Field Safety Corrective Action (FSCA) in the MedTech industry is a complex and time-consuming process, due to both the global nature of the market and the scale of operations. Every year, approximately 12,000 product FSCAs are initiated, affecting over 60 million individual products¹. The complexity of FSCA’s vary depending on the type of product, the country of distribution, and the nature of the FSCA itself. Managing this process effectively is a significant challenge.

FSCA’s in the MedTech sector can be categorised into voluntary and mandatory. Even straightforward tasks like issuing a notification to inform users of a potential issue with a product can be complex when it involves reaching users in multiple countries. For instance, sending out notifications in 50 different countries requires translating the field safety notice into multiple languages, ensuring accurate distribution and verifying that each facility acknowledges receipt of the notice. This is particularly challenging when some organisations rely on outdated systems to manage FSCA’s. IQVIA provide a service to overcome these challenges offering multi-lingual capability both in terms of translations and talking to customers in their native language.

MedTech companies often need to secure responses from receiving facilities such as hospitals and healthcare providers. Identifying the correct points of contact, obtaining confirmations, and tracking responses across various countries and regions adds another layer of complexity. Different countries may also have unique FSCA processes, making it difficult to maintain consistency in tracking responses and reporting. For companies without modern centralised systems, this can lead to inefficiencies, delays, and a higher risk of errors.

More complex FSCA’s, such as those involving product upgrades, replacements, or large-scale returns, add further logistical challenges. For example, upgrading medical devices may require sending teams into the field to physically install new equipment, re-train staff, or remove defective products. The coordination involved in these processes can be overwhelming, especially if companies attempt to manage them manually. IQVIA can facilitate product returns, collation, warehousing or destruction on behalf of MedTech companies and can also arrange in-person attendance at customer sites to facilitate updates to devices.

A lack of efficient systems can also result in communication breakdowns, delayed actions, and even noncompliance with regulatory requirements, all of which can have serious consequences for patient safety and the company's reputation and IQVIA can work with organisations to offer a global platform which captures data in one place.

The challenge of unpredictability

A significant challenge in FSCA management is the unpredictable nature of them. While companies accept that FSCAs are an inevitable part of the MedTech business, they cannot predict when an issue will arise or the scope of the problem. Some companies may go years without experiencing an FSCA, while others may face multiple FSCAs over a short period of time. This unpredictability makes it difficult for companies to plan ahead.

It can be hard for MedTech companies to have a dedicated FSCA management team because FSCAs can be infrequent, so keeping staff solely for these operations can be expensive. When an FSCA does occur it requires significant time and coordination, which can overwhelm existing teams who do not have the capacity, experience, know-how and proper processes to manage the additional work. This influx of work adds intense pressure, particularly when teams are already managing other critical responsibilities. Without a suitable plan in place to manage FSCA’s, companies may experience delays, inefficiencies, and regulatory noncompliance.

Due diligence

Successful FSCA management in the MedTech industry requires a high level of due diligence. Companies must ensure that they have made every reasonable effort to contact affected parties, including repeated attempts via phone calls and emails. Regulatory authorities require proof of these efforts, making it essential for companies to document their actions. This is particularly challenging for smaller organisations that may lack the necessary resources, manpower, and systems to do this.

The use of technology has become essential for managing FSCA’s effectively. Traditional methods, such as using spreadsheets and manual tracking, are no longer adequate to meet the complexities of global FSCA’s. A robust customised platform helps companies streamline and automate many parts of the FSCA process reducing the risk of errors.

A comprehensive global platform for FSCA management handles every aspect of the process, from in-field resources for field actions to initial notifications and consignee response tracking. This ensures that MedTech manufacturers can demonstrate due diligence to regulatory authorities by showing that they made multiple attempts to secure a response from all affected parties.

NHS Supply Chain

NHS Supply Chain supports the NHS by procuring products and delivering consumables and medical equipment on behalf of the NHS in England and Wales. They have an essential role in handling MedTech FSCA’s by coordinating with suppliers and healthcare providers to manage these swiftly and efficiently.

When an FSCA is issued, the primary responsibility typically lies with the manufacturer or their appointed agent, who introduced the product into the UK market. NHS Supply Chain helps ensure regulatory compliance by maintaining rigorous processes that align with current regulatory standards, as their role in NHS procurement gives them a strong brand and regulatory responsibility.

To manage an FSCA, NHS Supply Chain works with cross-functional experts to assess alerts from the MHRA, stopping the distribution of affected products when needed and coordinating FSCA’s for high-risk items. This process may include removing stock from distribution centres and notifying NHS Trusts. They also collaborate with manufacturers to ensure they cover any financial costs associated with the FSCA.

Tightening legislation within the UK

The Post-market Surveillance (PMS) Statutory Instrument (SI), laid in Parliament in October 2024 marks the first significant update to UK medical device regulations framework, spearheaded by the Medicines and Healthcare products Regulatory Agency (MHRA). This UK-wide MedTech regulatory reform introduces major updates to PMS and corrective actions for medical devices, with key provisions including: