Software in Medical Devices, by MD101 Consulting

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Monday 23 April 2012

Class A, B or C (continued)

I didn't have time to post anything worth it this week.
To give a side view of my last post about software classes, here is a link to DO-178B on wikipedia. It is the reference about software embarked in aircrafts.
If you take time to read this document, you will see that it goes very further than what we have today in IEC 62304. The constraints about design on high classes are very very hard to respect. That's normal, when you think that software is used in flight commands and other stuff in the cockpit.
It has some side effects, mainly to stretch software development projects, and to ban software from some parts of the plane, for cost-driven reasons.
For example, a microcontroler plus software plus electric motors would be perfect to memorize and retreive the position settings of the pilot's seat. But the cost to develop such software is very high, as the pilot's seat is seen as a critical component. Aircraft manufacturers prefer replacing software and microcontroler by good old analogic electronics to do the same task on some models.
In my humble opinion, the constraints of the two highest classes for software in aircrafts would be to high for medical devices. There is always a pratician, or an emergency medical service, able to "catch" the patient if something goes wrong. Whereas there is nobody to "catch" a falling plane if its flight commands fail. The consequences of risks are far higher in aircrafts, with potentially hundreds of victims in an accident.
That is why classes A, B and C, and their design constraints are enough for medical devices.

Next week, I'll talk about exemptions of ISO13485 for standalone software medical devices.

Friday 6 April 2012

Inflation of software medical devices - part 3

This article is the last of three articles which deal with the concept of "inflation" of medical devices. The first one was on inflation of standards, the second about inflation of regulations. This one, the most interesting to my eyes, is about multiplication of apps on mobile devices, especially smartphones and tablets.
More that 6000 apps are classified in the "heath", "heathcare" or "medical" categories of the Apple or Android appstores. Many of these apps are classified as medical devices and are in the scope of regulations like FDA and CE Mark. Note that some apps may be regulated the FDA but not the CE Mark or vice-versa.

Continue reading...

Thursday 5 January 2012

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.

Continue reading...

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