Software in Medical Devices, by MD101 Consulting

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Pfizer recalls Rheumatology Calculator smartphone App

Dozens of companies recall their medical devices every month. A recall happens when something wrong happened with the device, like a bad labeling or a bad sterilization. It's the responsibility of the manufacturer to warn ALL their customers and the government agencies that a given lot or batch of products has a defect. The batches shall be destroyed or sent back to the manufacturer for further analysis.
That's what happened to Pfizer with its Rheumatology Calculator, a smartphone app used to compute a score to assess the desease of patients according to complex algorithms. There is a bug in the app and it gives wrong results.

Pfizer had to remove it from Android market and Apple Store. At the time I publish this post, if you search for this App, you won't find it in either stores. Pfizer had also to warn government agencies. See swissmedic recall here, the agency of Swizterland, and MRHA recall here, the agency of the UK (scroll down or search Pizer in both web pages).

Disclamer: what I write below is not linked to the way Pfizer manages the lifecycle of the Rheumatology Calculator App. I don't have any further information than what I wrote above.

How to recall a smarphone App?

In the case of a smartphone app, it is not possible to recall it eventually. Once the app has been downloaded by the user, there is no possibility to erase it from the phone. Or if there is a possibility, I haven't seen the case yet. In the case of Apple, I trust them to apply coercitive measures on banned Apps! For Android, I don't know if they can ban apps. On top of that, the user is the weak link, who has to synchronize his smartphone with the store to get the latest evolutions. Many users, like me, synchronize only once a month. So a buggey app can be used a long time by a user before he is warned about the situation.
A software medical device manufacturer shall certainly send a mail to every user to request him to remove the app. Maybe he shall ask the Apple and Android markets to give him the list of users who downloaded the app. App Markets are highly controled places. Everything is logged. So it shouldn't be a problem to warn the users to remove an App and to get an acknowledgement that it was actually removed.

How to prevent a recall?

A recall shall happen when a critical bug is found in software. In the field of medical devices, a critical bug is something, which gives a bad result or does a bad action, leading to a bad decision of the pratician or the patient. Such bug can be hidden a long time, until a user does something which was never encountered and tested, like an unexpected combination of parameters and actions.
The only way to prevent this kind of situation is to have a good software development process. Software on smartphones, which gives information about diagnosis, may be class IIa according to the EU regulations and class II according to the FDA regulations. According to the IEC 62304 standard, which deals with software development, this kind of software may be in class B.
When software falls into this class, a software development process shall be implemended with the majority of the requirements found in the IEC 62304. This definitely is the best way to avoid a recall.

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