Respiratory System: Medical Equipment

(asked on 22nd July 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the implications for its policies of the US Food & Drug Administration Safety Communication entitled Flexible Bronchoscopes and Updated Recommendations for Reprocessing, issued on June 25th, 2021; and what discussions he has had with (a) his US counterpart, (b) the Medicines and Healthcare Products Regulatory Agency and (c) relevant stakeholders on the potential implementation of US FDA recommendations in the UK.


Answered by
Edward Argar Portrait
Edward Argar
Minister of State (Ministry of Justice)
This question was answered on 11th October 2021

There are currently no plans to implement the United States Food and Drug Administration’s (FDA) recommendations in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of the FDA’s ‘Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication’, issued on 25 June 2021. While there have been no specific discussions the FDA’s recommendations broadly align to the UK guidelines and work practices set out in ‘Management and decontamination of flexible endoscopes’ Health Technical Memorandum, published in 2016 and regularly updated.

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