March 9, 2015
More On The Endoscope-Related CRE Outbreaks
By Michael D. Shaw
Last week’s story on this topic generated plenty of interest, so we continue our coverage…
Yet another prestigious hospital joins the ranks of those reporting Carbapenem resistant enterobacteriaceae (CRE) infections, linked to endoscopic retrograde cholangiopancreatography (ERCP) endoscopes. On March 4th, Cedars-Sinai Medical Center in Los Angeles discovered that four patients were infected with CRE, and 67 others may have been exposed.
Lisa McGiffert, director of the Safe Patient Project at Consumers Union, and a longtime activist regarding hospital-acquired infections, said that “It’s highly likely many hospitals around the country have had outbreaks, and they haven’t been able to connect the dots until this problem was disclosed at UCLA. It’s just a little late—especially for those who got infections and maybe died as a consequence.”
As discussed in last week’s piece, the magic bullet to end this horror seems to be true sterilization of the scopes with ethylene oxide (EtO). This finding was published on October 8, 2014 in JAMA, in an article entitled “New Delhi Metallo-ß-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated With Exposure to Duodenoscopes.”
Notably, EtO is hardly new technology, introduced 70-odd years ago. So why, people asked me, are these ERCP scopes not being sterilized with EtO? Good question. In fact, this was one of two questions repeatedly posed to me, via e-mails, phone calls, and from a Boston-based talk show host.
Regarding the non-use of EtO, the answer is cost. EtO sterilization is not expensive per se, but its 10-12 hour cycle time means that more scopes (at nearly $40,000 each) would need to be placed in inventory, to maintain the production flow of the ERCP procedures. Other reprocessing methods are quicker, but have proven to be less effective. However, in light of the CRE outbreaks, EtO sterilization—at least for these scopes—appears to be making a comeback. Bear in mind that other types of endoscopes are not immune from superbug contamination, and EtO should strongly be considered for these, as well.
This column is aware of a three hour cycle EtO sterilizer, now undergoing FDA 510(k) clearance procedures. More information will be presented when available.
The second good question concerns the astonishing level of detachment in this matter, shown by the gastroenterology doctors. Although official recognition of gastroenterology as a subspecialty of internal medicine dates back to 1941, the field came into its own with the emergence of endoscopy in the 1970s. How odd that the devices that virtually put gastroenterology on the map—not to mention enabling its high fees—are somehow dissociated from the practitioners, themselves.
And, let’s not forget the unsung heroes of each hospital’s central service/sterile processing department (CS/SPD). These are the people responsible for sterile processing of all devices, including endoscopes. It is not widely publicized that reprocessing instructions for the Olympus duodenoscope under fire (TJF-Q180V) comprise a 106-page booklet, along with a companion 45-page Cleaning and Disinfection Checklist. Similarly detailed instructions must be followed for dozens of other devices.
Nor is it widely publicized that CS/SPD salaries are relatively low. Based on recent data, those with manager/director titles can earn around $70,000/year, while a lead CS/SPD technician makes about $34,000. For those keeping score at home, GI-docs pull in about ten times the compensation of the technician. I would hazard a guess that before these CRE infections, few gastroenterologists had ever seen, let alone read, a reprocessing manual for an endoscope.
The CRE/ERCP scope matter reveals many flaws of our health care system, including infection control breaches; soulless detachment and expediency; regulatory malfeasance; and official cover-ups. It is long past time to address these problems.