Category Archives: PACS

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.

PACS 2.0

Dalai has a post about PACS customization that touches on something that I have been thinking about. The current state of what vendors call customization is sadly pathetic. Changing some options is not customization. The first and most basic method of customization is being able to build completely custom UIs. This goes far beyond hanging protocols and would allow the user to alter any visual element in the PACS. The second is having an open and documented API for third party software developers to build software that runs inside or on top of the PACS. This is a toolkit for programmers. The third would be a widget like interface, something like Google IG or netvibes. This would allow power users who are not software developers but are comfortable with editing HTML or other markup languages to make addins and UI widgets.

Why would a PACS vendor ever offer such a thing? Well why does Microsoft allow anyone to write software that runs ontop of Microsoft Office? The reason is simple. Software that is built as a platform is much more valuable than a standalone application. Open source office software is not going to have trouble trying to take market share from Microsoft Office because it is not as good, but rather because vendors and organizations have built thousands of pieces of software that add value to Microsoft Office, making it much more valuable than what comes out of the box.

The first PACS vendor to treat their PACS like a platform will have a real advantage. A good platform is hard to replicate. It is a strong competitive advantage. Do I see this happening? No. PACS companies are too busy replicating each others features to think about truly changing the industry. This is one time where a company should lead its users.

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Osirix is an open source DICOM viewer for Mac. This year at RSNA as usual the osirix team had many talks and demos. One of the talks happened to be in the session that I was also presenting in. The presentation that I listened to was about authoring teaching files using Osirix and other Mac applications and then publishing them to the web. The presenter also showed how simple tagging could be used to tag cases. Come on guys. This sucked.

The teaching files were authored by saving JPEG images and them using an apple web page generator with templates to make a web page that looks nice and upload to an apple site. This is the same single vendor approach that we have been fighting for 15 years in Radiology. Just because it is a mac and has shiny buttons does not make it better. Every piece that was showed can be done on Windows today. Support for the IHE TCE profile, which allows teaching files to be authored from inside the PACS and sent to any TCE aware teaching file was not discussed. Tagging was limited to a single persons tags. Have some imagination. Tagging is about sharing. I love For anything that I tag I can see what other people used. I think that tagging has limited value when it is not social.

In the year 2006 we are trying to build interoperable software. We know we can build single vendor solutions that work. We can build them on any platform. The Osirix people should be looking to the web, not the Mac if they want to really push software in radiology. A collaborative teaching file written in AJAX on a platform like Zoho would be awesome. Allowing people access to your system is what we need. Another Osirix exhibit I saw should how using apple technologies two Osirix system can talk to each other through the Internet. Good Lord. Do the authors really think we are so stupid to think that this is some great breakthrough that apple and the osirix team have achieved. Frankly I am disgusted by what I saw. It is just someone saying "Me too, me too. Look what I can do." Nothing that was shown was original.

What was cool at RSNA

There was only one thing that I saw at RSNA this year that was cool and innovative. That was the next generation software from TeraRecon. It is called iNtuition. TeraRecon has always had a great product with their AquariusNET software. It provides 3D visualization of medical images using server side rendering. I will talk in detail about this some other time.

The new features were great. Automatic anatomy labeling. Woah. The software can now pick out anatomy. This has huge implications for the future since this will open up many new applications that use it. Also iNtuition provides good workflow which previous software did not. The beginnings of what could be the first 3D native PACS may be emerging.

All in all this is a huge step forward. It was also the only really cool and new thing that was shown which was disappointing.

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RSNA Blogger Meetup

So the blogger meetup did not work out as planned. We could not find eachother in NetWorks, which at 5:30 PM during RSNA is a mad house. I did however meet Dalai from Dalai PACS. I had a great time talking with him about IT issues in Radiology. Next year I want to have a more formal event, possibly with some sponsorship or something. Maybe a blogger panel or some kind of discussion would be good too. I will write more when I get home but I don’t know when that will be since it is snowing here in Chicago and lots of flights have been cancelled.

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Agfa Impax 6.0

So Agfa has launched Impax 6.0 last year as a new version of their PACS. I met with some of their architects during its development and I was very excited about some of its features, such as its use of web services. There is a lot of functionality exposed through web services that can be tapped into through custom software, or better yet through orchestration platforms like BizTalk. It used LDAP for user management which means that single sign on is a possibility. So I was excited.

The installation that I watched was a disaster. Granted things are better now. I am not sure how some of the builds got out of QA. Part of me wonders if Agfa (and Agfa is hardly alone here in the PACS industry) has a serious QA effort. Now what I am going to say I relied on about six radiologists. All of that stuff I said about Impax being good as an IT system does not matter. The system was engineered without good workflow. Most of them considered it to be at best no better than the last version of Impax and at worst a moderately sized step backwards.

Dalai PACS has covered some of the problems with Agfa in much more detail. I highly recommend that you read what he has to say about all this.

Today Agfa visited him to talk about his problems. I hope something comes from it. I want Agfa to be a competitive player. More competition will give us better products.

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Picking PACS is like getting married

When people get married it is often after dating for a period of time that lets them get to know each other. It is important to pick a compatible mate for the long term. Buying enterprise software like PACS is basically the same. You and the software are going to wake up everyday and spend numerous hours working together. It is important to pick software that you will be happy to see every morning.

The selection process is partially about mitigating risks that a new system brings with it. As a PACS consultant I want the user to feel happy to see the system in the morning. No matter what I think of a system I am not the one that has to get up and use it. The client is. When a client asks what PACS system they should buy I will have them pick their top three systems from the users perspective. I will rank the same systems on many other criteria and give that to the client.

Why do some PACS workstations have 4 monitors?

As facilities migrate toward PACS one of the key decisions that must be made is the monitor configuration. Most facilities that are going to PACS now will opt for 2 high resolution monitors and 1 regular monitor for worklist. At some older facilities such as the Baltimore VA Medical Center (one of the first sites to go live with PACS) you will still find 4 monitor workstations or 4+1 monitor workstations. This is partially legacy from the first generation of PACS systems. When the PACS was installed at the Baltimore VA in 1993 it was originally supposed to have 8 monitors in 2 rows of 4 to replicate a light box. A light box used to hold the film while a radiologist read them and it could typically hold 8 sheets of film at a time. Because of budget constraints one row of monitors was eliminated, leaving 4 monitors which is what was delivered.

So in 2006 PACS software has come in to its own and does not need more than 2 high resolution monitors. Software has overcome virtually any reason to need 4 monitors. If your PACS still wants 4 monitors you should look long and hard at alternatives the next time you are considering a major upgrade or the purchase of a new system.

The bottom line: There was no workflow reason for 4 monitors.

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