EpiPen failures not to be ignored

Recent data surrounding reported EpiPen failures should not be ignored. Data reviewed has found that, in the last few years, there has been hundreds of reports of EpiePen failures that have led to a number of hospitalisations, and potentially some deaths.

One issue reported after a failed delivery from an EpiPen was the needle sticking out of the device at an angle, preventing delivery of lifesaving adrenaline that can stop an allergic reaction from killing someone.

Given the importance of lifesaving devices, these reported EpiPen failures cannot be ignored.

There have been previous recalls of EpiPen devices, but the data that had been compiled of apparent failures was focused more on general EpiPen failures as opposed to batch failures that were known problems. Some of the reports go back over several years, and we don’t think that it’s the kind of data that should be put to one side and ignored. We think it needs to be closely looked at.

According to the data, reports of EpiPen failures have grown and grown in the last six years, to the point where the reported failures were three times higher in 2017 than they were in 2016. A sharp rise was seen in 2014, followed by a gradual increase, and then a huge jump last year. As well as delivery problems with the needles, some devices have been susceptible to leaks, and some devices simply haven’t worked at all.

Any reported failures of a medical device need to be carefully assessed. At the end of the day, we cannot expect every medical device to be perfect and to operate without any problems or hiccups at all. There is, however, an important duty on medical manufacturers to ensure they test products thoroughly before they’re released to market, and ensure follow-up reviews are conducted, and ensure that any problem – no matter how big or small – is properly investigated.

In the past, there have been reported cases of EpiPen failures that were allegedly not properly investigated, which must never happen.

This is a trend that must be closely monitored by healthcare regulators across the world.