Author: Rachel Benway, Product Manager Reed Tech
Since 2016, Reed Tech has been designing and curating the Navigator™ for Medical Devices database. At this point, it is a vast and rich source of medical device data. Using this database, we were able to run some interesting demographics on FDA recalls.
Navigator contains recall data going back to 2010. There are currently over twenty-one thousand individual recalls. As would be expected, recalls of Class II products are the most common since there are many more Class II products.
At the moment, there are six thousand, six hundred seventy-eight individual recalls that are open. And the average length of time that each recall event is open is 502 days.
It appears that recalls are increasing in length over the last few years.
Additionally, we can aggregate individual recalls by root causes. Device design is the most common FDA root cause followed by nonconforming material/component, process control and software design. All of these top root causes are within the control of the manufacturer.
Medical device recalls are an especially interesting event to study as they are costly for the entire industry with an estimated cost of between 2.5 and 5 billion dollars per year*. Recalls can also cause damage to a manufacturer’s reputation and slow down their research and development as money has to be moved to management of the recall**. For hospitals, reputation and patient safety are at risk when devices are recalled. Additionally, recalls can severely lower the value of an investment or business transactions. With the ability to predict recalls, everyone will have more information to power better decisions in terms of managing the perception of a recall, purchasing options and investment due diligence.