Suits have been filed for injury and death from infections from difficult-to-clean medical equipment.
We all get routine medical tests from time to time and need to be able to trust that the equipment our doctors and hospitals use for diagnostic testing is safe. It has been unsettling to hear recent media reports about potentially fatal antibiotic-resistant germ exposures linked to the use of unsterile endoscopic equipment at major hospitals in Los Angeles and Seattle.
Reported to have occurred sometime in the time frame from August 2014 through February 2015, depending on the hospital, these infections were with Carbapenem-Resistant Enterobacteriaceae, referred to as CRE or more informally as a superbug because of resistance to antibiotics, causing fear, illness and even fatality. Common CREs include Klebsiella that can cause a variety of diseases like pneumonia or meningitis; and E. coli that can result in severe gastrointestinal distress and even kidney failure.
Some hospitals have offered free testing kits to patients who were exposed to the equipment. Media reports say that officials and health practitioners are wondering whether other illnesses and deaths from CRE across the country may also have been caused in the same manner.
The piece of equipment at issue is a particular endoscope called a duodenoscope – a tiny, lighted, flexible scope – inserted through the mouth and throat to examine the esophagus, stomach and intestine for various diseases and health conditions. Manufactured by Olympus Corp. of the Americas, the scope has allowed CRE to survive despite following manufacturer’s disinfection instructions between patients.
Following the recent outbreaks, the manufacturer issued revised cleaning instructions that emphasize in particular the need for vigorous manual cleaning, an important step in the disinfection process. The manufacturer also recommended retraining of involved personnel.
Following these events, the U.S. Food and Drug Administration or FDA issued a Safety Communication in February 2015 in which it warned that the complex scope design includes “microscopic crevices” that may interfere with the disinfection process, even that recommended by the manufacturer. The agency is monitoring the situation, has asked for reports on further issues with cleaning the scopes and has scheduled a public meeting on the issue in May 2015.
The Los Angeles Times also reported in March 2015 on what it called a “startling admission” that the FDA had confirmed that the scope in question has been for sale since 2010 “without the necessary government approval,” but that it is not being recalled because it would cause an equipment shortage of a “widely used” device.
At least five lawsuits have been filed against the manufacturer so far for injury or death from the recent California exposures. Legal claims in those suits include wrongful death, negligence and fraud, according to the Los Angeles Times.
When someone is harmed by dangerous medical equipment or inadequate infection control in a hospital setting, it is important to talk to legal counsel with extensive medical malpractice experience about whether there are legal remedies available such as a lawsuit. Depending on the circumstances, responsible parties may include manufacturers of dangerous equipment, negligent disinfection or cleaning service providers, negligent hospitals or medical practitioners and others.
For New York patients harmed by dangerous medical equipment or health care-related infection, the seasoned medical malpractice attorneys at Rosenbert, Minc, Falkoff & Wolff, LLP, have five offices in the New York City area from which they serve clients.
Keywords: suit, lawsuit, injury, death, infection, medical equipment, hospital, endoscope, antibiotic resistant, endoscopic equipment, Los Angeles, Seattle, CRE, superbug, duodenoscope. Olympus, disinfection, manufacturer, FDA, wrongful death, negligence