All posts by SlSavyon

Deadly superbug infected patients at Virginia Mason

A deadly bacteria has been linked to a commonly used medical device. The pattern of illnesses and deaths showed up in Chicago and Pittsburgh, with the biggest outbreak right here in Seattle. Eleven deaths occurred at Virginia Mason alone, but it’s not clear if those deaths were directly related to the superbug infection.

The bigger fear now is that the problem is nationwide and other hospitals aren’t looking for it.

“You have to understand that this issue dates back to 2011, 2012,” said Dr. Andrew Ross, section head of gastroenterology at Virginia Mason.

It wasn’t until spring 2013 that the Centers for Disease Control an Prevention even recognized this new superbug called CRE (carbapenem-resistant Enterobacteriaceae) as a nationwide threat. Later that same year, Dr. Ross said Virginia Mason voluntarily agreed to be part of surveillance efforts overseen by King County.

“This is a little bit like a rock. If you don’t look underneath the rocks, you’re not going to find what you’re looking for,” Dr. Ross said.

King County found CRE infections linked to a special endoscope, a flexible tool used to treat gallbladder stones, pancreatic cancer and other problems in the gut.

Half a million of these procedures are performed across the country every year.

“This is really the perfect storm. You have an instrument that on the whole is difficult to completely disinfect and at the same time you have a bug that’s become more and more resistant to antibiotics,” said Dr. Ross.

At the tip of the duodenoscope is a tiny opening called the sanctuary site, where debris and bacteria can collect.

“(It’s) frankly very, very hard to clean,” said Dr. Ross.

Virginia Mason’s solution was to buy more scopes to put into the rotation, then to create a “penalty box,” where the used scopes are stored, once they are cleaned and disinfected.

This quarantine lasts for 48 hours, then the scope are tested again to make sure they harbor no bacteria.

“Since we’ve implemented this penalty box, we’ve seen no more transmissions so we know that it works,” said Dr. Ross.

He said that makes Virginia Mason the safest place in the country now to have one of these procedures.

Still, that solution cost the hospital nearly $1 million, something that’s impractical to implement nationwide.

The ultimate solution, Dr. Ross says, needs to be a design change.

There are three manufacturers of these scopes. All three have this same design flaw.

Contrary to some reports, Dr. Ross says patients who contracted CRE during the surveillance period were informed they had the infection.

Virginia Mason, however, did not contact patients who may have been exposed to the bacteria prior to the surveillance period.

Contaminated Medical Equipment May Be Responsible for Multiple Infections and at Least Two Deaths

Specialized endoscopes are routinely used to diagnose and treat both pancreatic and bile-duct diseases. Though single-use, disposable equipment has been advocated by some experts, the multiple-use endoscopes requiring sterilization after each procedure are generally employed. Despite careful compliance with manufacturers’ sterilization instructions, however, the equipment is frequently found to harbor bacteria that were not removed during “sterilization.” According to the U.S. Food and Drug Administration (FDA), the endoscopes’ design may prevent adequate cleaning.

dirty medical toolsHospitals nationwide have reported infections with an antibiotic-resistant bacterial “superbug” in dozens of patients who have undergone endoscopies with this equipment, which is suspected to have contributed to at least two deaths. According to the U.S. Centers for Disease Control and Prevention (CDC), superbug infections can result in death in half of infected patients.

Defective medical equipment has the potential to cause serious injury and death. The Killino Firm has extensive experience with cases arising out of injuries caused by defective medical equipment or other products. If you have been injured or made ill in this manner, contact our attorneys for more information about your legal rights and options.

Who Can Be Held Responsible for Illnesses and Deaths Caused by Defective Medical Equipment?

Medical equipment that is defective in its design, manufacture, or warnings may lead to the liability of equipment manufacturers and other entities involved in the equipment’s production and distribution for injuries and deaths determined to have been caused by the equipment defect. A reusable endoscope that requires sterilization to protect patients from injury or death may be found defective in design in a products-liability personal-injury or wrongful-death action if the product design hinders effective sterilization.

A manufacturer’s warnings or instructions regarding the use and/or sterilization of reusable endoscopes may also be found to render the product defective if a consumer’s explicit following of the instructions does not make the product reasonably safe for the consumer’s use. The reusable endoscopes, which are manufactured primarily by Olympus Corp, Fujifilm Holdings Corp., and Pentax, may be found defective both in their design and in their instructions regarding equipment sterilization, as the design itself makes the equipment difficult to clean properly and the equipment-cleaning instructions are inadequate to accomplish their purpose.

