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Curbside Consult with Dr. Jayne 5/2/11

This has been a bit of a crazy week for me, with entirely too many hours at the hospital. I had a pounding headache after a particularly chaotic shift. After taking the proverbial two aspirin and trying to unwind with some quality Internet surfing, I came across a blurb about the noise levels in hospitals. Could this be the culprit?

Digging deeper into the Chicago Tribune, the article cited “alarm fatigue,” a significant safety issue for hospitals. If you haven’t experienced this personally and you live in the IT or medical device worlds, you’ve probably heard clinicians complaining about what the article describes as “incessantly beeping devices.” I definitely met this face to face while rounding on the cardiac floor, where every patient has a heart monitor.

The Trib mentions the Food and Drug Administration’s responsibility for regulating medical devices, and the scope of its reach is broad. Ever wonder what all they regulate? It’s much more than X-ray machines and prosthetic knees. A list of the various regulated devices is here. I had no idea they regulated some of the things they apparently regulate. Maybe I can use some of them for trivia at my next cocktail party.

Based on their extensive reach, I’m actually pretty surprised they haven’t yet gotten into the electronic health records arena. Many people are calling for FDA regulation. The Tribune article brings up some important points, however. FDA, in its regulation of devices, hasn’t been able to find the “sweet spot” between specifying the appropriate alarms to adequately support clinical care while reducing the fatigue caused by overly sensitive parameters.

The piece cites a noise researcher from McMaster University as saying, “People don’t pay attention to alarms; they exist as much for legal liability reasons as much as for actually doing anything for patients.” If we have this situation with devices that have been regulated for years, what does that say about the ability of the FDA to improve the performance of electronic documentation systems?

As cited in the article, ERCI Institute has a top ten list of technology hazards. For 2011, alarm-related adverse events is number two, right between radiation overdose (!) and cross-contamination from flexible endoscopes (yuck). Data loss and “other health IT complications” is number five. This is a pretty serious list: surgical fires and misconnected intravenous lines also made the cut.

The Chicago Tribune isn’t the only major outlet to report on this issue. The Boston Globe ran a piece in February. Their investigation revealed 942 alarms per day on a 15-bed unit at Johns Hopkins Hospital — a rate of one critical alarm every 90 seconds. In studies, up to 85% of alarms have been shown to be false alarms. The FDA is apparently stretched thin already, failing to follow up on case reviews with manufacturers in some cases.

Organizations other than the FDA have gotten into the alarm fray. Joint Commission made alarm recommendations part of its National Patient Safety Goals in 2004, but dropped them in 2005. Some safety experts have lobbied to block hospital staff from turning off critical alarms, a move that was rejected by an industry working group due to caregiver objections and the need to “permit the clinical staff to solve the problem in peace and quiet.”

As a clinician, I experience alarm fatigue every day. Cardiac monitors start beeping when patients turn or cough. IV machines beep when infusions are completed (even if the next infusion isn’t due to start for another 23 hours). My hospital’s EHR warns me that the diabetes drug I’m about to prescribe should be used with caution because it might lower blood sugar. Kind of sad, since that’s the main reason I’m prescribing diabetes medications in the first place — to lower blood sugar levels!

I’d love to see some standards put in place. Standards created by rational clinicians based on data and science, not based on the risk of lawsuits or on anecdotal experiences. The FDA doesn’t seem to have a track record in this area and they don’t seem to have the horsepower to take on regulation of another industry. As a physician, if they had additional funding, I’d like to see them tackle the dietary supplement industry first. How many patients are harmed by taking entirely unregulated substances marketed by greedy manufacturers who can say whatever they want because their product is classified as a food rather than as a drug?

Other federal agencies charged with regulating or advising in these areas haven’t fared much better. The United States Preventive Services Task Force is charged with recommending preventive health care services based on evidence-driven criteria. However, their recommendations have been blasted (and undermined) by various disease-centric organizations and professional groups and even the payment policies of CMS. It’s hard to explain to a patient why a test isn’t justified based on mountains of clinical evidence when they can counter with, “Then why does Medicare cover it?”

Let’s say we’re going to tackle alarm fatigue. Who can do it, how should they do it, and where are we going to get the money to pay for it? I’m interested to hear your ideas.

E-mail Dr. Jayne.