doc.: IEEE 802.15-<15-08-0441- 00-0000 > Submiss ion <Rick Hampton>, <Partners Healthcare, Boston> <July 2008> Slide 1 Project: IEEE P802.15 Working Group for Wireless Personal Area Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) Networks (WPANs) Submission Title: [A day in the life of wireless medical device network risk management] Date Submitted: [10 July 2008] Source: [Rick Hampton] Company [Partners HealthCare System] Address [Boston, MA] Voice:[Add telephone number], FAX: [Add FAX number], E-Mail: [[email protected]] Re: [If this is a proposed revision, cite the original document.] [If this is a response to a Call for Contributions, cite the name and date of the Call for Contributions to which this document responds, as well as the relevant item number in the Call for Contributions.] [Note: Contributions that are not responsive to this section of the template, and contributions which do not address the topic under which they are submitted, may be refused or consigned to the “General Contributions” area.] Abstract: [Description of document contents.] Purpose: [Description of what the author wants P802.15 to do with the information in the document.] Notice: This document has been prepared to assist the IEEE P802.15. 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.
Transcript
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
<July 2008>
Slide 1
Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)
Submission Title: [A day in the life of wireless medical device network risk management]Date Submitted: [10 July 2008]
Re: [If this is a proposed revision, cite the original document.]
[If this is a response to a Call for Contributions, cite the name and date of the Call for Contributions to which this document responds, as well as the relevant item number in the Call for Contributions.][Note: Contributions that are not responsive to this section of the template, and contributions which donot address the topic under which they are submitted, may be refused or consigned to the “General Contributions” area.]
Abstract: [Description of document contents.]
Purpose: [Description of what the author wants P802.15 to do with the information in the document.]
Notice: This document has been prepared to assist the IEEE P802.15. 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 P802.15.
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
IEEE 802 Plenary Tutorial Session
Rick Hampton
Wireless Manager
Partners HealthCare
Information Systems
"A Day In The Life: Wireless Risks In The Hospital Environment"
• Many wireless/radio systems for many different purposes• Placed in context as part of the hospital system (collection
of devices and utilities required to care for the sick and injured) these communications systems are life-critical in nature. Failure of some could lead to injury, illness, or death of patients, healthcare staff, and visitors
• IT industry is marketing the unified IT w/LAN as the single best solution moving forward
• The IT LAN, wired and wireless, must meet high standards for availability, reliability, and manageability not seen before
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
Some Problems Experienced:
• Pre-deployment– Site survey tools “best guess”… at best!
• Deployment– Too many ways IT vendors can choose to implement Standards– EVERY new wireless device is problematic
• Reliability– “Sell it now, fix it later!” mentality in IT industry– Too many bugs associated with proprietary work-arounds– Can’t keep up with code revisions
• Maintainability– Some automated management tools don’t work– “Legacy support” – Medical devices have MUCH longer design
cycle and life-span than IT equipment• 17 floors of 802.11FH still used for medical monitoring
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
Regulatory Concerns of Wireless Medical Devices
• FDA does not yet regulate the IS LAN as a medical device.
• If connecting a medical device to the IS LAN adds functionality to the device, the LAN could become part of the device and additional regulatory requirements (510k) would likely be required.
• Since the device manufacturer has no control over the IS LAN, it is prudent for the IS department to begin assessing and ensuring the extra level of reliability required by the addition of medical devices.
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
Regulatory Concerns of Wireless Medical Devices (Cont.)
• IEC 80001 Draft Standard – Title: Application of risk management for IT-networks incorporating medical devices– Expected to be ratified in 2010– Addresses IT/Medical integration “head on”– Requires risk analysis and mitigation to be done
on an ongoing basis for networked medical systems
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
Regulatory Concerns of Wireless Medical Devices (Cont.)
• FDA Medical Device Data System (Proposed) is a device intended to provide one or more of the following uses:– The electronic transfer or exchange of medical device data from a
medical device, without altering the function or parameters of any connected devices.
– The electronic storage and retrieval of medical device data from a medical device, without altering the function or parameters of connected devices.
– The electronic display of medical device data from a medical device, without altering the function or parameters of connected devices.
– The electronic conversion of medical device data from one format to another format in accordance with a preset specification.
• Major concern is that automating systems removes transparency of error generation from end user and over-reliance upon flawed systems
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
The Challenges(To be more fully addressed by subsequent presenters)
• Current standards address only the most basic requirements requiring IT vendors to create multiple proprietary work-arounds– May not be compatible between vendors– Need to work with “generic” devices and be transparent
• 802.11 QoS for medical devices (or lack thereof)• Inability to segregate wireless traffic (not enough SSIDs)• Some current automated wireless management systems fail
miserably– Unreliable - Cause dropout of clients– Present undesirable conditions for every medical device manufacturer
I’ve worked with– We have 2000+ APs, all managed manually
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
The Challenges (Cont.)
• Wireless systems will need “NOC-level” real-time spectrum management capabilities
• IT industry goals often do not take into account clinical/medical goals – conflicts result– VoIP, RFID, etc., may required different/conflicting
wireless architecture (QoS, deployment, security, etc.)• Current wireless standards are implemented for
consumer environments, not enterprise healthcare– Bluetooth Version 1.0 – notorious interferer– 802.11n, Zigbee, Wibree, and other “standards”
coming and not all may be useful in hospitals
doc.: IEEE 802.15-<15-08-0441-00-0000 >
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
Overlapping wireless technologies in the 2450 MHz ISM band
• Understand and acknowledge that 802.11 committees have an important role in improving healthcare in hospitals, in homes, in life in general
• Establish formal link with IEEE 11073 and other medical device standards committees
• Take a leadership position in rectifying issues outlined by this group of presenters through the creation of meaningful standards for medical devices