Though the sterilization instructions included with these endoscopes was approved by the FDA, the equipment may still be found defective under products-liability law and Medical Malpractice law. Medical equipment may also be found defective despite the manufacturer’s compliance with industry standards. In addition, a hospital that negligently uses defective equipment may be found liable for resultant injuries or deaths.

Obtain Legal Assistance from The Killino Firm, P.C.

The Killino Firm Philadelphia is nationally recognized for its dedication to obtaining justice for people who have been injured or killed due to defective and dangerous products. If you have been injured or one of your family members has died through exposure to a defective product, The Killino Firm can help you secure the justice you deserve from the responsible parties.

FDA panel: Endoscopes unsafe, need updated designs

An FDA advisory panel last week declared that duodenoscopes, linked to sometimes lethal antibacterial-resistant outbreaks across the U.S., are unsafe as designed.

The panel urged the FDA to act on this information, but didn’t ask for a halt to further use of the devices.

“We have heard enough data to say these devices are not safe using current conditions. Everyone in this room is a potential patient, and no one would accept anything other than a device free of pathogens,” panel member Dr. Irving Nachamkin of the University of Pennsylvania told the LA Times.

The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually.

“We need to take steps to assure [patients] – and health providers that perform the procedures – that this procedure can be done as safely and effectively as possible,” acting FDA commissioner Dr. Stephen Ostroff said.

Global Capsule Endoscopes Market 2015 Vendors, Driver, Challenge, Trends

Global Capsule Endoscopes Market 2015 Vendors, Driver, Challenge, TrendsGlobal Capsule Endoscopes Market 2015

Our analyst researched the following companies as the key players in the global capsule endoscopes market: Chongqing Jinshan Science & Technology Group Co. Ltd., IntroMedic Co. Ltd., Medtronic plc and Olympus Corp.


Other Prominent Vendors in the market are: Check-Cap, Cook Medical, Fuji Medical Systems, Pentax, Philips Healthcare, RF, Siemens and SynMed


Commenting on the report, an our analyst said: “Increased Usage of Capsule Endoscopy is one of the key trends upcoming in this market.  Capsule endoscopy is currently the best available option and is now used by many physicians worldwide. The procedure is superior to barium X-ray testing and other traditional processes. Technological advancements in capsule endoscopy are expected to propel the market toward the understanding of obscure gastrointestinal bleeding and detection of gastrointestinal and other related diseases.”


According to the report, the increasing elderly population is the major driver of the growth of the market. The elderly are susceptible to gastrointestinal disorders. Hence, the growing elderly population has led to increased use of capsule endoscopy for disease diagnosis. For this reason, various hybrid imaging technologies are being introduced to increase the image quality of the procedure.


Further, the report states that the presence of alternative conventional endoscopy procedures poses a serious challenge to the market growth. Many patients still prefer these procedures over capsule endoscopy.


The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

FDA: ERCP Endoscopes Pose Unique Reprocessing Challenges

Effective reprocessing of endoscopes that are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures requires continued vigilance to prevent dangerous infections, according to a US Food and Drug Administration (FDA) advisory panel that met today and yesterday.

The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee met to discuss the unique challenges associated with reprocessing ERCP endoscopes.

At least six outbreaks ― some lethal ― have occurred within recent years despite proper adherence to manufacturers’ instructions and recommendations from professional organizations about the reprocessing of duodenoscopes. Most concerning is that infections have been linked to rare bacteria, especially multidrug-resistant organisms.

More than 600,000 ERCP procedures are performed in the United States each year. In ERCP, a specially trained physician threads a duodenoscope through the esophagus, stomach, and duodenum, then injects contrast media directly into the biliary tree to visualize the biliary and pancreatic duct anatomy. This allows the physician to assess for obstruction or narrowing of the ducts caused by cancer, gallstones, inflammation, infection, or other disorders. The procedure can enable immediate and sometimes life-saving treatment.

The duodenoscope is a reusable, flexible, lighted tube with a hollow channel that enables other instruments to be inserted through it for tissue sampling and treatment of some abnormalities. Its unique features make it difficult to reprocess so that it can be used in subsequent patients. Duodenoscopes have many small parts that are hidden and can be difficult to reach; therefore, meticulous reprocessing is necessary to avoid transmitting infections to subsequent patients.

Several reasons may account for why outbreaks have occurred. Insufficient manual cleaning, failure to follow the manufacturer’s recommended cleaning instructions, or failure to use enough disinfectant may be to blame. Some infections have been linked to contamination from tap water or irrigating solutions. Finally, improper use of automated endoscope reprocessors (AERs), inadequate drying, and defective equipment may all play roles.

