Issues%20in%20Medical%20Device%20Wireless%20Communication%20Technology%20Usage

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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 [phone]
E-Mailt.cooper_at_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.
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Agenda
ISO/IEEE 11073 Medical Device Wireless Issues -
2002-09-11

• Wireless Technology Issues in Healthcare

• Problem Resolution Activities

• Opportunities for Involvement

• Q A

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Objectives

• Raise awareness of coexistence issues within the
  healthcare environmentits 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!
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Wireless in Healthcare
What is the state of affairs for Wireless
technology usage in the Healthcare Enterprise?
Anarchy!
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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
Physio
EKGs,
Bedside
Lab
Payers
"MIB"
Monitors
Pumps, Vents
Monitor
Instruments
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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
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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)
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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

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Wireless in Healthcare
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

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Wireless in Healthcare
Three key problem areas

1. Inter-device preditor/prey Incompatibility

1. Biological effects of long-term exposure to
   wireless signals

1. 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
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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

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Fixing the Problem
What is being done to address EMI/EMC issues
within healthcare?
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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)

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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

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Fixing the Problem
Note Freqs 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.
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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.

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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

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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.
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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.

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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

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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

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Fixing the Problem
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!

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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

• Toeducate, discuss, and define a model policy
  for healthcare organizations to use address
  EMI/EMC issues

• Web www.medrecinst.com/conferences/wireless

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ISO/IEEE/CEN

• ISO TC215 WG 2.1 - Devices

• IEEE 1073 Medical Device Comm. Standards

• CEN TC251 WG4 Technology for Interoperabi
  lity

Harmonized into a single set of international
standards for Point-of-care Medical Device
Communication (Including RF-based Transports!)
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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

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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/
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ISO/IEEE 11073

• Discussion

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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_at_ieee.org