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Improper Sterilization of Endoscopes Linked to Bacteria-Resistant Infections

Introduction

The following article analyzes medical issues associated with the spread of drug-resistant bacteria due to improperly-sterilized endoscopes used during invasive medical procedures. Despite an awareness of the problem since 2008 and numerous warnings issued by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA), infections associated with endoscopes continue to result in injuries and fatalities in hospitals and other health-care facilities nationwide.  In many instances, hospitals failed to properly disinfect such devices due to the design of newer instruments, which makes them harder to clean, according to several sources cited in this article. In addition, a recently-released report from the United States Senate's Health, Education, Labor, and Pensions Committee claims that certain medical device manufacturers were aware of such design flaws but failed to correct such issues in a timely manner after infectious outbreaks in the United States and other countries.[i] More research may need to be conducted to determine if endoscopes made by other manufacturers have similar design flaws which prevent health care workers from properly sterilizing such devices. The existing regulatory system might also need to be modified to protect the health and well-being of the general public.

Background

Endoscopes have been used by medical practitioners since the early 19th century to examine the interior of patients' bodies. However, advancements in medical technology in recent decades have dramatically improved the ability to view and record images taken inside a patient. There are two main types of endoscopes:

  • Rigid endoscopes - Medical devices that maintain their original shape during an invasive medical procedure.
  • Flexible endoscopes - Devices that change their shape automatically or can be manually adjusted to correctly align with the contours of a specific organ being examined during a medical procedure.

Within these two broad categories, there are many different types of endoscopes designed for various types of procedures. Millions of endoscopic procedures are performed each year in the United States. Some of the most common procedures include:

  • Colonoscopy - Examination of the entire colon and large intestine. This procedure is commonly used to determine whether a patient has colon cancer or polyps, which are growths inside the colon which could potentially develop into cancer. Colonoscopies are generally recommended every 10 years for patients 50 years old or older to assess the risk of developing colorectal cancer.[ii]
  • Flexible sigmoidoscopy - Examination of the rectum, also known as sigmoid colon. While similar to colonoscopies, flexible sigmoidoscopies only involve examining part of the colon. Such procedures are often used to determine the cause of rectal bleeding or other medical issues associated with the colon.
  • Upper Gastrointestinal Endoscopy - Examination of the stomach, esophagus and duodenum, the first section of the small intestine. The duodenum connects the stomach to the jejunum, a portion of the small intestine. Duodenoscopes are often used to examine the duodenum.
  • Laparoscopy - Minimally-invasive surgical procedure used to examine the liver, stomach and other organs located in the abdominal region. This procedure is also often used to examine a woman's reproductive organs (including her uterus and ovaries) for cysts, fibroids and other growths.

Cause of infections

In recent years, different types of endoscopes and duodenoscopes have been developed for use in a wide variety of medical procedures. However, as different devices become available, the prevalence of infections associated with such procedures has increased because certain devices require different sterilization methods.

In particular, flexible endoscopes are susceptible to collecting "biological dirt" during colonoscopies and similar medical procedures. Specifically, up to 30 percent of endoscopes examined by researchers in a 2013 study of 5 hospitals nationwide found that reusable endoscopes contained such potentially harmful substances, even after being cleaned.[iii]

Reusable, flexible endoscopic devices are especially hard to disinfect because they acquire high levels of microbial contamination during each use. The CDC cited several studies in 2008 concerning this issue. The CDC wrote:

For example, the bioburden found on flexible gastrointestinal endoscopes after use has ranged from 105 colony forming units (CFU)/mL to 1010 CFU/mL, with the highest levels found in the suction channels.[iv]

As a result, different cleaning methods need to be utilized to disinfect such reusable devices. Specifically, the CDC and American Society for Gastrointestinal Endoscopy (ASGE) recommend soaking such devices in disinfectant to remove all potentially harmful material.[v] Many hospital workers, however, have failed to perform this final, critical step, often because they have not been properly trained to do so.[vi] In some cases, patients received life-threatening infections, creating grounds for a medical malpractice lawsuit.

These infections were caused by contaminated closed channel duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, a medical procedure in which endoscopes are used to examine a patient's bile duct. The 2016 U.S. Senate report singled out 3 companies (Olympus Corporation, Pentax and Fujifilm), which the report claims had a "systemic and unacceptably slow response" to evidence that their duodenoscopes could not be effectively cleaned in between usage.[vii]

Types of infections

The 2016 U.S. Senate report was issued in response to 25 infection outbreaks affecting more than 250 people in the United States, France, Germany and the Netherlands. Duodenoscopes manufactured by Olympus Corporation, Pentax and Fujifilm caused the infections, the report claims. In many instances, patients were exposed to Carbapenem-resistant Enterobacteriaceae (CRE). Such "superbugs" are especially hard to treat because CREs are often resistant to antibiotics, according to the CDC.[viii]

New York-Presbyterian/Weill Cornell Medical Center in New York City was affected by such an outbreak in December 2012. An estimated 20 patients treated using Olympus Corporation devices were infected, according to the 2016 U.S. Senate report.

