Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.  

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you

Hello Anon,

Unless you are quite familiar with cleaning and disinfecting validations yourself, it is always wise to get expert assistance on this.  There are a number of labs conducting this type of testing like Nelson Laboratories.  These labs assist in the review of your device to properly set out a cleaning validation which you are correct using soils to put on the device and then testing the cleaning process.  This is a fairly well established testing protocol as done for many other type of devices to show they are "clean."  The disinfecting protocol depends on the level of disinfection you are claiming and the type of disinfecting that are used or more precisely can be used.  There are many different types of disinfectants and depending on the needs of your device could be just wipes or solutions to use; also need to consider any damage may occur from disinfectants because some materials have adverse reactions to the chemicals.  This can be quite an involved activity depending on your device, so it would be good to obtain expert support either in guidance or actual testing.

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

Original Message:
Sent: 24-Apr-2020 11:36
From: Anonymous Member
Subject: cleaning/disinfection validation for non-critical devices

This message was posted by a user wishing to remain anonymous

Hi all,
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you

Anon,

Lexamed, Steris and NAMSA also do this work, as do many others besides Nelson labs.  Richard  is correct that it is best to get help if you are not experienced in the details.

You didn't  identify the type of your device, but labs usually ask for the whole finished device or representative  prototype to look it over,   and to evaluate its materials and surface finishes, to develop an initial  protocol.. Sometimes labs suggest total immersion, which is crazy for an electronic device where only its surface contacts the user or patient. So if you give them a complete device, you might make it only a shell,  if electronics are sealed on the inside and in use a customer wouldn't  be immersing it. Discuss this with a lab.

I would recommend getting at least 3 competitive quotes, because prices can vary incredibly.  But be sure you are asking  for the same scope of work and exact same protocol when you bid it out, and that the lab has experience.  Do not just let them run independently.  Assign someone in your organization to ride herd on the lab, and ask for  draft protocol and draft reports for your review before they are finalized.....you will be much happier if you don't  just throw it "over the wall".

Good  luck!

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 25-Apr-2020 02:45
From: Richard Vincins
Subject: cleaning/disinfection validation for non-critical devices

Hello Anon,

Unless you are quite familiar with cleaning and disinfecting validations yourself, it is always wise to get expert assistance on this.  There are a number of labs conducting this type of testing like Nelson Laboratories.  These labs assist in the review of your device to properly set out a cleaning validation which you are correct using soils to put on the device and then testing the cleaning process.  This is a fairly well established testing protocol as done for many other type of devices to show they are "clean."  The disinfecting protocol depends on the level of disinfection you are claiming and the type of disinfecting that are used or more precisely can be used.  There are many different types of disinfectants and depending on the needs of your device could be just wipes or solutions to use; also need to consider any damage may occur from disinfectants because some materials have adverse reactions to the chemicals.  This can be quite an involved activity depending on your device, so it would be good to obtain expert support either in guidance or actual testing.

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

Original Message:
Sent: 24-Apr-2020 11:36
From: Anonymous Member
Subject: cleaning/disinfection validation for non-critical devices

This message was posted by a user wishing to remain anonymous

Hi all,
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you

This message was posted by a user wishing to remain anonymous

Thank you both for your clear answer. I have actually already planned to contact NAMSA and Nelson Labs for biocompatibility, so I will try to include cleaning as well in the discussion. I will also include a third lab, as suggested. 
My trouble sometimes is that I get pushed back by my company with the rationale that I am overkilling the problem and there are no high risks for noncritical (intact skin) items. I heard the same commentary on my proposal of performing cytotoxicity, irritation, and sensitisation testing due to the lack of a comprehensive comparison with a comparator.
My logic agrees on some of these comments (yes, I find absurd for a small companies spending tons of money and time in tests that are not so critical - and use animals-, when people and patients are in contact every day with objects that don't have the same level of scrutiny).
However, it is hard to defend these positions in front of regulators and the risk is to get deficiencies for missing testing.
I wonder what your thoughts are on this and if you have any suggestion on how to reinforce the importance of these items in my company or, on the contrary, if there are ways to justify the lack of testing with risk analysis. 

