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Life or death software
A proposal for open-source anesthesia software heightens
----the drama of the question: Who's at fault when software fails?

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By Andrew Leonard

August 5, 1999 | Heart rate, pulse, temperature, blood oxygenation levels -- there's a lot to keep track of when a patient undergoes anesthesia. And that's just the beginning. Anesthetic gases and intravenous knock-out drugs come in a bewildering variety, and even the best anesthesiologists don't always know exactly how the drugs will interact with a human body. A lot can go wrong -- a mistake can lead to brain death in a flash.

Stefan Harms, a resident in the department of anesthesiology at the University of Manitoba in Winnipeg, believes that anesthesiologists could use better help. One part of the answer, he's convinced, is better anesthesia software -- programs that will monitor and record patient data, conduct real-time modeling of the effect of different drugs, and even directly control the infusion of those drugs. Yes, there are anesthesia machines and software packages that address some of these jobs, says Harms, but they are either too expensive or they don't do everything Harms wants. Sure, if you're a hospital with $60,000 to fling about, you can buy a state-of-the art Narkomed 6000 -- but many hospitals are on a tighter budget.

When he isn't in the operating room taking care of patients, Harms is hacking on the five computers in his basement. And he thinks he knows how to achieve his dream of low-cost, reliable anesthesia software -- by going the open-source route. Last year, Harms founded LAMDI, the Linux Anesthesia Modular Device Interface. Harms thinks that the open-source software development model, in which the source code to a program is made freely available to the general public for redistribution and modification, offers fruitful possibilities for addressing anesthesiological software needs.

Harms is placing his bets on a central tenet of open-source ideology -- the belief that freely available source code encourages a "peer-review" process that produces software that is less buggy and more reliable than proprietary "closed-source" software. The theory is that when everyone can hack on the code, fix problems as they find them, and add their own new features, the code quickly improves. It has worked for the Linux-based operating system, says Harms. Why shouldn't it work for anesthesiology software, where avoiding crashes and bugs is a life-or-death situation?

"There is a compelling argument for open source just for safety reasons," says Harms. "If you use tools and software that are not peer-reviewed, you should be more liable if something goes wrong."

But is the anarchic open-source world really appropriate for the operating room? Who would be liable if the software crashed and the patient died? Some hacker grad student at MIT or Stanford? The anesthesiologist? The hospital? Can free software pay the price of patient mortality?

Lawyers, doctors, and programmers are far from united in their answers to these questions. The problem of software product liability is a hot-button issue for all software developers, whether closed or open source. Commercial software publishers, right now, are pushing for nationwide legislation that would absolve developers of any contractual responsibility for a mishap caused by their software. At the same time, government agencies such as the United States Food and Drug Administration take a very hard look at software that is used in medical procedures. It's all very well to download Linux from the Net and install it on your Web server. But it's a completely different matter to get the latest pharmacokinetic drug-infusion software up and running in the operating room.

The obstacles faced by Harms in his quest for open-source anesthesia software suggest that there are some serious potential limits for the open-source software model. The experience of some medical programmers who have placed their code in the public domain indicates that open source is certainly no panacea for the problems faced by medical practitioners. But there are still some intriguing possibilities. If liability issues can be addressed, and if the peer-review component embedded in open-source software can be proven to result in pragmatically better software, then, suggest some open-source enthusiasts, wouldn't it be our duty to proceed down the open-source road?

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