Project: IEEE P802.19 Coexistence TAG

1. Project: IEEE P802.19 Coexistence TAG Submission Title: [EMI-EMC Issues in POC Medical Device Communications] Date Submitted: [11September, 2002] Source: [Todd Cooper] Company [Chair, IEEE 1073 Standards for Medical Device Communications] Company [MDCIG IEEE-ISTO] Address [445Hoes Lane, Piscataway, NJ 08855-1331, USA] Voice [858-484-8231], FAX: [509-355-5073] E-Mail:[t.cooper@ieee.org] Re:[Point of Care ~ Medical Device Communications Standards] Abstract: [Wireless Technology Issues in Healthcare] Purpose: [Raise awareness of coexistence issues within the healthcare environment] Notice: This document has been prepared to assist the IEEE P802.19. It is offered as a basis for discussion and is not binding on the contributing individual(s) or organization(s). The material in this document is subject to change in form and content after further study. The contributor(s) reserve(s) the right to add, amend or withdraw material contained herein. Release: The contributor acknowledges and accepts that this contribution becomes the property of IEEE and may be made publicly available by P802.19. Todd Cooper, MDCIG

2. Agenda ISO/IEEE 11073 Medical Device Wireless Issues - 2002-09-11 • Wireless Technology Issues in Healthcare • Problem Resolution Activities • Opportunities for Involvement • Q & A Todd Cooper, MDCIG

3. Objectives • Raise awareness of coexistence issues within the healthcare environment…it’s a real problem! • Obtain perspective of 802.x on coexistence issues – Getting the right message out • Determine how best to address resolution of the technical problems given multiple stakeholders. Caveat: I am not a wireless expert! Todd Cooper, MDCIG

4. Wireless in Healthcare What is the state of affairs for Wireless technology usage in the Healthcare Enterprise? Anarchy! Todd Cooper, MDCIG

5. ASTM E-1394 over E-1381 Wireless in Healthcare Clinical Administrative Gen/Med Laboratory C/N/ICU Clinical Data Admissions, Orders Results Charting Repository (CDR) Discharges, Transfers (ADT) HL7 In-House Services HL7 HL7 Master Person HL7 HL7 Index (MPI) Radiology HL7 DICOM HL7 Scheduling HL7 Enterprise Information DICOM Echo Lab System "Backbone" HL7 HL7 Billing HL7 Hospital Labs E1467 X12N ISO / IEEE 1/1073 Instruments Bedside EKGs, Physio Lab Payers "MIB" Monitor Pumps, Vents Monitors Instruments Todd Cooper, MDCIG

6. Wireless in Healthcare “Healthcare” geography… • Hospitals (in-patient) • Clinics (out-patient) & Offices • Home / Chronic Care • Remote / Telemedicine • Mobile (ambulance / ambulatory patients) Each environment comes with its own unique & dynamic EMI/EMC context Todd Cooper, MDCIG

7. Wireless in Healthcare What wireless technology is being used? If it exists, it can be found somewhere in healthcare! • Traditional radios used by emergency personnel • Telecommunications equipment used by everyone • LAN/WAN networks • Personal (& “body”) area networks (not to mention extra-healthcare environment sources of EM signals) Todd Cooper, MDCIG

8. Wireless in Healthcare Who is using wireless technology? • Companies want to use ‘latest technology’ to maintain competitive edge • Hospital I.T. personnel want to use what has the best performance and is … cool! • Doctors love gadgets … including wireless “tools” • Patients & visitors bring anything and everything into the healthcare environment • Purchasing departments look for cost-effective technologies Todd Cooper, MDCIG

9. Wireless in Healthcare So what’s the problem? Because of a lack of understanding and management of EMI/EMC issues within the healthcare industry and environment… • Medical devices have malfunctioned, resulting in serious injury, even death • Systems have failed to provide critical patient status and alert information • Lack of coordination and management results in Band-Aids not solutions Todd Cooper, MDCIG

10. Wireless in Healthcare Three key problem areas… • Inter-device “preditor/prey” Incompatibility • Biological effects of long-term exposure to wireless signals • Coexistence of multiple wireless technologies around the point-of-care / healthcare environment #1 & #2 are being addressed by numerous groups, but coexistence is just surfacing as a major issue Todd Cooper, MDCIG

11. Wireless in Healthcare Coexistence will become increasingly important… • Ubiquitous usage of wireless technology will only continue to increase. • Increasingly sophisticated and distributed systems will implement safety and mission critical healthcare functions using components that include wireless communications links Todd Cooper, MDCIG

12. Fixing the Problem What is being done to address EMI/EMC issues within healthcare? Todd Cooper, MDCIG

13. Fixing the Problem Many organizations are looking at the issues… • Government • (FDA / CDRH, FCC) • Standards Organizations • (IEEE, ANSI, AAMI, ISO, IEC, etc.) • Industry Groups • (AHA, AMA, JCAHO, etc.) • Universities • (e.g., Univ. of Oklahoma Center for the Study • of Wireless EMC) Todd Cooper, MDCIG

