September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 1 Project: IEEE P802.19 Coexistence TAG Submission Title: [EMI-EMC Issues in.

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.



Agenda

Wireless Technology Issues in Healthcare

ISO/IEEE 11073 Medical Device Wireless Issues - 2002-09-11

Problem Resolution Activities

Opportunities for Involvement

Q & A



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



What is the state of affairs for

Wireless technology usage in the

Healthcare Enterprise?

Anarchy!

Wireless in Healthcare



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




“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




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)




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




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




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




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




What is being done to address EMI/EMC issues within healthcare?

Fixing the Problem



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



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



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



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



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



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



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




• 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




• 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



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



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



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



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



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



Discussion

ISO/IEEE 11073



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

September 2002 doc.: IEEE-802.19 02/004r0 SubmissionTodd Cooper, MDCIGSlide 1 Project: IEEE P802.19 Coexistence TAG Submission Title: [EMI-EMC Issues in.

Documents

healthcare slide

02004r0 submissiontodd

healthcare enterprise

wireless signals

healthcare isoieee

healthcare purpose

healthcare industry

healthcare environmentits