Incident Reporting
  
 

The Medical Devices Agency (MDA) is an executive of the Department of Health. Their role is to take all reasonable steps to help safeguard public health by working with users, manufacturers and lawmakers to ensure that medical devices meet appropriate standards of safety, quality and performance and that they comply with the relevant Directives of the European Union. One way in which they do this is by investigating reports of adverse incidents involving medical devices.


Where the results of investigations have implications for patients or users, MDA issues a Hazard/Safety notice or a Device Alert advising of hazardous products or unsafe procedures.


An adverse incident involving a device should be reported to the MDA if the incident had lead to, or were it to occur again could lead to: -

  • a death
  • life/threatening illness or injury
  • deterioration in health
  • temporary or permanent impairment of a body function or damage to a body structure
  • the necessity for medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure;
  • unreliable test results leading to inappropriate diagnosis or therapy

In order to ensure the effectiveness of the distribution and to ensure an audit trail is available for these notices, the following systems have been devised.


Procedure to be followed if a fault is found with a Medical Device see Appendix C

  1. If a member of staff identifies a problem with a medical device their Manager should be informed immediately, who will in turn inform the Health and Safety Risk Advisor?

  2. The equipment must be taken out of action and quarantined, as an independent investigation may be required, under no circumstances should the medical device be returned to the manufacturer without prior consultation with the Health and Safety Risk Advisor or the EBME Manager. Details of settings, dose rates or other volitile data must be recorded.


  3. An incident for must be completed and forwarded to the Health and Safety Risk Advisor.


  4. The EBME Department must be contacted and given the following details: -

  • Name of equipment
  • Model number/type of equipment
  • WSHA number/equipment serial number
  • Location of the equipment
  • Incident report form number
  • Name of person reporting the incident
  • Contact number of person reporting the incident
  • The Red INCIDENT REPORT label must be completed and attached to the equipment

  1. The Health and Safety Risk Advisor and the EBME Manager will consider the appropriate course of action to be taken and if necessary will contact the Medical Devices Agency.

  2. The Health and Safety Risk Advisor will advise the following members of staff of the situation. Chief Executive, Director of Operations, Medical Director, Director of Personnel and Corporate Resources and the Director of Facilities (Liaison Officer).


Distribution of Hazard Notices – see Appendix A


  1. The Medical Devices Agency will issue hazard/safety notices and device alerts to the Chief Executive.

  2. The Chief Executive will forward them immediately to the Director of Facilities.

  3. The Director of Facilities will distribute the notices to relevant members of staff for action where appropriate. A return slip will be attached to advise the notice has been received and if necessary of any action taken.

  4. Copies will also be sent to relevant members of staff for information, dependant on the nature of the notice/alert.


Procedure to follow if a Hazard Notice requires action – see Appendix B


  1. The relevant Clinician/Manager should act on instructions detailed in the notice.

  2. The Clinician/Manager should then inform the Director of Facilities of action taken, using the reply slip provided.

  3. The Health and Safety/Risk Advisor will inform the following where appropriate, Medical Devices Agency, Health and Safety Executive, CNST. In addition to the following for information, Chief Executive, Director of Operations, Medical Director, Director of Personnel and Corporate Resources.



Titles of MDA Safety Warnings


The criteria for the various safety warning categories are as follows: -


Hazard Notices are issued: -

  • in cases of actual death or serious injury, or death or serious injury would have occurred but for fortuitous circumstances or the timely intervention of health care personnel (or a carer), and

  • where the medical device is clearly implicated, and

  • where immediate action is necessary to prevent reoccurrence

Device Alerts are issued: -

  • in cases where there is the potential for death or serious injury, or there may be implications arising from the long term use of the medical device,

  • where the medical device is likely to be implicated

  • where the recipient is expected to take immediate action on the advice

Safety Notices are issued to recommend or inform:

  • where action by the recipient will improve safety

  • where it is necessary to repeat warnings on long standing problems

  • to support or follow up any manufacturers field modifications