Other common infections and harmful substances patients have been exposed to during endoscopic procedures using improperly-disinfected medical devices include:[ix]

  • Hepatitis B
  • Hepatitis C
  • HIV
  • Parasites
  • Prions - Creutzfeldt-Jacob Disease (CJD)

Reaction

In response to an FDA investigation and 19 outbreaks worldwide involving their products, Olympus Corporation voluntarily agreed on Jan. 15, 2016 to recall the Olympus TJF-Q180V duodenoscopes to modify the medical instruments and make the necessary repairs.[x]

Awareness of problems associated with infected endoscopes has existed since at least 2008. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) recommended guidelines that year aimed at eliminating infectious outbreaks. In Volume 67, No. 6 of the journal "Gastrointestinal Endoscopy" published in 2008, the ASGE advised medical facilities to provide "extensive training of staff involved in endoscopic reprocessing is mandatory for quality assurance and for effective infection control."[xi]

Also in 2008, the CDC revised its guidelines regarding how to properly sterilize and disinfect health care facilities. In its 2008 guidelines, the CDC specifically singled out endoscopic devices as a source of infections. The CDC wrote:

Physicians use endoscopes to diagnose and treat numerous medical disorders. Even though endoscopes represent a valuable diagnostic and therapeutic tool in modern medicine and the incidence of infection associated with their use reportedly is very low (about 1 in 1.8 million procedures), more healthcare-associated outbreaks have been linked to contaminated endoscopes than to any other medical device. [xii]

Because of such risks, hospitals across the country have notified patients that they may have been exposed to life-threatening illnesses and should receive immediate medical testing. Such incidents include:

  • Testing for blood-borne pathogens in thousands of veterans who received colonoscopies using improperly-disinfected devices at Veterans Affairs facilities in Tennessee, Georgia and Florida.[xiii]
  • Testing for infectious diseases of 456 Atlanta-area patients who underwent colonoscopies in 2013 using endoscopes that were not properly disinfected.[xiv]
  • Testing of 281 Hartford-area patients who underwent endoscopic procedures in 2015 using improperly disinfected devices.[xv]

Legal rights

A patient who contracts an infection that can be causally linked to an endoscopic procedure may have a valid products liability claim against the manufacturer of the device. Many of the involved endoscopes are manufactured by Olympus, Pentax and Fujifilm. If there is evidence that the manufacturer(s) knew that these devices could harbor and spread serious infections despite being cleaned according to the manufacturer's instructions, that could be the basis for a lawsuit based on product liability and/or negligence.

Additionally, hospitals have a duty to monitor infection rates and determine the source of those infections, as well as to implement proper infection control procedures. If a patient contracts an infection in a hospital, that is called a nosocomial infection. A patient who suffers injury due to a nosocomial infection, whether it stems from an endoscope or some other source, may have a valid lawsuit based upon medical malpractice.

Hospital acquired infections tend to be more serious and difficult to treat because the infectious organisms are more likely to be resistant to antibiotics than those acquired in the community. Such infections may require treatment with antibiotics that tend to cause damage to the liver, kidneys or other organs. The morbidity and mortality of these infections is very high and may give rise to a lawsuit for substantial damages for pain, suffering and economic losses, or in the worst case scenario, for wrongful death of the patient.

Conclusion

Despite continued efforts to combat infectious diseases caused by contaminated endoscopes and duodenoscopes, such problems continue to persist. Perhaps even more troublingly, it appears that some companies knew there were design flaws with their medical devices that could lead to dangerous infections and failed to take corrective measures to fix those problems. The 2016 U.S. Senate report states that several corporations "failed to meet the obligations placed upon them by the current regulatory system."[xvi] Under the current regulatory system, hospitals and medical device manufacturers are required to self-report any problems or infectious outbreaks to the FDA. The FDA and CDC need to consider changing this policy to protect the rights of patients and families affected by such systematic failures of the health care industry. Specifically, the CDC and FDA need to be more proactive to avoid similar infectious disease outbreaks in the future.

For more information

Contact Jonathan C. Reiter, an attorney based in New York City. His law firm handles medical malpractice and many other types of cases in New York State. The firm has offices in Manhattan and the Bronx.

Jonathan C. Reiter Law Firm, PLLC
The Empire State Building
350 5th Avenue, Suite 6400
New York, NY 10118
866-324-9211

[i] United States Senate, Health Education, Labor, and Pensions Committee. U.S. Sen. Parry Murray, Ranking Member. "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients," Minority Staff Report. Jan. 13, 2016

[ii] Mayo Clinic, "Tests and Procedures, Colonoscopy"

[iii] Association for Professionals in Infection Control and Epidemiology, "Three out of 20 scopes used to examine GI tracts and colons improperly cleaned," June 7, 2013

[iv] Centers for Disease Control and Prevention, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008"

[v] Gastrointestinal Endoscopy Journal, "Infection control during GI endoscopy," Vol. 67, No. 6, 2008, pages 781-790.

[vi] Centers for Disease Control and Prevention, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008"

[vii] United States Senate, Health Education, Labor, and Pensions Committee. U.S. Sen. Parry Murray, Ranking Member. "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients," Minority Staff Report. Jan. 13, 2016

[viii] Centers for Disease Control and Prevention, "Carbapenem-resistant Enterobacteriaceae (CRE) Infection: Patient FAQs."

[ix] Gastrointestinal Endoscopy Journal, "Infection control during GI endoscopy," Vol. 67, No. 6, 2008, pages 781-790.

[x] U.S. Food and Drug Administration, "FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk," Jan. 15, 2016

[xi] Gastrointestinal Endoscopy Journal, "Infection control during GI endoscopy," Vol. 67, No. 6, 2008, pages 781-790.

[xii] Centers for Disease Control and Prevention, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008"

[xiii] Los Angeles Times, "Unclean colonoscopy instruments: 3 in 20 have 'dirt' from colons," June 7, 2013

[xiv] Atlanta Journal-Constitution, "456 Piedmont patients warned about improperly cleaned devices," April 30, 2013

[xv] The Hartford Courant, "Hartford Hospital Says Patients Might Have Been Exposed To E. Coli," March 4, 2015

[xvi] United States Senate, Health Education, Labor, and Pensions Committee. U.S. Sen. Parry Murray, Ranking Member. "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients," Minority Staff Report. Jan. 13, 2016