This is a tough time to run an endoscopy service. You have duodenoscopes essentially considered unsafe by the FDA being reprocessed in recalled automatic endoscope reprocessors. What the heck is going on? And what can you do about it? While experts continue to debate how to properly reprocess duodenoscopes that have been linked to deadly superbug outbreaks across the country, the bad news regarding endoscope reprocessing continues to pour in:
- The FDA has warned the 3 main duodenoscope manufacturers that they didn't report infections linked to the use of their scopes, or failed to ensure their scopes could be properly cleaned.
- Last month the FDA recalled an estimated 2,800 automatic endoscope reprocessors made by Ivyland, Pa.-based Custom Ultrasonics.
- To top it off, the ECRI Institute, an independent healthcare research firm in suburban Philadelphia, has tabbed dirty endoscopes as the top technology hazard for 2016.
Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP) have become infected with carbapenem-resistant Enterobacteriaceae (CRE) that remained in improperly cleaned duodenoscopes. Highly publicized outbreaks have occurred at the UCLA Medical Center in Los Angeles, the University of Pittsburgh Medical Center, Advocate Lutheran General Hospital in Park Ridge, Ill., and Virginia Mason Medical Center in Seattle, Wash. Last month, the widow of a 55-year-old man who was allegedly exposed to CRE during an ERCP performed at Carolinas Medical Center in Charlotte, N.C., filed a wrongful death lawsuit against duodenoscope manufacturer Olympus and Custom Ultrasonics.
In August, the FDA sent warning letters to Olympus, Fujifilm and Pentax, informing the manufacturers that their duodenoscopes are misbranded. Then, in October, the FDA gave the companies a month to submit written plans for assessing how their scopes are being reprocessed and what steps can be taken to improve the process.
Another bombshell hit last month when the FDA ordered the immediate recall of nearly 3,000 AERs manufactured by Custom Ultrasonics. According to the recall, Custom Ultrasonics must validate the ability of its AERs to effectively clean and disinfect specific duodenoscopes. The company says in a statement that it is complying with the request, that its washer/disinfecter has not been linked to any transmissions of infection from endoscope to patient and that it stands behind the safety of its machines. A company spokesman declined to comment further.
REPROCESSING WAR ROOM
Laura Raio, CFER, the materials and technical services manager at The Endo Center at Voorhees (N.J.), recently attended a workshop run by a major scope manufacturer and was appalled by the questions attendees asked about seemingly basic reprocessing steps. "In an organization, a manager might be very knowledgeable about endoscope reprocessing, but what about the staff in the cleaning room who are actually doing the work?" she asks.
Her advice? Be a stickler about ensuring your reprocessing staff are properly trained and constantly monitored. All techs at The Endo Center are state-certified in flexible endoscopic reprocessing. There's a nationwide movement to make certification mandatory, but it's been a requirement to work for Ms. Raio for 7 years running.
She says training in endoscope reprocessing should drill home the importance of the job and prepare staff to follow required steps during the reprocessing of each scope. Every new hire at The Endo Center undergoes one-on-one training for a minimum of 2 weeks. "I tell them that this tiny reprocessing room will close the building if we don't do things correctly," says Ms. Raio.
She believes reprocessing mistakes occur at facilities where staff members work alone, which lets them think perhaps correctly that no one would know if they skipped a step here and there. To avoid that issue, Ms. Raio staffs her reprocessing room with 1 cleaning person and 2 techs at all times. "They tell on each other consistently, and approach each other if something isn't done correctly, which is good," says Ms. Raio. "When you're in that room, you're expected not to make a mistake."
You must also protect your reprocessing staff from outside pressures to keep up with a volume-driven specialty. Have you ever had a physician drop in on the reprocessing staff to implore them to pick up the pace? Ms. Raio has. "I've told them 'If you ever walk into this room again, we'll close the building. Get out!'" she says, in a tone that makes you thankful you're not one of the pushy docs. "I'm serious. They do not walk into my room. Ever."
