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Good Morning
Please accept my apologies if this has been a previous discussion point, however I was unable to locate a discussion
Our Neonatal Intensive Care unit is hoping to change the supplier of their bottles to a more sustainable option. The current manufacturer provides a sterile, single use, individually wrapped bottle. The new supplier will provide a “clean by manufacture” that they state meets AS4187. on reading their documentation i was unable to find evidence of what this statement is based on.
Could you please advise what is happening in your facility?
And if you are using a “clean by Manufacture” bottle can you please advise what guidelines you used to base this decision on.Kind regards
Patricia Knight
CNC | Infection Prevention Service
John Hunter Hospital Campus
Lookout rd, New Lambton
Tel 02 49855452 | 0447 574606 patricia.knight@health.nsw.gov.au
Please visit http://intranet.hne.health.nsw.gov.au/hne_infection_prevention__and__control
For Infection Prevention resources
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OFFICIAL
Hi Patricia, I can add a few things from the reprocessing part of your question. I would say that the manufacturer’s statement refers to providing validated instructions for use that include information required for safe reprocessing, including;
* The state in which the RMD is provided (should be fully processed on receipt into the facility even if manufactured using clean processes)
* The intended state of reprocessing in which the RMD is to be used – refer Spaulding classification
* The methods of cleaning, disinfection and/or sterilisation required to deliver the RMD in its intended state, including any specific minimum settings that were determined in validating the methods
* Limiting Values i.e. the range for each process variable such as temperature, pressure and chemical exposure, outside of which the device will be adversely affected
* Information on the maintenance, lifecycle or checking of the RMD or componentsAS/NZS4187 also specifies normative references for processes and equipment, so for an IFU to meet the standard it would need to instruct the user in a way that meets those too e.g. the type of washer-disinfector listed.
I have found that the above information can be presented in very wide a variety of ways despite a supplier claiming that it “meets AS4187”, and that a careful check by the CSSD manager or person responsible for reprocessing is vital prior to purchase. IFUs can range from a highly specific set of instructions that allows no deviation from the manufacturer’s validated steps, to a generalised set of processes telling the user to consult local standards in their jurisdiction. Getting more information from the manufacturer and/or vendor can be very fraught so it pays to interrogate before you buy.
Regards,
Andrew Ellis
State Coordinator, Sterilisation & Reprocessing
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
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
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Good Morning
Please accept my apologies if this has been a previous discussion point, however I was unable to locate a discussion
Our Neonatal Intensive Care unit is hoping to change the supplier of their bottles to a more sustainable option. The current manufacturer provides a sterile, single use, individually wrapped bottle. The new supplier will provide a “clean by manufacture” that they state meets AS4187. on reading their documentation i was unable to find evidence of what this statement is based on.
Could you please advise what is happening in your facility?
And if you are using a “clean by Manufacture” bottle can you please advise what guidelines you used to base this decision on.Kind regards
Patricia Knight
CNC | Infection Prevention Service
John Hunter Hospital Campus
Lookout rd, New Lambton
Tel 02 49855452 | 0447 574606 patricia.knight@health.nsw.gov.au
Please visit http://intranet.hne.health.nsw.gov.au/hne_infection_prevention__and__control
For Infection Prevention resources
[cid:image001.png@01D8E2D1.E04C7920] [cid:image002.png@01D8E2D1.E04C7920]This message is intended for the addressee named and may contain confidential information. If you are not the intended recipient, please delete it and notify the sender.
Views expressed in this message are those of the individual sender, and are not necessarily the views of NSW Health or any of its entities.
MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to acipclist@acipc.org.au
To send a message to the list administrator send an email to admin@acipc.org.au
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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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