Is medical malpractice on the decline? One might think so according to the statistics; in 2014, there were approximately 8,900 paid medical malpractice claims in the United States, down from nearly 15,000 in 2003. But there’s a catch: the number of settled claims doesn’t come close to reflecting the scope of damages that result from faulty and poorly maintained medical equipment.
Often, patients are unaware that they have been the victims of malpractice. How can a layperson be expected to tell the difference between an unavoidable hospital infection resulting from a weakened immune system and one contracted due to an uncleaned endoscope?
Here, then, are the top five device offenders in the medical malpractice spotlight for 2016:
1) Anesthesia machines and smartphones don’t mix
In 2014, Ars Technica reported that the ARKON Anesthesia System had a software glitch that would cause the machine to stop working if a cell phone was plugged into one of its USB ports, causing patient hypoxia or even death. At least 16 of these units were alleged to have been deployed in hospitals in North Carolina and South Carolina.
Why anyone would ever need to plug a smartphone into a medical device is unclear, but the glitch was deeply worrying, considering that there is a serious issue with hospital staff using their smart devices while at work, even during surgery.
2) Uncleaned flexible endoscopes
In a controversy that added ammunition to the Veterans Health Administration scandal of 2014, 10,000 veterans were reportedly exposed to blood-borne contamination at various veterans’ hospitals around the country, all due to poorly cleaned endoscopy equipment.
As dire as that sounds, in 2015 it was reported that as many as 100,000 endoscopy patients were exposed to outbreaks of potentially fatal superbugs at hospitals in Seattle, Los Angeles, Pittsburgh, and the suburbs of Chicago, beginning in 2012. The culprit was a colonoscope designed by the Olympus, the world’s leading manufacturer of gastro-intestinal endoscopes. Olympus had failed to instruct hospital staff that a part of their redesigned equipment had new cleaning protocols. As a result, for years hospitals were unknowingly using potentially infected endoscopes.
3) Infusion pumps plagued by defects
Infusion pumps, those ubiquitous bedside devices used to deliver fluids and medications to patients at regular intervals, have a deeply troubling history of recalls and malfunctions. From 2005 through 2009, the Food and Drug Administration (FDA) received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths, culminating in the recall of 87 fusion pump models.
4) Alarms that “cry wolf”
According to research published in the journal AACN Advanced Critical Care, 72–99 percent of clinical alarms are false. This high rate of false alarms desensitizes medical staff, a condition referred to as “alarm fatigue,” which can compromise patient safety when an alarm is genuine.
Beginning in January 2016, all hospitals in the United States have had to comply with the Joint Commission Alarm Safety Goal, which requires hospitals to adhere to a strict regime of alarm safety guidelines. However, there is no guarantee that these guidelines, which are still in their early review and implementation phases, will successfully reduce alarm fatigue. It may require years of work to get the issue under control.
5) Gamma camera defects
Defects in gamma cameras, those hulking, box-like machines that perform a variety of scans across a patient’s entire body, have been linked to 40 product recalls. Concerns originated with a patient’s death in 2013—a malfunction caused him to be crushed. Since then, gamma cameras have come under great scrutiny by both the FDA and the ECRI Institute, a nonprofit organization that researches patient care.
The gamma cameras contain sensors that are supposed to keep the machine’s large moving components from getting too close to a patient, but these have malfunctioned many times, sometimes resulting in serious injury.
“It’s like positioning a grand piano with sub-millimeter accuracy within half of an inch of a patient,” said Jason Launders, director of operations for ECRI’s health devices group.
By no means is this a comprehensive list of medical technology dangers that need to be addressed to make our hospitals and clinics safer and more reliable. The ECRI Institute has compiled a comprehensive breakdown, The Top 10 Health Technology Hazards of 2016, which is free to the public (registration is required).