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Hi Michael,
I have been very interested to read the commentary and everyone’s thoughts around this.
I would agree with your initial assessment of the situation. While AS/NZS 4187:2014 is very “light on” regarding the storage of sterile clinical consumable, I would agree for the most part that the principles of storage should apply. However, we are in fact grouping the storage requirements for 3 different things together. My understanding of these are:
1. Storage of sterile reusable medical devices – those that are reprocessed by the health service
2. Storage of sterile clinical supplies that apply to “where reusable equipment, instruments and devices are used” (see wording under ISSUE in the advisory).
* I have always taken to mean the sterile consumables used in Operating theatres and procedural units including endoscopy.
* These supplies are usually opened and passed onto critical aseptic fields.
* This would also include that separate class of sterile “implantable” consumables. Some of these have very specific storage requirements set by the manufacture, including temperature and humidity.
3. Storage of sterile clinical supplies for aseptic procedural use (PIVC insertion, IDC insertion, wound dressings etc).
The storage requirements for points 1 & 2, should most definitely meet the requirements specified in the Standard in relation to shelving, cardboard “shipping” boxes, airconditioning, restricted access etc.
The requirements for point 3, should not be assessed (by surveyors) to the same level. Most general ward clean or storage rooms, are going to have non sterile items co-located there is just not enough space! There are other factors to consider including,
* grouping of like supplies or those for the same body system together, to help time poor staff
* cleaning schedules
* the right shelving/baskets
* ensure that the inside dispensing boxes that contain batch & product details are kept with the supplies and not “restocked”
* staff education, etc
When I have asked manufacturers of generic sterile clinical supplies what their storage requirements are, they have not specified either temperature or relative humidity (RH) limits. They tell me, that as most of these are sterilised by Ethylene Oxide, the acceptable ranges for temperature and RH are broader than what is required for RMDs. And only to be concerned if it is documented on the inside dispensing box. The risk of damage relates to functionality of the consumable than with infection control risks.
These are my thoughts and how I have interpreted the Standard. Hope it helps.
Kind regards
Mandy Davidson
RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A
Clinical Nurse Consultant – 4187 compliance, PPE Stores, COVID Virtual Ward lead
Infection Prevention & Control
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Hi Glenys
It was a ward store room, and the items commented on where things like disposable sterile urinary catheters on the same shelf as unsterile gauze packs.
Cheers
Michael
Michael Wishart | Infection Control Coordinator, CICP-E
St Vincent’s Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
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Can you tells us a bit more?
What area was the storage room/area in?
What was the sterile and non-sterile stock?
Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
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E: infexion@ozemail.com.au
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I’ve 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
St Vincent’s Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
M +61 448 954 282 | T +61 7 3326 3068 | F +61 7 3607 2226
E michael.wishart@svha.org.au |
W https://www.svphn.org.au
St Vincent’s Private Hospital Brisbane | 411 Main Street KANGAROO POINT QLD 4169
M +61 448 954 282 | T +61 7 3240 1208 | F +61 7 3240 1166
E michael.wishart@svha.org.au |
W https://www.svphb.org.au
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