Transcript 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:

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:[[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.
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) [email protected]
Submission
Slide 28
Todd Cooper, MDCIG