One issue is that the design of duodenoscopes may make it difficult to properly reprocess them. Some hospitals use high-level disinfection, which involves use of chemical disinfectants that may not necessarily kill all organisms. Duodenoscopes can be damaged by the high heat commonly used with steam sterilization. Some hospitals use chemical sterilization with ethylene glycol, which raises the issue of toxicity and worker safety.

Even when duodenoscopes are cleaned properly, they may be rinsed improperly with tap water or other liquids, introducing new bacteria. Another issue concerns storage and transfer of the duodenoscopes to the operating room after cleaning, also potential sources of contamination. A third issue concerns proper drying of duodenoscopes and the potential for biofilm formation. Biofilms need water for survival and could potentially contaminate duodenoscopes.

How One Hospital Stopped a Superbug Outbreak in Its Tracks

Specialized endoscopes that are used to perform a common medical procedure have contributed to at least 13 deaths and 121 injuries in recent years by spreading bacteria among patients. Next week a panel of medical experts will meet at the Food and Drug Administration to consider the safety of the devices. The instruments, known as duodenoscopes, have intricate channels that can harbor pathogens from one patient and spread them to others, even after cleaning. The panel will weigh whether the existing cleaning guidelines are adequate and, if not, how to improve them.

U.S. regulators might take a cue from a Dutch hospital that faced the same problem three years ago: a spike in drug-resistant infections detected in January 2012 among patients who underwent the procedures using the same model of Olympus scope suspected of spreading bacteria in several outbreaks in the U.S. Researchers report in a recent article in the journal Endoscopy that the hospital, Erasmus MC University Medical Center, in Rotterdam, halted its outbreak by reverting to an older model of scope that researchers believe is easier to clean.

The problem isn’t isolated to a single model of the device. Nine U.S. hospitals have reported outbreaks linked to scopes from all three major manufacturers: Olympus, Pentax, and Fujifilm. But the Olympus scope, model number TJF-Q180V, is getting extra scrutiny for two reasons. Olympus is the dominant maker of the scopes, with about 85 percent of the U.S. market, according to the FDA. And that particular modelhas not been cleared by the FDA’s process for overseeing medical devices, though earlier versions have.

Olympus didn’t respond to a request for comment. The Japanese device maker is facing 14 lawsuits in California, Pennsylvania, and Washington state “alleging injuries sustained by the use of the same product—the TJF-Q180V duodenoscope,” according to a May 1 filing in U.S. District Court in California.

The model features a sealed channel that may be difficult to rid of trapped organic material. The version it replaced, the Dutch researchers wrote, features a removable cap that can be taken off so the inside pieces of the scope can be flushed clean. In the Rotterdam outbreak, 22 of the 30 patients infected over five months had the procedure done with an Olympus TJF-Q180V. Reverting to using the earlier Olympus scope stopped the outbreak.

Duodenoscopes are used to diagnose and treat problems in tiny ducts connecting the small intestine to the pancreas or gallbladder. The procedure is done more than 600,000 times a year in the U.S., the FDA says.

Under the FDA’s rules for medical devices, manufacturers are allowed to determine on their own whether to notify the regulator about changes to an existing product. Olympus sold the new model to hospitals for years before the FDA determined it needed a separate review and asked the company to submit a new application in March 2014. The lack of clearance wasn’t made public until this year. The agency is still evaluating that submission. The FDA says there’s no evidence the lack of clearance is associated with the infections.

The FDA is aware of the report from Erasmus, agency spokeswoman Jennifer Dooren said in an e-mail. The U.S. regulator hasn’t pulled the scope from the market, citing concerns about causing a shortage of instruments needed for sometimes life-saving treatments. In March, Olympus issued new instructions for cleaning the scopes, which the FDA urged hospitals to adopt “as soon as possible.”

Olympus warned hospitals in Europe about the difficulty in cleaning the new model scopes as early as January 2013, the Los Angeles Times reported in April. That was two years before problems came to light in the U.S. The FDA didn’t publicly warn that effective cleaning of the devices “may not be possible” until a Feb. 19 safety alert, the day after news of an outbreak at UCLA Medical Center made headlines.

The agency and the manufacturer have faced criticism and inquiries from members of Congress. U.S. Senator Patty Murray, a Democrat from Washington, has asked the FDA for a full review of problems with the devices, including whether the agency’s system for monitoring changes to devices is adequate.

Cartilage graft in pediatric endoscopic tympanoplasty shows good results

Children 10 years old and younger do just as well as older children with endoscopic type 1 tympanoplasty for repairing perforated ear drums, a new 80-patient study shows.

The findings confirm that it is not necessary to wait until a child reaches puberty to repair the ear drum, Dr. Osama G. Abdel-Naby Awad, of Minia University Hospital in Minia, Egypt, told Reuters Health by email. Also, Dr. Awad added, while these operations are typically performed with microscopes, the findings show that endoscopes can be used with good results.

