Medical Sector
MHRA Guidelines on managing medical devices states:
"A device management procedure will help to ensure that risks associated with the use of medical devices will be minimised".
Reponsible organisations should set up and regularly review a device management procedure, to ensure whenever a medical device is used it is:
- Suitable
- Used in accordance with the manufacturer's instructions
- Maintained in a safe and reliable condition
- Disposed of appropriately at he en of its useful life
- Test should be carried out by an adequately trained and appropriately qualified person
- Organisations must maintain thorough records.
Testing and Calibration is central to this.
The Department of Health and the MHRA will audit and police to ensure the above guidelines are followed.
It is estimated that within the UK, over 1 million items of healthcare equipment are tested and calibrated each year. It’s important for patient well-being, and to minimise the possibility of litigation, that such equipment is operating correctly, tested regularly and calibrated accurately.
Test the Tester
But the tests are only as good as the testers. This guide has been produced to help healthcare staff source and commission appropriate testing and calibration contractors.
- Contractors should ensure that their staff have been positively vetted through the Criminal Records Bureau, to safeguard patient information and confidentiality.
- Contractors should be able to demonstrate that they have received the appropriate training from relevant and recognised training establishments.
- Contractors should supply a list of NHS Hospital referrals on request to demonstrate that the hospital EBME team have professionally assessed the skills of the contractor and endorsed their competence.
- Contractors should demonstrate that they operate to ISO9001 quality standards.
JPen Medical conforms to these best practice guidelines. To be sure your equipment is being tested correctly, check whether your tester complies with the guidelines above.
Contact us for more information on: 02920 809090
