TORONTO, Ontario, CANADA: COLTENE SciCan recently announced that Health Canada has authorized an interim order that allows the department to issue expedited authorization for sale or import of medical devices to deal with the current significant risk of COVID‐19 to the health and safety of Canadians.
This interim order expanded use allows for the emergency use of the BRAVO 17V or 21V Porous Wrapped 121°C Cycle in decontaminating compatible N95 flat-fold style respirators (3M 1870+, 9210 + models only), up to 10 times for single‐user reuse by healthcare personnel.
Additional information pertaining to the IO can be found on the COLTENE SciCan COVID-19 resource page, https://www.scican.com/corona-virus-resources/:
- Health Canada Authorization for Expanded Use.
- Instructions for Healthcare Personnel: Preparation of Compatible Flat-Fold Style N95 Respirators for Decontamination Using the SciCan BRAVO Chamber Autoclaves.
- Instructions for Healthcare Facilities: Decontamination of Compatible Flat-Fold Style N95 Respirators Using the SciCan BRAVO Chamber Autoclaves.
Also available is a fact sheet addressing the following topics:
- What are the symptoms of COVID-19?
- What do I need to know about the emergency use of decontaminated N95 respirators?
- Preparing compatible N95 respirators for decontamination.
- Use of decontaminated N95 respirators.
- What are the known and potential benefits and risks of using decontaminated N95 respirators?
- What is an interim order?
- Where can I go for updates and more information?
(Source: COLTENE SciCan)
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