Alarms, CT scanners and infusion pumps top 10 most hazardous health tech list

November 10, 2011
by Brendon Nafziger, DOTmed News Associate Editor
A patient's monitor alarm getting ignored, the overuse of CT scans and faulty infusion pumps topped a new list of the 10 greatest health care technology hazards.

Every year, health care research nonprofit ECRI Institute compiles a list of the most pressing medical technology troubles, along with some advice to ensure your institution is better prepared to face them.

This year's Top 10 Health Technology Hazards for 2012 list includes some familiar woes (inappropriate CT scans, alarm hazards, sharps injuries), showing the tenacity of some problems. But it also highlights growing hazards, including hard-to-use home medical devices, an emerging threat as the American population gets older and requires more assistance at home.

Some concerns, like defibrillator failures, #10 last year, have fallen off the list. ECRI said a public workshop with the Food and Drug Administration at the end of last year helped address defibrillator issues, and while it's still a problem, other serious topics were included because they're being overlooked.

"Even though the defibrillator topic is not on the list for 2012 we still think it’s an important issue for health care organizations to pay attention to," James P. Keller, Jr., ECRI Institute vice president of health technology evaluation and safety, told DOTmed News by e-mail. "But it was replaced by topics like poor usability of home care devices because the new items were judged to be more critical concerns and in our opinion are not high enough priorities for many hospitals."

Here are this year's top hazards:

10. Perplexing home-use devices

New to the list this year is an especially timely hazard: home-use devices, such as feeding pumps and ventilators, that can be devilishly tricky for patients to actually use. About 7.6 million people use medical devices at home, according to a Food and Drug Administration report from last year. As America's population ages -- the FDA said in 20 years, more than 72 million Americans will be over age 65 -- more people will rely on these devices, as providing services at home, such as ventilator-assistance, is several times cheaper than at the hospital. The only problem is that devices used at home can be too confusing for a layperson to use. Instructions might be missing or written in impenetrable, technical prose, and the products will be vulnerable to power outages or interference by curious pets and children -- dangers that are, generally, absent in the hospital setting. The FDA says from 1997 to 2009, it received 19,000 reports of adverse events from "home." True, it's not always clear what caused these mishaps, but they can be serious -- the agency said in one case, a woman had to visit the emergency room to treat burns on her chest caused by electrodes from a mail-order cardiac monitor.

9. Incomplete anesthesia pre-check

Making sure anesthesia equipment is in working order before use -- checking that gas cylinders are full and breathing circuits are properly hooked up -- is so critical for safety, in the early 1990s, anesthesiologists got together and developed a "pre-checkout" list providers were encouraged to use. However, while widely adopted, ECRI says that, in practice, inspections can be "inconsistent and incomplete." Sometimes, safety steps are skipped altogether as staff can mistakenly think someone else has already performed them or that they're covered by the equipment's own semi-automated "self-check." Among ECRI's recommendations: delegate clear responsibility for who should perform what.

8. Needlestick injuries

Holding the same rank as on last year's list, sharps injuries remain a significant health care challenge. According to the Centers for Disease Control and Prevention, about 385,000 such injuries occur to health care workers every year, usually nurses, exposing them to blood-borne pathogens like HIV and hepatitis C. And a 2009 Massachusetts public health survey estimated an annual rate of 28 sharps injuries per 100 occupied beds. Thanks to federal legislation, the introduction of safer devices and aggressive publicity campaigns, including most recently "Stop Sticks" by the National Institute for Occupational Safety and Health, the injury rate has been falling in nonsurgical hospital settings -- dropping about one-third from 2001 to 2006. But it's still climbing in surgeries, rising almost 6.5 percent over the same period, the CDC said.

7. Surgical fires

Up two spots from 2011, surgical conflagrations are rare, but not as rare as you might think. According to ECRI, between 550 and 650 such fires occur every year, and they generally get reports of one to two fires a week. These fires, often happening in oxygen-rich environments, such as surgeries using open oxygen delivery systems, can cause horrific, even deadly burns. According to ECRI, about 20-30 fires a year cause serious injury, and one or two are fatal. In response, ECRI and the Anesthesia Patient Safety Foundation have come up with a number of recommendations. For instance, the groups urge providers to discontinue open oxygen delivery in surgeries involving the head, face and upper chest, where possible.

6. Feeding-tube tragedies

Inserting an enteral feeding tube -- meant to deliver foodstuffs to the gut -- into the wrong connector can have fatal consequences, in this hazard, also making a reappearance from last year. To prevent misconnections, the FDA has urged manufacturers to make tubes with safeguards like color-coding and "design incompatibility." The International Organization for Standardization is also working on a standardized enteral connector to prevent such mishaps, ECRI said, but as it will be some time before that's finished, the institute recommends a number of precautions, such as always tracing lines to their source before plugging anything in.

