Home › Forums › Infexion Connexion › Cleaning and disinfection of Dialysis machine
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29/01/2021 at 7:54 pm #77683AnonymousInactive
Author:
AnonymousOrganisation:
State:
HI everyone
Our healthcare service recently installed new dialysis machines across a wide area. Unfortunately there was no consultation with infection prevention and control for advice on managing the infection risk of the machines, in particular cleaning and disinfection.
The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%) Isopropanol 60% . There is a further large warning in the IFU stating clearly that only these 2 disinfectants are to be used to clean the touch screen. The rest of the machine maybe cleaned and disinfected with 2 in 1 wipe used in most hospitals .
The IFU do not provide sufficient information or guidance on cleaning the Touch Screen to prevent damage and voiding warranty. The Touch Screen is the most frequently touched area of equipment and likely to become highly contaminated with pathogens from healthcare worker hands. Therefore cleaning and disinfection between patients to prevent healthcare associated infections in this vulnerable high risk group is vital. The IFU describes the disinfection process but not the cleaning process.
The Australian Guidelines for the Prevention and Control of Infection in Healthcare NHMRC 2019 – Page 59 which states:
Physical (mechanical or manual) cleaning is the most important step in cleaning. Sole reliance
on a disinfectant without physical cleaning is therefore not recommendedGiven that these machines are currently installed and in use and the company representatives maintain that only alcohol is to be used to clean the touch screen, I was wondering if anyone else had a similar experience and would share with me how you managed the situation.
After all we all know cleaning and disinfection is vital in preventing the transmission of pathogens ,no more so during this COVID-19 Pandemic.
Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse ManagerCentral Australia Health Service
Department of Health
Northern Territory GovernmentInfection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871
cate.coffey@nt.gov.aut. 08 8951 7737
http://www.health.nt.gov.auMESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
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02/02/2021 at 11:17 am #77691Helen VertoudakisParticipantAuthor:
Helen VertoudakisEmail:
helen@verthealth.com.auOrganisation:
Vert HealthState:
Hi Cate
Unfortunately, this is not the only type of equipment that I’ve heard cannot be cleaned properly – or has restrictions by the manufacturer on disinfection recommendations due to the nature of these screens. If damaged, the manufacturer can more often than not often tell by the nature of damage caused what type of product has been used – so, it’s a difficult situation.One way around this is to cover the touch screen, say with clear screening – something like you may use on your computer or mobile – depending on the type of clear screen – can be removed and replaced with fresh one for each patient and the touch screen can still have the disinfectant between each patient before the new clear screen/or cleaned and disinfected screen is attached.
Otherwise, do they recommended to use microfiber on the screen? Could wet a good quality microfiber cloth with the disinfectant- that way, at least the cloth can give some of the cleaning action required. If using a disinfectant on the cloth – the cloth lifetime will diminish more quickly than simply using with water- microfiber manufacturer should have some detail about this.
Hope this helps….
Helen[cid:image002.jpg@01D6F954.F25ABBD0]
Innovate for a Healthier FutureHelen Vertoudakis | Director | Vert Health
helen@verthealth.com.au | Ph +61 433 027 373 |
PO Box 536 Broadway NSW Australia 2007
http://www.verthealth.com.au[cid:image003.png@01D6F8A1.0768F370]
[cid:image004.png@01D6F8A1.0768F370]
[cid:image005.png@01D6F8A1.0768F370]
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in connection with any computer virus, data corruption, delay, interruption, or unauthorised access and amendment.HI everyone
Our healthcare service recently installed new dialysis machines across a wide area. Unfortunately there was no consultation with infection prevention and control for advice on managing the infection risk of the machines, in particular cleaning and disinfection.
The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%) Isopropanol 60% . There is a further large warning in the IFU stating clearly that only these 2 disinfectants are to be used to clean the touch screen. The rest of the machine maybe cleaned and disinfected with 2 in 1 wipe used in most hospitals .
The IFU do not provide sufficient information or guidance on cleaning the Touch Screen to prevent damage and voiding warranty. The Touch Screen is the most frequently touched area of equipment and likely to become highly contaminated with pathogens from healthcare worker hands. Therefore cleaning and disinfection between patients to prevent healthcare associated infections in this vulnerable high risk group is vital. The IFU describes the disinfection process but not the cleaning process.
