Duodenoscope Superbug Outbreak: What You Need to Know

By ThinkReliability Staff

The bacteria involved in the outbreak are deadly: The recent outbreak in California involves Carbapenem-resistant Enterobacteriaceae (CRE). According to Centers for Disease Control and Prevention (CDC) Director Tom Frieden, “CRE are nightmare bacteria. Our strongest antibiotics don’t work and patients are left with potentially untreatable infections.” About 50% of patients with a CRE bloodstream infection will die. At least 7 people were infected at the UCLA Medical Center from October 2014 to January 2015, two of whom died.

Duodenoscopes are frequently used: Duodenoscopes are thin flexible scopes with a light and miniature camera attached, used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat liver, pancreas and bile-duct problems. The FDA hasn’t recalled the scopes because, according to US Food and Drug Administration (FDA) spokeswoman Leslie Wooldridge, “The FDA feels that the lifesaving nature of ERCP, performed on more than 500,000 patients annually in the U.S., makes it important for these devices to remain available.”

Duodenoscopes have been causing problems with infection for a long time: The President of the American Gastroenterological Association, John Allen, M.D. says that duodenoscopes have been causing superbug infections since 1987. He says, “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.” 16 patients developed serious infections after the use of a duodenoscope in France in 2008-2009, as reported in the journal Endoscopy. A 2013 outbreak infected 39 patients in Chicago (after which a duodenscope was destroyed because decontamination efforts were unsuccessful). The FDA received 75 reports involving 135 patients related to duodenoscope contamination from 2013 to 2014. 18 patients in North Carolina have been infected by CRE from duodenoscopes so far this year (2 of those patients have died).

Cleaning duodenoscopes is really difficult: The two duodenoscopes found to have been infected in the California outbreak were “sterilized according to the manufacturer’s specifications”, says the medical center. The FDA issued a warning February 19, 2015, noting that “Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” Effectively, even following the instructions may not fully sterilize the duodenoscope.

The FDA is working on label changes for duodenoscopes: According to Dr. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, “We are working to expedite modifications to the label. We are also talking about updating the risk information.” The FDA recommends that hospitals “consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.” The FDA has also asked duodenoscope manufacturers to prove that their recommended methods provide adequate disinfection.

Some worry that may not be enough: Says Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, “the devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch.” The CDC is working with duodenoscope manufacturers on a reprocessing (cleaning and sterilizing for reuse) protocol for the instruments. In the meantime, the UCLA Medical Center has turned to gas sterilization and has reported no new infections since the switch. However, the procedure is highly toxic and poses a risk to staff and patients. The FDA says it is “not something that we routinely recommend”.   Hospitals in North Carolina are screening patients for CRE and isolating infected patients, as well as decontaminating their rooms after they’re released. They’ve also enhanced the cleaning and sterilization processes for duodenoscopes.   At least one hospital is quarantining each device for 48 hours to verify by culture that it’s free of CRE and other infections.

It’s all part of a much bigger problem: Some worry that the time and money being spent dealing with the real, though comparatively small, risk of infection from contaminated duodenoscopes takes away from the broader effort of preventing all hospital infections, especially those that are resistant to antibiotics. The CDC has determined that about 1 in 25 patients acquire a hospital-acquired infection during a hospital stay (see our previous blog on this issue). Says David Ropeik, a consultant in risk perception and communication, the concern over this issue is “going to flare up and then it’s going to go away” but “the world will still be at serious peril from a risk we don’t take seriously, which is antibiotic resistance. Germs are figuring out how to resist our antibiotics faster than we can make new ones.”

If you would like to learn more, attend our FREE webinar “Healthcare Case Study – Hospital-Acquired Infections” on Thursday, March 5, 2015 at 11 am EST.  Register here.

65 surgeries required for boy who swallowed button battery

By ThinkReliability Staff

As you can imagine, as someone who regularly analyzes and reports on disasters of every kind, my mind is never far from things that could harm my children. Though the types of events I typically include are well-publicized, the real dangers for children tend to be things closer to home, that one might reasonably consider harmless.

Even after our blog about the dangers of children swallowing batteries (regarding a study that said a child in the US visits an emergency room every 3 hours for issues involving a battery and that 84% of these are button batteries), I didn’t really get it. Sure, swallowing anything is bad, and batteries have nasty chemicals in them. But it wasn’t until I read the story of Emmett Rauch that I really got how bad these issues could be.

When Emmett was one, he swallowed a button battery. His parents could tell that something wasn’t right, and Emmett was diagnosed with a cold, then croup. Luckily at a pediatrician visit 3 days after he swallowed the battery, the pediatrician had second thoughts and sent Emmett to the ER for an x-ray. Once the button battery was discovered lodged in his esophagus, the rush to treat him began. Emmett would receive 65 surgeries over the next four-and-a-half years to rebuild his esophagus and vocal chords.

