As a Houston, Texas medical malpractice lawyer, I am currently representing two plaintiffs in separate lawsuits where improper sterilization of laparoscopic bariatric surgical equipment led to long-term Mycobacterial infections. The cases are pending in Houston and Austin.
From my research and investigation of these cases, I have learned that sometimes post-surgical infections are caused by poor cleaning and sterilization of equipment by healthcare providers, while at other times it may be the fault of manufacturers.
Duodenoscopes are a type of reused endoscope that have a particularly high risk of causing infections.
Duodenoscopes are flexible tubes with lighting that surgeons thread through the mouth, throat, and stomach to reach the first segment of the small intestine, called the duodenum. According to the U.S. Food & Drug Administration (FDA), duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures annually in America. This procedure is the least-invasive way to drain fluids from blocked biliary and pancreatic ducts.
In late 2013, the U.S. Centers for Disease Control and Prevention (CDC) found a potential association between multi-drug-resistant bacteria and duodenoscopes. The CDC and FDA found that these troubling infections were still occurring despite confirmation that healthcare providers were following manufacturer recommendations for cleaning, disinfection, and sterilization the equipment.
As a medical negligence attorney, it is clear to me that the manufacturer recommendations were inadequate and needed improvement. Yet, hospitals and facilities need to make sure that their personnel are properly trained on cleaning complicated equipment. For example, duodenoscopes have many small working parts, so without proper cleaning, tissue or fluid from one patient can remain in the device when it is used on a subsequent patient. This explains the well-documented outbreak of drug-resistant infections involving this type of surgical equipment.
In 2015, the FDA warned that the complex design of duodenoscopes makes reprocessing difficult. Reprocessing is the detailed, multi-step process to clean, disinfect, and sterilize reusable surgical devices. The FDA has been monitoring device manufacturers to require enhancement of safety during this process to make sure that the devices are actually cleaned and disinfected.
In February 2018, the FDA, CDC, and American Society for Microbiology released voluntary standardized protocols for duodenoscope surveillance sampling and culturing.
On March 9, 2018, the FDA issued warning letters to all three duodenoscope manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, and Pentax of America) for failure to provide sufficient data to address the post-market surveillance (safety) studies.
We are here to help
If you or a loved one developed a severe infection after surgery, it may have been caused by an improperly cleaned and sterilized piece of surgical equipment. The medical malpractice attorneys at Painter Law Firm, in Houston, Texas are here to help.
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Robert Painter is a medical malpractice attorney at Painter Law Firm PLLC, in Houston, Texas. He is a former hospital administrator who represents patients and family members in medical negligence and wrongful death lawsuits against hospitals, physicians, surgeons, anesthesiologists, and other healthcare providers. In 2017, H Texas magazine named him one of Houston’s top lawyers. In May 2018, the Better Business Bureau recognized Painter Law Firm PLLC with its Award of Distinction.