(2) what responsibility the Healthcare Commission has to report (a) on and (b) to the Medicines and Healthcare Products Regulatory Agency on the compliance of NHS trusts with guidelines on managing medical devices;
(3) whether the Healthcare Commission has powers to enforce Medicines and Healthcare Products Regulatory Agency guidelines on managing medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) published its updated Device Bulletin on the management of medical devices in November 2006. The MHRA does not have powers to enforce its advice, which is for guidance only; the Healthcare Commission does not have powers to enforce MHRA advice either. It is the responsibility of each NHS organisation to ensure that appropriate governance systems are in place to ensure that medical devices are managed and used correctly.
The Healthcare Commission assesses the performance of the NHS against the standards set out in Standards for Better Health (Department of Health 2004). In carrying out its assessments, the Commission looks specifically at, among other aspects of safety, the management of risks associated with the acquisition, use, and proper decontamination of medical devices in accordance with guidance issued by the MHRA.
If an organisation is found not to be complying with a core standard, it is the responsibility of the relevant strategic health authority (SHA) in the first instance to support it to achieve the necessary improvement. In exceptional individual cases where an organisation's failure to comply with a compulsory core standard is of significant and sufficient concern, and where the Department and the SHA agree that departmental engagement can add value, the Department would work with the SHA to ensure that improvement was made.
The Healthcare Commission reports to the Secretary of State. The Commission publishes its assessment of NHS performance in its annual health check; performance ratings for 2005-06 were published in October 2006 and are publicly available on the Commission's website at www.healthcarecommission.org.uk.