Guide to
Field Safety Corrective Actions for Medical
Devices and In-vitro Diagnostic Medical
Devices
SUR-G0001-4
2 AUGUST 2012
This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
1 SCOPE
The Health Products Regulatory Authority (HPRA) is the Competent Authority (CA) in Ireland
for medical devices. This guide outlines how to achieve an effective interface between the
legal manufacturers or their authorised representatives and the HPRA in the event of a field
safety corrective action (FSCA) for a medical device, active implantable medical device or an
in-vitro diagnostic medical device and associated accessories. It aims to describe what an
FSCA is and clarifies the role played by the legal manufacturer or authorised representative
and by the HPRA in ensuring that an efficient and effective FSCA is carried out.
2 INTRODUCTION
There are three Directives and related Irish Regulations that are applicable to medical devices,
active implantable medical device and in-vitro diagnostic medical devices. Under the
legislation manufacturers are required to notify the CA of incidents occurring following
placing of devices on the market, i.e. Article 10 of Medical Devices Directive (93/42/EEC),
Article 8 of the Active Implantable Medical Devices Directive (90/385/EEC) and Article 11 of
the In-vitro Diagnostics Medical Devices Directive (98/79/EC).
Regarding serious risk to the safety of patients or other users, Article 14b of Directive
93/42/EEC, Article 13 of IVD Directive 98/79/EC and Article 14 of AIMD Directive 90/385/EEC
allows for necessary and justified transitional action in relation to a product or group of
products, limiting the availability of such products in order to ensure that public health
requirements are observed.
In addition the ‘safeguard clause’ (Article 8 of Directive 93/42/EEC, Article 8 of Directive
98/79/EC and Article 7 of AIMD Directive 90/385/EEC) may be invoked where it is considered
that the medical device in question may compromise the health and safety of the patient,
users or, where applicable, other persons. If the particular health monitoring measure or
safeguard clause is to be used the HPRA will notify the EU Commission, member states and
the manufacturer giving the reasons for the decision.
3 DEFINITION OF A FIELD SAFETY CORRECTIVE ACTION AND A RECALL
According to the European Commission Guidelines on a Medical Devices Vigilance System
MEDDEV 2.12-1 the definition for a FSCA is:
“Field safety corrective action is an action taken by a manufacturer to reduce a risk of death
or serious deterioration in the state of health associated with the use of a medical device that
is already placed on the market. Such actions should be notified via a field safety notice.”
SUR-G0001-4 2/7
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
The FSCA may include:
- the return of a medical device to the supplier;
- device modification;
- device exchange;
- device destruction;
- retrofit by purchaser of the manufacturer’s modification or design change;
- advice given by the manufacturer regarding the use of the device (e.g. where the device is
no longer on the market or has been withdrawn but could still possibly be in use e.g.
implants or change in analytical sensitivity or specificity for diagnostic devices).
A device modification can include:
- permanent or temporary changes to the labelling or instructions for use;
- software upgrades including those carried out by remote access;
- modification to the clinical management of patients to address a risk of death or serious
deterioration in state of health related specifically to the characteristics of the device.
For example:
- For implantable devices it is often clinically unjustifiable to explant the device. Corrective
action taking the form of special patient follow-up, irrespective of whether any affected
un-implanted devices remain available for return, constitutes a FSCA.
- For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients
for retesting or the retest or review of previous results constitutes a FSCA.
- Advice relating to a change in the way the device is used e.g. IVD manufacturer advises
revised quality control procedure - use of third party controls or more frequent calibration
or modification of control values for IVDs, constitutes a FSCA.
This guide uses the definition of FSCA as a synonym for recall as mentioned in article 10(1),
paragraph 1b) of the Medical Device Directive (93/42/EEC) and article 11 In-vitro Diagnostic
Directive (98/79/EC) since there is no harmonised definition of recall.
An FSCA only applies to a medical device that has already been distributed by the
manufacturer. An FSCA does not arise when a manufacturer is exchanging or upgrading
devices in the absence of a safety risk or when removals from the market are for purely
commercial reasons.
The manufacturer should issue field safety notices (FSN) when implementing a FSCA. Copies
of FSNs should be sent to the CAs of countries where they are applicable. In addition a copy
of the FSN for devices in Class IIa, Class IIb, Class III and IVDs listed in Annex II or those for
self testing should be forwarded to the CA in the country where the Notified Body (NB) is
situated and which made the attestation which led to the CE marking being attached to the
device.
SUR-G0001-4 3/7
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
4 DETERMINING THE NEED FOR A FIELD SAFETY CORRECTIVE ACTION
The manufacturer of the medical device in question takes responsibility for determining the
need for an FSCA. A number of issues should be considered in determining the need for an
FSCA including:
1 The hazard arising from the device shortcoming
2 The probability of the hazard occurring
3 Whether the risk outweighs any possible hazard caused by the FSCA due to its
temporary / permanent removal from use, modification, exchange, retrofit or due to
new advice being provided by the manufacturer.
An FSCA may be triggered by information indicating an unacceptable increase in risk. This
information may arise from post-market surveillance by the manufacturer. On occasions the
HPRA may advise manufacturers or their authorised representatives to implement an FSCA in
relation to a medical device due to a risk of serious injury or death to patients, users or others
which has been brought to the attention of the HPRA through incident reports or other
means.
