67.2 The government response
After careful consideration of responses, it remains the government’s intention to proceed with proposals to regulate the re-manufacturing of single-use devices, as set out in the consultation. The majority of respondents were supportive of the consultation proposals, which would bring into scope of the UK medical devices regulations, factors that are currently set out in guidance. This will include requiring that the packaging and instructions for use clearly state that the single-use device is a re-manufactured version of the original and that the re-manufacturer can be clearly identified on the packaging and labelling.
We consider that a move from guidance-based best practice to regulatory requirements will
provide clarity and increase patient safety, ensuring that appropriate enforcement can be taken against re-manufacturers who fail to abide by the regulatory requirements. In developing the regulations, we will give careful consideration to the important issues raised around patient consent and the commercial sensitivity issue raised around re-manufactures being able to access an original manufacturer’s technical file. We will supplement the regulatory changes with supportive guidance and ensure that any technical terms are clearly defined.
The majority of respondents were in favour of introducing requirements for persons who remanufacture single-use devices on behalf of healthcare institutions. After careful consideration of feedback, it is the government’s intention to proceed with the approach outlined in the consultation. As such, we intend to require that the supply of re-manufactured single-use devices be through a closed loop contract between the re-manufacturer and the healthcare institution, and that a re-manufactured single-use device should only be used on an individual patient during a single procedure and, after that use, the single-use device should be returned to the contracted re-manufacturer. . .
See also page 143 for Section 13 – Environmental Sustainability and Public Health Impacts