Dr. Awad and Dr. Khalf Hamid, also of Minia, report on a series of 80 patients treated with endoscopic type 1 tympanoplasty, using split-thickness tragal cartilage for grafting, in an article online April 30 in JAMA Otolaryngology-Head & Neck Surgery. Forty patients were 10 and younger, and 40 were older than 10. All were treated with the endoscopic inlay approach using a 2.7 mm endoscope.

Thirty-four patients in the younger group (85%) had complete healing of their perforation, as did 36 (90%) children in the older group. Improvement in the air-bone gap (ABG) occurred in 75% of the younger group and 80% of the older group. Mean ABG was 8.0 dB in the younger group and 10.5 dB in the older group. The operations, all performed by Dr. Awad, lasted a median 55.03 minutes.

The surgery tended to be more successful in patients who had undergone adenotonsillectomy previously, but the difference was not statistically significant.

Dr. Awad said he and his colleagues are now investigating using the endoscopic approach to cleaning the middle ear in patients with chronic otitis media with cholesteatoma.

“Our new approach for tympanoplasty in children eliminates the need for the painful incisions to take the graft from behind the ear, which helps the children for better compliance throughout the follow-up period and improves these kids’ lifestyle,” he added.

FDA advisory panel to investigate duodenoscope safety

The Food and Drug Administration received 142 reports of possible infections of patients undergoing procedures with the type medical scope responsible for outbreaks at two medical centers over the past six months.

The figure was included in a report issued in advance of a two-day FDA advisory committee meeting scheduled May 14-15 that will examine the efficacy of the cleaning processes for duodenoscopes recommended by their manufacturers. The panel is expected identify best practices providers can follow that will further reduce the risk of contamination.

An FDA review of incident reports dating from 1997 up to this past February found there 146 reports of “patient infection, exposure or device contamination” associated with the use of duodenoscopes for endoscopic retrograde cholangiopancreatography procedures. Nearly all of those reports came in the past five years.

The agency also revealed that it received 152 medical device reports of patient exposure to infection associated with the use of automated endoscope reprocessors, the machines used to disinfect the scopes, between 1992 and March this year.

The agency concludes in the report that it still believes the benefits of the procedure “outweigh the risks in appropriately selected patients.” It adds, however that the transmission of infection, “although uncommon, represents a serious public health concern.”

Efforts to improve disinfection methods have been given greater attention over the last several months in the wake of two outbreaks of carbapenum-resistant enterobacteriaceae, or CRE, between August 2014 and January 2015 at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center. As many as 250 people were exposed to the drug-resistant bacteria, leading to 11 infections and two deaths.

More than 668,000 ERCPs were performed in 2014, according to the report. The procedures are done to evaluate and treat conditions within the pancreatic and bile ducts. Given the vital role duodenoscopes play in identifying and treating such diseases, the FDA has continued to recommend their use despite recognizing the difficulties involved in disinfecting the devices, even when guidelines are followed.

“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to a safety warning about the devices the FDA issued in February. “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.”

In March the FDA issued final guidance on processes to clean and disinfect reusable medical devices, including duodenoscopes. The guidance requires manufacturers to submit testing data to validate that their cleaning instructions are effecting in reducing the risk of bacterial contamination.

Microendoscope could eliminate unneeded biopsies

In a clinical study of patients in the United States and China, researchers found that a low-cost, portable, battery-powered microendoscope developed by Rice University bioengineers could eventually eliminate the need for costly biopsies for many patients undergoing standard endoscopic screening for esophageal cancer.

Rebecca Richards-Kortum with microendoscope for cancer screening

The research is available online in the journal Gastroenterology and was co-authored by researchers from nearly a dozen institutions that include Rice, Baylor College of Medicine, the Chinese Academy of Medical Sciences and the National Cancer Institute.

The clinical study, which involved 147 U.S. and Chinese patients undergoing examination for potentially malignant squamous cell tumors, explored whether Rice’s low-cost, high-resolution fiber-optic imaging system could reduce the need for unnecessary biopsies when used in combination with a conventional endoscope — the worldwide standard of care for esophageal cancer diagnoses.

The study involved patients from two U.S. and two Chinese hospitals: Mt. Sinai Medical Center in New York, the University of Texas MD Anderson Cancer Center in Houston, the Cancer Institute and Hospital of the Chinese Academy of Medical Sciences in Beijing and First University Hospital in Jilin, China.

In the study, all 147 patients with suspect lesions were examined with both a traditional endoscope and Rice’s microendoscope. Biopsies were obtained based upon the results of the traditional endoscopic exam.

