1. © 2007 ECRI 1 XV. Medical Device Fires in Surgery TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. © 2007 ECRI 2 August 18-25, 2003

3. © 2007 ECRI 3 August 18-25, 2003 The Face of Medical Error Surgical Fire

4. © 2007 ECRI 4 L.A. Times, October 7, 1988

5. © 2007 ECRI 5

6. 6 Surgical Fire – A Medical Error Worthy of Attention Retained Instruments Wrong Site Surgery Surgical Fires Luer Mis-Connections Organ Transplant Tissue Matching Errors Medical Gas Mix-ups MRI Projectiles Endoscope Sterilization Failure Bed Crushings/Suffocations Infant Abductions ECG/Apnea electrode electrocutions

7. © 2007 ECRI 7 Surgical Fires: Awareness of a Continuing Risk Your Institutional Policies Recommendations for Prevention - Poster Statistics New Initiatives How to Educate Extinguishing (when prevention fails)

8. © 2007 ECRI 8 Educational Poster How do your policies/procedures measure up?

9. © 2007 ECRI 9 Incidence?

10. © 2007 ECRI 10 Statistics: Surgical Fires Searches of FDA device databases: –Jan 1995-June 1998 (3.5 years) –167 OR fires ECRI receives 1-3 reports per week. 2003 >12 ECRI field investigations

11. © 2007 ECRI 11 Statistics: Surgical Fires 50-100 per year, minimum (U.S.) 78% Oxygen Enriched 4% Prep agents (alcohol-based) 68% Electrosurgery 13% Laser 19% Cautery (hot wire), Light Sources, Bur Sparks

12. © 2007 ECRI 12 Statistics: Surgical Fires Searches of FDA device databases: –Jan 95-June 98; 167 OR fires –Jan 03-Sep 04; 95 OR fires ECRI receives 1-3 reports per week 2003 - 19 ECRI field investigations 2004 - 9 ECRI field investigations

13. © 2007 ECRI 13 Statistics: Surgical Fires Anatomic Locations –34% Airway –28% Face, Head, Neck, Chest –24% Elsewhere on body –14% Elsewhere IN body

14. © 2007 ECRI 14 Igniting a co-worker: very rare. Copyright Medfilms Inc.

15. © 2007 ECRI 15 Surgical Procedures and Fires: 22 Case Reports in Health Devices Jan 2003 Infant surgery (PDAs) Pneumonectomy Bronchoscopic surgery Cervical conization Hernia (infant) Circumcision (infant) C-section Et al. Facial surgery ECMO cut down Carotid endarterectomy Temporal arterectomy Tracheostomy Oral surgery Tonsillectomy

16. © 2007 ECRI 16 New Initiatives 2002-2004 ECRI - Ongoing publications 1980-present A Clinician's Guide to Surgical Fires: How They Occur, How to Prevent Them, How to Put Them Out. Health Devices Jan 2003; 32(1): 5-24. (Who is ECRI? See www.ecri.org.)

17. © 2007 ECRI 17 New Initiatives 2003-2004 National Guideline Clearinghouse (NGC) www.guideline.gov www.guideline.gov NGC accepted ECRI’s Clinician's Guide Nov 2003. www.guideline.gov/summary/summary.aspx?doc_id=3688&nbr=2914

18. © 2007 ECRI 18 New Initiatives 2002-2004 Massachusetts Dept. of Public Health. Healthcare quality safety alert: preventing operating room fires during surgery. March 2002 –www.state.ma.us/dph/dhcq/pdfs/ORFIRES.pdf New York Patient Occurrence and Tracking System, NY Dept of Health. Electrosurgical burns and fires occurrences. NYPORTS News and Alert 2003 June; Issue 13.

19. © 2007 ECRI 19 New Initiatives 2002-2004 JCAHO Sentinel Event Alert, June 2003 JCAHO 2005 National Patient Safety Goals –Ambulatory surgery –Office-based surgery

20. © 2007 ECRI 20 JCAHO. Preventing surgical fires [Sentinel Event Alert]. 2003 June 24; Issue 29. See: www.jcaho.org/about+us/news+letters/sentinel+event+alert/sea_29.htm

21. © 2007 ECRI 21 JCAHO 2003 Sentinel Event Alert A serious patient safety initiative Now greater responsibility on staffs for fire prevention –Administration and Risk Management –Surgeons, Anesthesiologists, OR Nurses

22. © 2007 ECRI 22 Each member of the surgical team should know about surgical fire risks.

