URGENT Re: Communication from Ministry of Health re N95Masks

Article of Interest Re -Reprocessing of N95 masks
April 14, 2020
VACANCY: Capital & Coast District Health Board, Wellington – Sterile Services Manager – closes 18 May 2020
May 5, 2020

As you may be aware ASP(Sterrad) sent out communications stating that you may be able to sterilise single use N95 masks. The communication states that this was supported by Medsafe.

I have attached  below a letter from Medsafe to Martin Bird  of the NZSSA Executive outlining their position on reprocessing of single use N95 masks.

I hope this will clarify the situation for you all.

Shelagh Thomas

 

On Fri, 1 May 2020, 3:13 PM , <Matthew.Spencer@health.govt.nz> wrote:

Dear Martin

Thank you for your email. This has recently been referred to us so I’m sorry there has been a delay in a response being provided to you.

To clarify, Medsafe (the NZ Medicines and Medical Devices Safety Authority, within the Ministry of Health) has not given permission to New Zealand hospitals to use the ASP Sterrad system to re-process N95 masks.  In light of the circumstances where COVID-19 may cause shortages of certain PPE within the health care system, ASP Sterrad approached Medsafe with plans to make its customers aware that its device systems could be used to re-sterilise certain types of PPE.  In the interests of ensuring useful information was available to users (in view of potential critical supply situations), Medsafe had no objection to the provision of this information to users. Our position of ‘no objection’ was largely based on the FDA approval for re-processing of N95 masks using the ASP Sterrad System (link below), and the possibility that there could be a huge demand and subsequent shortage of N95 masks in New Zealand at that point in time in the COVID pandemic in New Zealand.  Medsafe does not assess and approve medical devices and did not assess and approve this particular use / extension of use for this product.  It is, and always has been, for the users (DHBs and other health care facilities) to determine whether or not to use a particular device, or a modification of a device or a modification of the instructions for use, and proceed based on that assessment.  I acknowledge that it’s possible that the communications from the company have been misleading and I have today communicated with them about this.

At the moment, where there is no need to re-process single use PPE, it is the Ministry’s expectation that this form of re-processing will not be necessary and therefore that DHBs and other health care facilities will choose not to re-process. Should the supply of N95 masks dramatically change, DHBs may need to consider whether re-processing would be appropriate.

I hope this provides clarity for you.

https://www.fda.gov/media/136884/download

Regards
Matthew