The response to your query is detailed below and attached:Medical Devices Management Policy V7.0 Medical Devices Procedures V7.0 Safety Committee Feb 2014 – MDC Annual Report 2013 FINAL TOR Medical Devices Committee Jul 2014

1 – Has your organisation appointed a Medical Devices Safety Officer? If so, when, and who is it?

Yes –MDSO position in place April 2014. Medical Devices & Decontamination Manager

2 – Has your organisation drawn up a Medical Devices Management Strategy? If so, when, and please supply a copy.

Medical Devices Policy & Medical Devices Committee Annual Report.

3 – Has your organisation created a Medical Devices Management Group? If so, when, and how often does it meet?

Yes – Medical Devices Committee meets bi monthly, TOR attached, First Initiated in 2000. 4 – Has your organisation developed a Device Management Policy? If so, when, and please supply a copy.

5 – Has your organisation produced a training policy regarding the safe use of medical devices? If so, when, and please supply a copy.

No this is planned for November 2014. Training information is included currently within the Medical Devices Policy & Procedures documents.

6 – How many incidents (including those defined as “near misses”) has your organisation reported to the MHRA over the past (or most recently reported) 12 months?

August 2013 – August 2014 we have reported 26 incidents to the MHRA

7 – How many of those incidents involved a) the death of a patient or b) an injury to a patient?

24 of these had no harm to  patients and the remaining 2 incidents resulted in Low Harm/injury to a patient.