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Important Safety Information on Interference with Medical Telemetry Systems - Notice to Hospitals
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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
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 band1. 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 WMT2. 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
- 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.
- Continue to monitor Industry Canada's activities concerning WMT, including the Department's proposal to open additional bands for the WMT service2.
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:
- 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
- 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
