September 2002 doc.: IEEE-802.19 02/004r0 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. Submission Slide 1 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 ISO/IEEE 11073 Medical Device Wireless Issues - 2002-09-11 Agenda Wireless Technology Issues in Healthcare Problem Resolution Activities Opportunities for Involvement Q&A Submission Slide 2 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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! Submission Slide 3 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 Wireless in Healthcare What is the state of affairs for Wireless technology usage in the Healthcare Enterprise? Anarchy! Submission Slide 4 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 Wireless in Healthcare Clinical Administrative Gen/Med Orders Admissions, Discharges, Transfers (ADT) Master Person Index (MPI) HL7 Laboratory Results HL7 HL7 C/N/ICU Charting HL7 HL7 HL7 Clinical Data Repository (CDR) In-House Services DICOM HL7 Radiology Scheduling HL7 Billing Enterprise Information System "Backbone" DICOM HL7 Echo Lab HL7 HL7 Hospital Labs E1467 X12N ASTM E-1394 over E-1381 ISO / IEEE 1/1073 Instruments Payers Submission Bedside Monitor "MIB" EKGs, Pumps, Vents Slide 5 Physio Monitors Lab Instruments Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 6 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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) Submission Slide 7 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 8 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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… Submission • 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 Slide 9 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 Wireless in Healthcare 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 Submission Slide 10 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 11 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 Fixing the Problem What is being done to address EMI/EMC issues within healthcare? Submission Slide 12 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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) Submission Slide 13 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 14 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 Fixing the Problem Note: Freq’s used today in medical telemetry… 1. 450-460MHz (UHF)* 2. Vacant TV Channels 7-46* 3. ISM Frequencies (915MHz, 2450MHz) – Secondary Usage Only * Note: New devices using this frequency will not be approved by the FDA after October 2002. Submission Slide 15 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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. Submission Slide 16 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 17 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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. Submission Slide 18 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 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. Submission Slide 19 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 20 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 21 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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”! Submission Slide 22 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 23 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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!) Slide 24 Submission Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 GE Medical Philips Medical Viasys Healthcare Submission Gambro Lantronix Siemens Medical … Slide 25 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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/ Submission Slide 26 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 ISO/IEEE 11073 Discussion Submission Slide 27 Todd Cooper, MDCIG September 2002 doc.: IEEE-802.19 02/004r0 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 Submission Slide 28 Todd Cooper, MDCIG