1. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 1 Project: IEEE P802.19 Coexistence TAG Submission Title: [EMI-EMC Issues in POC Medical Device Communications] Date Submitted: [11 September, 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.

2. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 2 Agenda Wireless Technology Issues in Healthcare ISO/IEEE 11073 Medical Device Wireless Issues - 2002-09-11 Problem Resolution Activities Opportunities for Involvement Q & A

3. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 3 Raise awareness of coexistence issues within the healthcare environment…its 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! Objectives

4. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 4 What is the state of affairs for Wireless technology usage in the Healthcare Enterprise? Anarchy! Wireless in Healthcare

5. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 5 Instruments In-House Services Clinical DICOM HL7 Administrative Admissions, Discharges, Transfers (ADT) Billing HL7 Physio Monitors EKGs, Pumps, Vents Bedside Monitor ISO / IEEE 1/1073 E1467 Radiology Echo Lab Gen/Med Orders Laboratory Results HL7 DICOM HL7 C/N/ICU Charting Hospital Labs HL7 X12N Payers Clinical Data Repository (CDR) Master Person Index (MPI) HL7 Scheduling HL7 Enterprise Information System "Backbone" Lab Instruments "MIB" HL7 ASTM E-1394 over E-1381 Wireless in Healthcare

6. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 6 Healthcare geography… Hospitals (in-patient) Home / Chronic Care Remote / Telemedicine Clinics (out-patient) & Offices Mobile (ambulance / ambulatory patients) Each environment comes with its own unique & dynamic EMI/EMC context Wireless in Healthcare

7. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 7 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) Wireless in Healthcare

8. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 8 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 Wireless in Healthcare

9. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 9 So whats 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 Wireless in Healthcare

10. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 10 Three key problem areas… 1.Inter-device preditor/prey Incompatibility 2.Biological effects of long-term exposure to wireless signals 3.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 Wireless in Healthcare

11. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 11 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 Wireless in Healthcare

12. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 12 What is being done to address EMI/EMC issues within healthcare? Fixing the Problem

13. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 13 Many organizations are looking at the issues… Standards Organizations (IEEE, ANSI, AAMI, ISO, IEC, etc.) Government (FDA / CDRH, FCC) Industry Groups (AHA, AMA, JCAHO, etc.) Universities (e.g., Univ. of Oklahoma Center for the Study of Wireless EMC) Fixing the Problem

14. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 14 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 Fixing the Problem

15. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 15 Note: Freqs used today in medical telemetry… * Note: New devices using this frequency will not be approved by the FDA after October 2002. 3.ISM Frequencies (915MHz, 2450MHz) – Secondary Usage Only 2.Vacant TV Channels 7-46* 1.450-460MHz (UHF)* Fixing the Problem

16. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 16 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. Fixing the Problem

17. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 17 Key standards have been created for EMI/EMC: AAMI TIR-18 Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers Fixing the Problem

18. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 18 Question of the Day: Ban or Manage?! BUT (Esp. in U.S.) managing the problem is seen as the only pragmatic / workable solution. (Esp. in Europe) banning equipment from the healthcare environment which could result in EMI/EMC malfunctions is the optimal, most fail-safe approach Fixing the Problem

19. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 19 FDA Guidelines for Managing EMI/EMC… Establish a policy and process for managing spectrum usage within the healthcare facility Make use of available resources such 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. Fixing the Problem

20. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 20 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 Fixing the Problem

21. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 21 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 Fixing the Problem

22. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 22 But that doesnt 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! Fixing the Problem

23. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 23 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 Opportunities

24. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 24 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!) ISO/IEEE/CEN

25. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 25 Medical Device Communications Industry Group Support Standardization Activities Prototyping Projects Promote Standards Usage Supporters include… Baxter HealthcareGambro GE Medical Lantronix Philips Medical Siemens Medical Viasys Healthcare… IEEE Industry Standards & Technology Organization IEEE-ISTO MDCIG

26. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 26 Stay up to date… www.ieee1073.org! Standards Updates: www.ieee1073.org/standards/ Meetings: www.ieee1073.org/meetings/ Soon - Topics: www.ieee1073.org/topics/ Status Updates

27. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 27 Discussion ISO/IEEE 11073

28. September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 28 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 ISO/IEEE 11073