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

©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

©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)

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

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

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

©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

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

©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.

©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

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

©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)

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

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

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

©2007 ECRI 17 QUESTIONS? XVIII. Monitoring Technologies