FDA Regulation

Some emails this morning prompted me to write this. I have many thoughts on FDA regulations which are mainly formulated by my contact with companies that comply with FDA regulations. Note that I have no experience getting something FDA certified. If you do and want to comment please do so.

First I note that FDA regulation does not produce quality software. Whatever goes on does not include rigorous testing, How do I know? The number of bugs that appear in FDA regulated software. I have seen all sorts of bugs from showing the wrong patient data to crashing on legal DICOM to processing HL7 messages incorrectly. That is to say nothing of crashes, system hangs or other phenomenon. One of my colleagues could crash a leading vendors 3D workstation on demand. It was always funny to do it in their booth and watch their people squirm.

Second some vendors have used and still use it as an excuse to sell hardware at hugely inflated prices. Some are worse than others and at the slightest modification to a system throw up their hands and talk about how they cannot guarantee that their system will work. Once a vendor told us that hooking a trackball to a PACS workstation instead of a mouse could cause the software to click on random things. After all the mouse had not been validated. Fortunately our administrator told them just where they could stick that line. For anyone familiar with software you know that mouse movement is controlled through an abstraction layer and the software has no idea what it is talking to.

So just what is this regulation getting the customer? Not a lot other than expense. Quality software is built by having good developers and employing good software development techniques. People interested in this should check out the book ‘Dreaming in Code’ by Scott Rosenberg.

Now obviously this is anecdotal and you may reader may cry foul and say that this is all not really true. I know of no company that compiles data on software quality in healthcare. Healthcare software companies would throw up all kinds of roadblocks if this was attempted since I think most of them know what would be found. So all we have today in anecdote.

In summary I view the FDA regulation of software as a waste of time. It is good that they try to make sure that companies are not cooking people with radiation and that at some level they keep the pharma companies in line although that is a completely separate and very complicated issue.

  1. I agree its not as effective as it should be but I do think – particularly with PACS that the FDA (ideally) have a role making sure that vendors don’t foist some new (e.g.) reconstruction algorithm on users without having their methods examined in some fashion. The question of code quality, tho, I think CCHIT would be better placed (of course that means the two organisations talking to each other!). I have some thoughts: http://inflection-technologies.com/PACSFerret/2007/11/01/is-pacs-a-medical-device/

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