Don't hesitate to tap into the expertise of your endoscope manufacturers, suggests Ms. Raio. She has endoscope reps come to the facility 3 times a year for reprocessing in-services. "The staff assures me that they know how to do it," she says. "But I show them again and again and again."
Ms. Raio goes to as many educational meetings for endoscope reprocessing professionals as she can. When new devices or enhancements are launched, her staff is the first to know. In fact, she took them to that recent meeting where other professionals were asking questions about reprocessing steps that her staff considers beyond basic.
"My crew realized how good they are," says Ms. Raio, who understands the carrot is just as important as the stick. "They need to see that, so they know that I'm constantly pushing them for the right reasons.
"Cleaning scopes isn't hard I could show you how to do it with my eyes closed. The challenge is getting staff to follow every single step, every time."
Facilities that use Custom Ultrasonics reprocessors should transition to an alternative option "as soon as possible," according to the FDA. "What does that mean?" asks Lawrence F. Muscarella, PhD, the former director of research and development and chief of infection control for Custom Ultrasonics. "That could be 3 months for a facility." Dr. Muscarella, who left Custom Ultrasonics in 2013, is now an infection control consultant and president of LFM Healthcare Solutions in Montgomeryville, Pa.
There are practical reasons for not being able to make the switch overnight Dr. Muscarella believes the FDA will allow a grace period but you want to set a transition plan in motion immediately and start a paper trail to mitigate your facility's liability. "Document that you received the recall, develop a written plan and create a timeline that details what you will do to address the recall," says Dr. Muscarella.
He suggests facilities seek validation data from all AER manufacturers that show the devices can clean and disinfect duodenoscopes. "A certification letter from the AER manufacturer must spell out those terms, not just that they have the data, but that the FDA reviewed and accepted it," says Dr. Muscarella. "If the manufacturer commits in writing that it has FDA-approved validation data, it's probably safe to continue using the AER to reprocess duodenoscopes."
If the manufacturer can't provide such data, Dr. Muscarella says you should consider manually disinfecting duodenoscopes to reduce the risk of infection. In addition, the FDA has released 4 supplemental measures to enhance duodenoscope reprocessing, and urges facilities to perform one or more of the following options:
- microbiological culturing of duodenoscope channels at the distal end of the scopes and holding them out of rotation until the tests come back negative;
- ethylene oxide (EtO) sterilization following cleaning and high-level disinfection;
- use of a liquid chemical sterilant system; and
- repeat high-level disinfection cycles either manually or using AERs.
Even GI facilities that don't use duodenoscopes are feeling an increased scrutiny on their reprocessing practices, partly because of the recent headline-grabbing duodenoscope-related infections.
"The recent headlines make you think twice about what you're doing," says Travis Taylor, ST, endoscopy tech at Lebanon (Tenn.) Endoscopy Center. Mr. Taylor is the lone man in charge of preparing the facility's 7 scopes for the 200 or so cases it hosts each month. He's been doing it for 8 years and is backed up by a nurse with 27 years' experience.
Mr. Taylor prefers to have few hands preferably his own handling scope reprocessing. "I've been to other facilities where multiple people are cleaning scopes in various ways, and there's only one way to do it properly," he says.
Meticulous manual cleaning before placing scopes in the AER is key, says Mr. Taylor. He might not have another staffer in the room to check his work, but his own pride and conscience are enough to ensure scopes are prepped properly.
"You have to be very careful to not go on autopilot, but I'm very thorough," says Mr. Taylor, who will restart the manual cleaning process if there's any question in his mind that he missed a step along the way.
Mr. Taylor meets with his backup nurse every quarter to make sure they're on the same page and following the latest reprocessing guidelines issued by the endoscopes' manufacturer. He's also very aware there's always more to learn, and constantly seeks the latest information about best practices.