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Re: ‘Sterile stock’ storage??

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Hi All,

just wanting to provide some additional content to this discussion and to clarify the original advice being discussed is from the Australian Commission on Quality and Safety in Healthcare and not the CEC.

Some essential facts about AS/NZS4187:2014 that we seem to forget over time:

1. Normative references within AS/NZS 4187:2014 require mandatory compliance when they are referred to within the Standard.
2. Informative and further reading references within AS/NZS4187:2014 do not require mandatory compliance. These references can be used to guide practices, provide clarity on the mandatory requirements or be used as references for procedures or education programs.

Handling, transport and storage of released reprocessed RMDs is in Appendix A, Guidance (Informative) Section A9.5 provides the guidance on how this is achieved. It does not provide guidance on sterile consumables, the type of shelving required or the storage shelves/cupboards, drawers or containers.

The Australian Commission on Safety and Quality in Health Care Advisory A18/07:Reprocessing of reusable medical devices in health service organisationsrequires that health service organisations have completed the following mandatory key target to meet their accreditation requirements:
By 31 December 2022, the Commission expects organisations to comply with requirements in relevant national or international standards for storage of sterile stock in compliant shelving. Organisations must mitigate the risk of contamination of sterile stock in storage. This includes assessing and managing the risk of:
Humidity and temperature on stored sterile stock
The co-location of sterile and non-sterile stock in a storage area.

Sterile store rooms guidance for ventilation, humidity and temperature:

1. NSW Engineering Services Guideline (7.8.4)
2. AS/NZS4187:2014 (Amd 2019) Section A9.5
3. AusHFG Store – Sterile Stock, Central Core

Manufacturers instructions to be followed for sterile consumables

The CEC has provided a set of guiding principles to manage the co-location of sterile and non-sterile stock in storage rooms:

* Determine how sustainable improvements can be made to storage of sterile stock RMDs and consumables
* Separate sterile RMDs from consumables.
* Consumables should be stored on the bottom shelves if they are required to be stored on the same shelf with sterile RMDs. This prevents lint/fibres falling onto the outside RMD wrap
* If any carboard boxes/cartons of consumables can be emptied do this.
* Reduce the number of carboard boxes/cartons in the room as they do generate fibres when handled.
* Set up a de-boxing area away from stored sterile RMDs
* Packaging paperboard boxes used to provide identification of the consumable, size/gauge, batch details, prevent bending/damage etc should not be decanted into another container. If removing these consumables from paperboard boxes and there is potential to cause a clinical risk or compromise the sterility of the item, keep in paperboard boxes.
* The paperboard boxes should be stored below sterile RMDs reduce the potential of lint/fibres falling on sterile RMDs

With regular quality management systems that include auditing of storage conditions, cleanliness of storage area, packaging integrity etc (to maintain the required quality) in areas that store both released reprocessed RMDs and sterile consumables, the ACSCHC requirements for co-locating sterile and non-sterile stock in a storage area will be met.

Regards

Kathy Dempsey RN, DippApSc, BSc (Nursing), MNSc (Infection Control & Hospital Epidemiology)
SHEA/CDC Cert Infection Control, Cert Med Micro, DipLdrshp&Mgt.CICP-E; Future Leaders of Healthcare DrPH Candidate

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From: ACIPC Infexion Connexion On Behalf Of Terry
Sent: Friday, 24 September 2021 12:51 PM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: Re: [ACIPC_Infexion_Connexion] ‘Sterile stock’ storage??

Thank you Andrew for providing a solid, risk based approach to the storage of clean and sterile consumable products and CSSD produced sterile items across a range of environments we see in healthcare.

I need to have my two cents worth – so please read the information below.

For commercially produced sterile products we need to remember that:

* Commercial products are sterilised in their robustly tested Sterile Barrier System. These studies include exposure to a wide range of temperature and humidity conditions and undergo accelerated ageing studies to ensure that the packaging will maintain sterility across a wide range of conditions and over time in accordance with ISO11607-1. Where there are conditions that impact on the integrity of the sterile barrier system, these will be clearly labelled on the product there are a wide range of symbols to depict avoid exposure to sunlight, moisture, temperature range and in some cases humidity range.
* Nowhere in the instructions for managing commercially sterilised products does it say STORE IN A HEPA FILTERED ENVIRONMENT. If it was important that it was, you would see this on the labelling as ISO11607-1 says that any specific storage conditions must be included in the information provided to the user / consumer, hence those symbols I mentioned in the point above.
* You may not be aware of this but most commercial products in cardboard dispenser boxes are STERILISED within their dispenser boxes, so the dispenser box itself is sterile. The external shipper or transport carton must be removed before taking the products into the clean area, however there is no reason at all to decant products from their dispenser boxes, unless the dispenser box itself has been used as the shipping carton, without other protective packaging applied.
We also need to remember that for CSSD produced sterile RMDs:

* The RMDs are packaged in a Sterile Barrier System. The manufacturers of the Sterile Barrier System have performed studies exposing their product to a wide range of conditions in accordance with ISO11607-1 to ensure that the sterile barrier can maintain sterility after exposure to conditions such as shock and vibration, compression, temperature, humidity, method of transportation, pressure changes, integrity over time, including ageing studies just like the sterile barrier systems that are used for commercial packaging.
* Nowhere in the instructions for using a Sterile Barrier System that I have ever read [and I have read a lot] does it say STORE IN A HEPA FILTERED ENVIRONMENT. If it was important that it was, you would see this in the instructions for use as ISO11607-1 says that any specific storage conditions must be included in the information provided to the user / consumer.
I also think it is important to remember that we are placing CSSD and commercially produced sterile products on non-sterile but [it should be] clean shelving.

