Are hospitals really safe?

Now that we have access to more information about health care and what goes on inside a hospital, what should we be most worried about? How do human errors prevent us from getting the best possible health care when we do have access to fabulous diagnostic tools and intelligent health care professionals? But This week, I found 3 articles giving scary details about medical errors done in hospitals. Do you know that according to various estimations, the number of preventable deaths caused each year by medical errors in American hospitals alone range from 98,000 to 195,000? And here are some causes of these medical errors. Last week, the Baltimore Sun wrote that flaws in medical coding can kill, adding that FDA officials think that the spread of computers creates new dangers. The next day, Penn researchers released a study stating that they’ve identified flaws in the barcoded technology used to reduce medication administration errors. And today, Technology Review reports that the interoperability of medical devices could make hospitals safer, meaning it’s not safe today. Scary stories… [(Update: July 10, 2008) One of my alert readers told me that the two first sentences of this post were unclear. So I've rewritten them.]

Let’s start with the introduction of the Baltimore Sun article. “After a routine piece of medical equipment started mysteriously killing hospital patients a few years ago, the federal government turned to a small team of its software experts in suburban Maryland for help. The team’s discovery — a flaw in a computer code that caused a drug pump to administer heavy overdoses — led to a recall, warnings and rewriting of the equipment’s software. The discovery also illustrated a new threat behind some lifesaving medical devices.”

And don’t think that this software recall was an isolated case. “Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software.”

Of course, like with any other software these days, it’s difficult to identify — and fix — the bugs. “Finding a killer buried in a medical device’s source code is not straightforward detective work. The directions for an implantable defibrillator might run over 100,000 lines — as long as War and Peace — and cover a multitude of possible actions that could take a decade for the device to run through.” Brian Fitzgerald, who heads the FDA’s software specialists, adds that his “team of investigators doesn’t have that kind of time, especially when patients are dying.”

Now, let’s turn to the Penn researchers study. “In the first study of its kind, researchers led by The University of Pennsylvania School of Medicine’s Ross Koppel, Ph.D. studied how hospital nurses actually use bar-coded technology that matches the right patient with the right dose of the right medication. The surprising result is that the design and implementation of the technology, which is often relied upon as a ‘cure-all’ for medication administration errors, is flawed, and can increase the probabilities of certain errors.”

The researchers said that some nurses were overwhelmed by some difficulties inherent to the system. “The researchers found a remarkably high proportion of scans involved nurses overriding the technology with workarounds to compensate for difficulties with the barcode systems. These researchers found that nurses scanning the barcode on the medication or the patient’s ID bracelet overrode the technology for 4.2% of patients charted and for 10.3% of medications charted. In contrast, vendors of barcode medication administration (BCMA) systems report error rates that are a small fraction of this study’s numbers; but vendors focus primarily on the ability to physically affix and read barcodes, not on the totality of the many processes in actual use.”

The Penn team still thinks that improvements of the current system could benefit to patients. “Hospital patients, on average, are subject to one medication administration error a day, according to the Institute of Medicine, and in hospitals, medication administration accounts for 26% to 32% of adult patient medication errors. Thus, an automated system using barcodes to reconcile a patient’s medications and orders with the patient’s identity would be a great advance, helping to ensure the right patient receives the right dose at the right time.”

Finally, let’s look at the Technology Review article which carries the ironic title, “‘Plug and Play’ Hospitals,” and which states that “medical devices that exchange data could make hospitals safer.”

Here is the introduction. “The bewildering variety of new medical devices in U.S. hospitals promises higher standards of care. But it also poses new opportunities for error. A growing number of physicians believe that the interoperability of medical devices — their ability to communicate with each other — could make hospitals safer and more efficient. ‘Today, there are many proprietary systems available from different vendors, but the problem is, these systems can’t talk to one another,’ says Douglas Rosendale, a surgeon who works on information integration at Veterans Health Administration and Harvard Brigham and Women’s Hospital. ‘If they can’t interface, then they can’t share information, which could have an impact on patient care.’”

As Kristina Grifantini reports, “Julian Goldman, director of the Center for Integration of Medicine and Innovative Technology’s Medical Device Interoperability Program, based at Massachusetts General Hospital, has developed two demonstration projects that illustrate the idea of the ‘plug and play”‘ operating room.”

However, Goldman is not very optimistic about the issue of the interoperability of medical devices — at least in the short term. One “barrier is old-fashioned competitiveness. A vendor that produces medical equipment tends to make its devices compatible only with each other. But as Goldman points out, many emergency rooms need such specialized equipment that no one vendor can produce all of it. So selecting a single vendor won’t solve the interoperability problem. ‘We’re probably a ways off from true interoperability,’ said [Douglas Rosendale, a surgeon who works on information integration at Veterans Health Administration and Harvard Brigham and Women's Hospital.] ‘However, there is clearly momentum growing in this area. As computer technology and device dependence grows, that means interoperability is going to be more and more obvious.’”

Please read the three articles mentioned above before forging your opinion. And tell me if you think these studies are exaggeratedly alarmist or not.

Sources: Jonathan D. Rockoff, The Baltimore Sun, June 30, 2008; The University of Pennsylvania School of Medicine news release, July 1, 2008; Kristina Grifantini, Technology Review, July 9, 2008; and various websites

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