Regulation of Alarm Remote Notification Systems

Transcription

1 Regulation of Alarm Remote Notification Systems Shawn Forrest Center for Devices and Radiological Health Food and Drug Administration Medical Device Alarms Summit October 5, 2011

2 Evolving Clinical Environment Central Alerting Bedside Alerting Remote Alerting 2

3 What are Secondary Alarm Notifications? Intended to supplement Primary notifications User reliance is intended to be on Primary notifications, typically from Bedside monitor Central station 3

4 Related Example Classification Regulation: 21 CFR Cardiac Monitor (including cardiotachometer and rate alarm) Product Code: MSX Physiological Monitors Network and Communication System Classification: Class II (requires 510(k)) No current classification specific to secondary alerts 4

5 FDA Device Review Premarket notification (510(k)) demonstrates substantial equivalence to a predicate device Devices are cleared/approved only for their labeled intended use Secondary alarms are an additional layer of protection Primary alarms are assumed to be functional 5

6 Evolving Clinical Environment Central Alerting Bedside Alerting Intended use of devices should be considered in the monitoring paradigm. Remote Alerting 6

7 Postmarket Experience MAUDE reports provide insights on potential remote notification problems Networking hardware failures Hardware conflicts Spontaneous system reboots Network traffic precludes/delays delivery Receiver loses connection or connects to wrong network (and doesn t notify) Receiver batteries unexpectedly depleted 7

8 Design Considerations Validated network requirement specs Acceptable latency Closed-loop system Backup routing Receiver Ensures constant connection to correct network Ensures battery reliability Logs alarms and connection to assist troubleshooting End-to-end compatibility 8

9 Device Alarm Review Verification and Validation based on level of risk In the case of alarm systems, the risk of missing a critical alarm should guide testing Key aspects: Wireless & EMC validation Software validation Alarm-related standards 9

10 RF Wireless Technology Draft Guidance Document 10

11 Wireless Medical Device Validation Performance Quality of Service Latency Data Integrity Electromagnetic Compatibility Wireless Coexistence Security 11

12 Software Validation Guidance 12

13 Software Validation Guidance 13

14 Software Validation Guidance 14

15 Software Validation for Remote Alarm Notification Controlled development process Hazard analysis for alarms should guide design Requirements and design specifications should adequately address alarm reliability Validation should include comprehensive assessment of potential alarm failure modes 15

16 Related Recognized Standards IEC Ed. 2:2006, General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems AAMI / ANSI HE75:2009, Human factors engineering - Design of medical devices 16

17 Potentially Related Initiative Mobile Medical Applications Draft Guidance Document Public Workshop held 9/12-13, all comments due by 10/19 orkshopsconferences/ucm htm 17

18 Unrelated Initiative Medical Device Data Systems (MDDS) Final rule issued Feb 15, 2011 to reclassify from Class III (default) to Class I Does not include devices intended to be used in connection with active patient monitoring. Includes only systems that transfer, store, convert from one format to another, or display medical device data. 18

19 Conclusion Monitoring systems providing Secondary remote notifications should be implemented based on their Intended Use. Reliance should be on the primary alarms (bedside and central station) 19