Regulatory Open Forum

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights. We develop a medical device that is to be reprocessed between uses, using wipes (LLD).
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Hi Yaara,

I might be able to provide some assistance here. Feel free to contact me at josh.a.vanderiet@gmail.com.

Thanks!

Josh

------------------------------
Joshua Van De Riet
Modi'in
Israel
------------------------------

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Hello Yaara,

Welcome to the forums.  This sounds like a good example of applying usability in use of a product.  It would be recommended, if not done already, to map out the task processes, control points, and ranges of activities which can be performed.  In your situation, there are a few things going on which may need further discussions, however, remember usability is directly linked to risk management and labelling (instructions for use).  Consideration and validation needs to be made regarding disinfecting time, contact time, efficacy of the wipes, etc.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 25-Feb-2021 01:41
From: Joshua Van De Riet
Subject: Usability Validation of low level disinfection

Hi Yaara,

I might be able to provide some assistance here. Feel free to contact me at josh.a.vanderiet@gmail.com.

Thanks!

Josh

------------------------------
Joshua Van De Riet
Modi'in
Israel

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Thanks Richard.

------------------------------
Yaara Yarmut
Auckland
New Zealand
------------------------------

Original Message:
Sent: 25-Feb-2021 03:56
From: Richard Vincins
Subject: Usability Validation of low level disinfection

Hello Yaara,

Welcome to the forums.  This sounds like a good example of applying usability in use of a product.  It would be recommended, if not done already, to map out the task processes, control points, and ranges of activities which can be performed.  In your situation, there are a few things going on which may need further discussions, however, remember usability is directly linked to risk management and labelling (instructions for use).  Consideration and validation needs to be made regarding disinfecting time, contact time, efficacy of the wipes, etc.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Feb-2021 01:41
From: Joshua Van De Riet
Subject: Usability Validation of low level disinfection

Hi Yaara,

I might be able to provide some assistance here. Feel free to contact me at josh.a.vanderiet@gmail.com.

Thanks!

Josh

------------------------------
Joshua Van De Riet
Modi'in
Israel

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Yaara,

I have few questions...
1- Do you want to assess the effectiveness of the product/indication, or the protocol to be use in the clinic? 
2- Where are the wipes used on? Depending on the use (type of surface), it will be under the EPA and not FDA. The EPA provides clear directions on the test protocol to be used, but you will need to determine the time needed to disinfect. 

Nurses are way too busy to keep checking time therefore, it is important to provide enough fluid in the packaging to ensure enough wet time.

Kind regards,

Valeria

------------------------------
Valeria Sena-Weltin, M.S., RAC(US)
Angelini Pharma Inc.
RA & QA Lead
Gaithersburg, MD
------------------------------

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Hi Valeria,

Thank for your message. I think I may have been misunderstood - we are not developing the wipes, we are developing a device that should be disinfected with wipes. We are trying to assess the cleaning+disinfection process written in our IFU. As the device is only intended to contact intact skin we aim for LLD - which has been validated. I'm just not sure how to deal with the fact that nurses usually wipes the device once (thoroughly), but will not come back to make sure the device is still wet for x minutes.

------------------------------
Yaara Yarmut
Auckland
New Zealand
------------------------------

Original Message:
Sent: 25-Feb-2021 17:33
From: Valeria Sena-Weltin
Subject: Usability Validation of low level disinfection

Yaara,

I have few questions...
1- Do you want to assess the effectiveness of the product/indication, or the protocol to be use in the clinic?
2- Where are the wipes used on? Depending on the use (type of surface), it will be under the EPA and not FDA. The EPA provides clear directions on the test protocol to be used, but you will need to determine the time needed to disinfect.

Nurses are way too busy to keep checking time therefore, it is important to provide enough fluid in the packaging to ensure enough wet time.

Kind regards,

Valeria

------------------------------
Valeria Sena-Weltin, M.S., RAC(US)
Angelini Pharma Inc.
RA & QA Lead
Gaithersburg, MD

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Hi Yaara

It's very true. Wipes are popular because they're easy to use, but it's not so easy to use them as instructed.​

Your next step might be a risk assessment. Knowing that the devices will usually be wiped just once, and not have the full wet time, how likely is pathogen transmission on the next skin contact? You might decide the risk is acceptable.