Regarding disinfection, would it be sufficient to use a low-level EPA registered disinfectant according to its labeling and validate through visual inspection that there are no damages to the device? Or again the same considerations (validation through testing labs) need to be taken into account?
Thanks for your help
Original Message:
Sent: 25-Apr-2020 02:45
From: Richard Vincins
Subject: cleaning/disinfection validation for non-critical devices

Hello Anon,

Unless you are quite familiar with cleaning and disinfecting validations yourself, it is always wise to get expert assistance on this.  There are a number of labs conducting this type of testing like Nelson Laboratories.  These labs assist in the review of your device to properly set out a cleaning validation which you are correct using soils to put on the device and then testing the cleaning process.  This is a fairly well established testing protocol as done for many other type of devices to show they are "clean."  The disinfecting protocol depends on the level of disinfection you are claiming and the type of disinfecting that are used or more precisely can be used.  There are many different types of disinfectants and depending on the needs of your device could be just wipes or solutions to use; also need to consider any damage may occur from disinfectants because some materials have adverse reactions to the chemicals.  This can be quite an involved activity depending on your device, so it would be good to obtain expert support either in guidance or actual testing.

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

Original Message:
Sent: 24-Apr-2020 11:36
From: Anonymous Member
Subject: cleaning/disinfection validation for non-critical devices

This message was posted by a user wishing to remain anonymous

Hi all,
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you

Original Message------

This message was posted by a user wishing to remain anonymous

Thank you both for your clear answer. I have actually already planned to contact NAMSA and Nelson Labs for biocompatibility, so I will try to include cleaning as well in the discussion. I will also include a third lab, as suggested. 
My trouble sometimes is that I get pushed back by my company with the rationale that I am overkilling the problem and there are no high risks for noncritical (intact skin) items. I heard the same commentary on my proposal of performing cytotoxicity, irritation, and sensitisation testing due to the lack of a comprehensive comparison with a comparator.
My logic agrees on some of these comments (yes, I find absurd for a small companies spending tons of money and time in tests that are not so critical - and use animals-, when people and patients are in contact every day with objects that don't have the same level of scrutiny).
However, it is hard to defend these positions in front of regulators and the risk is to get deficiencies for missing testing.
I wonder what your thoughts are on this and if you have any suggestion on how to reinforce the importance of these items in my company or, on the contrary, if there are ways to justify the lack of testing with risk analysis. 

Regarding disinfection, would it be sufficient to use a low-level EPA registered disinfectant according to its labeling and validate through visual inspection that there are no damages to the device? Or again the same considerations (validation through testing labs) need to be taken into account?
Thanks for your help

Hi Anon,

Richard and Ginger are both right. You have to go to an external laboratory.
Be careful of the prices and the estimated delivery times. Also, if you compare prices, be sure that you compare the same experimental design. The lab must create a product-oriented protocol which can vary a lot from lab to lab.
For me, if the product have only intact skin contact, I do not find it necessary to go with artificial soil contamination. Usually artificial soil simulates the blood and tissues and I cannot see your device coming in contact with either blood or exposed tissues.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 24-Apr-2020 11:36
From: Anonymous Member
Subject: cleaning/disinfection validation for non-critical devices

This message was posted by a user wishing to remain anonymous

Hi all,
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you

Take a look at the  ASTM standards in the area of cleaning validation - which would give you a good start.  e.g.: 

ASTM F3208-19 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices  

ASTM E2314-03(2014) Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability

For a complete list look at this search link:   https://www.astm.org/search/fullsite-search.html?query=cleaning%20medical%20devices&resStart=0&resLength=10&toplevel=products-and-services&sublevel=standards-and-publications&dltype=allstd&

and also at ISO: 

ISO/TS 15883-5 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy 


Arthur 

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
------------------------------

Original Message:
Sent: 24-Apr-2020 11:36
From: Anonymous Member
Subject: cleaning/disinfection validation for non-critical devices

This message was posted by a user wishing to remain anonymous

Hi all,
we are a small company and have a non-critical device (intact skin contact) that can be reused by multiple patients. So far we have been addressing cleaning and disinfection in a very basic way (i.e., by using disinfection products commonly used in healthcare environments).
Reading the FDA guidance on reprocessing, it looks like we need to conduct validation activities to demonstrate: 1) that the methods (manual in our case) are adequate to allow the device to undergo further processing and to eventually be reused safely; and 2) that the reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

I am looking for advice on how to develop cleaning and disinfection validation protocols that are not too burdensome and how to perform testing. Do you recommend to involve testing labs to examine soil residuals and bacteria presence even for non-critical devices?
Thank you