Medical devices hold an important role in many people’s lives, allowing them to be treated for a variety of disorders and live relatively healthy and normal lives in spite of troubling conditions. Unfortunately, if these devices are not subjected to strict quality checks, such as leak testing services, or properly cleaned, they can cause just as many problems for patients and medical institutions. This is currently the problem facing a number of doctors and patients in Los Angeles, as a common medical device has been linked to the outbreak of a drug-resistant bacterial infection.
On Thursday, February 19, the Food and Drug Administration (FDA) released a warning for a popular type of endoscope, or specialized tubular device that is threaded down a patient’s throat to their small intestine. The FDA reported that the device is difficult to clean properly, making it possible for deadly bacteria to be transmitted to patients. Currently, such an outbreak is believed to be responsible for two deaths and the possible infection of 179 others.
The alert came after the University of California, Los Angeles (UCLA) Health System reported that seven patients who had undergone procedures with the endoscope had been infected with carbapenem-resistant enterobacteriaceae, or CRE. This type of bacteria typically lives in the human gut, but some deadly forms of CRE have enzymes that can break down antibiotics. While the organizations involved do not know how deadly the type of CRE involved is, there is some hope it can be treated.
Doctors have known for some time that the device in question was difficult to clean due to its complicated design; in fact, the same implement was connected to an E. coli outbreak in Chicago in 2013. However, officials from the Los Angeles County Department of Public Health have found no breaches in overall infection control. Currently, the outbreak has been traced to one endoscope that may not have been properly washed and dried, but the FDA has noted that some outbreaks have occurred even when the devices have been cleaned according to the manufacturers’ instructions.
This incident has stressed the importance of maintaining the sterility of medical devices, which is commonly achieved through leak detection equipment, cleaning, and other steps. For example, leak testing services are often used to check for flaws in the device itself as well as the packaging, which ensures that the product remains sterile. There are a number of different types of leak testing services, ranging from air leak tests to helium leak tests, which allows manufacturers to be sure their devices meet the strict standards set by the FDA and other agencies.
The 179 patients believed to be effected by the outbreak underwent procedures between October and January. As of Thursday, no new cases had been reported.