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1.1 Introduction
1.2 Safety requirements
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1.1 Introduction
This policy is based on the guidance produced by the Department of Health, Medical Devices Agency, National Audit Office, Electricity at Work Regulation, Health and Safety at Work Act and recommendations made in the Clothier report. Guidance is based upon MDA DB9801 "Medical Device and Equipment Management for Hospital and Community-based Organisations," DB9801 Supplement " Checking & Testing of newly delivered Medical Devices", National Audit Office HC475 "The Management of Medical Equipment in NHS Acute Trusts in England," NHS Executive " Controls Assurance Standard" .
1.2 Safety requirements.
All medical equipment purchased for use within the West Suffolk Hospitals NHS Trust must comply with the relevant safety requirements. This is also a stipulation of the Trust's insurers.
- Electromedical Equipment:-
EN60101-1 1989: Medical electrical equipment.
part 1 - General requirements for safety
For specific equipment a part 2 may apply ie
Section 2.2: Specification for high frequency surgical equipment.
- Laboratory and measurement equipment.
EN61010-1 1993: Safety requirements for electrical equipment for measurement control and laboratory use.
General requirements
- Medical Equipment:-
BS4272 part 3 1989: Anaesthetic and Analgesic machines.
BS5682: Terminal units, hose assemblies and connectors for use with medical gas pipelines.
EN850 1997: Medical gas cylinders, valves and yoke connections.
EN737-1 1998: Terminal units for compressed medical gases and vacuum.
EN737-2: Active anaesthetic gas scavenging systems.
EN738: Pressure regulators for use with medical gases.
EN738-2: Manifolds and line pressure regulators.
EN738-3: Pressure regulators integrated with cylinder valves.
EN738-4: Low-pressure regulators intended for incorporation into medical equipment.
EN794 : Lung ventilators.
EN794-1: Particular requirements for critical care ventilators.
EN794-3: Particular requirements for emergency and transport ventilators.
- PC Controlled Diagnostic and Therapeutic equipment:-
Much modern diagnostic and therapeutic medical equipment is software driven from laptop or pc computer set ups. To the untrained eye this equipment looks like a standard pc seen in any office. As part of the safe guards required to protect patient confidentiality and data integrity it necessary to ensure that only directly related programs are loaded onto the system.
It will also be necessary to demonstrate that "down loaded" data/images are available only to authorised users and that "modified" or unauthorised data/images are prevented from being "loaded" onto the system.
A backup of the system software should be taken to ensure the proper restoration of the system files in the event of a system failure. A structured process of backups should be instigated to prevent loss of patient data to a recognised backup media.
Both system software and patient data should be stored in a secure area remote from the equipment.
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