Quality assurance forum

Medical Devices Maintenance

Published on 09 23, 2013

The correct functioning, the life span and the validity of the CE marking of a medical device is subject to the prompt  and  correct maintenance programme carried out as indicated  by  the Manufacturer in the Instructions Manual and as prescribed by the law. 

The fact that the maintenance is compulsory is stipulated in various Laws and in particular:

  • Directive 93/42/EC “Medical Devices ”

“medical devices can be put on the market or put in use only if they are compliant with the requirements of this normative, if correctly supplied and installed, if they undergo adequate maintenance and are used in compliancy with the designed use.

  • Directive93/42/EC “Medical Devices “

The instructions for use must contain … d) all the necessary information to enable the correct installation of the device and to check its correct and safe functioning  as well as all the information necessary regarding thenature and frequency of the maintenance operations and where applicable, the calibration required to guarantee the correct and safe functioning of the device”;  

  • The minimum structural, technological and organisational requirements for business in the health field and regional norms. 

The correct management of a medical device is an essential element if it is to be considered such for its whole lifespan. In fact failure to carry out the Manufacturer’s instructions automatically causes the loss of the essential requirements as described in the MDD 93/42/EC and therefore even though it may still bear the CE mark impressed it is no longer compliant with the Directive.

The Manufacturer declines any responsibility for the incorrect functioning and /or for any damage / injury, use of the device may cause.  The characteristics and the performance of the device in its original state can be maintained only if the following maintenance procedures are regularly carried out:

  • ordinary maintenance:

This activity, which is the direct responsibility of the owner of the device, should be undertaken at given intervals as indicated in the Manual supplied by the manufacturer. It is designed to check the state of functioning of the device through visual and/or functional tests.  It is generally carried out by staff within the structure as long as they are able to guarantee the minimum requirements indicated my the manufacturer in the Instructions Manual. 

  • periodical revision:

These are both visual and functional tests which can be carried out only by the Manufacturer or a Service Centre  approved by the Manufacturer.  The frequency of the revisions is stipulated  by the Manufacturer and is indicated in the Instruction Manual.

a)  Extraordinary maintenance:  This regards any service that is not programmed and is not contemplated in the ordinary maintenance and testing programme.  Normal causes could be due to manufacturing defect, failure to carry out a correct maintenance programme, incorrect / unauthorised  use of the device or by any unexpected cause. As for the periodical revision, only  the  Manufacturer or a Service Centre  approved by the Manufacturer  are authorised to carry out extraordinary maintenance.  

  • life span extension:

The life span of a device depends on type of use, storage and maintenance and therefore only the Manufacturer or the Authorised Service Centre can authorise extension. 

All activities of maintenance/revision/extension of life span of Spencer Italia srl devices can be considered valid only if carried out by the Manufacturer or a Service Centre  approved by the Manufacturer.