Regulatory Open Forum

I'm working on a project for a client, a US medical device manufacturer, who could have received returned product that has had patient contact.

I have not worked in this area for a few years, so I'm not sure I'm up to date. Then, the situation was covered under universal precautions which typically included:

Decontamination of returned product at the returning site before the return

Personal protective equipment, PPE, for any person handling returned product

Segregation of returned product to prevent contamination of new product

Decontamination at the receiving site, the device manufacturer, before investigation

As I recall, for example, FDA recommended certain disinfectants  recommended by OSHA. Many of the requirements focused on blood-borne pathogens.

In my client's case it is unlikely the returned product has blood contamination, but universal precautions assume this kind of contamination.

What is the current state of recommendations? Is there a comprehensive guide for US based medical device manufacturers?

Hello Dan,

Personally, I still use the combination of the Bloodborne Pathogen standard and OSHA's requirements under 29 CFR 1910 for handling of returned goods with potential exposure: https://www.cdc.gov/niosh/learning/safetyculturehc/module-5/5.html#:~:text=The%20Bloodborne%20Pathogen%20Standard%3A&text=Requires%20the%20use%20of%20Universal,infectious%2C%20to%20protect%20against%20pathogens. and https://www.osha.gov/bloodborne-pathogens/worker-protections which are considered the most stringent rules in US for worker exposure.  There are some guidance papers and procedures written around these which are not necessarily on the OSHA or CDC website.  As an example, I know the cleaning and disinfecting process is a little different between hospitals in different States and also how companies manage exposure.  I think the only comprehensive guides you will find are published by other association groups, private entities, or individual hospitals (https://www.dhs.wisconsin.gov/hai/precautions.htm as an example).  The procedures I write now for handling returned goods was based off one of the university hospitals procedure - I do not remember which one now - but it was fairly comprehensive and written well.

I'm working on a project for a client, a US medical device manufacturer, who could have received returned product that has had patient contact.

I have not worked in this area for a few years, so I'm not sure I'm up to date. Then, the situation was covered under universal precautions which typically included:

Decontamination of returned product at the returning site before the return

Personal protective equipment, PPE, for any person handling returned product

Segregation of returned product to prevent contamination of new product

Decontamination at the receiving site, the device manufacturer, before investigation

As I recall, for example, FDA recommended certain disinfectants  recommended by OSHA. Many of the requirements focused on blood-borne pathogens.

In my client's case it is unlikely the returned product has blood contamination, but universal precautions assume this kind of contamination.

What is the current state of recommendations? Is there a comprehensive guide for US based medical device manufacturers?

Richard,

Thank you. This is very helpful.

Dan

Hello Dan,

Personally, I still use the combination of the Bloodborne Pathogen standard and OSHA's requirements under 29 CFR 1910 for handling of returned goods with potential exposure: https://www.cdc.gov/niosh/learning/safetyculturehc/module-5/5.html#:~:text=The%20Bloodborne%20Pathogen%20Standard%3A&text=Requires%20the%20use%20of%20Universal,infectious%2C%20to%20protect%20against%20pathogens. and https://www.osha.gov/bloodborne-pathogens/worker-protections which are considered the most stringent rules in US for worker exposure.  There are some guidance papers and procedures written around these which are not necessarily on the OSHA or CDC website.  As an example, I know the cleaning and disinfecting process is a little different between hospitals in different States and also how companies manage exposure.  I think the only comprehensive guides you will find are published by other association groups, private entities, or individual hospitals (https://www.dhs.wisconsin.gov/hai/precautions.htm as an example).  The procedures I write now for handling returned goods was based off one of the university hospitals procedure - I do not remember which one now - but it was fairly comprehensive and written well.

I'm working on a project for a client, a US medical device manufacturer, who could have received returned product that has had patient contact.

I have not worked in this area for a few years, so I'm not sure I'm up to date. Then, the situation was covered under universal precautions which typically included:

Decontamination of returned product at the returning site before the return

Personal protective equipment, PPE, for any person handling returned product

Segregation of returned product to prevent contamination of new product

Decontamination at the receiving site, the device manufacturer, before investigation

As I recall, for example, FDA recommended certain disinfectants  recommended by OSHA. Many of the requirements focused on blood-borne pathogens.

In my client's case it is unlikely the returned product has blood contamination, but universal precautions assume this kind of contamination.

What is the current state of recommendations? Is there a comprehensive guide for US based medical device manufacturers?

Dan, not sure I can add much more to Richard's great reply. My instinct was to go to the MHRA's Managing Medical Devices guidance, as it used to contain information on reporting adverse incidents and how to handle devices under investigation (or so I recalled, it has been a long time since I referred to it regularly)...but it does not. It does have some guidance on decontamination but it is more general about when in-use etc. It does however point to these NHS guidance documents for decontamination in general:

• Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – 8 July 2016: Guidance
• Health Technical Memorandum 01-04: Decontamination of linen for health and social care – 9 June 2016: Guidance
• Health Technical Memorandum 01-05: decontamination in primary care dental practices – 26 March 2013: Guidance
• Health Technical Memorandum 01-06: Decontamination of flexible endoscopes – 30 June 2016: Guidance

You probably already have this covered, but it is worth remembering to ensure that sufficient evidence of the device's state before cleaning and then decontamination is gathered (e.g. photos, videos). Back in my MHRA days, we would obtain as much as we could safely before we then did any cleaning and decontamination. And the method of cleaning, decontamination should probably recorded so that there is evidence of what was done to the device. This depends on the incident and the potential for any criminal or legal proceedings.

Richard,

Thank you. This is very helpful.

Dan

Hello Dan,

Personally, I still use the combination of the Bloodborne Pathogen standard and OSHA's requirements under 29 CFR 1910 for handling of returned goods with potential exposure: https://www.cdc.gov/niosh/learning/safetyculturehc/module-5/5.html#:~:text=The%20Bloodborne%20Pathogen%20Standard%3A&text=Requires%20the%20use%20of%20Universal,infectious%2C%20to%20protect%20against%20pathogens. and https://www.osha.gov/bloodborne-pathogens/worker-protections which are considered the most stringent rules in US for worker exposure.  There are some guidance papers and procedures written around these which are not necessarily on the OSHA or CDC website.  As an example, I know the cleaning and disinfecting process is a little different between hospitals in different States and also how companies manage exposure.  I think the only comprehensive guides you will find are published by other association groups, private entities, or individual hospitals (https://www.dhs.wisconsin.gov/hai/precautions.htm as an example).  The procedures I write now for handling returned goods was based off one of the university hospitals procedure - I do not remember which one now - but it was fairly comprehensive and written well.

I'm working on a project for a client, a US medical device manufacturer, who could have received returned product that has had patient contact.

I have not worked in this area for a few years, so I'm not sure I'm up to date. Then, the situation was covered under universal precautions which typically included:

Decontamination of returned product at the returning site before the return

Personal protective equipment, PPE, for any person handling returned product

Segregation of returned product to prevent contamination of new product

Decontamination at the receiving site, the device manufacturer, before investigation

As I recall, for example, FDA recommended certain disinfectants  recommended by OSHA. Many of the requirements focused on blood-borne pathogens.

In my client's case it is unlikely the returned product has blood contamination, but universal precautions assume this kind of contamination.

What is the current state of recommendations? Is there a comprehensive guide for US based medical device manufacturers?