Re: HEPA filters in OR complex corridors

14/05/2021 at 12:36 pm #77988 Quote

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Hi Michelle,

Thanks for bringing this point up.

I think we need to be quite clear about what cardboard is allowed or not allowed to come into our clean or sterile storage areas.

Not all cardboard is bad and some cardboard, i.e. in the form of dispenser boxes has actually been sterilised, along with its contents, so technically the dispenser box itself is sterile or at least has been sterilised when it comes to you in an intact outer shipper carton. If you have ever been to an industrial/commercial sterilising facility that uses Gamma irradiation or Ethylene Oxide sterilisation, you will see boxes [shipper cartons] of the products going through the sterilisation process. Obviously, during transport and handling, the outer shipper cartons become contaminated and thus the reason why we remove these cartons prior to bringing in the contents into our clean or sterile storage areas.

Of course, this is a different scenario if you receive a box containing sterile products inside, that looks like a dispenser box but clearly has shipping forms on the exterior. The products from these boxes need to be removed before placing them into the storage areas. Similarly if you see cardboard boxes being topped up, being repurposed and used as dividers between sterile items or are being reused as storage containers, then they should be removed, as cardboard cannot be cleaned.

I trust this assists in clarifying issues around cardboard in clean or sterile storage areas.
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination

PO BOX 2249, Greenvale, VIC Australia 3059
Mobile: +61 (0)438 109 692
Email: terry@steamconsulting.com.au
Website: http://www.steamconsulting.com.au

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From: ACIPC Infexion Connexion On Behalf Of Michelle Kennedy (Hunter New England LHD)
Sent: Friday, May 14, 2021 10:31 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: Re: [ACIPC_Infexion_Connexion] HEPA filters in OR complex corridors

HI Terry, thanks for bringing up shipping containers-I know your mean the big ones but the smaller containers are everywhere . I am disgusted that these containers are allowed in any healthcare facility and have wondered for some time now that we are auditing our OTs and CSSDs every month on cleaning, maintenance etc. but stepping around and ignoring these dirty cartons in our clean spaces. Has there been any discussion around this? Has anyone from the ACSQHC commented during accreditation?
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Thank you

Michelle Kennedy

CNC | Hunter New England Infection Prevention Service
Maitland/Kurri Kurri Hospitals
550-560 High Street
Maitland NSW 2320
Tel 02 4939 2467 or 0437919767 |
michelle.kennedy@health.nsw.gov.au

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From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of Terry
Sent: Friday, 14 May 2021 10:14 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: Re: [ACIPC_Infexion_Connexion] HEPA filters in OR complex corridors

Hi Mary,

My opinion is that requiring HEPA filtration in ALL sterile storage areas [as often interpreted by people reading AS1668.2] is not reasonable or necessary and I really wish could be at least clarified by Standards Australia. Perhaps an email to them for clarification of the requirements around AS1668.2. might be warranted?

We need to remember that commercially produced sterile medical devices are transported in shipping containers, aircraft and trucks and none of these have HEPA filtration. Whilst the products are protected by shipper cartons during these movements, I am yet to find any IFU from any manufacturer of these sterile products, or even from the manufacturers of sterile barrier systems used for CSSD produced sterile RMDs, that contain a requirement that their products be stored in a HEPA filtered environment.

Now Im hearing that this non-existent requirement for HEPA filtration for storage of sterile medical devices has been taken even further by requiring HEPA filtration in OR corridors!

The only time HEPA filtration makes sense for a sterile storage area is when this is also a set up room between two operating rooms or a central sterile core that operating rooms open onto. In these cases, if the sterile store is HEPA filtered, then we can make this room more positive than the operating rooms and blow air from the sterile store into the operating room without compromising patient safety, unlike the opposite situation where the operating room is more positive to the sterile store, potentially blowing patient soiled air into this space.

It also makes some sense for a CSSD Sterile store to be HEPA filtered, as this then protects cooling sterile products that are potentially vulnerable from exposure to contaminated air.

Our European colleagues think we are nuts because we required HEPA filtration in sterile storage areas but not specifically in the packaging areas where the medical devices are at the most risk of compromise prior to packaging and sterilisation.

If you need any international evidence that HEPA filtration is not required in a sterile storage environment, a UK Guidance document HBN13 mentions Class 8 cleanroom requirements for the packing area [IAP] but has no mention of specific ventilation for the processed products store, other than it be at a positive pressure to the dispatch area and negative pressure to the cooling area.

I hope this feedback on my take on requirements for sterile storage is of some use.
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination

PO BOX 2249, Greenvale, VIC Australia 3059
Mobile: +61 (0)438 109 692
Email: terry@steamconsulting.com.au
Website: http://www.steamconsulting.com.au

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I endeavour to achieve a sensible work-life balance: There is no need to reply to this email from you outside of your normal working hours. Please expect the same from me.

From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Mary Willimann (Subiaco)
Sent: Monday, May 10, 2021 3:59 PM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: [ACIPC_Infexion_Connexion] HEPA filters in OR complex corridors

Dear Brains trust

I was wondering if anyone has information/references relating to having HEPA filters installed in OR complex corridors. This is something that has been raised here as being required to ensure compliance with AS: 4187 but I have been unable to find anything to support it. We do have covered case carts to transport our RMDs so we are a bit confused about the need for all of the corridors to be HEPA filtered as well.

Any help would be gratefully received!

Kind regards
Mary

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