A safety alert arrives: what a hospital should be able to answer within hours

A manufacturer reports that a batch of a device may fail. Or an alert arrives from the health authority. The question the hospital asks is always the same: do we have it, where is it and who received it? Whether it is answered in hours or in weeks does not depend on what is done that day, but on what was recorded before.

Where the alert comes from

The European Medical Device Regulation (EU) 2017/745 (MDR) requires a manufacturer taking a field safety corrective action to inform users without delay through a field safety notice. The notice must allow the affected devices to be identified, including their UDI, and explain what the user has to do.

National authorities may also circulate their own alerts, and the channels vary from country to country. The underlying question is the same.

Four questions you need to be able to answer

1. Do we have the device? Knowing whether the affected reference and batch were purchased or received, and in what quantity.
2. Where is it? Locating the units left in the central store, in the rooms or in the supplier’s consignment stock, and setting them aside so they are not used.
3. Who received it? Identifying the patients who were implanted with it, so the clinical team can decide on follow-up.
4. What have we done? Keeping a record of who was informed, what was withdrawn and when, in case the authority or the manufacturer asks.

With well-recorded traceability, the first three questions are answered in hours. Without it, in days or weeks, going through delivery notes, theatre records and patient files.

What usually goes wrong

• The product master does not help. The manufacturer’s reference does not match the internal one, or nobody knows which batches were received.
• The material is scattered. There are units in several stores, in the rooms and on consignment, and nobody has the full picture.
• Use was not recorded. The implant was noted on paper, from memory or in a system that is not linked to the rest.
• The alert has no owner. It lands in an inbox, gets forwarded and it is unclear who coordinates and who closes it.

Getting ready before it arrives

The best response to an alert is built on ordinary days:

• A clear procedure, with someone who coordinates and the departments involved (supply, pharmacy, operating theatres) knowing what their part is.
• Use recorded at the point of use, linking each device to the procedure and the patient. We explain it in UDI traceability.
• Visibility of stock by location and batch, including consignment stock.
• Alert drills: from time to time, simulate that a real batch is affected and check how long it takes to answer the four questions. The Synexia platform can run these simulations and identify the supposedly defective material.

If the drill takes hours, the hospital is ready. If it takes days, it knows where to start.

To see how we approach it, see our Implants and consignment stock and Smart rooms and stores solutions, or take our self-assessment.