FDA Liaison Report to IEC SC62A MT23 October 2006

FDA Liaison Report

for ASC C63TM SC8 Meeting

24 October 2007

Jeffrey L. Silberberg

1.  Lab activities

a.  Work through PC-69 group on testing EMC of implantable pacemakers and ICDs with RFID readers

b.  Development of metal detector simulator for medical device immunity testing. Paper on CDRH test method and sample results published in IEEE Transactions On Biomedical Engineering, Vol. 54, No. 9, September 2007: Testing the Immunity of Active Implantable Medical Devices to CW Magnetic Fields up to 1 MHz by an Immersion Method, Valentin Buzduga, Donald M. Witters, Jon P. Casamento, and Wolfgang Kainz

c.  Paper published in Summer 2007 IEEE EMC Society Newsletter (Issue 214) Safety Evaluation of Walk-Through Metal Detectors, Dagang Wu, Rui Qiang, Ji Chen, Wolfgang Kainz, and Seth Seidman

d.  MRI implant heating computational methods and lab testing with ASTM MRI group

e.  ICES TC-34 SC2 Mtg at CDRH 10/18/07) Round Table Discussions on Development of SAR Evaluation Standards to Support Emergent Wireless Personal Communication Devices and Technologies

2.  Standards activities

a.  ANSI-accredited standards committee C63

·  C63.18 (ad hoc test method) Edition 2

·  C63.19 (compatibility between wireless devices and hearing aids)

·  C63.9 (immunity of office equipment)

b.  IEC SC62A MT23 (see separate liaison report)

c.  AAMI PC-69 part 2 for 0 to 30 MHz testing

·  CDRH collaborations with device manufacturers in testing over 40 pacemaker and ICD devices for immunity to emissions from 7 different RFID systems

·  Results being prepared for publication

d.  ISO TC 150 SC 6/ WG 5 on implanted neurostimulators and WG 4 on implanted infusion pumps. Developing revisions to address testing suggested in ISO 14708-1 standard for immunity to 150 A/m exposure over 0to 100 kHz, falling off inversely with frequency up to 30 MHz.

·  DIS ISO 14708-3 Implanted Neurostimulators incorporates significant new text on lower frequency magnetic field susceptibility and testing.

e.  ISO TC 173 SC 1 on ISO 7176 wheelchair standards

·  Revisions and CD on part 21 for EMC of powered wheelchairs and scooters

·  Several other parts of the 7176 standard are being revised, and new parts being drafted such as stair-climbing wheelchairs

f.  AAMI EMC committee

·  Working on Ed. 2 of TIR 18, guidance on EMC in healthcare facilities

3.  CDRH outreach

a.  CDRH EMC group

·  In-house class presented to CDRH personnel on engineering/physics basics of EMC/EMI and lab testing, including presentations by Don Witters and Mike Violette

·  Presentation/participation in Third Edition IEC 60601-1 Conference, Kista Sweden, 14 May 2007

b.  Coordination and meetings with FCC re: medical device concerns (10/5/07 FCC report on HAC requirements), ongoing work with C63.19 and ATIS

4.  Other

a.  FDA draft guidance, Radio-Frequency Wireless Technology in Medical Devices

·  Comments being incorporated

b.  RFID

·  CDRH RFID web page posted, including mention of risk of [RFID reader] emissions affecting electronic medical devices

http://www.fda.gov/cdrh/rfid/

c.  EMC in Healthcare meeting – Ottawa Ontario Canada July 2007 – Two presentations by J. Silberberg – EMC Standards and Guidelines, EMI Problem Reports

d.  CT scan x-ray interference with electronic medical devices

·  CDRH Postmarket Issue Action Team formed to study the problem

·  High-dose-rate x-rays appear to be the source of interference

·  Drafting of notifications and recommendations in progress

·  Inquiry made to MedSun members