©ECRI VI. Device Inspection and Testing: Investigation Guidelines TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, USA Tel: , ext Web Sites:

©2007 ECRI 2 Device Inspection and Testing: Investigation Guidelines  Guidelines – Hospital Perspective  Destructive vs Non-destructive testing  Testing Single Use Devices  Infection Control Safety Issues  Performance Testing  Standardized Inspection Forms  Accident Reconstruction testing  Data Collection and Recording  Use of Referral Laboratories

©2007 ECRI 3 Investigation Guidelines: Hospital Perspectives  Immediate Action Plan  Investigation Team  Members:  Clinical Department Head  Clinical Staff Members  Risk Manger  Biomedical Engineering  Legal Counsel  Safety Committee  Not on Team: Anyone responsible for patient or device.

©2007 ECRI 4 Time is critical Elements of an Investigation –Preserve and impound evidence –Collect and review information-patient and device related –Interview personnel –Assess the injury –Inspect and test devices Investigation Guidelines: Hospital Perspectives

©2007 ECRI 5 Performance Testing Comprehensive Limited Destructive Non-destructive Sufficient tests

©2007 ECRI 6 Destructive vs Non-destructive Testing Start with Device Examination –Non-destructive –External condition –Identifiers –Size parameters –Low magnification –Signs of wear and abuse (iatrogenic damage?)

©2007 ECRI 7 Testing Single Use Devices (Disposables) Non-destructive exam Compare to exemplar (sample) Seek manufacturing defects in moldings –Flash, voids Misbranding Misassembly Iatrogenic damage Non-destructive performance tests

©2007 ECRI 8 Infection Control Safety Issues Many devices will be contaminated prior to testing –Surgical devices. –Respiratory therapy equipment –Anesthesia ventilators –Blood processing equipment –Patient held items –Telemetry transmitters Medical vacuum systems likely soiled

©2007 ECRI 9 Infection Control Safety Issues Observe basic infection control practices for personnel Decontamination of devices –Disinfection vs. sterilization –Will it destroy evidence? –How to do safe properly depends on device Research compatibility of techniques Device materials important considerations

©2007 ECRI 10 Infection Control Safety Issues Basic Infection Control Practices –Hand washing –No eating –Lab coat –Gloves –Do not rub eyes or other mucous membranes

©2007 ECRI 11 Infection Control Safety Issues Decontamination Procedures –Check with vendor on compatible techniques –If no vendor recommendations, seek input from hospital’s sterile supply processing personnel

©2007 ECRI 12 Infection Control Safety Issues Decontamination Procedures (cont.) –Sterilization or high level disinfection Steam Ethylene Oxide (EtO) Cold Plasma Glutaraldehyde Formaldehyde

©2007 ECRI 13 Infection Control Safety Issues Decontamination Procedures (cont.) –Intermediate level disinfection Chlorine 1:10 dilution of common bleach Iodophors (iodine containing compounds) Isopropyl Alcohol –Low Level disinfection Ammonia compounds

©2007 ECRI 14 Infection Control Safety Issues Decontamination Procedures (cont.) –Begin with physical cleaning –Take care when cleaning sharp instruments Endoscopic/needlescopic accessories –Equipment returned to vendors: decontaminate per vendor instructions, if needed.

©2007 ECRI 15 Standardized Inspection Forms Universal Inspection Form Inspection and Preventive Maintenance Procedures (10 high-risk devices) –References –Test apparatus –Special precautions during testing –Test criteria Use for inspection to see if device is performing to specifications.

©2007 ECRI 16 Accident Reconstruction Testing “Testing to determine if a device is performing according to specification is not accident investigation.” Recreate conditions of use –Location in hospital, e.g. same mains outlet –Same settings Goal: Determine if something about the design or labeling contributed to accident.

©2007 ECRI 17 Data Collection and Recording 1. Incident Investigation Form 2. Patient Information – Patient Chart – Discussing the Incident with Staff

©2007 ECRI 18 Data Collection and Recording 3. Equipment Information –Disposables and packaging –Device Service History Before, during, and after incident Third party servicing issues

©2007 ECRI 19 Data Collection and Recording 3. Equipment Information (cont.) –Typical Settings –Who had contact with device after incident –Hazard and recall notices (ECRI’s HDA data)

©2007 ECRI 20 Data Collection and Recording 4. Need literature references or database information on: –StandardsHazards –ComplicationsWarnings –ContraindicationsFailures –Comparative Evals.Recalls –Tech. AssessmentsClinical Trials

©2007 ECRI 21 Data Collection and Recording 5. Injury Assessment –Elapsed Time –Colour Photographs –Characteristics and changes –Location of injury relative to devices 6. Autopsy /Pathology Report –Post-mortem report –Tissue pathology/histology reports

©2007 ECRI 22 Data Collection and Recording Documentation –Chain of evidence –Notebook –Test equipment calibration –Test methods –Test results –Photographs/video

©2007 ECRI 23 Data Collection and Recording Documentation (cont.) –Do not document conclusions unless it is requested (hospital protocol). –Third party or regulatory investigation: document conclusions based on information available to date.

©2007 ECRI 24 Use of Referral Laboratories Sometimes needed Metallurgical analysis –SEM –Electron microprobe –Micro-hardness Drug testing –Concentrations of mixed drugs

©2007 ECRI 25 QUESTIONS? VI. Device Inspection and Testing: Investigation Guidelines