The Australian Guidelines for the Prevention and Control of Infection in Healthcare NHMRC 2019 – Page 59 which states:
Physical (mechanical or manual) cleaning is the most important step in cleaning. Sole reliance
on a disinfectant without physical cleaning is therefore not recommendedGiven that these machines are currently installed and in use and the company representatives maintain that only alcohol is to be used to clean the touch screen, I was wondering if anyone else had a similar experience and would share with me how you managed the situation.
After all we all know cleaning and disinfection is vital in preventing the transmission of pathogens ,no more so during this COVID-19 Pandemic.
Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse ManagerCentral Australia Health Service
Department of Health
Northern Territory GovernmentInfection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871
cate.coffey@nt.gov.aut. 08 8951 7737
http://www.health.nt.gov.auMESSAGES 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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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.
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02/02/2021 at 2:00 pm #77692kate.ryan@austin.org.auParticipantAuthor:
kate.ryan@austin.org.auEmail:
kate.ryan@austin.org.auOrganisation:
State:
Hi Cate,
I am not going to be helpful in suggesting a solution for you! What I would like to do is use your example to encourage everyone needing to meet the needs of AS/NZ 4187 to push back on medical devices manufacturers and suppliers to ensure there are cleaning/disinfection/sterilisation options provided that are available in Australia and are TGA approved.Since I started in my role a year ago, I have been contacting many companies to request that they provide a suitable Australian reprocessing option when none is given in the IFU. For the most part they have been particularly helpful, and have gone on to provide me with letters of approval to use the products we have in our hospital, or they have gone as far as doing proper compatibility testing and updating their IFUs as a result.
For those few that are unwilling to engage in the conversation, we have informed them that we will not be using their product in future once the existing requires replacement, or if a new product, that we will not be able to purchase from them at all. At the same time I am in the process of tightening up our purchasing policy to ensure that RMDs, and reprocessing equipment can’t be purchased unless they meet strict criteria, namely that they can be reprocessed using the products/equipment we have available.
If we all start pushing back on industry to do their part to enable safe and effective reprocessing, we might start to make change. So I would suggest that you go back to the dialysis supplier and suggest that it is their role to provide an option as per section 3 of AS/NZ 4187, and that alcohol is not a TGA approved product for RMDs.
Kind regards
Kate Ryan
RMD Program Officer
[logo_austin]
0434 609 208 | 03 9496 6706
Infectious Diseases Department
Level 7, Harold Stokes Building
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
________________________________
EXTERNAL EMAIL: Do not click links or open attachments unless you recognise the sender and know the content is safe. If you are unsure please contact service.desk@austin.org.au.
________________________________
HI everyone
Our healthcare service recently installed new dialysis machines across a wide area. Unfortunately there was no consultation with infection prevention and control for advice on managing the infection risk of the machines, in particular cleaning and disinfection.
The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%) Isopropanol 60% . There is a further large warning in the IFU stating clearly that only these 2 disinfectants are to be used to clean the touch screen. The rest of the machine maybe cleaned and disinfected with 2 in 1 wipe used in most hospitals .
The IFU do not provide sufficient information or guidance on cleaning the Touch Screen to prevent damage and voiding warranty. The Touch Screen is the most frequently touched area of equipment and likely to become highly contaminated with pathogens from healthcare worker hands. Therefore cleaning and disinfection between patients to prevent healthcare associated infections in this vulnerable high risk group is vital. The IFU describes the disinfection process but not the cleaning process.
The Australian Guidelines for the Prevention and Control of Infection in Healthcare NHMRC 2019 Page 59 which states:
Physical (mechanical or manual) cleaning is the most important step in cleaning. Sole reliance
on a disinfectant without physical cleaning is therefore not recommended
Given that these machines are currently installed and in use and the company representatives maintain that only alcohol is to be used to clean the touch screen, I was wondering if anyone else had a similar experience and would share with me how you managed the situation.
After all we all know cleaning and disinfection is vital in preventing the transmission of pathogens ,no more so during this COVID-19 Pandemic.
Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse Manager
Central Australia Health Service
Department of Health
Northern Territory Government
Infection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871t. 08 8951 7737
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.
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02/02/2021 at 3:38 pm #77694Andrew EllisParticipantAuthor:
Andrew EllisEmail:
andrew.ellis@sa.gov.auOrganisation:
SA HealthState:
SAWell said Kate.
I won’t rehash the sentiment at length here but I have also taken this approach with RMDs at a local network and wider level, including requiring vendors to provide supplementary IFUs, where the original IFU was either arbitrary/unrealistic, or was limited to international cycles which don’t prevail in Australia and would require additional validation to perform here (see: steriliser cycle parameters).
One of the most common problems I have run into when resolving IFU conflicts is obtaining a reliable statement of compliance from the vendor e.g. “we can confirm that the process you have proposed will deliver a product compliant versus national standards” etc, and not a statement like “while this may decrease the life of the device, we confirm that it will not affect warranty replacement” – which is a very different offering and often conflated in the procurement process.
A conflict between the supplier’s IFU and the organisation’s reprocessing resources is a risk which has to be held or eliminated by one of the parties. If the supplier cannot or will not resolve it at the product realisation stage then that is a consideration for the organisation going ahead.
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
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
General public: http://www.sahealth.sa.gov.au/hospitalinfectionsThis email may contain confidential information, which also may be legally privileged. Only the intended recipient(s) may access, use, distribute or copy this email. If this email is received in error, please inform the sender by return email and delete the original. If there are doubts about the validity of this message, please contact the sender by telephone. It is the recipient’s responsibility to check the email and any attached files for viruses.
Hi Cate,
I am not going to be helpful in suggesting a solution for you! What I would like to do is use your example to encourage everyone needing to meet the needs of AS/NZ 4187 to push back on medical devices manufacturers and suppliers to ensure there are cleaning/disinfection/sterilisation options provided that are available in Australia and are TGA approved.Since I started in my role a year ago, I have been contacting many companies to request that they provide a suitable Australian reprocessing option when none is given in the IFU. For the most part they have been particularly helpful, and have gone on to provide me with letters of approval to use the products we have in our hospital, or they have gone as far as doing proper compatibility testing and updating their IFUs as a result.
For those few that are unwilling to engage in the conversation, we have informed them that we will not be using their product in future once the existing requires replacement, or if a new product, that we will not be able to purchase from them at all. At the same time I am in the process of tightening up our purchasing policy to ensure that RMDs, and reprocessing equipment can’t be purchased unless they meet strict criteria, namely that they can be reprocessed using the products/equipment we have available.
If we all start pushing back on industry to do their part to enable safe and effective reprocessing, we might start to make change. So I would suggest that you go back to the dialysis supplier and suggest that it is their role to provide an option as per section 3 of AS/NZ 4187, and that alcohol is not a TGA approved product for RMDs.
Kind regards
Kate Ryan
RMD Program Officer
[logo_austin]
0434 609 208 | 03 9496 6706
Infectious Diseases Department
Level 7, Harold Stokes Building
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
________________________________
EXTERNAL EMAIL: Do not click links or open attachments unless you recognise the sender and know the content is safe. If you are unsure please contact service.desk@austin.org.au.
________________________________
HI everyone
Our healthcare service recently installed new dialysis machines across a wide area. Unfortunately there was no consultation with infection prevention and control for advice on managing the infection risk of the machines, in particular cleaning and disinfection.
The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%) Isopropanol 60% . There is a further large warning in the IFU stating clearly that only these 2 disinfectants are to be used to clean the touch screen. The rest of the machine maybe cleaned and disinfected with 2 in 1 wipe used in most hospitals .
The IFU do not provide sufficient information or guidance on cleaning the Touch Screen to prevent damage and voiding warranty. The Touch Screen is the most frequently touched area of equipment and likely to become highly contaminated with pathogens from healthcare worker hands. Therefore cleaning and disinfection between patients to prevent healthcare associated infections in this vulnerable high risk group is vital. The IFU describes the disinfection process but not the cleaning process.
