More of the moment news concerning medical device recalls is appearing in the headlines. We checked the ‘Predicting Recalls Model’ and yes, more current recalls are scoring a ‘1’ in the model, meaning they were predicted.
Details of the recall involving the INGENIO family of pacemakers and CRT-can be found on the FDA website. Issues have been reported with the product transition to safety mode.
There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.
In the recall details of the HeartWare HVAD system, the company initiated the recall June 3, 2021 with 4,620 devices recalled in the US to date. More details can be found on the FDA website.
In both cases, the Predicting Recalls Model scored these products as highly likely for recall at multiple time points.
Using publicly available data and a machine-learning algorithm, we are seeing some startling results from the model.
With the insights provided by the model, we believe many stakeholders can make better decisions that improve patient safety, mitigate reputational risks, improve product quality, make better financial decisions and guide policy decisions.
These are more examples of how the multi-iterative, criteria-driven model has shown directionally to predict medical device recalls. Specialty categories have yielded the most interesting results.
What is the basis of the source data? The historical data from FDA and other public sources has been normalized, aggregated and forms the core analytical database of Reed Tech Navigator™ for Medical Devices.
The results are encouraging, creating additional possibilities for the many use cases that are solved utilizing the source database, Navigator™ for Medical Devices.