More than 100 patients have become infected with antibiotic-resistant superbugs after being treated with the medical device known as a duodenoscope. The camera manufacturer, Olympus, also makes about 85% of the duodenoscopes on the market today. After 25 superbug outbreaks and three deaths linked to the scopes, Olympus has announced it will finally recall the defective device. Unfortunately, this decision comes too late for many patients. Contact a Boston Personal Injury Lawyer Today.
A design flaw in the duodenoscope makes it nearly impossible to disinfect the device between uses. This defect has exposed hundreds of patients to an antibiotic-resistant bug called carbapenem-resistant Enterobacteriaceae (CRE).
What is a duodenoscope?
The duodenoscope is a medical device used to perform internal examinations of the body. Specifically, it is a flexible tube with a light that allows physicians to treat and diagnose intestinal problems related to the bile ducts and the pancreas. These reusable scopes must be disinfected and sterilized after each use. However, a problem with an internal mechanism has made proper sterilization virtually impossible.
In addition to a design flaw, improper sterilization is also related to inadequate training. Many of the duodenoscopes simply aren’t being cleaned well enough. “The cleaning protocols for flexible endoscopes need improvement, such as guidelines tailored to the type of scope or identifying if there is a critical step missing in the manual cleaning process, and documented quality-control measures,” said Marco Bommarito, lead research specialist at 3M Infection Prevention Division. “These types of improvements could have a positive impact on patient safety.”
What is CRE and What are the Symptoms?
CRE is a family of bacteria that have developed a high level of resistance to antibiotics. This bacteria can cause a range of health problems, including gastrointestinal illness and blood infections.
CRE can also cause urinary tract infections, ventilator associated pneumonia, intra-abdominal abscesses, and death. Symptoms include sores that don’t heal, fevers and chills, and extreme fatigue.
Olympus Knew About the Risks in 2012
Although Olympus knew about this serious health risk as far back as 2012, the industry giant failed to properly warn the medical community and neglected to recall its defective devices. In addition to not recalling the devices, Olympus actually began increasing duodenoscope prices as hospitals started to ask for safer scopes.
According to a Congressional report, Olympus and two other duodenoscope manufacturers, “failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues.” The U.S. Justice Department is currently investigating the company’s role in the CRE outbreaks. Continue reading