The Australian Guidelines for the Prevention and Control of Infection in Healthcare NHMRC 2019 – Page 59 which states:
Physical (mechanical or manual) cleaning is the most important step in cleaning. Sole reliance
on a disinfectant without physical cleaning is therefore not recommended
Given that these machines are currently installed and in use and the company representatives maintain that only alcohol is to be used to clean the touch screen, I was wondering if anyone else had a similar experience and would share with me how you managed the situation.
After all we all know cleaning and disinfection is vital in preventing the transmission of pathogens ,no more so during this COVID-19 Pandemic.
Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse Manager
Central Australia Health Service
Department of Health
Northern Territory Government
Infection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871t. 08 8951 7737
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
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Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
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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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03/02/2021 at 9:57 am #77699Michelle BibbyParticipantAuthor:
Michelle BibbyEmail:
michelle@INFECTIONPREVENTION.COM.AUOrganisation:
Infection Prevention AustraliaState:
I concur thank you Kate
My approach is the same for companies with regard to their SLAs and
requirement for IQ, OQ and PQ of reprocessing equipment.Many product “specialists” are new in the field and not across the
requirements of 4187, requiring up front payment and then not deliveringSo ask the question, don’t just assume they know what they are doing
otherwise you will receive validation reports that are not compliantRegards
Michelle
Michelle Bibby
Infection Prevention Australia
0429071165
michelle@infectionprevention.com.au
http://www.infectionprevention.com.au
Andrew (Health)
Dialysis machineWell said Kate.
I won’t rehash the sentiment at length here but I have also taken this
approach with RMDs at a local network and wider level, including requiring
vendors to provide supplementary IFUs, where the original IFU was either
arbitrary/unrealistic, or was limited to international cycles which don’t
prevail in Australia and would require additional validation to perform here
(see: steriliser cycle parameters).One of the most common problems I have run into when resolving IFU conflicts
is obtaining a reliable statement of compliance from the vendor e.g. “we can
confirm that the process you have proposed will deliver a product compliant
versus national standards” etc, and not a statement like “while this may
decrease the life of the device, we confirm that it will not affect warranty
replacement” – which is a very different offering and often conflated in the
procurement process.A conflict between the supplier’s IFU and the organisation’s reprocessing
resources is a risk which has to be held or eliminated by one of the
parties. If the supplier cannot or will not resolve it at the product
realisation stage then that is a consideration for the organisation going
ahead.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 AustraliaLevel 13 | 25 Grenfell Street | Adelaide SA 5000
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
General public: http://www.sahealth.sa.gov.au/hospitalinfections
This email may contain confidential information, which also may be legally
privileged. Only the intended recipient(s) may access, use, distribute or
copy this email. If this email is received in error, please inform the
sender by return email and delete the original. If there are doubts about
the validity of this message, please contact the sender by telephone. It is
the recipient’s responsibility to check the email and any attached files for
viruses.> On Behalf Of RYAN, Kate
Dialysis machineHi Cate,
I am not going to be helpful in suggesting a solution for you! What I would
like to do is use your example to encourage everyone needing to meet the
needs of AS/NZ 4187 to push back on medical devices manufacturers and
suppliers to ensure there are cleaning/disinfection/sterilisation options
provided that are available in Australia and are TGA approved.Since I started in my role a year ago, I have been contacting many companies
to request that they provide a suitable Australian reprocessing option when
none is given in the IFU. For the most part they have been particularly
helpful, and have gone on to provide me with letters of approval to use the
products we have in our hospital, or they have gone as far as doing proper
compatibility testing and updating their IFUs as a result.For those few that are unwilling to engage in the conversation, we have
informed them that we will not be using their product in future once the
existing requires replacement, or if a new product, that we will not be able
to purchase from them at all. At the same time I am in the process of
tightening up our purchasing policy to ensure that RMDs, and reprocessing
equipment can’t be purchased unless they meet strict criteria, namely that
