Simple checklist saves 1500 lives; feds axe it

A New York Times piece by Atul Gawande gives some good news and bad news about a life-saving checklist developed to prevent fatal infections in intensive care units.









The good news:

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

The bad news:

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

The government's decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk -- by exposing how poorly some of them follow basic infection-prevention procedures.

Truly stunning. The Times article is not long and is well worth reading, as is the New Yorker article from 12/10/2007 article from 12/10/2007 in which Gawande described the genesis of the checklist program. (That was before the Office for Human Research heard about it and gave it the shaft.)

More like this

I guess there are a lot of things in the newspapers that leave you shaking your head, but a recent Op Ed by surgeon Atul Gawande left both Mrs. R. and me shaking our heads simultaneously, accompanied by jaws headed south and and eyes bulging. Quite a visual, I admit. But consider the source. I'll…
The other day, I happened across an Op-Ed article in the New York Times that left me scratching my head at the seeming insanity of the incident it described. The article, written by Dr. Atul Gawande, author of Complications: A Surgeon's Notes on an Imperfect Science and Better: A Surgeon's Notes on…
...and scuttle one of the best efforts going to reduce the problem of antibiotic resistance. I discussed before how the antibiotic resistance problem is, in the context of hospital infections, an infection control problem: One of the hidden stories in the rise in the frequency of antibiotic…
Innovation in healthcare doesn't just mean new drugs and devices; sometimes, studying and updating procedures can result in big improvements for patients' health. In the New York Times, Gina Kolata reports on procedure changes hospitals have made to improve care for heart-attack patients: With no…