Infection Concerns Gain FDA Attention
Agency focuses on duodenoscope reprocessing
EXECUTIVE SUMMARY
The FDA has focused on scope cleaning in recent months, highlighting the potential for infections.
- The agency alerted healthcare providers to the risk of cross-contamination with some connectors used in gastrointestinal endoscopy.
- Regulators warned three duodenoscope manufacturers that they must comply with a federal order to conduct postmarket surveillance studies that assess duodenoscope reprocessing.
- Carbapenem-resistant Enterobacteriaceae outbreaks in surgery centers in recent years have prompted renewed attention to infection prevention strategies.
If infection prevention wasn’t already on ambulatory surgery centers’ (ASCs) radars, it should be after regulators sent multiple letters about equipment cleaning processes and infection risks to manufacturers and providers in the spring.
The FDA sent healthcare providers a recent alert about the risk of cross-contamination with some connectors used in gastrointestinal endoscopy. The 24-hour multipatient use endoscope connectors may not be safe, regulators say. “To date, the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use,” says the FDA’s letter to providers, dated April 18, 2018.
The agency recommends providers use connectors with features that prevent patient fluids from flowing backward into the endoscope, such as those that have a backflow prevention feature (Readers can view the FDA alert online at: http://bit.ly/2HsFwxR). Acceptable connectors could be single-use connectors that are discarded after one use, or they could be reusable connectors that are reprocessed before each use, the FDA says. (See also in this issue: Recommended Safety Measures for Endoscopy.)
The FDA also sent letters in March 2018 to three international duodenoscope manufacturers highlighting regulators’ concerns about the potential of deadly outbreaks of antibiotic-resistant organisms (http://bit.ly/2pxWWPk). FDA told Olympus, Fujifilm, and Pentax that they must comply with an earlier federal order about conducting postmarket surveillance studies that assess duodenoscope reprocessing.
Surgery centers might still feel the effect of carbapenem-resistant Enterobacteriaceae (CRE) outbreaks traced to duodenoscopes in hospitals several years ago, says Phenelle Segal, RN, CIC, FAPIC, president of Infection Control Consulting Services of Delray Beach, FL. The outbreaks resulted in the regulatory agencies improving their requirements for endoscope reprocessing, in general, which includes those used in ASCs, Segal says. “We saw outbreaks that had a tremendous impact,” Segal says. “When these infections occur, they increase the morbidity and mortality of patients because these organisms are highly resistant and many are non-treatable as we’ve run out of antibiotics to treat them.”
The outbreaks occurred because the duodenoscopes are very difficult to clean before they go into the reprocessor, she adds. The FDA ordered manufacturers to conduct postmarket surveillance to see whether duodenoscope labeling included user materials and instructions that would ensure users follow reprocessing instructions. Surveillance also required manufacturers to assess what percentage of clinically used duodenoscopes remained contaminated with viable microorganisms after reprocessing (http://bit.ly/2GXOwrf).
“What is so distressing is the FDA, despite being on top of this from the beginning with clear recommendations to manufacturers, had to warn them that there are obvious problems with their surveillance studies,” Segal says. “It’s clear these companies failed to comply with the order, and that poses a serious risk to patients’ morbidity and mortality because these infections kill if they can’t be treated.”
Olympus published a public letter in March 2018 saying the organization takes patient safety very seriously and is working to increase the ease and efficacy of endoscope reprocessing (https://bit.ly/2qSX5gf).
“Olympus takes this matter very seriously, and we are actively engaging healthcare professionals to participate in the postmarket study,” Jennifer C. Bannan, director of public relations for Olympus in Center Valley, PA, wrote in an email response to questions from Same-Day Surgery. “We have developed a robust plan with the goal of meeting the milestones set forth by FDA. Olympus has not completed the postmarket study of healthcare reprocessing of the TJF-Q180V duodenoscope.”
Fujifilm also responded by email about the warning letter, writing, “The health and safety of patients are Fujifilm’s number one priority, and we continually work with the FDA to ensure that our products and processes meet FDA requirements.”