Images of benign and precancerous lesions from Rice's microendoscope

A pathology exam revealed that more than half of those receiving biopsies — 58 percent — did not have high-grade precancer or cancer. The researchers found that the microendoscopic exam could have spared unnecessary biopsies for about 90 percent of the patients with benign lesions.

“For patients, biopsies are stressful and sometimes painful,” said lead researcher Rebecca Richards-Kortum, Rice’s Stanley C. Moore Professor of Bioengineering, professor of electrical and computer engineering and director of Rice 360°: Institute for Global Health Technologies. “In addition, in low-resource settings, pathology costs frequently exceed endoscopy costs. So the microendoscope could both improve patient outcomes and provide a significant cost-saving advantage if used in conjunction with a traditional endoscope.”

When examined under a microscope, cancerous and precancerous cells typically appear different from healthy cells. The study of cellular structures is known as histology, and a histological analysis is typically required for an accurate diagnosis of both the type and stage of a cancerous tumor.

Sharmila Anandasabapathy

To determine whether a biopsy is needed for a histological exam, health professionals often use endoscopes, small cameras mounted on flexible tubes that can be inserted into the body to visually examine an organ or tissue without surgery. Rice’s high-resolution microendoscope uses a 1-millimeter-wide fiber-optic cable that is attached to the standard endoscope. The cable transmits images to a high-powered fluorescence microscope, and the endoscopist uses a tablet computer to view the microscope’s output. The microendoscope provides images with similar resolution to traditional histology and allows endoscopists to see individual cells and cell nuclei in lesions suspected of being cancerous.

By providing real-time histological data to endoscopists, Rice’s microendoscope can help rule out malignancy in cases that would otherwise require a biopsy.

“While traditional endoscopy can rule out malignancy and eliminate the need for biopsies for some patients, in a significant number of cases the difference between malignant and benign lesions only becomes apparent through a histological analysis,” said study co-author Dr. Sharmila Anandasabapathy, professor of medicine and gastroenterology at Baylor College of Medicine and director of Baylor Global Initiatives and the Baylor Global Innovation Center.

Tim Quang demonstrates Rice's microendoscope

Richards-Kortum’s lab specializes in the development of low-cost optical imaging and spectroscopy tools to detect cancer and infectious disease at the point of care. Her research group is particularly interested in developing technology for low-resource settings, and the microendoscope was developed as part of that effort. It is battery-operated, inexpensive to operate and requires very little training. Results from the clinical study verified that both experienced and novice endoscopists could use the microendoscope to make accurate assessments of the need for a biopsy.

Clinical studies of Rice’s microendoscope are either planned or underway for a dozen types of cancer including cervical, bladder, oral and colon cancers.

“More than half of cancer deaths today occur in the developing world, often in low-resource areas,” Anandasabapathy said. “The World Health Organization and other important international bodies have called for increased global focus on noncommunicable diseases like cancer, and Rice’s microendoscope is a great example of what the right kind of technology can do to change health care in low-resource countries.”

Additional study co-authors include Timothy Quang, Dongsuk Shin and Richard Schwarz, all of Rice; James Godbold, Marion-Anna Protano, Michelle Lee, Josephine Mitcham, Erin Moshier, Alexandros Polydorides and Courtney Hudson, all of Mount Sinai Medical Center; Junsheng Cui, Hong Xu, Fan Zhang and Weiran Xum, all of the First Hospital of Jilin University; Guiqi Wang and Liyan Xue of the Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Sanford Dawsey of the National Cancer Institute; Mark Pierce of Rutgers University; Manoop Bhutani of the University of Texas MD Anderson Cancer Center; Neil Parikh of Yale University; and Chin Hur of Massachusetts General Hospital.


Reprocessing Flexible Endoscopes

Flexible endoscopes have many advantages and are very helpful devices in modern medicine to diagnose and treat many diseases. They could, however, also put patient safety at risk when reprocessing fails or is performed inadequately.


Since the first reported use of an early flexible endoscope in 1805, these instruments have continued to develop, especially since the 1960s when fibre optics were introduced. These procedures are not only minimally invasive and therefore less painful for the patient, but also result in, if compared to classic surgical procedures, less complications such as surgical site infections. They also enable rapid screenings, diagnosis and even direct treatment. With more than 18 million gastrointestinal endoscopic procedures and at least a half million bronchoscopies every year in the United States alone, these devices greatly benefit lifesaving diagnosis and treatment.

With the increasing use of these reusable medical devices, however, there are also adverse effects. During an endoscopy, endoscopes can be contaminated with tissues and microorganisms from patients. When reprocessed improperly, this can lead to false diagnosis or infections in subsequent patients. Despite all the guidelines on reprocessing flexible endoscopes, many publications and reports have described the transmission of microorganisms, infections and even outbreaks related to failures in cleaning and disinfection of flexible endoscopes.

