Acceptance Testing of Medical Equipment
The Electronic and Biomedical Engineering (EBME) department should ensure processes are in place for acceptance testing. These processes will check that equipment meets safety standards, meets clinical requirements, and the procurement requirements of the Hospital from the day it arrives. (This advice may be used in conjunction with this acceptance form.)
The first task is to ensure records are taken that can be entered into the equipment management database once the acceptance testing is completed.
- The generic equipment type, for example 'defibrillator'
- The Equipment number from (or to be entered into) the equipment database
- The model of the device (as shown on the manufacturers label)
- The job number allocated from the database to this acceptance test
- Any accessories that were delivered with the device must be listed and checked
- The order number for cross reference with the supplier
- The serial number
- The cost of the device with accessories
- The name of the manufacturer, and supplier (if different)
- The telephone contact details for the supplier
- The date of acceptance into the hospital
- The date of warranty expiry
- The signature of the technician who carried out the acceptance testing
- Location of the technical documents
- Location of the equipment (Ward or Dept)
- Person within the ward or department responsible for that device (Departmental equipment controller)
2. Acceptance Checks
When carrying out acceptance testing, not all tests are valid for all devices but the form must be an assessment tool for all. With every device the individual checks should be recorded as a 'Pass', 'Fail', or not applicable 'N/A'. If a device has any minor failures that can be easily rectified, any remarks and faults corrected must be recorded on the acceptance form and database.
2.1 General considerations when carrying out an acceptance check include inspection of the packaging, whether the equipment arrived intact (as specified in the order) with the correct accessories and documentation. The documentation must include a user manual and it would be good practice to ask for this in pdf format to allow it to be placed on the Hospital intranet. This allows easy access to all users, and as the NHS now has a goal to be paperless by 2017, we need to find ways to achieve this.
2.2 Technical inspections should firstly ensure that the equipment is complete and undamaged. All the control knobs and fuses etc are intact. If the device contains chemicals or liquids, these should be inspected to ensure that they are correct. If the device has Wheels, or castors ensure they roll freely and the brakes work. All labelling should be inspected to ensure it is in the correct language, and meets expectations. All medical devices should carry a CE mark with a four digit code to indicate compliance with: EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices / OJ L 169 of 12 July 1993
2.3 Electrical Safety Markings should be indicated on the device labels. I.e. Class I or II, Type B, BF, CF or Type AP, APG. Record Class and type on the acceptance form and on the database. You should be aware of the current electrical safety regulations regarding the device being tested.
2.4 It is important to check the mains connection, paying attention to the condition and type of cable, whether the plug is intact, the plug terminal connections are terminated properly with correct cable colour code, cord grip is attached, fuses are correct and in accordance with the rating stated on the device, or in the technical documentation. The equipment Protection is in accordance with current requirement, for example, some laser equipment will be terminated with a special interlocking electrical supply socket. Voltages are set to the correct value for the mains supply. Earth terminal symbol is correct (if applicable to the device).
2.5 Once the equipment classification and type have been determined, you then need to ensure the device meets the safety requirements by carrying out the electrical measurements that will determine a pass or fail for earthing of the equipment, earthing of accessories, insulation resistance, earth leakage current, enclosure leakage current, and patient leakage current where applicable to the device. (This will usually be carried out using an automated electrical safety analyser.)
2.6 Installation and Operational tests must ensure the equipment functions correctly. This should be done through the user carrying out tests, or the supplier carrying out tests. Once the equipment user has received adequate training to use the device safely, they should decide whether or not the device is operating correctly in the clinical environment and inform the technician once they are happy that everything operates as expected. In the UK, since 2010 it has become a regulatory requirement that devices are maintained correctly and used safely. The regulatory auditors from the Care Quality Commission have a 3 year target to inspect all public and private organisations against regulation 16, outcome 11 between 2012 and 2015.
Electrical Safety Tests
Electrical Safety Tests describe the electrical safety tests commonly available on medical equipment safety testers. Please note that although HEI 95 and DB9801 are no longer current, they are referred to in the text since many medical electronics departments have used them as a basis for local acceptance testing and even routine testing protocols. Protocols based on both sets of guidance are also available on many medical equipment safety testers.
Safety, availability and suitability of equipment
What do the regulations say?
(From CQC regulation 16.)
The registered person must make suitable arrangements to protect service users and others who may be at risk from the use of unsafe equipment by ensuring that equipment provided for the purposes of the carrying on of a regulated activity is-
- properly maintained and suitable for its purpose; and
- used correctly.
The registered person must ensure that equipment is available in sufficient quantities in order to ensure the safety of service users and meet their assessed needs.
- "equipment" includes a medical device; and
- "medical device" has the same meaning as in the Medical Devices Regulations 2002.
Regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 Outcome - What should people who use services experience? People who use services and people who work in or visit the premises:
- Are not at risk of harm from unsafe or unsuitable equipment (medical and non-medical equipment, furnishings or fittings)
- Benefit from equipment that is comfortable and meets their needs.
This is because providers who comply with the regulations will:
- Make sure that equipment:
- is suitable for its purpose
- is available
- is properly maintained
- is used correctly and safely
- promotes independence
- is comfortable.
- Make sure that equipment:
- Follow published guidance about how to use medical devices safely.
3. Formal Acceptance
Once all the regulatory criteria for acceptance have been satisfied, the device can be labelled with an asset number, and tested label then formally handed over to the user. After the equipment has been accepted the supplier should be informed, the internal supplies dept should be informed, and the equipment given to the user.
4. Further Action
Where modifications are necessary to ensure the device will pass acceptance, the supplier (as agreed by the hospital) should make these modifications. The modification should then be checked for compliance.
If any serious shortcomings remain, the device should be rejected and quarantined. If the defect is thought to be of a manufacturing nature, it may be necessary to inform the Medicines and Healthcare products Regulatory Agency (MHRA).
Author: John Sandham IEng MIIE MIHEEM
Date: Oct 2012
Medical Equipment References
Several Medical Equipment descriptions and references can be find at EBME site
There are more to see at EBME site