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Watch the Sterile Field! Conducting Research in the OR

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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 2 Introduction Planning and Logistics Operating Room Etiquette Documenting the Experience Global Insights Visualize Your Data Conducting Research in the OR contents Demonstration: Credentialing services Demonstration: Video clips from an OR observation
  3. 3. Farm Design, Inc. Prepared for UXPA 2013 Page 3 INTRODUCTION
  4. 4. Farm Design, Inc. Prepared for UXPA 2013 Page 4 Introduction Conducting research in the OR is more important than ever to ensure patient safety as medical devices become more complex and integrated. Device manufacturers are seeing the enormous value in observing and documenting 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 Engineering documentation for FDA and CE Mark. why this topic?
  5. 5. Farm Design, Inc. Prepared for UXPA 2013 Page 5 Introduction presenter Beth Loring Certified Human Factors Professional with 25 years of experience. 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 6 James Rudolph Senior Industrial designer with experience researching and designing products for the consumer, medical and lab industries. Master’s degree in Human Factors. Has observed 60+ surgical procedures, and performed ethnographic research in 10 different countries. Introduction presenter
  7. 7. Farm Design, Inc. Prepared for UXPA 2013 Page 7 PLANNING AND LOGISTICS
  8. 8. Farm Design, Inc. Prepared for UXPA 2013 Page 8 Getting into the OR can be one of the biggest and most time consuming hurdles. There are three common routes that we have taken: 1. Rely on the device manufacturer’s sales representatives. Sales reps have relationships with OR managers and surgeons. But: You may end up with all “friendly” surgeons. Or: You may end up with mostly key opinion leaders. Manufacturers provide a list of surgeons who may be 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 from online sources. Planning and Logistics getting into the OR 2. Recruit from leads provided by the device manufacturer. 3. Standard recruiting methods.
  9. 9. Farm Design, Inc. Prepared for UXPA 2013 Page 9 You will need to provide credentials proving that you are trained and immunized in order to enter the perioperative area. Our colleagues have been turned away at the door for not having adequate credentials. Planning and Logistics credentialing services Typical training includes: - HIPAA - Bloodborne pathogens - OR etiquette Immunizations include: - Hepatitis B - TB - Chicken pox and MMR - Flu shot - Additional shots may be required when traveling to different countries (Tetanus, Yellow Fever)
  10. 10. Farm Design, Inc. Prepared for UXPA 2013 Page 10 Documenting the experience is extremely important, but in the hospital environment it can be difficult or sometimes impossible. - Obtain permission from the institution ahead of time and confirm several times during the recruiting process that you will be taking photos or videos. - Patient consent: Planning and Logistics getting permissions You need to get patient consent. Often the institution will handle this for you. Consider bringing your own consent forms just in case. - Surgeons in teaching hospitals are more accustomed to photos and videos. - You should be trained in patient confidentiality and never take photos of the patient or his/her identifying information.
  11. 11. Farm Design, Inc. Prepared for UXPA 2013 Page 11 Planning and Logistics If using a credentialing service, you often sign in and print your badge 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 HIPAA agreement 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 12 Planning and Logistics OR attire Includes: scrub top, scrub pants, hat, mask, and shoe covers. Some institutions require eye protection now. Additional considerations: Operating rooms are cold – you may want a shirt underneath. Be sure to wear comfortable shoes! You will be standing for a long time on a hard floor. If the procedure uses X-ray, be sure to wear a lead apron and thyroid shield.
  13. 13. Farm Design, Inc. Prepared for UXPA 2013 Page 13 Planning and Logistics practical considerations Days in the hospital can be very long…up to 12 hours if you observe multiple cases. Expect to wait around. Sometimes surgeries don’t start at their appointed time. Often the number of observers allowed in the OR is limited. Sometimes the number of observers allowed in the OR should be limited…. because getting a good view of 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 patient is transferred and draped. Ask what you are allowed to bring into the OR, for example, a camera bag or briefcase.
  14. 14. Farm Design, Inc. Prepared for UXPA 2013 Page 14 OPERATING ROOM ETIQUETTE
  15. 15. Farm Design, Inc. Prepared for UXPA 2013 Page 15 Introduce 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 his or her role. You may be asked for your name or to provide a business card – they document who is in the room for every operation. Operating Room Etiquette communication CirculatorResident/Assistant Scrub Nurse/Tech Surgeon Anesthesiologist
  16. 16. Farm Design, Inc. Prepared for UXPA 2013 Page 16 There are some basic rules you should know regarding sterility: 4 Never, under any circumstances, brush up against the surgical table, draped equipment, or anyone sterile. Operating Room Etiquette sterility 2 Anything draped in clear plastic is also sterile (for example, the C-arm X-ray machine). 1 If it's blue, don't 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 and don’t touch it.
  17. 17. Farm Design, Inc. Prepared for UXPA 2013 Page 17 Operating Room Etiquette movement in the OR The safest bet is to stand up against the wall out of the way and wait to be told if they’d prefer you in a specific location. Keep your hands and arms close to your body. Stay away from the sterile field. If you have a briefcase or camera bag, tuck it out of the way in a corner or behind you near the wall. If you move around to get a better view, do so very slowly and carefully – there are tripping hazards.
