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Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths may have occurred as a result.
The heart controls the blood flow in our bodies and relies on aortic valves to ensure the blood is pushed in the right direction to reach our organs and limbs. However, over time, these valves can become weak or damaged and don’t close properly which can lead to blood leaking back into the heart, making it much harder for the heart to pump it outwards to the rest of our bodies, resulting in heart failure. Artificial mechanical valves can be fitted to replace the weakened or thickened valve.
The surgical procedure carries a low probability – yet extremely dangerous – risk of error if something goes wrong. Although the replacement valves are very durable and should last a long time, if the implanting procedure is carried out incorrectly, patients are put at risk.
In the five reported cases, at least two are known to have been fatal. In terms of fault, the MHRA noted that:
Manufacturers are urging surgeons and staff to not reattach a valve to its holder if it comes loose or breaks off to avoid these rare but potentially fatal errors. Notably, some manufacturers like St. Jude Medical (now Abbott) produce holders that are unidirectional so they can’t be put in the wrong way during assembly.
The MHRA received confirmation that three other manufacturers will also redesign their holders this way to avoid any future reoccurrences of the problem.
The MHRA believes the process of changing the manufacturing of the devices will take at least one year, and in that time they’re urging clinical staff and surgeons to familiarise themselves with the risks and how to spot any problems.
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