5. Managing medical device and IT updates

Updating software on medical devices is important to keep them in good working order, but it also presents some dangers. ECRI said, in one case that it heard about, a hospital had a patient monitoring system that was linked with electronic medical record information and also allowed doctors to view PACS images on the monitor's display. However, when they upgraded the monitor's software, it caused a medication administration system associated with the device to shut down. "ECRI Institute is aware of an increasing number of problems related to change in management, including issues involving wireless networks, cybersecurity, planned maintenance or software upgrades," the group said.

4. Endoscope cross-contamination

Endoscope cross-contamination can lead to some headline-grabbing horror stories. Almost three years ago, the Veteran Affairs department discovered that more than 10,000 patients might have been exposed to blood-borne germs at three VA hospitals between 2003 and 2009 because of improperly processed devices. "Flexible endoscope reprocessing requires consistent adherence to a multistep procedure," ECRI said. "Failure to properly perform any step, including some necessary manual tasks, could compromise the integrity of the process." The institute said at an October 2011 summit held between FDA and the Association for the Advancement of Medical Instrumentation, experts discussed one significant problem: health care workers often don't appreciate an instrument's reprocessing needs. "[C]linicians may prefer a given model of device but not appreciate that reprocessing that model could take more than the 15 or 30 minutes available between cases, meaning that reprocessing could be rushed and ineffective," ECRI said.

3. Infusion pump drug delivery errors

Infusion pumps deliver life-saving drugs and nutrients to patients - but they also are error-prone. According to the FDA, there have been almost 56,000 infusion pump problems, linked to more than 700 patient deaths. Numerous devices have been pulled from the market, and a recent recall is believed to affect more than 200,000 units. "Infusion pump technology has evolved over the years to address many safety issues, the most notable improvement being the introduction of 'smart' pumps," ECRI said. "But preventable errors, including misprogramming, do still occur."

2. CT, radiation therapy hazards

Last year, radiation therapy took the top spot on ECRI's technology hazards list, but this year it's combined with the dangers of CT scan radiation (#4 on the 2011 list), making patient exposure to unnecessary doses of ionizing radiation the second-most pressing health care tech problem. ECRI said the true rate of radiation therapy errors is unknown because of ambiguity surrounding what counts as a "reportable event." However, a 2008 World Health Organization literature review estimated that more than 3,000 patients have been affected by radiotherapy adverse events over the past three decades. As for CT scans, the technology is thought to account for nearly half the radiation dose from artificial sources, ECRI said, citing a 2009 study. While it has a number of life-saving roles -- in stroke, cancer and trauma diagnoses -- CT doses are rarely audited, ECRI said, so different institutions can use widely different doses for the same type of scan. Worries over medical radiation, often highlighted in the popular press, even warranted a sentinel event alert from the Joint Commission this summer.

1. Alarm management

Number two on last year's list was alarm fatigue -- when nurses are so overwhelmed by the cacophony of bleeps and bloops issuing from a patient's bedside that they tune them out, or even, sometimes, turn down the volume of the alarms. This year, for the number one hazard, ECRI expanded the category to include all the dangers of alarm management, including the problem of staff not being able to grasp quickly the urgency of an alarm or even tell what device it's coming from. "Alarm management is complex," reads a training poster on alarm safety developed by ECRI that is, appropriately, quite complex. The problem is so unruly that last month, ECRI, AAMI, FDA, the American College of Clinical Engineering and the Joint Commission convened a summit on how to handle it.

"I think that an important message from the summit is that there are steps that hospitals can take now to improve alarm safety," ECRI's Keller said.

Among ECRI's recommendations are to ensure proper staffing levels, establish protocols for addressing alarms, and work out that the right caregiver is notified that a specific alarm has sounded. Still, the institute warns that properly tackling a problem as knotty as this one requires looking at the health care organization as a whole. "Trying to fix one item in isolation may provide only a partial solution and may also introduce new opportunities for failure," ECRI said. "While some of our recommendations are specific to individual care areas, and are important to consider, don't let them keep you from looking at the bigger picture."

What's your risk level?

For those interested, ECRI has also launched this month a Web-based survey tool hospitals can use to see how "at-risk" they are for a given hazard.

"Hospitals can assign an appropriate staff member to complete the survey for each of the hazards," Keller said. "Our tool provides a risk level score based on the hospital’s answers. Hospitals can use this information to help prioritize their health technology-related safety efforts. Members of ECRI Institute’s Health Devices, Health Devices Gold, and SELECTPlus programs can access the tool from ECRI Institute’s website."

To see the full report, ECRI's Top 10 Health Technology Hazards for 2012, visit www.ecri.org/2012_top_10_hazards.