Guidelines are continuously revised and translated in local work procedures and quality protocols. Many control mechanisms, audits and quality checks are performed on the process of cleaning and disinfection of flexible endoscopes.

The fact that endoscope related infections still occur in spite of these quality improvements, however, triggers us to have a look at the process of reprocessing flexible episodes again and the need for new improvements.

Endoscopy related infections

Infections related to flexible endoscopic procedures and the related use of flexible endoscopes can be caused by either the patient’s own microorganisms or by microorganisms introduced into the patient via the flexible endoscope or its accessories. Many publications and reports on contamination, infections, and outbreaks due to improper reprocessed flexible endoscopes were published over the last decades. It’s bizarre that with no other reusable medical devices are these kinds of problems described. This implies that despite all the measures taken to clean and disinfect flexible endoscopes as detailed in international and nationwide guidelines, that there are well-known risks when using reprocessed flexible endoscopes.

The incidence of infections caused by transmission of microorganisms between patients or from the environment is estimated at approximately one infection per 1.8 million procedures. This indicates a negligible risk, which presumes that the use of flexible endoscopes – and therefore also their reprocessing – is highly safe. In fact, infection risks range from less than 1% in simple upper up to 11% for endoscopic retrograde cholangio pancreatography (ERCP).

Due to manipulation of the bile and pancreatic ducts during diagnostic and therapeutic procedures, ERCP is reported with the highest risk of infectious complications. There is a difference between diagnostic and therapeutic ERCP. Diagnostic ERCP is a safe procedure with a 1% rate of complications such as inflammation of the pancreas. Although therapeutic ERCP can also be regarded as a relatively safe procedure, about 3% of the patients may experience complications, including infections, bleeding and pancreatitis. Palabiyikoglu et alconcluded that at least 1.8% of all patients undergoing ERCP had an ERCP related sepsis, with a mortality rate of approximately 26%.

It’s assumed that, besides reported publications on outbreaks, infection rates related to flexible endoscopes are underestimated because infections after endoscopy may be under-recognised: they are easily masked by the primary signs and symptoms, and a good registration of infectious complications after endoscopy is often missing.

The design of modern flexible endoscopes, with their long narrow lumens, cross connections, springs, valves, occluded dead ends and the presence of rough or pitted surfaces could be mitigating factors in cleaning and disinfection.

Reprocessing flexible endoscopes

In today’s practice flexible endoscopes are regarded as semi critical instruments, as they contact mucous membranes and non-intact skin. The infection risks are also regarded as semi-critical. To conform to the Spaulding schedule these instruments require disinfection or a high-level disinfection.

The whole process of cleaning and disinfection is described in many nationwide and local guidelines and consists of the following steps: a pre-cleaning followed by a manual cleaning, finally automated cleaning and disinfection in an automated endoscope reprocessor using a chemical or thermal-chemical disinfection phase, followed by a thorough drying.

It’s remarkable that despite thorough reprocessing guidelines some flexible endoscopes aren’t clean at the end of reprocessing. Are there other factors at play than simply issues related to design that could have an adverse event on the outcome of reprocessing?

Important steps in reprocessing flexible endoscopes are yet to be automated, meaning the whole process is very time consuming and labour intensive, especially with today’s pressure on endoscope programmes, the number of flexible endoscopes, the capacity of endoscope reprocessors and the personnel available for reprocessing flexible endoscopes.

While time consuming, meticulous manual cleaning – with extensive brushing of all channels and components – prior to automated cleaning and disinfection is an essential step in reprocessing flexible endoscopes, eliminating more than 90% of debris, biofilms and microorganisms.

Routine sampling could be a worthwhile additional step that gives us information on not only the final reprocessing results, but could also provide an early detection of possible damages and niches in endoscope channels.

According to the earlier mentioned aspects as time and costs, we are also now studying the use of the ATP-method as a quick scan of cleanliness of endoscopes after reprocessing. Additional microbiologic controls can have an added value in the detection of early damages or niches in endoscopes.

Sheaths and sterilisation

Today there are some interesting alternatives that can be used to acquire really clean flexible endoscopes for using them more safely in tissues and organs, like sheaths or additional methods of cleaning and disinfection.

For some types of endoscopes like bronchoscopes or cystoscopies, sterile, disposable single-use sheaths are available, even with an integrated biopsy channel. These sheaths can have advantages if ‘sterile’ structures are passed or part of the diagnosis or treatment. Using these, the endoscope and its internal channels are kept clean. The use of sheaths can also have an advantage if there is a limited availability of flexible endoscopes. Sheath use provides a fast turnaround time, with a simple wipe down disinfection in-between patient use. To the author’s knowledge, as yet there are no cases of transmission of infections reported by using endoscopes with sheaths, but this may also be caused by underreporting and identifying infections related to endoscopy.

