The HPRA publishes notices relating to the safety and/or quality of medical devices. The issues covered by these notices will range from quality defect information to product recalls, to updated information on the appropriate use of the medical devices.The majority of these notices are for the attention of health professionals including those working in hospitals, community care settings and other health facilities. Some notices also include safety information for users of medical devices such as patients and carers.
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For example the HPRA may publish safety notices in the following instances:
- To highlight a serious public health issue or other key safety issues.
- To highlight an issue that has already been communicated by a manufacturer via a field safety notice but where the manufacturer has indicated to the HPRA that he has experienced difficulty reaching all customers or obtaining feedback from all customers.
- To highlight an issue when either the device manufacturer or Irish distributor no longer exist. For example where the manufacturer has gone into liquidation or where the manufacturer is not known e.g. counterfeit devices.
- To communicate concerning trends that the HPRA has noted with particular product families.
- To communicate safety concerns that the HPRA has noticed in monitoring vigilance issues e.g. equipment management issues, traceability issues.
Receiving and Circulating Safety Notices
If you would like to receive copies of these notices at the time of publication via e-mail please forward an e-mail request to devicesafety@hpra.ie
The recipients of the safety communication, (FSN, HPRA safety notice) should ensure that the communication reaches the most appropriate personnel within their organisation. They should also ensure that the issue outlined in the notice is considered, the risks assessed and the appropriate / recommended actions are completed.
Safety communication (such as FSNs and HPRA safety notices) should be forwarded to other organisations or persons where the devices have been transferred.
In some instances, the recipient of the notice may not be the most appropriate person to deal with the issue, therefore a well defined, effective mechanism for managing the communications is necessary.
Some organisations, hospitals and the community care setting have found that it is very beneficial to have one designated medical device vigilance contact, a local medical device vigilance team that meet to assess the issues that arise, local medical device vigilance procedures and a database to support the management of such communication. Such structures and defined responsibilities and processes help to ensure that the communications are dealt with in a timely manner. (See Medical Devices newsletter February 2004 Vol. 1 No. 7 and IMB newsletter May-August 2004 Vol. 1 No. 18 for more information.)