Responsibilities
Chief Executive
The Chief Executive has overall accountability for ensuring the Board has effective systems and controls in place to meet regulatory standards for the management of medical equipment. This includes ensuring that procedures exist to manage risks relating to medical equipment, the reporting of adverse events and the dissemination of safety (Hazard) notifications.
Medical Director
Executive responsibility for medical equipment management lies with the Medical Director. Responsibilities include:
- Ensuring efficient and effective medical equipment procurement planning is in place.
- Ensuring operational lifecycle management of medical equipment is appropriately monitored and controlled.
- Executive Sponsor of the Medical Equipment Group.
Responsibilities for re-usable medical equipment are included within appropriate schemes of delegation to the Head of Medical Physics with ongoing assurance, monitoring and validation of equipment planning and strategy being performed by the Medical Equipment Group. Assurances regarding these arrangements are provided within the Property and Asset Management Strategy and Medical Equipment Management Strategy.
Head of Medical Physics
The Head of Medical Physics is the operational and strategic lead for medical equipment lifecycle management. Responsibilities include:
- Production of medical equipment strategy.
- Production of medical equipment management operational policies procedures and systems of work.
- Production of long term, medium term and short-term equipment procurement plans.
- Continual quality improvement of all aspects of medical equipment lifecycle management.
- Chair and administrate the Medical Equipment Group.
- Provide medical equipment expert advice to organisational committees.
- Contract management.
- Linking with national groups relating to Medical Equipment Lifecycle Management.
Director of Nursing, Associate Medical Directors and Directors of Operations
The Director of Nursing, Associate Medical Directors and Directors of Operations are accountable to the Medical Director for ensuring that this policy is implemented within their respective Service Units and Directorates. In addition, Directors of Operations will:
- Verify all equipment plans to ensure compatibility with ongoing strategies.
- Verify all equipment purchases within their respective directorates ensuring that that all lifecycle running costs (consumables, maintenance) are identified and appropriately aligned to budgets.
Equipment Coordinator
The role of Equipment Coordinator as laid out in CEL 43 (2009) is formally held by the Head of Medical Physics. The Equipment Coordinator supports the designated Executive Director (Medical Director) in achieving the aims of the CEL.
The Equipment Coordinator acts as a single point of contact between the Board, Health Facilities Scotland and the MHRA for all safety issues relating to medical equipment and is responsible for:
- Ensuring managers and staff are aware of the procedures for reporting equipment related adverse incidents for implementing safety advice.
- Monitoring all equipment related adverse incidents reports from within the Board.
- Receiving emails from Health Facilities Scotland (HFS) and the MHRA notifying of alerts and bulletin, and cascading within own organisation.
- Monitoring relevant websites for information on equipment safety and management issues.
- Discussing equipment safety issues with HFS and the MHRA.
- Promoting equipment safety by staff education and training.
- Building and maintaining communication links with HFS.
- Attending Equipment Coordinators conferences and seminars.
- Monitoring internal cascade systems to ensure alerts are received, assessed and acted on.
The role of the Equipment Coordinator is broadly comparable with the role of the MHRA Medical Devices Safety Officer in NHS England.
Head of Procurement
The Head of Procurement is responsible for:
- Achieving and demonstrating value for money though purchasing arrangements.
- The prevention of rogue medical equipment purchases.
- Oversight and expert adviser role in all equipment procurement.
- Ensuring appropriate policies, systems and controls are in place to ensure all medical equipment procurement is carried out in accordance with the Board’s Standing Financial Instructions and all applicable regulation and legislation.
Heads of Department / Service
Heads of Department / Service have a managerial responsibility to ensure that medical equipment is used in a safe manner. This includes:
- Having appropriate processes in place to ensure manufacturers instructions are adhered to
- Identifying and addressing training needs
- Ensuring operators are adequately trained, competent and confident to use the equipment
- Identifying, assessing and addressing risks associated with medical equipment within their departments and operational areas of responsibility
- Ensuring the equipment is looked after in day-to-day use
- Ensuring Hazard notices are responded to promptly
Heads of department also play an important role in identifying equipment requirements and advising the procurement process as a senior user.
All staff
The Board requires that all staff are competent and trained in the confident use of any medical equipment that they are required to use. All equipment users must ensure that medical equipment is only used as instructed by the manufacturer, for its intended purpose. Equipment users have primary responsibility for treating the equipment in a careful manner that is consistent with its importance and cost. Responsibilities also include pre-use checks and routine user maintenance and decontamination where required.
Committee responsibilities
The Medical Equipment Group
The Medical Equipment Group (MEG) is the key medical equipment governance group. It has as multidisciplinary membership comprising of clinical leads from all specialities and heads of department from all user areas. The MEG has the following key functions:
- Enables robust clinical input to medical equipment planning and acquisitions, allowing appropriately governed prioritisation and approval of purchases in the context of ongoing clinical strategies
- Allows Executive Director to delegate responsibility to Head of Medical Physics in an appropriate, controlled and monitored manner
- Allows Executive director and other stakeholders to monitor equipment lifecycle management performance against Key Performance Indicators and continuously evaluate the implementation of policy.
The Clinical Users Group
The Clinical User Group (CUG) is established to safely manage change relating to the use of all consumable medical devices. Responsibilities include:
- Coordination of the trial, review and evaluation of all new or alternative consumable medical devices used within NWTC Board
- Acts as a interface between the Board and Regional West of Scotland Technical User Groups as well as National Commodity Advisory Panels
The CUG is a multidisciplinary group with representation from key clinical areas and specialities. The group is chaired by the Associate Medical Director.
Capital Group
The Capital Group oversees and authorises the procurement of all re-usable medical devices. This includes revenue items. All device purchases are initially approved and prioritised by the MEG. The function of the Capital group in this context is:
- To approve funding for medical equipment purchase in line with equipment plans and other ongoing capital plans
- To ensure all lifecycle running costs (consumables, maintenance) are identified and appropriately aligned to budgets
- To ensure all medical equipment purchases receive formal approval from Head of Operations, Medical Physics, Infection Control, Procurement, IM&T, Housekeeping and CSPD.
Specialist equipment groups
The Board has a number of specialist equipment groups established to oversee equipment usage where specific risks exist. The groups are multidisciplinary and comprise of stakeholders appropriate to the specific equipment speciality. The main remits of the groups include:
- To safely manage change
- To ensure that appropriate advice, recommendations and legislation is adhered to
These groups include:
- Infusion Device Committee
- Point of Care Testing Committee
- Ionising Radiation Safety Committee
