch it or reach over it!3 If you’re unsure whether or not something is sterile,assume it is.5 Assume that anything lying on the floor is soiled anddon’t touch it.
  17. 17. Farm Design, Inc. Prepared for UXPA 2013 Page 17Operating Room Etiquettemovement in the ORThe safest bet is to stand up against the wall out ofthe way and wait to be told if they’d prefer you in aspecific location.Keep your hands and arms close to your body. Stayaway from the sterile field.If you have a briefcase or camera bag, tuck it out ofthe way in a corner or behind you near the wall.If you move around to get a better view, do so veryslowly and carefully – there are tripping hazards.
  18. 18. Farm Design, Inc. Prepared for UXPA 2013 Page 18DOCUMENTING THE EXPERIENCE
  19. 19. Farm Design, Inc. Prepared for UXPA 2013 Page 19Documenting the Experienceduring the procedureIf you’re new to observing surgeries, certain parts of theprocedure may bother you.Don’t worry, the more you’re in the OR, the less itbothers you.If you feel weak or light-headed, sit down or step out.Ask the circulator where it’s appropriate to sit.If you are ever asked to leave, for whatever reason, doso immediately and take your things.
  20. 20. Farm Design, Inc. Prepared for UXPA 2013 Page 20Ask if its OK to ask questions about what the surgeon is doing. Dont justassume its OK.Don’t take offense if the surgeon ignores you during the procedure.OR staff may not talk to you during a case. They are trying to listen to whatthe surgeon says.Do keep the camera rolling. It’s very easy to miss an important observationthrough side conversations and other distractions.Documenting the Experienceasking questions
  21. 21. Farm Design, Inc. Prepared for UXPA 2013 Page 21Documenting the ExperienceCamera viewsWe try to capture more than one view if possible:Hand-held camcorder to zoom in and out on the action.Camcorder on a tripod to record the overall workflow.Hand-held digital cameras for still shots and shortvideo clips.Head-mounted camera worn by the surgeon.• We use a GoPro Hero 2• Has WiFi Pac and WiFi Remote, HD, 1080p.
  22. 22. Farm Design, Inc. Prepared for UXPA 2013 Page 22Documenting the Experiencegetting digital media from hospital equipmentThere may be challenges in trying to get digitalrecordings, such as arthroscopic videos or x-ray images,from the hospital.Clarify with the hospital what storage format you willneed. For example, some arthroscopic equipment willonly record to specific DVD formats.Sometimes the surgeon will forget to start recordingvideo. If appropriate, remind the surgeon to press therecord button at key steps.Often, recorded media will have the patient’s nameclearly visible. These will need to be removed once youreceive the files.
  23. 23. Farm Design, Inc. Prepared for UXPA 2013 Page 23Documenting the ExperienceSchedule an interview with the surgeon and/or other OR teammembers after the surgery. This is a good time to ask questionsyou may have thought of during the case.When the case is over, we leave the room and wait in the stafflounge or (if it’s the last case) change out of our OR attire.We always have a standard list of questions, but often ask forclarification on what happened during the case.Be mindful of the physician’s time, end the interview with aprofound “thank you,” and offer the incentive if appropriate.after the procedure
  24. 24. Farm Design, Inc. Prepared for UXPA 2013 Page 24Documenting the Experiencedemonstration: video clip from an observation
  25. 25. Farm Design, Inc. Prepared for UXPA 2013 Page 25GLOBAL INSIGHTS
  26. 26. Farm Design, Inc. Prepared for UXPA 2013 Page 26Global Insightsnotes from around the world
  27. 27. Farm Design, Inc. Prepared for UXPA 2013 Page 27Global Insightsnotes from around the worldOften times patients are not fully anesthetized, soexpect some level of interaction between the surgeonand the patient during a procedure.There is a general aversion to waste, and an extremesensitivity to cost, so expect to see disposable surgicaldevices being used multiple times (they are sterilized).Despite cost and technological constraints, there aremany talented surgeons conducting new andinnovative surgical techniques – many of which wouldnot be attempted in the U.S.
  28. 28. Farm Design, Inc. Prepared for UXPA 2013 Page 28Global Insightsnotes from around the worldOR attire can be quite different. In India, for example,we’ve worn flip flops into the OR, leaving our feet andtoes exposed to the environment.To date, we’ve never been asked to show our ORcredentials or sign-up through a credentialing serviceto enter a hospital or surgical center outside the U.S.
  29. 29. Farm Design, Inc. Prepared for UXPA 2013 Page 29VISUALIZING YOUR DATA
  30. 30. Farm Design, Inc. Prepared for UXPA 2013 Page 30Visualize Your DataintroductionTimeTracker is a tool we use at Farm to help us visualize, explore and analyze proceduraldata. By turning quantitative data into visual information we are able to more effectivelyidentify patterns, trends, and differences between surgical approaches.
  31. 31. Farm Design, Inc. Prepared for UXPA 2013 Page 31Visualize Your Datapurpose• Explore lots of data quickly and efficiently• Better understand the step-by-step process• Compare approaches among surgeons• Identify steps that are taking a long time to complete• Identify repeated steps and back-tracking• Identify unmet needs, opportunities for improvement• Document tools used throughout the procedurePurpose of a Time Tracker
  32. 32. Farm Design, Inc. Prepared for UXPA 2013 Page 32Visualize Your Dataelements of a time trackerVisual attributes correspond to the procedural elementswe’re trying to understand.• Color indicates the high level goals the surgeon istrying to achieve.• Color tones represent specific tasks the surgeonconducts to achieve the goals.Horizontal length corresponds to time on task.Icons are used to highlight notes of interest – e.g.,specific steps in the procedure.Notes are used to capture rich details – surgeon quotes,usability challenges, etc.How it Works
  33. 33. Farm Design, Inc. Prepared for UXPA 2013 Page 33Visualize Your DataprocessTask analysis: Identify all tasks necessary tocomplete a surgical procedure.Affinity diagramming: Group tasks according to relevant relationships,such as major goals.Time tracker: Time a procedure and map the tasks to a timeline usingthe colors defined above; add relevant notes.
  34. 34. Farm Design, Inc. Prepared for UXPA 2013 Page 34Visualize Your Datalayering informationAdd relevant information to different layers – ones you canturn on and off to visualize trends. Consider: productopportunities, usability challenges, and photos.
  35. 35. Farm Design, Inc. Prepared for UXPA 2013 Page 35Visualize Your Dataconcluding thoughtsA few additional thoughts:• The visual time tracker is best utilized early on in the research effort• The data should evoke questions (why did surgeon one perform this step first?),which can be added to questionnaires for future observations• Play with the colors to highlight specific areas or individual tasks• Quantify the data (time spent doing step x, number of tool changes, etc.) to validateand better support your findings
  36. 36. Farm Design, Inc. Company ConfidentialTHANK YOUBusiness Center12 Silver Lake RoadP.O. Box 1260Hollis, NH 03049www.farmpd.comPhone: 603.465.9800Fax: 603.465.9801Development Center27 Proctor Hill RoadP.O. Box 1260Hollis, NH 03049Cleveland Clinic OfficeGCIC10000 Cedar AvenueCleveland, OH 44106BethL@farmpd.comJimR@farmpd.com

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