they can be reprocessed using the products/equipment we have available.If we all start pushing back on industry to do their part to enable safe and
effective reprocessing, we might start to make change. So I would suggest
that you go back to the dialysis supplier and suggest that it is their role
to provide an option as per section 3 of AS/NZ 4187, and that alcohol is not
a TGA approved product for RMDs.Kind regards
Kate Ryan
RMD Program Officer
0434 609 208 | 03 9496 6706
Infectious Diseases Department
Level 7, Harold Stokes Building
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
_____
> on behalf of Cate Coffey
<Cate.Coffey@NT.GOV.AU >
<ACIPCLIST@ACIPC.ORG.AU >
machineEXTERNAL EMAIL: Do not click links or open attachments unless you recognise
the sender and know the content is safe. If you are unsure please contact
service.desk@austin.org.au ._____
HI everyone
Our healthcare service recently installed new dialysis machines across a
wide area. Unfortunately there was no consultation with infection prevention
and control for advice on managing the infection risk of the machines, in
particular cleaning and disinfection.The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%)
Isopropanol 60% . There is a further large warning in the IFU stating
clearly that only these 2 disinfectants are to be used to clean the touch
screen. The rest of the machine maybe cleaned and disinfected with 2 in 1
wipe used in most hospitals .The IFU do not provide sufficient information or guidance on cleaning the
Touch Screen to prevent damage and voiding warranty. The Touch Screen is the
most frequently touched area of equipment and likely to become highly
contaminated with pathogens from healthcare worker hands. Therefore cleaning
and disinfection between patients to prevent healthcare associated
infections in this vulnerable high risk group is vital. The IFU describes
the disinfection process but not the cleaning process.The Australian Guidelines for the Prevention and Control of Infection in
Healthcare NHMRC 2019 – Page 59 which states:Physical (mechanical or manual) cleaning is the most important step in
cleaning. Sole relianceon a disinfectant without physical cleaning is therefore not recommended
Given that these machines are currently installed and in use and the
company representatives maintain that only alcohol is to be used to clean
the touch screen, I was wondering if anyone else had a similar experience
and would share with me how you managed the situation.After all we all know cleaning and disinfection is vital in preventing the
transmission of pathogens ,no more so during this COVID-19 Pandemic.Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse Manager
Central Australia Health Service
Department of Health
Northern Territory Government
Infection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871t. 08 8951 7737
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
–
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(without the quotes) to listserv@aicalist.org.auMESSAGES 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 –
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(without the quotes) to listserv@aicalist.org.auMESSAGES 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 –
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(without the quotes) to listserv@aicalist.org.auMESSAGES 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.
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04/02/2021 at 9:11 am #77704Michael WishartParticipantAuthor:
Michael WishartEmail:
Michael.Wishart@svha.org.auOrganisation:
State:
NSW[Posted on behalf of member – Moderator]
If you cant get specific details related to the decontamination and cleaning from a manufacturer you should report it to the TGA , in the last 12 months most medical devices have been subject to extreme chemical decontamination and cleaning, in most cases by support staff who dont have access to the manufacturers IFU , so if you are aware of any shortfall in detailed instructions, it’s in everybodys interest that this is brought to the TGAs attention and addressed by the company.
Medical equipment, their accessories and transducers are by definition Reusable and hence subject to NSQHS Advisory AS18/07 and AS/NZS4187:2014 hospitals are required to make sure all staff can access an IFU so it really is the make and model gold standard for cleaning.
It’s in the companys interest, it’s important with respect to patient and staff safety and it will end up costing your organisation a lot of money
Thanks
George Koning
CEO
BioClinical Services Pty Ltd
https://www.bioclinicalservices.com.au/infection-control
________________________________
I concur thank you Kate
My approach is the same for companies with regard to their SLAs and requirement for IQ, OQ and PQ of reprocessing equipment.
Many product specialists are new in the field and not across the requirements of 4187, requiring up front payment and then not delivering
So ask the question, dont just assume they know what they are doing otherwise you will receive validation reports that are not compliant
Regards
Michelle
Michelle Bibby
Infection Prevention Australia
0429071165
michelle@infectionprevention.com.au
http://www.infectionprevention.com.au
[cid:image001.png@01D6FA12.F46B8210]
Well said Kate.
