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Hi Jane,
Thank you for your kind words.
In short, AS1668.2:2012 requires:
* dirty utility areas [read CSSD cleaning areas] to be at a negative pressure to the surrounding environment and achieve 10 air changes per hour
* Sterile storage areas and set up rooms to be HEPA filtered and be at a positive pressure to the surrounding environment [even if the adjacent ‘enclosure’ is an OR]
Interesting to note that AS166.8.2 does not contain specifications for temperature or humidity control.
Next we have the Australasian Health Facility Guideline [AusHFG] that have some requirements for ventilation of the Sterile Supply Unit. The AusHFG has a requirement that the clean areas, i.e. the packing area in the CSSD to be ventilated to the same standard as an Operating Room, in other words, HEPA filtered, positive pressure and a minimum of 20 air changes per hour. The AusHFG have some specifications regarding temperature and humidity control but vary from AS4187:2014 recommendations in Appendix A.
With respect to ventilation, AS4187 references AS1668.2, NSW based engineering guidance and does not reference the AusHFG.
Our European and UK colleagues think we have rocks in our heads requiring sterile storage areas to be HEPA filtered because the products being stored in there have in place a Sterile Barrier System [SBS] or in other words are packaged and as long as the packaging is intact and managed in a hygienic way, the SBS will protect the RMDs from contamination. My colleagues do not understand why we don’t have clearly stated requirements for the packing areas to be ventilated to a clean room standard, as this is where our RMDs are most vulnerable to contamination and this contamination event may impact on the achievement of sterility.
As an aside, we are one country and I find it so frustrating that there are so many variations in the guidance documents and that we need to look at State/ Territory local requirements, Australian Standards and other guidance documents to find answers to what should be a very straightforward and easily resolved question.
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination
PO BOX 2249, Greenvale VIC Australia 3059
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Hello Terry ,
Do all Sterilizing departments need HEPA filters?
Our sterilizing department is directly 1 floor below the OT. We monitor temperature and humidity levels in our CSSD and the air conditioning keeps it at a consistent level but I think I read in the 4187 that HEPA filtration is needed.
By the way thank you for all the information coming through ACIPC.
A great wealth of knowledge.
Jane Howard
Infection control
Sydney private hospital
Ashfield
________________________________
Hi Jayne,
Every year your HEPA filters should undergo an integrity test, the flow velocity should be checked as should the number of air changes per hour, [ideally] a particulate count [ORs are usually specified to meet a Class 8 clean room standard or better] and the pressure differentials across doorways into the OR checked. These tests hould also be performed in other areas where HEPA filters are located.
This resource is ageing now, but still well worth a read.
https://www2.health.vic.gov.au/Api/downloadmedia/%7B7C0364A2-A34D-4088-99F9-77FF0A818AF3%7D
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination
PO BOX 2249, Greenvale VIC Australia 3059
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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.
CONFIDENTIAL COMMUNICATION: The information contained in this message may contain confidential information intended only for the use of the individual or entity named above. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or duplication of this transmission is strictly prohibited. If you have received this communication in error, please notify us by telephone or email immediately and return the original message to us or destroy all printed and electronic copies. Nothing in this transmission constitutes an agreement of any kind unless otherwise expressly indicated.
Hi Brains trust,
We are in the middle of accreditation this week and a question regarding to ‘micro’ testing of hepa filters in theatres was asked by one of the auditors to our maintenance team, IPC have the same auditor tomorrow so we may also get the same question??
Does anyone have any information regarding whether we should be air sampling for example, frequency of the testing, to ensure the Hepa filters are working. We have a maintenance schedule for the them, but the only time we have done air sampling or micro is on commissioning of new theatres. I am not aware that micro sampling is done routinely or is a requirement??
Many thanks inadvance
Jayne O’Connor RN ,BSc.,Inf.Cont
IPC Co-Ordinator
Sydney Adventist Hospital | 185 Fox Valley Road, Wahroonga, NSW 2076
p: +61 2 9487 9732 | f: +61 2 9473 8052 | m: +61 0406 752685 | e: jayne.oconnor@sah.org.au
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