The company adds, “Fujifilm is actively engaged in a 522 postmarket surveillance study and while certain milestones have been attained, on March 9, 2018, the FDA issued a Warning Letter noting failure to provide sufficient data and comply with requirements of certain aspects of the study. The FDA has not objected to the continued marketing of our products in the United States, and we will continue to work to meet FDA requirements. Meantime, federal infection control surveillance shows the potential for another CRE outbreak.”
Pentax did not respond to multiple requests for comment.
The CDC announced in early April that surveillance of antibiotic-resistant microbes showed a decrease in CRE, although the superbug persists in healthcare settings.1
The same is true of pathogens that are not susceptible to extended-spectrum cephalosporins (ESBL), according to the surveillance report (http://bit.ly/2EIjscY).
Infection control and prevention efforts are working, although ASCs and other healthcare facilities should not ease up on their staff education or cleaning protocols.
“The role of infection preventionists in the ambulatory care surgical arena has never been as demanding as now,” Segal says. (See also in this issue: The Essential Components of an ASC Infection Control Program.)
ASCs must provide extra training and competencies to their lead infection control professional, says Patrick Haley, CASC, manager of Central Coast Surgery Center in Freedom, CA.
“They lead the education for the rest of the staff,” Haley says. “There is an extra cost to that, but the bigger concern is the cost of what happens if something goes wrong.”
Dollars spent on infection prevention are investment dollars, he adds.
“The most expensive thing is to have a major incident, like a knee implant that is infected,” Haley says. Surgery centers must make certain they know about all infections that occur post-surgery and are related to the surgical procedure. “Part of what you have to do at surgery centers is mandatory infection tracking,” says Marcy Sasso, CASC, principal and director of compliance for Sasso Consulting in Point Pleasant, NJ.
“We must track every case for 30 days after the procedure by the physician,” Sasso says. “We have to see if there were any surgical site infections or post-op complications. And if the physician writes back that there was an infection, then we have to look at sterile processing and see how the patient got an infection.”
Sometimes, the physician will send information about an infection that is not related to the surgery. It could be a foot infection in a patient who received a breast implant. In those cases, the ASC can call the doctor and say that the infection was not related to the surgery and ask the physician to change the forms to say there was no infection related to the surgery center, she says. (See also in this issue: Common Infection Control Findings During ASC Surveys.)
Besides keeping up with reprocessing instructions, warning letters, and guidelines, ASCs must ensure all their infection prevention efforts are evidence-based, suggests Bruce Crookes, MD, chief of the division of general surgery and associate chief quality officer for perioperative services at the Medical University of South Carolina in Charleston. The World Health Organization and the American College of Surgeons maintain evidence-based reviews of all the actions that should be taken to reduce surgical site infections.
“We try to stick to those guidelines as closely as we possibly can, and make sure all of the necessary actions are in place,” Crookes says. The crucial element is making sure the surgery center’s culture reinforces taking the right prevention actions every time.
“One of the mottos I try to instill in folks is that whenever you cut corners, there are consequences,” Crookes says. “Cutting corners never gets you to a better spot. You always pay a price when that happens, so make sure people are meticulous about their care.”
REFERENCE
- Woodworth KR, Walters MS, Weiner LM, et al. Vital Signs: Containment of novel multidrug-resistant organisms and resistance mechanisms — United States, 2006-2017. MMWR Morb Mortal Wkly Rep 2018;67:396-401.
Recommended Safety Measures for Endoscopy
The FDA recommends that healthcare providers and staff that perform endoscopy take precautions to protect patients from infections. Here are their recommendations:
- Do not use 24-hour, multipatient-use endoscope connectors because they carry a risk of cross contamination.
- One option is to employ single-use endoscope connectors with backflow prevention features.
- A second option is to buy reusable endoscope connectors with backflow prevention features.
- Ensure reusable connectors are reprocessed according to their instructions for use, prior to each patient procedure.
The FDA has focused on scope cleaning in recent months, highlighting the potential for infections. The agency alerted healthcare providers to the risk of cross-contamination with some connectors used in gastrointestinal endoscopy. Regulators warned three duodenoscope manufacturers that they must comply with a federal order to conduct postmarket surveillance studies that assess duodenoscope reprocessing.
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