There might be some discussion about image quality when using sheaths. The costs of sheaths could be another point of discussion, but should be compared with other costs in the whole process of endoscope use and reprocessing including staff, time, logistics, and number of endoscopes.

In the Netherlands, Hilgers concluded in 2005 that, based on the results of bacteriological culturing and leakage tests that the use of a sterile sheath, in combination with applied operational protocols, can sufficiently guarantee safe and clean use of flexible endoscopes without an instrument channel.

In 2009, Alvarado concluded that the use of high quality, single-use, disposable sterile sheaths on nasopharyngoscopes with an in between enzymatic cleaning and disinfection with 70% ethanol can provide a reliably decontaminated instrument. Despite all this positive data, sheaths still are not regarded as a replacement for high-level disinfection. It is important to remember that even when using sheaths, guidelines must be strictly followed.

In our hospital we recently used sheaths on some flexible endoscopes used for intubation in the operating room. It was necessary to obtain some new endoscopes, suitable for the use of sheaths. Sheaths are only used with strict protocols, with a wipe off between disinfection and daily mechanical cleaning and disinfection. As yet the process has not been evaluated.

We stopped the use of sheaths, however, for flexible ear nose and throat (ENT) endoscopes without internal channels. Here ENT scopes were used with a new sheath for each patient and an in between wipe-down disinfection with isopropyl alcohol 70%. At the end of each day, these endoscopes were additionally reprocessed by using automated cleaning and disinfection on the reprocessing unit of the endoscopy department, using the same process as all other flexible endoscopes.

We noticed that the use of sheaths was expensive – approximately 70,000 Euros per year – and had additional costs for the daily cleaning and disinfection on the endoscopy department of around 20,000 Euros per year, as well as costs to repair ENT scopes. We also noticed that disinfection with alcohol 70% (as defined in working guidelines) between changing sheaths wasn’t always performed correctly. This also frequently resulted in sheaths getting stuck on the distal end of the endoscope, resulting in damaging these when removing sheaths.

In 2012 our ENT department built a new reprocessor for ENT scopes and other reusable ENT devices, which resulted in a new vision of using sheaths and reprocessing these ENT endoscopes. A new, special reprocessor for ENT endoscopes was installed. It was also necessary to increase the amount of flexible ENT scopes. Well-educated and experienced staff for reprocessing these endoscopes and other ENT devices were employed. The whole process on reprocessing these flexible ENT endoscopes was validated and controlled by microbiological sampling and ATP controls before and after reprocessing.

We concluded that this process was effective and safe. Nowadays after every patient use, each flexible ENT endoscope is manually cleaned and leak tested, and mechanically cleaned and disinfected. Flexible endoscopes are then packed and sealed as ‘ready for use’ and stored for usage. Although investigations into endoscopes, equipment and staff were carried out, this process is even more cost effective than the older method with sheaths. Of more importance, this process for ENT endoscopes is more guaranteed and is a qualitative and safe improvement for patients undergoing ENT endoscopy.

Especially therapeutic ERCP can be indicated as a surgical procedure, potentially shifting duodenoscopes used for this from semi critical to critical devices. This reinforces the need for an alternative in achieving cleaner, and therefore safer, flexible endoscopes. This could be achieved by an additional sterilisation of these, for example using a low temperature sterilisation with hydrogen peroxide plasma.

At a congress of the Dutch Steering Group for Flexible Endoscope Cleaning and Disinfection (SFERD), we presented data from two university hospitals in the Netherlands on possible episodes of sepsis related to ERCP with duodenoscopes. We concluded that 0.4-0.9% of all patients (n=492) who had had an ERCP could be marked as an post-ERCP sepsis.

Although these results were based on a retrospective quick search and we couldn’t relate the outcome to the contaminated duodenoscopes, based on literature we concluded that more efforts should be made to achieve clean duodenoscopes and thus a safe use of these devices, such as using low temperatures when sterilising.

Following our hospital protocol that spanned a 30 month period, 12 times duodenoscopes were indicated for low temperature hydrogen peroxide plasma sterilisation because they cultured positive with the same bacteria after two rounds of reprocessing (first initial sample after patient use followed by manual cleaning and automated reprocessing. Second sample after again automated reprocessing).