23. © 2007 ECRI 23 1.Administration alerting surgical staff on controlling ignition sources 2.Managing fuels, esp. flammable preps 3.Establish guidelines for minimizing oxygen under drapes 4.Testing procedure for staff 5.Reporting fire incidents JCAHO. Preventing surgical fires [Sentinel Event Alert]. 2003 June 24; Issue 29. On Web: www.jcaho.org. JCAHO 2003 Recommendations

24. © 2007 ECRI 24 Educate staff on how to: Control heat sources Manage fuels Including independent licensed practitioners and anesthesia providers Establish guidelines to minimize O2 under drapes JCAHO 2005 Patient Safety Goals for Ambulatory and Office-based Surgery http://www.jcaho.org/accredited+organizations/patient+safety/05+npsg/05_npsg_amb.htm

25. © 2007 ECRI 25 JCAHO 2005 Patient Safety Goals for Ambulatory and Office-based Surgery Hospital Administrator: “But, these goals do not apply to accreditation for my facility.”

26. © 2007 ECRI 26 August 18-25, 2003 Surgical Fire Victim

27. © 2007 ECRI 27 “The lack of JCAHO applying these goals to the accreditation process for other types of healthcare facilities does not remove the need for those other facilities and their practitioners to now be proactive in surgical fire prevention.” Mark Bruley 2004

28. © 2007 ECRI 28

29. © 2007 ECRI 29 How to Educate and Implement “Perhaps we must accept that there will always be a risk of surgical fires on our patients.” Y / N?

30. © 2007 ECRI 30 STRESS – Combined Responsibility Surgeons Anesthesia Staff OR Nurses and Techs How to Educate and Implement

31. © 2007 ECRI 31 “Buy-In” by: –Administration –Chief of Surgery –Chief of Anesthesia –Director of OR Nursing Educational and Guidelines Initiative –Clinical Education Staff –Risk Management How to Educate and Implement

32. © 2007 ECRI 32 Scheduled Education Sessions: –New staff –Annual refresher –Videos [see video evaluations in Health Devices 2003 (Jan);32(1).] How to Educate and Implement

33. © 2007 ECRI 33 Develop guidelines at your institution (as JCAHO recommends) Review your guidelines based on: –ECRI poster –Jan 2003 Health Devices Clinician’s Guide Encourage respectful communication (wrong-site surgery example) How to Educate and Implement

34. © 2007 ECRI 34 Evidence-based concerns Evidence-based recommendations for prevention Compare to other LOW INCIDENCE medical errors. How to Educate and Implement

35. © 2007 ECRI 35 Discuss LOW INCIDENCE medical errors. –“Wrong Site” Surgery 296 / 7 years=42/year (www.jcaho.org) 331/10 years=33/year (Phys Ins. Assoc Amer.) –Retained Instruments 1,500/year/30m surgeries (Gwanda AA. NEJM 2003;348(3)229-35) –Combined Prevention Responsibilities! How to Educate and Implement

36. © 2007 ECRI 36 Discuss LOW INCIDENCE errors (cont). –Surgical Fires >100 / year (ECRI, JCAHO, NY State Dept Health) –Combined Prevention Responsibilities! How to Educate and Implement

37. © 2007 ECRI 37 Cross-cultural Prevention

38. © 2007 ECRI 38 Fire Drills, see: 1.Flowers J. Code red in the OR— implementing an OR fire drill. AORN J. 2004 Apr;79(4):797-805 2.Salmon L. Fire in the OR; Prevention and preparedness [home study program]. AORN J 2004 July;80(1):42-60 3.Smith C. Surgical Fires: Learn not to burn [home study program]. AORN J 2004 July;80(1):24-40. How to Educate and Implement

39. © 2007 ECRI 39 Gas Zone Valve: rarely an issue for OR fires, but know where they are.

40. © 2007 ECRI 40 Prevention 1.Control Heat Sources 2.Control Fuels 3.Minimize O2 from Open Sources 4.Communicate

41. © 2007 ECRI 41 Ignition Sources

42. © 2007 ECRI 42 Ignition Sources

43. © 2007 ECRI 43 Heat, sparks, and flares from electrosurgery are often ignition sources.

44. © 2007 ECRI 44 Controlling Ignition Sources

45. © 2007 ECRI 45 Policies / Procedures

46. © 2007 ECRI 46 Oxidizers O2 & N2O enriched atmospheres exacerbate fire risk.

47. © 2007 ECRI 47 Nitrous Oxide = OEA

48. © 2007 ECRI 48 Supplemental Oxygen: Question the need. Supplemental O2

49. © 2007 ECRI 49 Define responsibilities for who questions need. If clinically indicated – see poster options –Delivered O2 ≤30% –Arrange drapes to minimize O2 buildup –Keep towel edges far from incision –Use incise drape –Coat hair in fenestration with H2O lube jelly –For coagulation, use bipolar ESU Supplemental Oxygen

50. © 2007 ECRI 50 Effect of dry CO 2 Absorbent