Download - Project: IEEE P802.19 Coexistence TAG
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 1Submission
Project: IEEE P802.19 Coexistence TAGProject: 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:[[email protected]]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.
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 2Submission
Agenda
Wireless Technology Issues in Healthcare
ISO/IEEE 11073 Medical Device Wireless Issues - 2002-09-11
Problem Resolution Activities
Opportunities for Involvement
Q & A
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 3Submission
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!
Objectives
September 2002 doc.: IEEE-802.19 02/004r0
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What is the state of affairs for
Wireless technology usage in the
Healthcare Enterprise?
Anarchy!
Wireless in Healthcare
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 5Submission
Instruments
In-House Services
Clinical
DICOMHL7
HL7
Administrative
Admissions,Discharges,
Transfers (ADT)
Billing
HL7
PhysioMonitors
EKGs,Pumps, Vents
BedsideMonitor
ISO / IEEE 1/1073E1467
Radiology
Echo Lab
Gen/MedOrders
LaboratoryResults
HL7 HL7
DICOMHL7
C/N/ICUCharting
Hospital LabsHL7
X12N
Payers
Clinical DataRepository (CDR)
Master PersonIndex (MPI)
HL7
Scheduling
HL7
HL7 Enterprise InformationSystem "Backbone"
LabInstruments
"MIB"
HL7
ASTME-1394 over E-1381
Wireless in Healthcare
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 6Submission
“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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 7Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 9Submission
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
Wireless in Healthcare
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 10Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 11Submission
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
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What is being done to address EMI/EMC issues within healthcare?
Fixing the Problem
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 15Submission
Note: Freq’s 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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 16Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 17Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 18Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 19Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
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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”!
Fixing the Problem
September 2002 doc.: IEEE-802.19 02/004r0
Todd Cooper, MDCIGSlide 23Submission
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
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
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Medical Device Communications Industry Group
Support Standardization Activities Prototyping Projects Promote Standards Usage
Supporters include…Baxter Healthcare GambroGE Medical Lantronix Philips Medical Siemens MedicalViasys Healthcare …
IEEE Industry Standards & Technology OrganizationIEEE-ISTO MDCIG
September 2002 doc.: IEEE-802.19 02/004r0
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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
September 2002 doc.: IEEE-802.19 02/004r0
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Discussion
ISO/IEEE 11073
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To find additional information or become involved in the standardization process, contact:
Todd CooperChair, IEEE 1073 General CommitteeTechnical Director, MDCIG, a program of the IEEE ISTO
(V) 858.484.8231(E) [email protected]
ISO/IEEE 11073