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Shafer includes a disclaimer with his program that states "administration of anesthesia using STANPUMP is your responsibility, not mine." But that's not quite enough. He has also been forced to explicitly label the program as "experimental" -- not approved for use with humans. Who forced him? The FDA.

"STANPUMP caused me considerable scrutiny by the FDA several years ago," says Shafer.

The problem, says Shafer, is that under FDA guidelines, STANPUMP qualifies as a "medical device" that must be licensed and approved by the FDA.

"I was liable for potential fines of several thousand dollars per distributed copy of the program," says Shafer. "At that point several thousand copies were in the hands of anesthesiologists, although few were using the device for clinical care, but clearly the regulatory issues alone opened me up for potential penalties in the millions of dollars ... The compromise I reached with the FDA was that as long as I clearly listed on the program that STANPUMP was experimental, and not approved for human use, I would be in compliance with the intent of the regulations."

"I hate to throw any cold water on their [LAMDI's] enthusiasm, because one never knows where things will lead. However, unless they are exceedingly committed in their efforts, I fear that there are some obstacles that they may have trouble overcoming," says Shafer. "It would cost me literally millions of dollars to obtain FDA approval for the program, a cost that would never be born by any potential revenue from the program. Thus, STANPUMP has no potential to meet the software needs of the anesthesia community ... Thus, FDA regulations alone appear to foreclose the viability of open-source software."

Shafer sees other problems besides the FDA. Operating systems like Linux benefit from the open-source model because there are hundreds of thousands of developers willing and eager to hammer on each new version of the code, looking for bugs.

"How many programmers are going to be excited about anesthetic drug delivery," wonders Shafer, "and in a position to test and debug open-source versions of the software? In the 10 years that STANPUMP has been in the public domain, about 10 individuals have actually taken the code and incorporated it into other programs, or used it to vet their own computer-controlled drug delivery programs. Of these, probably only two or three actually had the mathematical background to actually understand the pharmacokinetic routines."

Finally, notes Shafer, one simply can't depend on grass roots energy when working with patients in life-threatening situations.

"There are reasons that the FDA wants software to be vetted by its regulatory process," says Shafer. "There is a non-zero chance that my STANPUMP program might fail at some critical moment, and thus expose a patient to a grave risk. There are good programmers who test the hell out of everything, and there are lazy programmers who may distribute changes in the software that have never been tested. It is one thing to distribute Linux to several thousand people running WWW servers -- in the worst case several thousand WWW servers crash. It is quite another thing to distribute a new version of medical software, and suddenly several thousand balloon pumps stop working, resulting in death in hundreds of patients. A company simply has no alternative to very thoroughly testing every release of their software. However, the author of an open-source program may be trying to get a patch released between cases in the operating room -- with dire implications for the user."

The question is not hypothetical. Peter Kohn, a lawyer at a Philadelphia law firm that specializes in medical malpractice and product liability suits, says his firm is currently representing a client in the case of a woman who died while under anesthesia in the operating room. According to Kohn, the nurse-anesthetist who was administering the anesthesia is claiming that an anesthesia machine that was supposed to monitor the patient's blood oxygenation level failed to sound an alarm when the level got too low. Before the nurse noticed the problem, the patient had already suffered brain death.

Leonard Fodera, the lawyer handling the anesthesia case, says there is no evidence that the machine, or the machine's software, was at fault. In his opinion, doctors often tend to unfairly blame mishaps on machine failure. But he did concede the possibility that a lethal software or mechanical failure could occur -- and he argues that in such cases the manufacturer or software publisher should be found at fault.

Next page | Who pays the piper when software goes bad?