Samples were taken by a manual flushing of the biopsy/suction channel and air/water channel with sterile demineralised water from the distal (tip) to the proximal end of the endoscope (retrograde sampling). Bacteria varied from Candida parapsilosis to Enterobacter cloacae, Escherichia coli, Klebsiella pneumonia, Klebsiella oxytoca, Stenatrophomonas maltophilia or Pseudomonas aeruginosa. After noticing this, the endoscopes were blocked for patient use, again reprocessed and sampled. In 12 of these samples, the duodenoscopes were again positive with the same microorganism. According to our protocol these endoscopes were cleaned and disinfected again with additional decontamination (sterilised) using low temperature hydrogen peroxide plasma sterilisation.

After this process, again samples were taken. Comparing with the initial positive samples and outcome, all cultures after low temperature sterilisation with hydrogen peroxide were negative when sampled directly after this process.

Based on these experiences I appealed at the same Dutch congress of the SFERD not only for a continuously active surveillance of post-endoscopic infections after ERCP, but also for a standard procedure for low temperature sterilisation with hydrogen peroxide plasma of duodenoscopes after each use.

The success of this kind of sterilisation for flexible endoscopes was published in 2001 by Bäret al. In addition, last October Rutala wrote a very interesting editorial on this, titled ‘A need to shift from disinfection to sterilization?’ Of course, all alternatives to improve endoscope reprocessing and thus make safer the use of flexible endoscopes have both advantages and disadvantages. These are discussed in a lot of publications and important papers, always concluding that further investigations and studies should be performed.

On going investigation and debate is good, but in my opinion it’s also a factor for not taken decisions, knowing that ERCP related sepsis is a major complication with not only high mortality rates, but also leads to increased costs. The episode in February 2015 with contaminated duodenoscopes in the USA showed the urgency for real action to investigate in a reprocessing process and handling of flexible endoscopes that is much safer than today’s cleaning and disinfection. Of 179 patients exposed to carbapenem-resistant Enterobacteriaceae, seven became infected and two died.

The new Dutch guideline on reprocessing flexible endoscopes indicates that flexible endoscopes should be used that can be disinfected or sterilised following the most equivalent alternative for thermal disinfection when there is an infection risk that can be regarded as semi critical, or sterilisation when this infection risk is critical. They also state, however, that mechanical cleaning and disinfection of flexible endoscopes can be used as routine procedure when sterilisation, even with hydrogen peroxide plasma or Ethylene oxide (ETO), has too many logistic challenges – even if these endoscopes are to be used in an area regarded as critical.

Due to increased productivity and the legitimate argument for use regarding a limited amount of flexible endoscopes and other factors that could contribute to increasing costs, it will be a hard and thorough way to achieve a shift in patient safety, from semi safety to real safety.

Flexible endoscopes, especially duodenoscopes, are difficult to clean. Despite the availability of evidence-based and well-accepted guidelines for reprocessing, contaminated endoscopes can still result in clustered infections and outbreaks, even with multi-drug resistant microorganisms.

Although stringent conformity to all steps in these guidelines, especially those time consuming steps like manual cleaning and brushing, could be more effective in achieving cleaner endoscopes, today’s cleaning and disinfection should be completed by alternatives such as sterilisation.

This should at least be implemented for so called high-risk flexible endoscopes like duodenoscopes, especially when used for therapeutic ERCP as this can be regarded as a surgical procedure. Other flexible endoscopes can be regard as ‘critical’ instead of ‘semi critical’, not only because they really are contacting sterile tissues or organs, but also because more and more sterile devices like stents are implanted in situ permanently. When looking at patient safety in relation to the use of flexible endoscopes, therefore, there should be a shift from defining flexible endoscopes as semi-critical to critical devices, with a corresponding shift in the reprocessing processes.

Sterile disposable, single-use sheaths could be a good alternative in this, but may not be available for all endoscopes like duodenoscopes. Since alternatives for steam sterilisation are available to sterilise flexible endoscopes, like low-temperature hydrogen peroxide plasma sterilisation, this process could also be used to obtain safer flexible endoscopes than with today’s cleaning and disinfection. These additional steps could be very worthwhile, especially for endoscopes that are used in primary sterile tissues and organs, but the importance of the first steps in the cycle of reprocessing shouldn’t be neglected.

Sure it’s time consuming, but meticulous manual cleaning and brushing is the first and most essential step in reprocessing flexible endoscopes. It can’t be skipped or speeded up without adversely affecting the outcome of the whole process. There must be a continuous awareness on this first step, even on staff education and a strict adherence to existing reprocessing guidelines. These factors cannot be underestimated anymore and need serious time, staff and money.

Since there are good alternatives like sterile sheaths and low-temperature sterilisation with hydrogen peroxide plasma, there are no excuses not to obtain really safe flexible endoscopes. Time consuming and money driven factors should no longer inhibit patients from safe devices and safe care.