14. Fixing the Problem FDA/CDRH… • Maintains EMC group… • www.fda.gov/cdrh/emc • Working with the FCC, created … • Wireless Medical Telemetry Service (WMTS) • TV Ch. #37 (6MHz, 608-14MHz) • 1395-1400MHz, 1429-1432MHz • Works with other standards and healthcare organizations to educate and manage problems Todd Cooper, MDCIG

15. Fixing the Problem Note: Freq’s used today in medical telemetry… 1. 450-460MHz (UHF)* 2. Vacant TV Channels 7-46* • ISM Frequencies (915MHz, 2450MHz) – • Secondary Usage Only * Note: New devices using this frequency will not be approved by the FDA after October 2002. Todd Cooper, MDCIG

16. Fixing the Problem Key standards have been created for EMI/EMC: • IEC International Standard 60601-1-2 Medical Electrical Equipment; General Requirements for Safety; Collateral Standard – Electromagnetic Compatibility, Requirements & Tests • IEEE/ANSI C63.18 Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radio-frequency transmitters. Todd Cooper, MDCIG

17. Fixing the Problem Key standards have been created for EMI/EMC: • AAMI TIR-18 Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers Todd Cooper, MDCIG

18. Fixing the Problem Question of the Day: Ban or Manage?! (Esp. in Europe) banning equipment from the healthcare environment which could result in EMI/EMC malfunctions is the optimal, most fail-safe approach BUT (Esp. in U.S.) managing the problem is seen as the only pragmatic / workable solution. Todd Cooper, MDCIG

19. Fixing the Problem FDA Guidelines for Managing EMI/EMC… • Establish a policy and process for managing spectrum usage within the healthcare facility • Make use of available resourcessuch as EMC professionals and publications and Internet web pages on the subject of medical device EMC • Assess the EM environment of the facility and identify areas where critical medical devices are used. Todd Cooper, MDCIG

20. Fixing the Problem FDA Guidelines for Managing EMI/EMC… • Coordinate the purchase, installation, service, and management of all electrical and electronic equipment used in the facility to achieve EMC • Educate healthcare facility staff, contractors, visitors, and patients about EMC and EMI and how they can recognize medical device EMI and help minimize EMI risks Todd Cooper, MDCIG

21. Fixing the Problem FDA Guidelines for Managing EMI/EMC… • Establish and implement written policies and procedures that document the intentions and methods of the healthcare institution for reducing the risk of medical device EMI and achieving EMC • Report EMI problems to the FDA MedWatch program and communicate EMI/EMC experiences to colleagues in open forums such as medical/technical publications and conferences Todd Cooper, MDCIG

22. Fixing the Problem But that doesn’t fix the problem! • Technical coexistence issues still need to be resolved • Companies deploying technology in their devices still need to know how to best avoid if not prevent EMI/EMC issues relating to coexistence • Hospitals are often still stuck with having to “make it all work”! Todd Cooper, MDCIG

23. Opportunities National Summit on EMI with Medical Devices in Healthcare Organizations • October 15-16, 2002 Las Vegas (w/ CTIA Wireless I.T. & Internet 2002 conferences) • Sponsored by MoHCA & MRI, with participation by stakeholders from across the healthcare industry • To…educate, discuss, and define a model policy for healthcare organizations to use address EMI/EMC issues • Web: www.medrecinst.com/conferences/wireless Todd Cooper, MDCIG

24. ISO/IEEE/CEN • ISO TC215 WG 2.1 - Devices • IEEE 1073 Medical Device Comm. Standards • CEN TC251 WG4 – Technology for Interoperability Harmonized into a single set of international standards for: Point-of-care Medical Device Communication (Including RF-based Transports!) Todd Cooper, MDCIG

25. IEEE-ISTO MDCIG • IEEE Industry Standards & Technology Organization • Medical Device Communications Industry Group • Support Standardization Activities • Prototyping Projects • Promote Standards Usage • Supporters include… Baxter Healthcare Gambro GE Medical Lantronix Philips Medical Siemens Medical Viasys Healthcare … Todd Cooper, MDCIG

26. Status Updates Stay up to date… www.ieee1073.org! Standards Updates: www.ieee1073.org/standards/ Meetings: www.ieee1073.org/meetings/ Soon - Topics: www.ieee1073.org/topics/ Todd Cooper, MDCIG

27. ISO/IEEE 11073 Discussion Todd Cooper, MDCIG

28. ISO/IEEE 11073 To find additional information or become involved in the standardization process, contact: Todd Cooper Chair, IEEE 1073 General Committee Technical Director, MDCIG, a program of the IEEE ISTO (V) 858.484.8231 (E) t.cooper@ieee.org Todd Cooper, MDCIG