Surgery centers should refocus on infection prevention efforts in light of recent reports of breaches involving HIV, hepatitis, and the potentially fatal carbapenem-resistant Enterobacteriaceae (CRE).
- Two cases of CRE were reported to the FDA late in 2018.
- A New Jersey ambulatory surgery center (ASC) notified thousands of patients of potential exposure to infectious diseases, a breach attributed to reprocessing failures.
- The problems point to the need for ASCs to follow the highest level of infection prevention standards and guidelines.
Infection breaches occur rarely in ambulatory surgery centers (ASCs). But when they do, the consequences can be daunting.
Two recent infection breaches have renewed focus on surgery centers. The most recent, which the FDA reported on in December, involved two patients who developed the potentially fatal carbapenem-resistant Enterobacteriaceae (CRE) after undergoing colonovideoscope procedures on Oct. 12, 2018. As of this issue’s reporting deadline, the FDA had not released information on where the procedures were performed, the medical status of the infected patients, or whether the patients were ill prior to their developing CRE. The cause of the event remains unknown.
“To my knowledge, this is the first time CRE is linked to a colonoscope,” says Susan Hutfless, PhD, assistant professor and director of the Gastrointestinal Epidemiology Research Center at Johns Hopkins University. Hutfless conducts research on the rates of infection after colonoscopy and esophagogastroduodenoscopy in ASCs. (Editor’s Note: Read more about Hutfless’ work in the sidebar at the end of this article.)
In another potential infection exposure case, a New Jersey ASC sent letters to 3,778 patients asking them to be tested for hepatitis B, hepatitis C, and HIV because of a possible exposure at the surgery center between Jan. 1, 2018, and Sept. 7, 2018. The breach and patient letters were reported by dozens of local and national news outlets.
The New Jersey Department of Health shut down the center for several weeks starting on Sept. 7, 2018. The department’s investigation uncovered deficiencies in infection control related to sterilization and cleaning of instruments and medication injections.
From an infection preventionist’s perspective, the headlines suggest a potential breakdown in processes, according to Phenelle Segal, RN, CIC, FAPIC, president of Infection Control Consulting Services in Delray Beach, FL. “At times, I’ve seen these processes break down because of a lack of training and experience in reprocessing of medical devices and instruments,” she says. “My next thought is: Are they following nationally recognized guidelines and standards? ... We have various standards available.”
The New Jersey breach highlights potential equipment sterilization issues, but ASCs also must ensure other critical practices, such as safe injection practices and surgery site preparation, are adhering to infection prevention standards.
“It’s disappointing when things like that do occur, but it’s important to realize they’re extreme outliers; it’s very uncommon,” says Stanford R. Plavin, MD, owner of Ambulatory Anesthesia Partners and principal of Technical Anesthesia Strategies and Solutions, both in Atlanta. “Patients can feel confident, especially nowadays with the sophistication of the processes we use and how we manage them reduces risk even more dramatically to every patient.”
One way ASCs and anesthesiologists can reduce infection risk is by following the highest standards of infection prevention, including safety regulations, guidelines, and standards from the CDC. “We follow the one and only campaign — one patient, one needle, one syringe, one time for each injection,” Plavin offers.
ASCs that need laryngoscopes infrequently can use disposable ones. This reduces risk and saves time and effort in reprocessing/sterilizing the equipment, he adds. “It’s unfortunate if people are exposed to any pathogen because of improper sterilization technique or injection practices,” Plavin says. “About the only positive is that it brings things to light so people can do a self-analysis and make sure they’re maintaining quality and control and providing an utmost safe patient experience.”
Surgical site infections are very rare in ASC patients, but they do occur, and several factors increase the risk, according to a new study.1
“Most of these surgeries are low rates of infection,” says Robert H. Brophy, MD, study co-investigator, sports medicine specialist and professor of orthopaedic surgery at Washington University School of Medicine in St. Louis. Brophy says these New Jersey ASC outbreaks highlight why surgery centers should not let down their guard in maintaining infection prevention best practices, despite typically low rates of infection problems.
“It’s not to belittle it or sweep it under the rug, but you want to put it in context,” Brophy says. “It’s a reminder to always be careful because most of the time we’re doing things right. But anytime something comes up, look at it, and make sure you’re being vigilant.”
Brophy’s study of surgical site infections among 22,267 orthopedic surgery patients revealed that older patients were at a higher risk for infection, which was not surprising. “Patients with diabetes had a higher risk of infection,” Brophy adds. “Surgeries of the shoulder had the lowest rate of infection.”
People who underwent hip surgery demonstrated the highest rate of infection (18.6 times higher than the infection rate of hand and elbow surgery). However, the higher risk for hip surgeries still is not high enough of a risk to set off alarms. “It was just a relatively elevated risk, adjusting for other factors,” Brophy says. “We need a little more study, and it could be a variety of things.” Other infection risk factors included receiving combined general and regional anesthesia and more tourniquet exposure.
When ASC directors and physicians hear about infection breaches, they should put the reports in context.
“This could be an isolated incident or global concern. Learn from it, and apply the lesson that everyone should stay vigilant,” Brophy says. “What you see [with the infection breach at the ASC] in New Jersey is a reminder to be careful and do a better job, day in, day out. It’s worth looking at, learning from it, and making sure it doesn’t happen.” Segal suggests paying attention to the details. For example, consider asking questions such as: Have you completed infection prevention training? Are you experienced in infection prevention? Do you follow nationally recognized guidelines and standards? Is there oversight? Is your facility conducting competency reviews? “Do facilities have established, written policies and procedures that are updated?” Segal asks. “I often come across outdated policies that can date back years prior to their original implementation date, and there’s no record of their having been reviewed and revised.”
Another problem concerns following manufacturer’s instructions for cleaning, reprocessing, and sterilizing equipment and instruments. “That’s where we usually find the biggest deficit in facilities,” Segal notes. Today, manufacturers are better at specifying how to clean, disinfect, and sterilize their equipment and instruments. Still, there are occasions when manufacturers will not provide these detailed instructions, leaving it up to ASCs to create their own.
“I will insist they pull something together, or I would advise my clients to switch to different products,” she says. “We absolutely have to follow manufacturer’s instructions.”
For instance, Segal found that one company provided no instructions on disinfecting its glucose meters. “I advised [the company] that unless they developed disinfection instructions, my clients would move to a different manufacturer,” she recalls. The company had created cleaning instructions, which are not the same as disinfection instructions. After further discussion among all parties, the company went on to develop a proper disinfection process.
If it is not possible to obtain manufacturer’s instructions for use, perhaps because the equipment is old and the instructions do not exist, then it is imperative for the ASC to follow nationally recognized guidelines and standards. The good news in the ASC industry is that optimal infection prevention practices are widespread, according to Brophy. “The vast majority of surgery centers are following best practices and trying to stay up with them,” he says. “Just don’t lull yourself into sleep. We’re doing extremely well, but you need to stay vigilant and continue to pursue and maintain best practices.”
- Brophy RH, Bansal A, Rogalski BL, et al. Risk factors for surgical site infections after orthopaedic surgery in the ambulatory surgical center setting. J Am Acad Orthop Surg 2018; Dec 31. doi: 10.5435/JAAOS-D-17-00861. [Epub ahead of print].