Скачать презентацию XV Medical Device Fires in Surgery TRAINING SEMINAR Скачать презентацию XV Medical Device Fires in Surgery TRAINING SEMINAR

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XV. Medical Device Fires in Surgery TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for 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 1 © 2007 ECRI

August 18 -25, 2003 2 © 2007 ECRI August 18 -25, 2003 2 © 2007 ECRI

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

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

5 © 2007 ECRI 5 © 2007 ECRI

Surgical Fire – A Medical Error Worthy of Attention • Retained Instruments • Wrong 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 6 © 2007 ECRI

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

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

Incidence? 9 © 2007 ECRI Incidence? 9 © 2007 ECRI

Statistics: Surgical Fires • Searches of FDA device databases: – Jan 1995 -June 1998 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 10 © 2007 ECRI

Statistics: Surgical Fires • 50 -100 per year, minimum (U. S. ) • 78% 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 11 © 2007 ECRI

Statistics: Surgical Fires • Searches of FDA device databases: – Jan 95 -June 98; 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 12 © 2007 ECRI

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

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

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

New Initiatives 2002 -2004 • ECRI - Ongoing publications 1980 -present A Clinician's Guide 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. ) 16 © 2007 ECRI

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

New Initiatives 2002 -2004 • Massachusetts Dept. of Public Healthcare quality safety alert: preventing New Initiatives 2002 -2004 • Massachusetts Dept. of Public 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. 18 © 2007 ECRI

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

JCAHO. Preventing surgical fires [Sentinel Event Alert]. 2003 June 24; Issue 29. See: www. 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 20 © 2007 ECRI

JCAHO 2003 Sentinel Event Alert • A serious patient safety initiative • Now greater 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 21 © 2007 ECRI

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

JCAHO 2003 Recommendations 1. Administration alerting surgical staff on controlling ignition sources 2. Managing JCAHO 2003 Recommendations 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. 23 © 2007 ECRI

JCAHO 2005 Patient Safety Goals for Ambulatory and Office-based Surgery • Educate staff on JCAHO 2005 Patient Safety Goals for Ambulatory and Office-based Surgery • Educate staff on how to: • • Control heat sources Manage fuels Including independent licensed practitioners and anesthesia providers Establish guidelines to minimize O 2 under drapes http: //www. jcaho. org/accredited+organizations/patient+safety/05+npsg/05_npsg_amb. htm 24 © 2007 ECRI

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

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

“The lack of JCAHO applying these goals to the accreditation process for other types “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 27 © 2007 ECRI

28 © 2007 ECRI 28 © 2007 ECRI

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

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

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

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

How to Educate and Implement • Develop guidelines at your institution (as JCAHO recommends) How to Educate and Implement • 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) 33 © 2007 ECRI

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

How to Educate and Implement • Discuss LOW INCIDENCE medical errors. – “Wrong Site” How to Educate and Implement • 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/30 m surgeries (Gwanda AA. NEJM 2003; 348(3)229 -35) – Combined Prevention Responsibilities! 35 © 2007 ECRI

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

Cross-cultural Prevention 37 © 2007 ECRI Cross-cultural Prevention 37 © 2007 ECRI

How to Educate and Implement Fire Drills, see: 1. Flowers J. Code red in How to Educate and Implement 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. 38 © 2007 ECRI

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

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

Ignition Sources 41 © 2007 ECRI Ignition Sources 41 © 2007 ECRI

Ignition Sources 42 © 2007 ECRI Ignition Sources 42 © 2007 ECRI

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

Controlling Ignition Sources 44 © 2007 ECRI Controlling Ignition Sources 44 © 2007 ECRI

Policies / Procedures 45 © 2007 ECRI Policies / Procedures 45 © 2007 ECRI

Oxidizers O 2 & N 2 O enriched atmospheres exacerbate fire risk. 46 © Oxidizers O 2 & N 2 O enriched atmospheres exacerbate fire risk. 46 © 2007 ECRI

Nitrous Oxide = OEA 47 © 2007 ECRI Nitrous Oxide = OEA 47 © 2007 ECRI

Supplemental Oxygen: Question the need. Supplemental O 2 48 © 2007 ECRI Supplemental Oxygen: Question the need. Supplemental O 2 48 © 2007 ECRI

Supplemental Oxygen • Define responsibilities for who questions need. • If clinically indicated – Supplemental Oxygen • Define responsibilities for who questions need. • If clinically indicated – see poster options – – – Delivered O 2 ≤ 30% Arrange drapes to minimize O 2 buildup Keep towel edges far from incision Use incise drape Coat hair in fenestration with H 2 O lube jelly – For coagulation, use bipolar ESU 49 © 2007 ECRI

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