The Buffalo Veterans Affairs Medical Center is notifying 526 patients that the use of an improperly cleaned medical scope may have put them at risk of infection.
During a recent review of the disinfection process for the reusable equipment generally known as endoscopes, it was noted that steps in the manufacturer’s instructions may not have been followed in some cases by an employee of the hospital.
Medical center officials characterized the risk of infection as "very low," and announced they will offer screening to the patients at no charge.
Concerns around inadequately cleaned medical scopes usually revolves around the transmission of such illnesses as hepatitis C and HIV.
"Notification does not mean veterans were infected," medical center officials said in a brief statement on Wednesday.
The employee was "immediately relieved from the position," according to the statement.
The VA declined to offer any additional information — including what type of procedure the patients received, and over what time period.
The medical center also declined to say when or how the issue was discovered, how many scopes were involved, or what steps in the cleaning process were not followed.
For years, there has been increasing concern about infections linked to endoscopes, the flexible, lighted tubes that doctors use to peer inside patients' bodies. The devices are notoriously difficult to clean, and require myriad steps to prepare for reuse in another patient.
Organic residues often remain after manual cleaning, and contamination can persist even in institutions with documented adherence to reprocessing guidelines, research indicated.
Outbreaks have been associated with a number of different medical scopes, including duodenoscopes threaded into the top of the small intestine, gastroscopes passed into the stomach, colonoscopes inserted into the rectum to view the large intestine, and bronchoscopes to view the airways.
A study published this year in the American Journal of Infection Control examined 20 scopes over a seven-month period. The researchers found visual irregularities, such as fluid that could foster the growth of bacterial or fungi, discoloration and debris in channels.
Samples from 12 of 20 endoscopes had microbial growth after cleaning, and signs of organic residue were higher in gastroscopes than in endoscopes.
"This study demonstrated that more rigorous reprocessing practices may not be sufficient to ensure that patient-ready endoscopes are free from residual contamination, particularly when the endoscope has defects that could harbor organic debris and biofilm," the researchers reported in the journal.
The Food and Drug Administration and professional organizations have developed guidelines for appropriately cleaning the devices. In 2015, the FDA also emphasized the importance of training and oversight of cleaning staff, as well as adherence to manufacturers' instructions.
The risk of acquiring an infection from an inadequately sanitized medical device is relatively low given the large number of devices in use, although the potential for outbreaks remains an important public health concern, according to the FDA.
Infections from inadequately reprocessed devices are not often recognized or reported to federal authorities, so the number of infections linked to improperly cleaned endoscopes remains unknown.
This isn't the first time the Buffalo VA Medical Center's processes have come under question.
The Office of Special Counsel in 2014 cited the hospital for problems concerning safety standards for sterilizing medical equipment in a letter to former President Obama. However, the VA's Office of the Medical Inspector reported that no rules were violated or patients harmed.
Before that, in 2012, the hospital acknowledged that it inadvertently had been reusing single-use insulin pens, a situation that could have exposed hundreds of patients to infection.
A Department of Veterans Affairs Office of Inspector General report in 2013 determined that an employee discovered three insulin pens designed for single use with no patient labels in a supply drawer. Facility officials subsequently found three more pens without patient labels, and several nurses reportedly acknowledged using the pens on multiple patients over several years.