ANSM approves Oncodesign disinfection processes

Biodecontamination: strengthen patient safety as part of a global infection control strategy

Unconventional transmissible agents (NCTAs or prions) are responsible for transmissible spongiform encephalopathies (TSEs), which most popular disease is Creutzfeldt-Jakob Disease variant (vCJD) or "mad cow disease". 

This microbiological risk is a major public health issue. Indeed, the lack of a reliable diagnostic test and the extreme resistance of these agents to inactivation processes lead the companies working on the medical instrumentation security process to test new physicochemical processes against these pathogens and which are otherwise compatible with more fragile reusable medical devices (DMs) such as endoscopes.

The risk of human-to-human transmission linked to the use of reusable medical devices has been demonstrated for several decades. Securing reusable medical instrumentation through effective decontamination would therefore help to better control this risk.

Two touchdowns in 2018

This year, Oncodesign did this work for two companies, the Canadian TSO3 and the Korean company Human Meditek, to assess the efficacy of 4 prion disinfection processes. Oncodesign also guided them in the submission of their files to the ANSM, which resulted in their inclusion on the list of inactivating products and processes of the NCTA with respect to the SPP.

This Oncodesign’s commitment ensures patients that reusable medical instrumentation are very well decontaminated, that is also applicable to hospital hygiene practices.

An update of the Prion Standard Protocol

The current PSP was implemented in 2011 by the ANSM. A revision of this standard was published in 2018 - PSP2 v2018. The processes compliance listed on ANSM directory will be compulsory in 2021. Research is therefore continuing at Oncodesign to develop complementary methods to continue the use of efficient processes in hospital hygiene and support companies in this implementation compliance.


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