Biofilm Standards and Regulations Report

Abstract

In partnership with the US Centre for Biofilm Engineering (CBE), we hosted a workshop on Biofilm Regulations and Standardisation in Medical Devices and Pharma sectors, which took place in Birmingham, UK, on 29 April 2022.
The meeting was unique, bringing together over 40 representatives from industry, academia, metrology and standardisation and regulatory bodies to map the current landscape, needs, trends and expectations in biofilm standardisation within the UK and to establish industry and regulatory participation in a forward working group. Discussions were very candid, open and stimulating, with the aim of working together as a community to advance the field. The presence of international delegates was very useful and provided additional international context to the discussions.

The meeting was supported by the BBSRC Global Partnering Award and closely aligned to the mission of the International Biofilm Standards Task Group (of which both NBIC and CBE are co-founders): “To drive the international development and acceptance of standardised biofilm test methods in health care, the built environment and industrial systems.”
As pre-work and during the workshop, we posed two questions to be considered and debated:
What do you see as the current needs with respect to standards and regulations in your setting and business relating to biofilms?
What do you believe should be (i) done in terms of concrete next steps by this group? and (ii) the overall long-term goals?
The participants shared a plethora of different experiences, needs, ideas and unique views on the subject. Nevertheless, several clear points emerged, both from the pre-work feedback and from the in-person discussions:

There is both the opportunity and desire from the community to make progress in creating biofilm-related standards.
There is a strong need for a comprehensive review of standards, methods and practices that are currently in use by the community. Such a review would provide a basis for a gap analysis and identification of a pathway for biofilm standards development.
It is clear that ‘one size will not fit all’ due to diverse sectors and applications and the complexity of the biofilms themselves. It would be more practical to build a ‘component approach’, consisting of a base set of standards and guidance on how and when to use them.
It is crucial that regulators are part of the standardisation activities and engaged from the beginning.

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