Duodenoscope Reprocessing Remains Infection Prevention Challenge

The U.S. Food and Drug Administration (FDA) has announced that despite efforts to improve the cleaning and reprocessing of duodenoscopes, decontamination remains a significant challenge, with scope-related infections continuing to harm many patients.

The news comes from FDA's latest report concerning postmarket surveillance studies on rates of contamination after the cleaning and reprocessing of duodenoscopes manufactured by Olympus, Fujifilm and Pentax. In 2015, the FDA ordered these companies to conduct such studies gain a better understanding of the transmission of infections and assess the factors that contribute to their occurrence. The objective was to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, including those from multi-drug resistant bacteria infections. 

The implementation of these safety measures contributed to a notable decline in the number of medical device reports associated with patient infections. The number of reports peaked in 2015 at 250 and declined to fewer than 100 reports per year in 2017 and 2018, according to the FDA.

While these results are encouraging, considerable work remains. The FDA noted that it received reports of three deaths of U.S. patients in 2018 related to infections associated with duodenoscopes. In addition, from Oct. 15, 2018, through March 31, 2019, it received 45 reports of patient infection, one report of patient exposure and 159 reports of device contamination.

While the FDA's recommendations for cleaning and reprocessing of duodenoscopes has not changed, FDA indicated it is considering taking additional steps to reduce contamination rates. These include the following:

  • Consulting with the Centers for Disease Control and Prevention (CDC) and other federal agencies to obtain input and recommendations on infection control and reprocessing of duodenoscopes.

  • Discussing the matter at the Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting to obtain input on improving the safety of reprocessed devices.

  • Weighing whether additional recommendations will be necessary to help facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates.

FDA also indicated that it intends to hold duodenoscope manufacturers accountable if they fail to comply with the requirements of their postmarket surveillance studies. Furthermore, FDA noted that it is working with manufacturers on the development of new duodenoscope designs that could reduce the risk of contamination and disposable duodenoscopes that would eliminate the need for reprocessing.

Study: Patients With Dental Infections Receive Excessive CT Scans

The results of a study indicate that emergency settings overorder computed tomography (CT) scans for dental infections.

Published in the Journal of Oral and Maxillofacial Surgery, the study examined 470 adult patients who presented through an emergency department for odontogenic infection evaluation, of which 389 received CT scans.

Researchers set out to determine how many of these scans were unnecessary when considering the effectiveness of history and physical (H&P) examinations to accurately diagnose dental infections before patients undergo the CT scan. Unlike H&Ps, CT scans are expensive and linked to long-term potential for cancer.

The researchers found that nearly 57% of the total ordered scans were unnecessary, meaning patients presented without what researchers labeled as "red-flag" signs at physical examination. This included voice change, elevated floor of mouth, signs of inflammation of deep fascial spaces, periorbital edema, nonpalpable inferior border of the mandible, dyspnea, dysphagia or odynophagia, and trismus. Furthermore, unnecessary scans were found to be most prevalent in those patients with infections classified as low risk, with more than 78% of scans deemed unnecessary. 

In conclusion, the study authors' wrote, "Establishing guidelines to standardize ordering is the first step oral and maxillofacial surgeons can take to decrease unnecessary CT scans. Guidelines, in theory, would decrease the amount of unnecessary scans ordered and standardize ordering practices among providers."

CDC Hoping Chlorhexidine Soap Will Stop Superbug Infections

The Centers for Disease Control and Prevention (CDC) is funding research in California and Illinois hospitals and nursing homes that it hopes will help stop or at least considerably reduce drug-resistant infections, according to an NPR report.

The approach these organizations are taking primarily centers around doctors and healthcare workers washing patients with antimicrobial chlorhexidine soap. CDC provided funding to 50 facilities in the two states, more specifically in Chicago and Orange County, Calif., for the efforts.

NPR reports that in Chicago, researchers are working with nursing home and long-term acute care hospital staff to screen patients for carbapenem-resistant Enterobacteriaceae (CRE) upon admission and then bath them daily with the soap. Efforts also include a handwashing campaign and increased communication concerning CRE among hospitals.

Researchers working in Orange County are collaborating with hospital and nursing home staff to use an antiseptic wash, together with an iodine-based nose swab. The expectation is that these efforts will "prevent new people from getting drug-resistant bacteria and keep the ones who already have the bacteria on their skin or elsewhere from developing infections," according to the report.

Preliminary data from the Orange County project (which concludes in May) show that after 18 months, there was a 25% drop in drug-resistant organisms in nursing home residents, 34% percent in long-term acute care hospital patient and a 9% decline in traditional hospital patients. Results from the Chicago project are pending, with the project ending in September.