In certain cases it may be necessary to use precautionary measures in the interest of public
health and restrict or prohibit products subject to particular requirements. In other cases for
safety reasons it may be necessary to mandate the use of the safeguard clause to remove a
medical device from the marketplace.
5 FIELD SAFETY CORRECTIVE ACTION NOTIFICATION TO THE HPRA
When a manufacturer or their authorised representative decides to initiate a FSCA he should
notify the CA of each Member State in which the FSCA is to be conducted. In addition, the CA
of the country where the legal manufacturer / authorised representative resides should be
informed.
The notification should be made before or when the FSN is being issued. Where possible, the
HPRA should be informed of a FSCA prior to its initiation of the action but an urgent FSCA
should not be delayed pending HPRA notification.
The manufacturer should use the FSCA form to notify the CA of the FSCA. When the action is
associated with an incident, the manufacturer should submit the ‘Manufacturers incident
report form’ and the ‘Field safety corrective action report form’ (using the appropriate forms
outlined below).
If a manufacturer or his authorised representative is reporting an incident which has given rise
to an FSCA, the incident and the field safety notification may be submitted using the ‘Field
safety corrective action report form’ and the ‘Field safety notice’ template provided in Annex
SUR-G0001-4 4/7
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
4 and Annex 5 respectively of the European Commission Guidelines on a Medical Devices
Vigilance System MEDDEV 2.12-1.
Manufacturers should also consider the notification obligations to their Notified Body and to
other regulatory bodies outside of the EEA if the product has been distributed in that
territory.
6 INITIAL INFORMATION TO BE PROVIDED TO THE HPRA
When the need for an FSCA has been established the manufacturer should gather all relevant
information on incident reports, the product and its distribution, and the action proposed.
Some information may not be available immediately (e.g. distribution chains, batch size etc.).
Notification to the HPRA should not be delayed pending collation of these data.
The report should be made using the ‘Field safety corrective action report form’ and the ‘Field
safety notice’ template which are available on request from the HPRA or may be downloaded
from the HPRA website. They can also be obtained in Annex 4 and Annex 5 respectively of the
European Commission Guidelines on a Medical Devices Vigilance System MEDDEV 2.12-1.
The field safety corrective action report form is divided into the following sections:
Part 1: Administrative information
Part 2: Information on the submitter
Part 3: Manufacturers Information
Part 4: Authorised Representatives Information
Part 5: National Contact Point Information
Part 6: Medical Device Information
Part 7: Description of the FSCA
Part 8: Comments
If the cause of the FSCA is known at the time of issuance of the FSN it should be specified. If
distribution is limited, the information given above may be provided over the telephone but
in all cases an FSN should be subsequently issued.
In all cases the FSN should be sent to the device user. If the name of the appropriate
healthcare user is not known then the FSN should be addressed to the head of the
appropriate hospital department, community medical centres and to the chief executive
officer and relevant healthcare professional (e.g. pharmacy or GP) as appropriate.
An interim report should be submitted to the HPRA providing an update on progress of the
reconciliation of stock affected by the FSCA, together with confirmation, where practicable,
that the customers have received the FSN. It should also give a progress report on the
investigation to date and any corrective action which is being considered.
SUR-G0001-4 5/7
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
7 LIAISON WITH OTHER COMPETENT AUHTORITIES
When the HPRA acts as the lead CA according to the European Commission Guidelines on a
Medical Devices Vigilance System MEDDEV 2.12-1, a National Competent Authority Report
(NCAR) report is prepared and forwarded to all other EEA member states and the European
Commission in the format detailed in Annex 6 of the guideline.
The HPRA will inform manufacturers or their authorised representative of actions being taken
to advise other EEA states. When an NCAR report is being prepared the manufacturer will
usually be contacted and the text verified for accuracy.
8 CORRECTIVE ACTION
On completion of an FSCA the manufacturer or his authorised representative should provide
details to the HPRA of the proposed corrective action to prevent reoccurrence of the problem
that gave rise to the FSCA.
9 WHO TO CONTACT AT THE HPRA
When an FSCA is being considered, the Human Products Monitoring Department of the HPRA
should be contacted, where possible, before initiation.
For further information and for copies of the guidance documents and vigilance forms please
contact:
Human Products Monitoring Department
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: devicesafety@[Link]
Information is also available from the HPRA website at [Link].
SUR-G0001-4 6/7
HPRA Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices
APPENDIX 1 CHECKLIST OF KEY ACTIVITIES AND DECISIONS TO AID THE FSCA
PROCEDURE
1 Is an FSCA needed?
2 What level of communication is needed?
3 What should users do with affected product?
4 How urgent is this? Should some early warning be provided or can it wait for the FSN
5 Is there a need for recalling or retesting of patients or review of patients results?
6 Draft FSN.
7 Is there time to consult with the HPRA regarding the draft FSN?
8 Decision on best method to distribute the FSN letter.
9 What form of proof of delivery / receipt is needed?
10 Agree milestones with the HPRA for the interim and final report.
11 Progress FSCA
12 Issue interim report.
13 Progress in-house corrective action to prevent recurrence of the problem.
14 Issue final report to the HPRA, including validation of corrective measures.
SUR-G0001-4 7/7
