Sunday, May 2, 2010

FDA says commercial software kills, but Open Source won't?

In the last couple of weeks the Food and Drug Administration (FDA) has decided to take on the external Infusion Pump industry. Saying that these devices have harmed to many people, because of bad interface designs, and bad software.

  • "Software Defects. Many of the problems that have been reported are related to software malfunctions. For example, some pumps fail to activate pre-programmed alarms when problems occur, while others activate an alarm in the absence of a problem. Other software errors can lead to over- or under-infusion. In one case, a software problem called a “key bounce” caused an infusion pump to occasionally register one keystroke (e.g., a single zero, “0”) as multiple keystrokes (e.g., a double zero, “00”)."
  • "User Interface Issues. There have also been numerous reports of confusing or unclear on-screen user instructions, which may lead to improper programming of medication doses or infusion rates. For example, the design of the infusion pump screen may not make clear which units of measurement (e.g., pounds versus kilograms) should be used to enter patient data, leading to inappropriate dosing."

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, and in the home.

The FDA is going to be holding a public meeting May 25 and 26, 2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting must register by 5 p.m. on May 18, 2010.

"The Food and Drug Administration (FDA) is announcing a public meeting regarding external infusion pumps. The purpose of the meeting is to inform the public about current problems associated with external infusion pump use, to help the agency identify quality assurance strategies to mitigate these problems, and to solicit comments and input regarding how to bring more effective external infusion pumps to market."fu

The public meeting will be held at the Hilton Silver Spring hotel, 8727 Colesville Rd., Silver Spring, MD 20910.

To correct these Infusion Pump problems the FDA has started their Infusion Pumps Improvement Initiative.

The FDA has partnered with the University of Pennsylvania to create the Generic Infusion Pump (GIP) project. This project is to develop a set of generic infusion pump (safety) models and reference specifications that can be used as a reference standard to verify safety properties in different classes of infusion pumps. They supply an example State Machine among other things.

While I think that the FDA University Partnership is a good thing, I have blogged in the past about the split between industry practice and academic research, where I ask How do we get safe software from Academia that deals with real world economics of real hardware?. I've sat on Government committees in the past where I was the only person who actually had to ship a product. Without input from people doing the work on the ground directives from-on-high usually result in impossible to meet requirements, that allows one to ship a prodcut. Lets hope that this Open Source initiative saves lives.

The FDA offering its in-house expertise to help prevent malfunctions in infusion pump software. "FDA’s software experts are proficient in static analysis of software code, which can help to identify programming errors. In its letter to infusion pump manufacturers, FDA is offering manufacturers the option of submitting the software code used in their infusion pumps for analysis by agency experts prior to premarket review of new or modified devices, in order to facilitate the early detection and correction of any design defects."

The FDA is launching a new infusion pump website, which features basic information about infusion pumps and commonly seen problems. The site also describes actions that patients and professionals who interact with infusion pumps – including hospital staff and administrators, as well as home users – could take to help prevent safety problems. FDA encourages all users to report infusion pump problems, in order to help the agency develop a better understanding of the risk-benefit profile of these devices and take appropriate actions to enhance patient safety.

Something else the FDA has started to take on is Home Use Medical Devices. Homes can present design challenges that we as designers do not think of because we see them so often they do not enter our conscious mind, such as Cat Fur. For example cat fur in a patient's kidney dialysis tubing entered the patient's body and caused peritonitis, a potentially life-threatening infection of the membrane that lines the organs inside the abdomen. [Was the cat fur left over from the static tests?]

A more generic problem in the medical arena is Alarm Fatigue. Having just spent a lot of time in the hospital with my late father, I know how annoying, and how often the various medical alarms are turned off or ignored. Philips warning letter illustrates the point: Switching the alarm source from Heart Rate to Pulse without considering that ECG and arrhythmia alarming is not available in this mode about bad interface and Alarm Fatigue.

Over at Safety Leaders you can find a lot more information on medical mistakes such as the documentary, Chasing Zero: Winning the War on Healthcare Harm.