Hospitals have no legal obligation to tell patients about the presence of pathogens at their facilities — including the antibiotic-resistant CRE superbug — due to an antiquated policy gap, according to Bloomberg News. This comes as an unsettling revelation to many, considering that CRE outbreaks suspected to have been passed by contaminated medical scopes have been linked to at least 2 patient deaths and dozens of serious infections.
Update: PENTAX Updates Duodenoscope Cleaning Instructions
February 19, 2016 – PENTAX Medical has updated the reprocessing and operation instructions for its ED-3490TK Video Duodenoscope. These instructions include new procedures for cleaning, high level disinfection and sterilization.
What’s the Problem?
Some hospitals have secretly investigated bacterial outbreaks for months and even years without informing their patients, according to Bloomberg. For example, an outbreak that began in a Seattle hospital in 2012 wasn’t even made public until earlier this year. When it was discovered that 7 people had been infected with the CRE superbug — including 2 who died — at the Ronald Reagan UCLA medical center in February, the facility warned 179 other patients they may have been exposed to the deadly bacteria during routine endoscopic retrograde cholangiopancreatography (ERCP) procedures that involved use of contaminated medical devices called duodenoscopes.
“Our No. 1 priority is the health and safety of our patients and we believe in honesty and transparency,” said hospital spokeswoman Dale Tate.
How are the Bacteria Spread?
There are many ways bacteria can be passed in a hospital setting. Staff might not wash their hands adequately or often enough, or surgical sites may be improperly prepared. The U.S. government requires medical facilities to track and disclose data on 6 types of bacterial infection, but the CRE superbug isn’t 1 of them.
CRE, or Carbapenem-Resistant Enterobacteriaceae, is a novel strain of a kind of bacteria that lives in the gastrointestinal (GI) tracts of humans and other warm-blooded animals. CRE is highly dangerous when it travels beyond the gut, where it can cause pneumonia, meningitis and severe infections of the bloodstream and urinary tract. The bacteria is resistant to last-resort antibiotics, and up to half of those infected die of resulting complications.
Patients exposed to CRE via a contaminated duodenoscope may be infected right away; however, others may become “colonized” — they don’t have symptoms or get sick, but the bacteria live in their GI tracts. This could lead to an infection at a later date or potentially transmit the pathogen to other patients in a hospital setting.
Infection Data Not Shared With Public
Certain states require healthcare providers to report bacterial outbreaks to public health officials, while others require medical facilities to report cases of patient harm called “sentinel levels.” Adverse events linked to medical devices are supposed to be submitted to the FDA, but little of this information ever reaches patients or the general public.
FDA didn’t issue a warning about the contaminated duodenoscopes until a day after news broke about the CRE superbug infections at UCLA. The agency updated its warning on March 4, stating that the duodenoscope manufacturer, Olympus Medical, never received approval to sell the device.
Superbug Outbreak Reports Filed Late
Reports from manufacturers about contaminated duodenoscopes linked to several recent outbreaks were submitted to the FDA late or not at all, according to USA Today. The companies are required to file Medical Device Reports (MDRs) within 30 days of learning that a product may pose safety risks. However, in at least 8 recent outbreaks of drug-resistant bacteria linked to duodenoscopes, the agency wasn’t aware of the problem until long after it was over, and in some cases disclosures were never made.