Introduction

The purpose of this policy is to outline the systems and processes to ensure Trust medical equipment is always safe to use, used correctly, and operated by competent, trained staff.

This policy applies to all devices managed by the Trust but with specific reference to:

  • Medical Engineering
  • Point of Care
  • Sterile Services
  • Moving and handling team

Within these departments, each co-ordinates their own separate systems of device management to reflect the differing nature of equipment in use. Equipment used within Imaging, Pathology and Pharmacy Departments also operate separate operational policies. This overarching policy does however require that all departments have internal governance assurance checks to ensure compliance with this policy and national standards and regulation.

 

Definition of Medical Devices

Medical devices are defined by the Medical Device Regulations, which are contained in Statutory Instruments, SI 1992, 3146; SI 1994, 3017 and SI 1995 1671.

The term “medical device” refers to any healthcare apparatus, material or article which is used for a patient in the diagnosis, treatment, prevention or alleviation of illness or injury. This policy applies primarily to electro-medical equipment. Point of Care Testing (POCT) is limited to analytical processes that would traditionally be performed by Pathology Departments.

 

Policy Details

Download: PDF version
Compiled by: Graham Biggar, Head of Estates and Facilities Infrastructure
Ratified by: Risk Scrutiny Committee
Date Ratified: January 2017
Date Issued: August 2017
Review Date: January 2020
Target Audience: All healthcare staff
Contact name: Graham Biggar, Head of Estates and Facilities Infrastructure

 

See also:

  • Point of Care Testing Policy
  • Single Use, Single Patient Use and Limited Use Medical Devices Policy
  • Sterile Services CFPP01-01 & CFPP01-06; and HTM01-01 & HTM01 as of 06 Jan 2018
  • Medical Devices Training for Clinical Staff Policy
  • Moving and Handling Policy
  • Policy for Decontamination
  • Central Alert System (CAS) Policy
  • Cleaning and Disinfection Policy
  • Health and Safety Policy
  • Incident Reporting Policy
  • Supplier Representatives Policy
  • Trust Standing Financial Instructions