  18. 18. Farm Design, Inc. Prepared for UXPA 2013 Page 18 DOCUMENTING THE EXPERIENCE
  19. 19. Farm Design, Inc. Prepared for UXPA 2013 Page 19 Documenting the Experience during the procedure If you’re new to observing surgeries, certain parts of the procedure may bother you. Don’t worry, the more you’re in the OR, the less it bothers 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, do so immediately and take your things.
  20. 20. Farm Design, Inc. Prepared for UXPA 2013 Page 20 Ask if it's OK to ask questions about what the surgeon is doing. Don't just assume it's 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 what the surgeon says. Do keep the camera rolling. It’s very easy to miss an important observation through side conversations and other distractions. Documenting the Experience asking questions
  21. 21. Farm Design, Inc. Prepared for UXPA 2013 Page 21 Documenting the Experience Camera views We 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 short video 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 22 Documenting the Experience getting digital media from hospital equipment There may be challenges in trying to get digital recordings, such as arthroscopic videos or x-ray images, from the hospital. Clarify with the hospital what storage format you will need. For example, some arthroscopic equipment will only record to specific DVD formats. Sometimes the surgeon will forget to start recording video. If appropriate, remind the surgeon to press the record button at key steps. Often, recorded media will have the patient’s name clearly visible. These will need to be removed once you receive the files.
  23. 23. Farm Design, Inc. Prepared for UXPA 2013 Page 23 Documenting the Experience Schedule an interview with the surgeon and/or other OR team members after the surgery. This is a good time to ask questions you may have thought of during the case. When the case is over, we leave the room and wait in the staff lounge or (if it’s the last case) change out of our OR attire. We always have a standard list of questions, but often ask for clarification on what happened during the case. Be mindful of the physician’s time, end the interview with a profound “thank you,” and offer the incentive if appropriate. after the procedure
  24. 24. Farm Design, Inc. Prepared for UXPA 2013 Page 24 Documenting the Experience demonstration: video clip from an observation
  25. 25. Farm Design, Inc. Prepared for UXPA 2013 Page 25 GLOBAL INSIGHTS
  26. 26. Farm Design, Inc. Prepared for UXPA 2013 Page 26 Global Insights notes from around the world
  27. 27. Farm Design, Inc. Prepared for UXPA 2013 Page 27 Global Insights notes from around the world Often times patients are not fully anesthetized, so expect some level of interaction between the surgeon and the patient during a procedure. There is a general aversion to waste, and an extreme sensitivity to cost, so expect to see disposable surgical devices being used multiple times (they are sterilized). Despite cost and technological constraints, there are many talented surgeons conducting new and innovative surgical techniques – many of which would not be attempted in the U.S.
  28. 28. Farm Design, Inc. Prepared for UXPA 2013 Page 28 Global Insights notes from around the world OR attire can be quite different. In India, for example, we’ve worn flip flops into the OR, leaving our feet and toes exposed to the environment. To date, we’ve never been asked to show our OR credentials or sign-up through a credentialing service to enter a hospital or surgical center outside the U.S.
  29. 29. Farm Design, Inc. Prepared for UXPA 2013 Page 29 VISUALIZING YOUR DATA
  30. 30. Farm Design, Inc. Prepared for UXPA 2013 Page 30 Visualize Your Data introduction TimeTracker is a tool we use at Farm to help us visualize, explore and analyze procedural data. By turning quantitative data into visual information we are able to more effectively identify patterns, trends, and differences between surgical approaches.
  31. 31. Farm Design, Inc. Prepared for UXPA 2013 Page 31 Visualize Your Data purpose • 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 procedure Purpose of a Time Tracker
  32. 32. Farm Design, Inc. Prepared for UXPA 2013 Page 32 Visualize Your Data elements of a time tracker Visual attributes correspond to the procedural elements we’re trying to understand. • Color indicates the high level goals the surgeon is trying to achieve. • Color tones represent specific tasks the surgeon conducts 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 33 Visualize Your Data process Task analysis: Identify all tasks necessary to complete 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 using the colors defined above; add relevant notes.
  34. 34. Farm Design, Inc. Prepared for UXPA 2013 Page 34 Visualize Your Data layering information Add relevant information to different layers – ones you can turn on and off to visualize trends. Consider: product opportunities, usability challenges, and photos.
  35. 35. Farm Design, Inc. Prepared for UXPA 2013 Page 35 Visualize Your Data concluding thoughts A 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 validate and better support your findings
  36. 36. Farm Design, Inc. Company Confidential THANK YOU Business Center 12 Silver Lake Road P.O. Box 1260 Hollis, NH 03049 www.farmpd.com Phone: 603.465.9800 Fax: 603.465.9801 Development Center 27 Proctor Hill Road P.O. Box 1260 Hollis, NH 03049 Cleveland Clinic Office GCIC 10000 Cedar Avenue Cleveland, OH 44106 BethL@farmpd.com JimR@farmpd.com

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