Archived - Notice to Hospitals - Important Safety Information on Interference with Medical Telemetry Systems

Starting date:

March 14, 2006

Posting date:

March 14, 2006

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001485

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Interference with Medical Telemetry Systems

POSTED BUT NOT FAXED

This notice supersedes the Notice to Hospitals issued by Health Canada on December 28, 2005, as Industry Canada has provided updated information.

March 14, 2006

To: Director, Clinical/Biomedical Engineering

Risk Manager

Hospital Administrator

Nursing Home Director

Please distribute to the relevant Departments of Biomedical Engineering, Emergency Medicine, Intensive Care, Coronary Care including any hospital floors where cardiac patients are monitored and other involved professional staff and post this NOTICE in your institution.

Subject: Recent changes to US FCC Rules in the 460-470 MHz Band may affect Canadian Wireless Medical Telemetry Systems Located Near the US Border

The purpose of this notice is to advise health care facilities of the potential risk of electromagnetic interference with wireless medical telemetry (WMT) systems operating in the 460-470 MHz frequency band.

The US Federal Communications Commission (FCC) announced in November, 2005, that beginning in January, 2006, it will issue new land mobile licences in the 460-470 MHz band.¹ These new licences will be for transmitters of 2 watts or higher and will include hand-held and other mobile transmitters such as those operated by police, firefighters, emergency teams, ambulances, taxis and commercial trucks. The FCC rule change is unlikely to affect Canadian WMT users. However, Canadian health care facilities near the US border should be aware of an increased potential for interference to the WMT service in the 460-470 MHz band.

In 2004, Industry Canada sent a notice to health care facilities to advise of the potential for interference to WMT equipment in the 460-470 MHz band from the new General Mobile Radio Service (GMRS) radios for personal and family communications. At that time, Industry Canada encouraged WMT users to migrate to other medical telemetry bands. However, Industry Canada continues to allow WMT systems to operate in the 460-470 MHz band as a licensed service on a "no interference, no protection" basis.

In December, 2005, Industry Canada published a general public consultation paper proposing to open several new bands for WMT.² In this paper, Industry Canada advised against the long-term use of medical telemetry in the 147-216 MHz, 470-608 MHz and 614-746 MHz bands due to the potential for interference to WMT equipment.

Recommendations

1. If your medical telemetry system is still operating in the 147-216 MHz, 470-608 MHz or 614-746 MHz bands, you should consider changing its frequency to a less vulnerable band, such 608-614 MHz. If you are unsure what frequency your system uses, consult the manufacturer.
2. Continue to monitor Industry Canada's activities concerning WMT, including the Department's proposal to open additional bands for the WMT service.²

Health Canada depends on health care professionals to report adverse incidents related to medical devices. Any serious or unexpected adverse incident related to medical devices should be reported to Health Canada at the following address:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Tel: The Inspectorate Hotline 1-800-267-9675

Fax: (613) 954-0941

The Medical Devices Problem Report Form and Guidelines can be obtained from the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:

Medical Devices Bureau

E-mail: mdb_enquiries@hc-sc.gc.ca

Tel: (613) 957-4786

Fax: (613) 957-7318

References:

1. FDA Public Health Information: Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands. http://www.fda.gov/cdrh/safety/111605-wmts.html
2. Industry Canada. Proposals and Changes to the Spectrum in Certain Bands below 1.7 GHz. DGTP-004-05. December, 2005. http://strategis.ic.gc.ca/epic/internet/insmt-gst.nsf/en/sf08495e.html