I think good practice looks like:

* Storing sterile items [whether CSSD produced or commercially prepared] on separate shelves to non-sterile but clean items.
* Sterile items ideally will be placed above the non-sterile items.
* The products will be protected from direct sunlight and sources of moisture.
* The shelving or containers and the storage room / cupboards / drawers would be cleaned on a regular basis.
* Products would only be touched when necessary and with clean hands.
* The air conditioning to the room would not have been recirculated from other enclosures and would be sufficient to provide the temperature and humidity conditions required to maintain sterility of the most sensitive product noting that some commercially produced items cannot have humidity exceed 60%.
I trust that the above makes some sense and when it comes time to the public review of the new Standard that will be replacing AS/NZS4187 and AS/NZS4815 that all of you will contribute comments and suggested improvements to the draft document so situations like this, that are left open to interpretation are clarified and solid, risk based guidance is included in the new Standard.
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination

PO BOX 2249, Greenvale VIC Australia 3059
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From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Ellis, Andrew (Health)
Sent: Friday, 24 September 2021 11:04 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: Re: [ACIPC_Infexion_Connexion] ‘Sterile stock’ storage??

Hi All,

The current SA Health Standard 3 Audit does not require that RMDs stored outside theatres/CSSD are stored on a specifically labelled shelf. In the set of questions for a ward/clinical area there is:

1. Is the sterile stock storage area dedicated to that purpose only?
sterile reusable medical devices should be stored on or in designated shelving, cupboards, drawers or containers1. Non sterile stock may be stored in the same area but segregated from sterile stock by a barrier, dividers or partition 2.

Where reference 1 is AS/NZS4187 and reference 2 is the QLD Health Guideline cited in the AusHFG and other documents.

One of our large, regional health networks recently conducted a survey with me of their sterile storage conditions across sites, including two hospitals with CSSDs/theatres, and six remoter health services which had only ward and OPD/ED areas, but may have either used RMDs reprocessed offsite, or commercial stock only. Much like an earlier response on this thread breaking down the continuum of sterile storage conditions, we broke these environments into broad categories;

1. Areas which are defined in the AusHFG, AS1668.2 etc as requiring HEPA filtration, positive pressure, minimum ACH and so on These are CSSD and Theatre sterile stores for RMDs. Patient equipment and other non-sterile items were to be eliminated but sterile consumables were acceptable if managed appropriately. FFE, finishes etc were naturally of the highest level.
2. Store rooms in clinical areas such as wards which are primarily for sterile and clean consumables We agreed on minimum elements of design and construction, FFE and access control. This included temperature and RH monitoring, noting that engineering controls per (1) were not mandated here. The health network had employed UsB dataloggers in order to determine baseline environmental conditions. Improvements generally included use of resilient, sheet-type coved flooring, wire shelving and containers, non-porous materials and relocation of equipment and deboxing activities as necessary. A lot of these rooms needed general repairs and works including installation of bulkheads and decommissioning of old fixtures including in the ceiling to reduce dust collection, as they were frequently repurposed rooms in the more remote sites.
3. Point of use storage such as in a treatment room, which was to be minimally restocked from a suitable location and to include at a minimum, compliant containers and a cleaning schedule, protection from contamination and monitoring of stock rotation and environmental conditions. RMDs were present in some of these e.g. Podiatry clinics, but one area was rationalised back to storage and issue from CSSD because the point of use storage was not able to be adequately controlled.
4. Bulk storage for not yet deboxed sterile consumables and fluids, which may also house patient equipment and unsterile personal care items (bulk boxes continence pads etc) relocated from the areas above.
It was not possible in some ward/clinical areas to split these into separate rooms, so in some cases 2, 3 and 4 had to be physically separated as best we could, but design and construction were to meet the higher of the levels.

Regards,

Andrew Ellis
Sterilising and Reusable Medical Device Reprocessing State Coordinator
Infection Control Service | Communicable Disease Control Branch
Health Regulation & Protection
Department for Health and Wellbeing | Government of South Australia
Level 13 | 25 Grenfell Street | Adelaide SA 5000
Ph: (08) 7425 7152 | Mobile: 0435 389 541 | Email: andrew.ellis@sa.gov.au
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
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From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of RILEY Sinclair
Sent: Friday, 24 September 2021 8:15 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: Re: [ACIPC_Infexion_Connexion] ‘Sterile stock’ storage??

Hi Michael
Im not at work today so I cant forward you a copy but the SA Health Standard 3 Store Room audit which refers to RMD items stored outside of theatre actually asks
Are RMD stored on an individual shelf and is that shelf labeled.

Yes crazy I know haha
Leah

On Wed, 22 Sep 2021 at 12:33 pm, Michael Wishart <Michael.Wishart@svha.org.au> wrote:
Ive just had my mind blown by an auditor who tells me I cannot store any sterile stock on a shelf with non-sterile stock. I reply by saying that no sterile RMDs are stored on shelves with non-sterile stock, and they say, no ANYTHING that comes sterile should not be on the same shelf with something non-sterile.

Have I missed something? I have always understand that the very specific storage requirements for RMDs did not apply to most commercially sterilised single use items. Sure, there are commercially sterilised disposables that have very specific storage requirements, but the majority of high volume disposable sterile goods can be safely stored on a shelf with non-sterile stock in an appropriately air-conditioned storage room. AS4187 does not cover storage of non-RMDs, correct?

Can someone either tell me I am wrong, and I missed this big time, or that I did not miss anything, and the auditor is incorrect. Or some variation of these.

Help?

Thanks
Michael

Michael Wishart | Infection Control Coordinator, CICP-E

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