Amazingly, Emmett is a survivor. He’s one of the lucky ones. There have been 15 deaths associated with small batteries over the last 6 years. Emmett’s mother, Karla Rauch, is now an activist for button battery ingestion awareness. The issues resulting in deaths and injuries to children (primarily under the age of 5) regarding button batteries are as follows:

Chemical reaction caused by batteries in the esophagus: Batteries (even “dead” ones) contain chemicals that create current. The moistness of the esophagus can cause a chemical reaction that can burn holes in the tissue.

Accessibility of button batteries: Kids like shiny things and they like to put things in their mouth. The first line of defense is preventing access to small batteries. Here’s how:

– Keep loose batteries out of reach of children

– Ensure battery compartments on products are secured

– Buy products with battery compartments that require a tool to open if possible

– Use duct tape to secure products with batteries that don’t require a tool

Difficulty of diagnosis – at home: Because the batteries are so small, kids will likely still be able to breathe after swallowing them, limiting parent’s ability to figure out that they’ve swallowed something they shouldn’t. Because of the ubiquity of small batteries, parents may not realize they’re missing.

Difficulty of diagnosis – at the hospital: An x-ray is required to determine that a child has swallowed a battery. An x-ray may not be called for if a doctor thinks (as is common) that the coughing or apparent throat damage is due to another sickness. Even though button batteries have been around for a while, they’re still not a risk that is very apparent to most people. So, if you think there is a possibility your child may have swallowed a battery, act quickly:

– Seek immediate medical attention if you believe a battery has been swallowed

– Do not let the child eat or drink

– Do not induce vomiting

– Tell the medical staff it may be a small battery

– If possible, provide information on the battery

To view an overview of this issue and solutions, please click on “Download PDF” above. Thanks to Karla Rauch for sharing her story. To learn more, see www.emmettsfight.com.

Explosion, Deaths at Maternity Hospital Follow Gas Leak

By ThinkReliability Staff

A gas tanker was providing fuel to a maternity hospital in Mexico City when the gas workers discovered a leak. They contacted the fire department, had the hospital evacuated, and attempted to put out the leak. Unfortunately, the leaked gas exploded, killing at least 2 nurses and 2 babies, and leveling most of the hospital.

Dozens more infants, patients and nursing staff were injured, along with the three gas workers present at the scene. The gas workers have all been arrested, though the charges against them have not been released. While it appears that the workers are being held responsible for the tragedy, providing an objective, factual analysis as to what happened can provide useful information to reduce the risk of the issue happening again.

When performing a root cause analysis of an issue (as we will do here in a Cause Map), it’s important to first capture the impacts to the organizational goals as a result of the incident being investigated. In this case, the patient safety goal is impacted because of the deaths of two infants and the injuries to dozens of patients. The safety of hospital employees was impacted due to the deaths of two nurses and injuries to many more. Additionally, the safety of the gas company employees was impacted because all three of the gas workers were injured.

The environment was impacted due to the gas leak. The compliance goal was impacted because the three workers were arrested. The patient services and operations goals were impacted by the evacuation from the hospital (which is very difficult on patients and staff, although it likely saved many lives in this case). The property goal is impacted because of the severe damage to the hospital and the labor goal is impacted by the rescue efforts. (Hospital neighbors are reported to have provided considerable assistance to the rescue efforts at no small risk to themselves.)

Any time deaths or injuries result from an explosion, it is important not only to determine what caused the explosion, but whether the response could have been improved. In this case, the explosion occurred while the hospital was being evacuated, though a specific timeline of the leak, evacuation and explosion has not been released. Further analysis into the evacuation will help determine whether improvements could have saved lives.

In the case of the explosion, the fuel was provided by the leaked gas. Adequate oxygen was present in the air, and the ignition source (heat) could have been provided by hospital operations (the gas was being delivered near the hospital kitchen) or potentially by work being done to repair the leak (such as static or a spark). The gas leaked due to a faulty gas delivery hose. When a faulty part contributes to a tragedy such as this one, it’s important to determine not only how the damage occurred (if possible), but whether inspections or maintenance could have reduced the risk of an incident. Clearly if the hose had been discovered to be faulty and replaced before the delivery took place, the risk of an explosion would have been greatly decreased.

A broader issue for the entire country is the question of why gas leaks and explosions are fairly common. Part of this is because there is no infrastructure to pipe gas underground and it instead has to be delivered by truck. A similar incident involving a hose issue on a gas truck killed three in Queretaro in July last year. The company that provided the gas to the hospital in this case says that it has 1,000 trucks that deliver gas to over 80% of the country. With such a large distribution network, accidents are bound to happen. However, clearly more effort needs to go into making sure that the impact on human lives is reduced.