Recalls for medical devices - a quality problem

When it comes to functional safety systems, quality is critical: not only are high investments at stake, but also danger to life and limb. Furthermore, such an incident can jeopardize the existence of a company. Increasing complexity in systems leads to increasing quality problems. To name just one example: The number of medical device recalls has increased by 71% in a two-year period. And that's not all.

According to Qualio an average of around 60 million medical devices were recalled per quarter in 2016 and 2017. However, in 2018 and 2019, this figure increased to almost 100 million recalls per quarter. However, this figure only relates to the USA. The statistics are still subject to strong fluctuations, as can be seen in the raw data:

Find more statistics at Statista

Incidentally, the outlier in Q1 2018 is not attributable to a single product. Even if the figures later fell again, there is no reason to sound the all-clear.

Software the main reason for recalls

Not really surprising is the fact that in many cases software is the reason for the recall. (See, for example, the Medtronic PR disaster.) With 23% however, this is only just the most common reason, closely followed by incorrect labeling (21%).

Recalls do not have to be large. For example, in the USA there is about one recall every five days, which indicates many small recalls and not a few large ones.

More threats to life

The severity of recalls has also increased. In the USA, recalls are divided into classes I-III. With Class I, there is a serious risk to health and life. The number of Class I recalls increased by almost 10% between 2017 and 2018.

What to do?

It certainly makes sense to invest in quality assurance. A first step is to understand compliance requirements and implement them correctly. In Europe, for example MDR (Medical Device Regulation) a topical issue. This EU regulation must be implemented by May 2021 at the latest. However, there is no reason to wait - after all, MDR was already adopted in 2017.

But even the best quality assurance cannot always recognize and solve all problems in time. This is why we recommend being able to implement a recall quickly and efficiently at all times. This includes, for example, continuously tracking suppliers, customers and products. The same applies here as with backups: we hope that we will never need them, but we should always be prepared for the worst.

Photo by Natanael Melchor on Unsplash