Medical Device Field Safety Corrective Actions

EU lay of the land 

Medical devices, like all products can potentially go wrong. Robust processes are usually in place at manufacturing organisations to help prevent safety problems, but even the best designed product can be found later to have unexpected design or production flaws which could cause a safety issue during use. This blog looks at what steps could be taken to address an identified safety issue for a medical device sold into the EU.

Field Safety Corrective Action (FSCA), Recall or Mandatory Field Action

If that safety issue could result in a risk of death or serious deterioration in health, and the product is being sold or made available in the EU, the manufacturer will need to consider if a Field Safety Corrective Action (FSCA) is required to remediate and make safe other medical devices they manufacture which could go wrong in a similar way. Terms such as recall and mandatory field action are often used interchangeably with Field Safety Corrective Action.

Key role of Post Market Surveillance

Effective periodic post market surveillance, adverse safety trend identification and monitoring of safety information in public databases are all suitable means of identifying whether there are any emerging safety issues which need to be further monitored or corrected. In the vast majority of cases, medical devices are not found to have major safety problems when assessed in this way. Early detection and correction of identified safety issues issues using these processes can reduce the quantity of affected devices being sold and used, therefore shrinking the total cost of required remediation for businesses.

PMS data sources for medical devices

The manufacturer should gather and analyse the data on the product fault investigations, sales data, manufacturing information and other relevant data. Assess the risk management file for the device, whether the issue encountered is a commonly encountered side effect within normally expected limits, clinical risk information and the risk to benefit ratio of the device. Use this to determine the clinical risks, and whether the threshold and criteria for initiating a Field Safety Corrective Action or recall has been met.

A decision is then made by the manufacturer whether a field safety corrective action should be performed, based on the results of investigations. The result of this investigation and decision made should be documented.

Remediation in case of  FSCA

There are several ways in which the device could be remediated if a field safety corrective action is required;

• Return or destruction of a defective device, to remove the product from use
• Exchange of a defective device with a non-defective replacement
• Modification of a defective device, for example replacement of a defective component, implementation of a design change or a software update
• Retrofit of a device modification
• Update of information for safety, for example a new contra-indicated patient group in the IFU

Completing an EU Field Safety Corrective Action notification

The steps involved in completing an EU Field Safety Corrective Action notification. Are generally considered to be;

1. Collate sales and distribution information on all potentially affected products codes, batches and individual devices, which may exhibit the safety issue.
2. Assess safety information and make a decision on whether a Field Safety Corrective Action is required.
3. Draft a Field Safety Notice, there is an EU published template document Translations of the field safety content may be required.
4. Provide the field safety notice and relevant information to the competent authority in each member state.
5. Obtain consent from each EU competent authority on the content of the field safety notice.
6. Inform all distribution supply chain partners, customers and end users, to cascade the information through.
7. Set regular follow ups if responses to the Field Safety Notice are not received.
8. Perform any necessary remediations, replacements or other corrective actions to the affected devices
9. Keep the competent authority informed of the status of the corrective actions in their country, at the frequency requested.
10. When all recall activities have been completed, send a notice of closure to the competent authority in each country.

This is a high level summary of key requirements, the full process and additional considerations are outlined in more detail within EU medical device regulations and EU guidance documents.

If you need support in understanding how and whether to perform an EU field safety corrective action, or need support in performing the necessary regulatory actions IMed can help.

Why not get in touch at hello@imedconsultancy.com or by calling 01295 724286 and find out?