Materiovigilance

RN: Do you know anything about MV?

TN: Oh, I’m afraid not at all !

RN: It is a procedure by which the medical staff and the company concerned by the medical devices identify, record and signal some dysfunction for investigation and treatment of adverse events and the means of responding to sanitary alerts. For example, if the extra corporeal membrane oxygenation device presents any flaw, the MV procedure should be set off immediately. And anything about the extra corporeal membrane oxygenation (ECMO)?

TN: Yes. I guess it’s that when patients are unable to provide oxygen for their own blood, or in case of poor blood circulation, we put them on a life support device. The blood is withdrawn from a large vein in the body and passes through a pumping mechanism and then through the device that puts oxygen back into the blood and removes carbon dioxide from it. The blood is then returned to the body and circulated in such a way as to sustain life.

RN: This is exactly it.

TN: But what’s the point between MV and ECMO?

RN: This is where MV comes in, actually. As I told you before, the procedure aims at monitoring any incident or any risk of incident that might result from the use of medical devices. In that case, for example, if the ECMO happens to be defective in anyway, preventive or corrective measures are then triggered for the patient’s safety.

TN: Are there any special directives that regulate MV?

RN: Yes. The European directives guarantee the users’ protection and require that all products and materials to be controlled according to « harmonized » standards and specifications.

TN: What are these standards about?

RN: They concern the health and safety of the patients. In other words, these directives insist on what we call acceptable risks versus the benefits for the patients, but also on the conformity of the products to the European health and safety standards according to the bills L. 5 211-1 and L. 5 212-2.

TN: Oh, but can you more specific on that?

RN: Sure. It says that the manufacturer of the devices, the users and any third party must signal, forthwith, any incident or risk of incident that would jeopardize the patients’ health and safety which might result in death or serious health deterioration of the patients, users or any other person, whether intentional or accidental. And therefore, the National Agency of Health Safety must immediately be notified.

TN: Therefore, the objective of MV is to avoid any material error or dysfunction of medical devices that would expose any user to danger, and to take the appropriate preventive and corrective measures. But then does MV apply to all medical domains?

RN: Oh no, just on single-use consumables, passive or active implants, equipment, and even manufacturers’ software for therapeutic or diagnostic aims. Therefore, we exclude products of human origin like blood, plasma, organs, drugs and cosmetic products, for example.