Did you know...,In MHRA DB 2015: Managing Medical Devices, it states:
Section 2.1 Management Responsibility
• Healthcare organisations should appoint a director or board member with overall responsibility for medical device management.
• The management structure for medical devices should have clear lines of accountability up to board level.
• Healthcare organisations should set out a long-term approach and objectives for the management of their medical devices.
Section 2.6 Monitoring and Audit
• An Audit Report should be submitted to the board examining policies and procedures for the safe acquisition, use, maintenance and repair, decontamination and disposal of medical devices.
• External monitoring and audit by the Care Quality Commission (CQC).
• The CQC will inspect against their ‘Essential standards’ of quality and safety.
• Healthcare organisations need to review their policies and systems for managing the use of medical devices regularly.
I think there are many NHS and Private Healthcare organisations who are unaware there is a regulatory responsibility for a designated director to be responsible for devices, even though this has now been around for over 5 years.
Anyone out there have a director interested and active in medical devices management?