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Stop Order for Reprocessing Intramuscular Stimulation (IMS) Plungers

As per letter of July 16, 2012 from the Chief Medical Officer of Health, Alberta Health and Wellness:

TO: REGULATORY BODIES REGISTRARS:

RE: Stop Order for Reprocessing Intramuscular Stimulation (IMS) Plungers

As your are aware, the Chief Medical Officer of Health (CMOH) of Alberta issued an order to stop use on reusable IMS plungers in April 2008. The order to stop was issued as the CMOH determined the instructions provided by the manufacturers for some of the IMS plungers were not sufficiently detailed to enable users to determine the required process to correctly reprocess these medical devices for safe re-use.

This letter is to confirm that sufficiently detailed, validated cleaning and reprocessing instructions have been provided with respect to the following:

Name of IMS Plunger: MR-6 Needle Injector
Name of Manufacturer: Electro-Therapeutics Devices Ltd.

The order to stop use is lifted with respect to the above IMS plunger only and is effective as of the date of this letter.

The order to stop of April 2008 remains in effect with respect to all other reusable IMS plungers until such time as Alberta Health confirms to you that it has received validated cleaning and reprocessing instructions from these manufacturers.

Thank you for your co-operation and support in this matter.

Sincerely, Dr James Talbot
Chief Medical Officer of Health, Alberta Health

cc: Dr Martin Lavoie, Deputy Chief Medical Officer of Health
Margaret King, Assistant Deputy Minister, Family and Population Health Division, Alberta Health
Dr Mark Joffe, Medical Director, Infection Prevention and Control, Alberta Health Services
Leanne Dekker, Vice-President, Infection Prevention and Control, Alberta Health Services

Please note that GunnIMS Plungers were manufactured by Dong Bang of Korea and the stop order remains in effect by Alberta Health Services.