Every year, about 9,000 people develop antibiotic-resistant CRE infections, resulting in 600 deaths. Because the bacteria is antibiotic-resistant, up to half of infections are fatal.
What is CRE?
Carbapenem-resistant Enterobacteriaceae (CRE) is a type of bacteria that has recently evolved resistance to nearly all antibiotics. In 2001, researchers discovered that CRE could create an enzyme that de-activates antibiotics — including carbapenem, which is a “last-resort” antibiotic when nothing else works. For patients who are infected, treatments for CRE are toxic. An estimated 50% of infections cause death.
How Do CRE Infections Spread?
CRE does not spread through the air by coughing or sneezing. It most often spreads in hospitals or long-term care facilities on medical devices, such as catheters, ventilators, or endoscopes. CRE can also spread by touching an infected wound or feces.
Does CRE Always Cause Infections?
No. Healthy people sometimes have CRE living inside their body. They are “colonized,” which means it is not causing diseases or symptoms, but they are not infected and they do not need treatment.
Infections can occur, however, if CRE spreads to a healthy person’s bladder, lungs , or bloodstream. It can also rapidly spread outside the intestines in sick patients who are on antibiotics (which disrupt the normal balance of good and bad bacteria in the gut) or in poor health.
CRE Infection Symptoms
CRE can cause a wide range of infections, all with different symptoms — pneumonia, bloodstream infections, open wounds, and urinary tract infections. In general, symptoms of an infection include:
- Muscle aches or cramping
- Coughing and sneezing
- And more
Who Is Most At Risk?
- Patients undergoing medical procedures involving endoscopes, which are long, flexible tubes that are inserted into the mouth or rectum and re-used on multiple patients.
- Patients who need a ventilator (breathing machines), urinary (bladder) catheter), or intravenous (vein) catheter.
- Patients who are on antibiotics for a long time.
FDA Warning: “Superbug” CRE Infection Outbreaks
The FDA has issued a Safety Communication to warn about the risk of antibiotic-resistant “superbug” infections from contaminated medical scopes. The warning was issued after an outbreak of CRE infection at UCLA exposed 179 patients, including 7 who were infected and 2 who died. Other hospitals have also reported outbreaks:
- In May 2015, at least 39 CRE infections were linked to a deadly outbreak at Virginia Mason Medical Center in Seattle, Washington.
- In March 2015, at least 67 patients were exposed and 4 developed antibiotic-resistant CRE infections after undergoing medical procedures involving an Olympus duodenoscope at Cedars-Sinai Medical Center in Los Angeles.
- In February 2015, a hospital in North Carolina reported that three people have been infected and one person has died from CRE infections.
What is the Problem?
Hospitals do not have to inform patients when they are exposed to CRE on dirty medical scopes, which may explain why it took years for some recent outbreaks to come to light. However, as more hospitals report “superbug” outbreaks, studies suggest that 3% of scopes may remain contaminated after high-level disinfection. The White House and state lawmakers are demanding action to curb the emergence of CRE and other “superbug” bacterial infection outbreaks.
Olympus Duodenoscope CRE Infection Lawsuits
Many of the infections have been traced to duodenoscopes made by Olympus Corp. The company warned hospitals in Europe about the risk of transmitting “superbug” infections on contaminated duodenoscopes in January 2013, but failed to warn hospitals in the United States. In March 2015, Olympus issued an urgent update on how to clean the duodenoscope that has recently been linked to deadly CRE infections. The company is facing a growing number of lawsuits from people who were infected with CRE, including wrongful death lawsuits.
CRE Infection Outbreak Leads to Lawsuits
In mid-2014 through January 2015, at least 179 people were exposed to CRE on a contaminated medical device called a duodenoscope, which is inserted into a patient’s throat. The procedure, known as ERCP, is commonly used to treat gallstones, cancer, and other diseases of the digestive tract.
At least seven people were infected with CRE, including two who died. The FDA has issued a Safety Communication to warn that the devices have a complex design that is nearly impossible to sterilize.
The manufacturer of the scope, Olympus Medical Systems, is now facing a lawsuit from an 18 year-old victim who nearly died. The lawsuit claims the scope is unreasonably dangerous and defective. The Los Angeles Times warns:
“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety. Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”