More evidence of confusion among clinicians over medical apps (UK) + MAUDE

A paper just published in the Annals of Medicine & Surgery entitled A UK perspective on smartphone use amongst doctors within the surgical profession also sheds some interesting light on the use of mobile apps by surgeons.

Given the recent advice to members by the RCP against the use of apps that are medical devices though not CE certified, the following finding is of especial interest, as it is widely considered that many clinical calculators meet the EU legal definition of a medical device:

…when looking specifically at senior doctors, the most common type of app utilised was clinical calculators followed by reference guides/handbooks and then drug reference guides.

The paper also confirms findings by this editor and others that clinicians are confused by the wide range of apps available and lack guidance on the effectiveness & efficacy of individual apps.

The majority of participants did not have any relevant suggestions for app development, which may suggest that there is an uncertainty over the catalogue available. Given concerns voiced in both our study and the work of others questioning the reliability of available resources, a possible solution would be the creation of a UK based app directory to outline availability with verification of performance and validity. However given the complexity of this regulation, peer review specific to the UK may have to suffice.

A short & interesting read that very much supports the need for a reference source for clinician-facing apps, and an objective measure of the benefits they deliver: recommended.

Whilst writing, Prof Mike Short has also drawn my attention to a related, very short, article entitled To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter? which thankfully concludes that:

Certainly, adhering to the standards listed <in the article> massively increase administrative overhead in research and development, extend the “time to market” and causes increased costs. However, this is the price to pay for success to reach the goal: Impact on patient care. Therefore, the answer to the question in the title of this article is: Software can be a medical device and from this point of view, we have to accept administrative overheads – and the regulatory framework can be a useful guide-line.

Perhaps more interestingly though it includes reference to the FDA’s ‘Manufacturer and User Facility Device Experience (MAUDE) which records product problems (obviously in the US), including those for medical software. Wouldn’t it be great if the EU had such a database for medical apps?

Important: DHACA’s response to the RCP advice on medical apps


