XXII Surgical Instrument Breakage TRAINING SEMINAR ON MEDICAL

XXII. Surgical Instrument Breakage 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 ©ECRI 2007 1

Surgical Instrument Breakage • Typical Devices • Examination and Performance Testing • Metallurgical/Materials Testing • Human Factors Issues Copyright ECRI 1998 2

Surgical Instrument Breakage • Damaged or broken due to: • • • Use in excess of design strength User abuse (esp. orthopedic tools) Cleaning and reprocessing Steam quality during sterilization Design and labeling 3 © 2007 ECRI 3

Surgical Instrument Breakage • Human Factors Issues – Fudd's First Law of Opposition: If you push something hard enough, it will fall over. In other words: delicate instruments can be made only so strong • Ureteroscope case 4 © 2007 ECRI 4

Surgical Instrument Breakage • Delicate Powered Probes – Phacoemulsifiers – Vitrectomy – Cryosurgical – Laser fibers • Before each use – Inspect for damage – Ensure proper setup and performance 5 © 2007 ECRI 5

Surgical Instrument Breakage Meniscus Cutters Inspect for: – Bent Cutters – Bent shafts –

Surgical Instrument Breakage • Delicate Instruments: probes, rongeurs, hook scissors, burs, drills – Arthroscopic – Bronchoscopic – Endoscopic – Ophthalmic • Before each use – Inspect for damage – Ensure proper setup and performance 7 © 2007 ECRI 7

Surgical Instrument Breakage Circumcision Clamps Inspect for: – Proper size – Proper mating parts

Surgical Instrument Breakage • Examination and Performance Testing • Pre-use performance inspection needed: Reusables

Surgical Instrument Breakage • Disposables • • Package seals Correct device in package Debris in package or in device Lumens patent External defects (broken, cracked) Connections appropriate Valves and ports oriented and functional 1 © 2007 ECRI 10

Surgical Instrument Breakage • Failure Analysis • Visual examination • Microscopic examination • Scanning Electron Microscope (SEM) examination • Functional testing: CAUTION! • Testing of exemplar (sample of same type) • Case 17 11 © 2007 ECRI 11