If it's not acceptable, you might think about other disinfection methods.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 25-Feb-2021 20:13
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi Valeria,

Thank for your message. I think I may have been misunderstood - we are not developing the wipes, we are developing a device that should be disinfected with wipes. We are trying to assess the cleaning+disinfection process written in our IFU. As the device is only intended to contact intact skin we aim for LLD - which has been validated. I'm just not sure how to deal with the fact that nurses usually wipes the device once (thoroughly), but will not come back to make sure the device is still wet for x minutes.

------------------------------
Yaara Yarmut
Auckland
New Zealand

Original Message:
Sent: 25-Feb-2021 17:33
From: Valeria Sena-Weltin
Subject: Usability Validation of low level disinfection

Yaara,

I have few questions...
1- Do you want to assess the effectiveness of the product/indication, or the protocol to be use in the clinic?
2- Where are the wipes used on? Depending on the use (type of surface), it will be under the EPA and not FDA. The EPA provides clear directions on the test protocol to be used, but you will need to determine the time needed to disinfect.

Nurses are way too busy to keep checking time therefore, it is important to provide enough fluid in the packaging to ensure enough wet time.

Kind regards,

Valeria

------------------------------
Valeria Sena-Weltin, M.S., RAC(US)
Angelini Pharma Inc.
RA & QA Lead
Gaithersburg, MD

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------

Thanks Anne,

This is the approach we decided to take, as the risk is very low, even with wiping the device once.

------------------------------
Yaara Yarmut
Auckland
New Zealand
------------------------------

Original Message:
Sent: 26-Feb-2021 07:14
From: Anne LeBlanc
Subject: Usability Validation of low level disinfection

Hi Yaara

It's very true. Wipes are popular because they're easy to use, but it's not so easy to use them as instructed.​

Your next step might be a risk assessment. Knowing that the devices will usually be wiped just once, and not have the full wet time, how likely is pathogen transmission on the next skin contact? You might decide the risk is acceptable.

If it's not acceptable, you might think about other disinfection methods.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 25-Feb-2021 20:13
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi Valeria,

Thank for your message. I think I may have been misunderstood - we are not developing the wipes, we are developing a device that should be disinfected with wipes. We are trying to assess the cleaning+disinfection process written in our IFU. As the device is only intended to contact intact skin we aim for LLD - which has been validated. I'm just not sure how to deal with the fact that nurses usually wipes the device once (thoroughly), but will not come back to make sure the device is still wet for x minutes.

------------------------------
Yaara Yarmut
Auckland
New Zealand

Original Message:
Sent: 25-Feb-2021 17:33
From: Valeria Sena-Weltin
Subject: Usability Validation of low level disinfection

Yaara,

I have few questions...
1- Do you want to assess the effectiveness of the product/indication, or the protocol to be use in the clinic?
2- Where are the wipes used on? Depending on the use (type of surface), it will be under the EPA and not FDA. The EPA provides clear directions on the test protocol to be used, but you will need to determine the time needed to disinfect.

Nurses are way too busy to keep checking time therefore, it is important to provide enough fluid in the packaging to ensure enough wet time.

Kind regards,

Valeria

------------------------------
Valeria Sena-Weltin, M.S., RAC(US)
Angelini Pharma Inc.
RA & QA Lead
Gaithersburg, MD

Original Message:
Sent: 24-Feb-2021 20:20
From: Yaara Yarmut
Subject: Usability Validation of low level disinfection

Hi everyone.
My first post...I'm struggling a bit with usability testing of our disinfection instructions (using wipes), and was wondering if you might have some insights.
When assessing disinfection performance as part of our usability testing (on nurses) it appears that none of the users takes into consideration the contact time. They all use the wipes and make sure all relevant surfaces are wet but then just leave the device to dry and do not use additional wipes to make sure the device stays wet for the required duration. We keep getting feedback that as long as the device is wet it is enough and that they never check for specified contact time.
I'm wondering if someone here has had similar experience and whether you only assess that they perform the disinfection appropriately (i.e. disinfect the necessary surfaces, gloves etc.) or whether you measure contact time as well. Only dealt with sterile devices up to date so never dealt with this issue.
Thanks in advance!

------------------------------
Yaara
New Zealand
------------------------------