I wont rehash the sentiment at length here but I have also taken this approach with RMDs at a local network and wider level, including requiring vendors to provide supplementary IFUs, where the original IFU was either arbitrary/unrealistic, or was limited to international cycles which dont prevail in Australia and would require additional validation to perform here (see: steriliser cycle parameters).
One of the most common problems I have run into when resolving IFU conflicts is obtaining a reliable statement of compliance from the vendor e.g. we can confirm that the process you have proposed will deliver a product compliant versus national standards etc, and not a statement like while this may decrease the life of the device, we confirm that it will not affect warranty replacement which is a very different offering and often conflated in the procurement process.
A conflict between the suppliers IFU and the organisations reprocessing resources is a risk which has to be held or eliminated by one of the parties. If the supplier cannot or will not resolve it at the product realisation stage then that is a consideration for the organisation going ahead.
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 AustraliaLevel 13 | 25 Grenfell Street | Adelaide SA 5000
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
General public: http://www.sahealth.sa.gov.au/hospitalinfections
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Hi Cate,
I am not going to be helpful in suggesting a solution for you! What I would like to do is use your example to encourage everyone needing to meet the needs of AS/NZ 4187 to push back on medical devices manufacturers and suppliers to ensure there are cleaning/disinfection/sterilisation options provided that are available in Australia and are TGA approved.
Since I started in my role a year ago, I have been contacting many companies to request that they provide a suitable Australian reprocessing option when none is given in the IFU. For the most part they have been particularly helpful, and have gone on to provide me with letters of approval to use the products we have in our hospital, or they have gone as far as doing proper compatibility testing and updating their IFUs as a result.
For those few that are unwilling to engage in the conversation, we have informed them that we will not be using their product in future once the existing requires replacement, or if a new product, that we will not be able to purchase from them at all. At the same time I am in the process of tightening up our purchasing policy to ensure that RMDs, and reprocessing equipment can’t be purchased unless they meet strict criteria, namely that they can be reprocessed using the products/equipment we have available.
If we all start pushing back on industry to do their part to enable safe and effective reprocessing, we might start to make change. So I would suggest that you go back to the dialysis supplier and suggest that it is their role to provide an option as per section 3 of AS/NZ 4187, and that alcohol is not a TGA approved product for RMDs.
Kind regards
Kate Ryan
RMD Program Officer
[logo_austin]
0434 609 208 | 03 9496 6706
Infectious Diseases Department
Level 7, Harold Stokes Building
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084
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HI everyone
Our healthcare service recently installed new dialysis machines across a wide area. Unfortunately there was no consultation with infection prevention and control for advice on managing the infection risk of the machines, in particular cleaning and disinfection.
The manufactures instruction for use (IFU) recommend Ethanol (60% to 70%) Isopropanol 60% . There is a further large warning in the IFU stating clearly that only these 2 disinfectants are to be used to clean the touch screen. The rest of the machine maybe cleaned and disinfected with 2 in 1 wipe used in most hospitals .
The IFU do not provide sufficient information or guidance on cleaning the Touch Screen to prevent damage and voiding warranty. The Touch Screen is the most frequently touched area of equipment and likely to become highly contaminated with pathogens from healthcare worker hands. Therefore cleaning and disinfection between patients to prevent healthcare associated infections in this vulnerable high risk group is vital. The IFU describes the disinfection process but not the cleaning process.
The Australian Guidelines for the Prevention and Control of Infection in Healthcare NHMRC 2019 Page 59 which states:
Physical (mechanical or manual) cleaning is the most important step in cleaning. Sole reliance
on a disinfectant without physical cleaning is therefore not recommended
Given that these machines are currently installed and in use and the company representatives maintain that only alcohol is to be used to clean the touch screen, I was wondering if anyone else had a similar experience and would share with me how you managed the situation.
After all we all know cleaning and disinfection is vital in preventing the transmission of pathogens ,no more so during this COVID-19 Pandemic.
Thanks very much
Cate Coffey
RN BaAScN MPH&TM Grad Cert Infection Control Nursing
Clinical Nurse Manager
Central Australia Health Service
Department of Health
Northern Territory Government
Infection Prevention and Control Unit
Alice Springs Hospital
PO Box 2234, Alice Springs, NT 0871t. 08 8951 7737
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