1. ©ECRI 2007 1 XVIII. Monitoring Technologies 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 XVIII. Monitoring Technologies Critical alarms: Performance Considerations ECG/Arrhythmia/Telemetry monitors Apnea Monitors Pressure Monitors – Breathing Circuit – Physiologic Pulse Oximeters

3. ©2007 ECRI 3 Types of Monitors ECG –Arrhythmia –Telemetry EEG Apnea Fetal CO 2 Pressure –Blood –Intra-cranial –Breathing circuit Exhaled Volume Pulse Oximeter Heart Rate

4. ©2007 ECRI 4 Critical Alarms: Performance Considerations Initialization Activation (When should they sound?) Identification Disabling and Silencing Remote Alarms Volume Limits (Physiologically reasonable) Power (Mains/Battery)

5. ©2007 ECRI 5 Patient Monitoring Accidents Alarm Design Accessory Transducers –Blood pressure –Intra-cranial Pressure –Intrauterine pressure Accessory Cables and Leads

6. ©2007 ECRI 6 Patient Monitoring Accidents Software –Arrhythmia Detection –Patient Data Systems –Memory/Trending Telemetry Systems “Hot swapping”

7. ©2007 ECRI 7 Patient Monitoring Accidents Equipment Interfaces –Bedside Monitors –Central Stations –Telemetry Transmitters –Patient Data Systems

8. ©2007 ECRI 8 Alarm “Malfunctions” Actual alarm malfunctions are rare Most alarm-related problems occur because alarms are defeated by staff members (either inadvertently or deliberately), environmental factors keep alarms from being heard, or device design allows staff to easily defeat alarms

9. ©2007 ECRI 9 Alarm “Malfunction” Causes Frequent nuisance alarms Environmental Factors Inadequate protocols and training Poor device design

10. ©2007 ECRI 10 High-Priority Care Areas Intermediate and general care areas hold greatest alarm safety risk because... Environment makes hearing alarms difficult (e.g., large area, low nurse-to-patient ratio) Staff are often inadequately trained in use of monitoring equipment and ventilators, including alarm setting and response procedures.

11. ©2007 ECRI 11 High-Priority Devices Ventilators Ensure that minute volume and low peak inspiratory pressure alarms are set appropriately. Verify adequate alarm volume. Consider vents with responsive-valve features to reduce nuisance high- pressure alarms. Physiologic Monitoring Systems Clearly establish who bears responsibility for alarm events Consider next-generation pulse oximeters to limit nuisance alarms Educate staff on the significance of ECG leads- off alarms

12. ©2007 ECRI 12 ECG/Arrhythmia Monitors Bedside Central Station Telemetry Ventricular Fibrillation/Tachychardia Failure to Alarm Settings Alarm Silence functions Cables and Leads

13. ©2007 ECRI 13 ECG/Arrhythmia Monitors Accident Cases Examples –Ventricular Fibrillation/Tachychardia –Failure to Alarm Settings Alarm Silence functions Cables and Leads Investigative Considerations Case ECG Monitor (defibrillating sleeping patient)

14. ©2007 ECRI 14 Apnea Monitors Types of sensors Electrocution cases Remote alarms for home use

15. ©2007 ECRI 15 Pressure Monitors Calibration Compatibility with transducers CV Pressure MedSun Case 15: Transducer Inaccuracy

16. ©2007 ECRI 16 Pulse Oximeters Pressure Necrosis Burns Light sensitivity Testing –New simulators –Your finger

17. ©2007 ECRI 17 QUESTIONS? XVIII. Monitoring Technologies