![]() ![]() ![]() Any sterilizer used to process IMS needle plungers, must be validated for narrow lumen devices. This Should Be Done At Least Twice A Year As Practice Procedures Are Constantly Being Updated. Information And Guidelines On Sterilizing Protocols. It Is The Responsibility of the IMS Practitioner To Contact Their Local Health Authority For Needling Precaution Procedures and Sterilizing of Instruments Protecting Albertans through effective regulation and leadership Office of the Chief Medical Officer of HealthĪlberta Health and Wellness, Government of AlbertaĬollege of Physical Therapists of Alberta With some IMS plungers were not sufficiently detailed to enable users to determine the required process to correctly reprocess for safe re-use. The stop order was issued by Alberta’s Acting Chief Medical Officer of Health because of the risk of transmitting blood borne infections from patient to patient and manufactures instructions The decision was communicated to IMS manufacturers/distributors along with the necessary steps required before the stop order can be lifted. If you have in the past purchased this medical device from iSTOP or other suppliers for resale distribution, please contact your customers regarding this recall as instructed above.Īlberta Health and Wellness (AHW) recently reconfirmed a stop order on reusable IMS plungers remain until validated cleaning and reprocessing instructions are received from IMS manu-facturers/distributers. In accordance with section 64 of the Canadian Medical Device Regulations, if you own one or more Piezo-DX Quartz Stimulators, please discontinue all clinical and/or personal usage and distribution of this particular medical device. This medical device is now being recalled by Health Canada because the manufacturer of the Piezo-DX Quartz Stimulator (ITO Company Ltd.) does not have a current Medical Device License from Health Canada. This particular medical device has been sold in Canada since 2002. This is to notify you that the Piezo-DX Quartz Stimulator device is currently being recalled from the Canadian market. Pending update information from manufacturers.Īs a valued member, iSTOP would like to keep you informed about safety issues regarding the treatment of Chronic Pain. Stop order remains in effect for all other reusable IMS plungers. Per letter dated Jfrom Chief Medical Officer of Health, Alberta Health and Wellness: Manufacturer: Electro-Therapeutics Devices Ltd. Stop use order with respect to named plunger has been lifted: 5655 Cambie St., Vancouver, BC, Canada V5Z 3A4 | P. ![]()
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