Regulatory Open Forum

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

Thank you for the link!

I also found it in English:

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/07022020_good_practices_for_the_sterilisation.pdf.pdf

This seems to be a requirement for the hospital, not the medical device manufacturer. Though, it seems we must accomodate it if we wish to sell in hospitals. Does anyone know of any other country-specific requirements like this?

The document from the Belgium SHC gives the required disinfection parameters. Is this for the manufacturer to validate? Or are the processes they are referring to validated by the hospital itself?

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

Thank you for the link!

I also found it in English:

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/07022020_good_practices_for_the_sterilisation.pdf.pdf

This seems to be a requirement for the hospital, not the medical device manufacturer. Though, it seems we must accomodate it if we wish to sell in hospitals. Does anyone know of any other country-specific requirements like this?

The document from the Belgium SHC gives the required disinfection parameters. Is this for the manufacturer to validate? Or are the processes they are referring to validated by the hospital itself?

------------------------------
Kimberly Chan
Lansdale PA
United States

Original Message:
Sent: 18-Oct-2023 03:59
From: Quang Tran
Subject: Belgium hospital additional sterilization requirement

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

------------------------------
Quang Tran
VP QARA
Antony
France

Original Message:
Sent: 17-Oct-2023 10:24
From: Kimberly Chan
Subject: Belgium hospital additional sterilization requirement

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this? 

------------------------------
Kimberly Chan
Lansdale PA
United States
------------------------------

Dear Kimberly

Yes, there are other regulatory authorities (RA) who have issued cleaning/ disinfection/ sterilisation/ reprocessing guidelines/ regulations. 

One example is Swissmedic, the RA of Switzerland for reprocessing.

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/reprocessing.html

Another example is Denmark who issued new rules on reprocessing and reuse of single-use medical devices in 2021. See news article link below. 

https://www.bechbruun.com/en/news/2021/new-rules-on-reprocessing-and-reuse-of-single-use-medical-devices

Recommend to search each RA website of the country in which your product is sold. 

Best Regards,

Stephanie

Thank you for the link!

I also found it in English:

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/07022020_good_practices_for_the_sterilisation.pdf.pdf

This seems to be a requirement for the hospital, not the medical device manufacturer. Though, it seems we must accomodate it if we wish to sell in hospitals. Does anyone know of any other country-specific requirements like this?

The document from the Belgium SHC gives the required disinfection parameters. Is this for the manufacturer to validate? Or are the processes they are referring to validated by the hospital itself?

Hi there, There is additionnal domestic regulation in Belgiu. Disinfection is required to protect users who handle the device before sterilization.

https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/20230414_css-9682_recommandations_sterilisation_vweb_0.pdf

Hello, we had a request from a Belgium Hospital to include disinfection instructions to our IFU prior to sterilization. My understanding is that sterilization is a higher level of decontamination than disinfection. I don't understand why we would need to disinfect before performing sterilization. We already have cleaning instructions prior to sterilization.

They have said it is a requirement in the regulation, but given that we are CE marked, and our device has passed technical file review for MDR, I don't know if this is an additional requirement for Belgium that I was unaware of. Can someone shed some light on this?