- There are approximately 15,000,000 endoscopic procedures every year in the United States, which include Colonoscopy, Sigmoidoscopy and bronchoscopy.
- Approximately 2.7% of all endoscopic procedures result in cross-contamination due to non-sterile endoscopes. These cross infections have been referred to as medicines dirtiest secret.
- Common diseases transmitted through endoscopic cross-contamination are Hepatitis B and C, Tuberculosis, Salmonella, Human Papoloma Virus, Pseudomanus, Aeroginosa, Flu Viruses and other common bacteria. HIV, E. Coli and Kreuttzveld Jacobs Disease (Mad Cow Disease) can possibly be contacted through endoscopic procedures.
- The current standard of care in the reprocessing of endoscopes is disinfection, which does not kill all microbial life. A sterilization standard would kill all microbial life.
- Flexible endoscopes have valves and joints that are impossible to scrub, in which some channels are two to six feet long and just millimeters wide. With their intricate channels and valve systems, endoscopes are rife with joints, crevices and pores that regularly trap blood and tissue.
- Cross-contamination occurs because heavy encrustation’s of patient material, including dried blood, feces and mucous have been found inside the suction channels in flexible endoscopes which supposedly had been disinfected.
- Flexible endoscopes are repaired everyday in service centers throughout the United States. Upon taking each piece apart from an endoscope that is supposedly disinfected, one can regularly observe mucous, blood and fecal matter dripping from endoscope valves.
- Approximately 270,000 infections a year in the United States are a result of endoscopic cross-contamination. Furthermore, there are approximately 25,000 infections a year in New York due to endoscopic cross-contamination.
- In 1992, the FDA and the Centers for Disease Control and Prevention adopted a sterilization standard for all reused dental devices entering a patient’s mouth. However, for endoscopy, they retained the same disinfection standard deemed unsafe for dentistry.
- The chemical used to disinfect endoscopes is Gluteraldehyde which if not thoroughly rinsed off can cause colitis.
CFSE is dedicated to preventing all future cases of cross-contamination due to endoscopic procedures. We believe we can prevent 270,000 healthy patients from getting sick by:
- Lobbying for legislation all across the Country to change the standard of care in the reprocessing of endoscopes from disinfection to sterilization. Currently, legislation is pending in New York to change the standard to sterilization and to have the difference thoroughly explained to all patients
- Informing the public of this health epidemic and patients who may not even know that they may have contracted a disease from cross-contamination.
- Build a coalition of victims, concerned citizens and health professionals to fight against the needless amount of cross-contamination.
- Prevent this archaic practice and push the medical profession to use the new technology out there to achieve complete sterilization.
- Enlist as many people as possible to join our cause to fight for and protect the 15,000,000 people every year who have an endoscopic procedure and to make sure that these endoscopies are safe and sterile.
- Convince the hospitals, doctors and other medical facilities to explore all new technologies to achieve a sterilization standard, including, but not limited to protective single use sterile barrier devices.
Endoscopy is a minimally invasive technique that is being used with increased frequency in a growing number of medical applications. Endoscopic therapeutic procedures, unlike more traditional open surgical procedures, can be performed without a major incision, in most cases without general anesthesia, and, therefore, safer and less expensive than traditional surgical procedures.
Flexible endoscopes are tubular instruments that enter the body through a natural orifice and enable physicians to view the interior of a body organ or cavity remotely and perform various screening, diagnostic, and therapeutic procedures. Flexible endoscopes generally utilize fiberoptic bundles or video camera technology for image production. The physician can steer the distal portion of a flexible endoscope with control knobs on the endoscopes operator body. By maneuvering the tip of the endoscope, the physician can access body regions through lengthy and twisted passageways, such as the colon, and perform a variety of procedures. Most flexible endoscopes contain a series of channels running the length of the endoscope for delivery of air, water, suction and accessory devises, such as biopsy forceps and cutting instruments.
Flexible endoscopes are widely used in hospitals, clinics and physicians’ offices, primarily on an outpatient basis. Flexible endoscopes are designed primarily for screening, diagnostic and therapeutic procedures in fields such as gastroenterology, surgery, primary care, otolaryngology and pulmonary medicine.
Your Dentist Drill is Cleaner Than Your Doctor’s Endoscope
For the previous three decades it has been the contention of the Center for Disease Control and Prevention, the American Society of Gastroenterology, and rank and file physicians, that endoscopic cleanliness poses no threat for patient to patient cross-contamination and therefore sterilization of the endoscope is unnecessary. Similar statements were made about the use of non-sterilized instruments utilized by dentists. Then, a series of studies led by Dr. David Lewis of the U.S. Environmental Protection Agency at the University of Georgia, who is currently assigned to the U.S. EPA, to study cross-contamination with medical devices. He sought to quantify the risk associated with non-sterilized dental instruments and the variety of infectious diseases, from TB to Creutzfeldt-Jacob disease (a human form of Mad Cow disease). This issue is of particular concern to people who are immune suppressed, such as people who are HIV Positive, and are at even greater risk for acquiring such infectious diseases. Dr. Lewis’s research found that bacteria and viruses, including the Aids virus, can hide in lubricants and patient debris trapped in dental devices and could survive disinfecting. Based on these findings, it was determined that the use of non-sterilized dental instrumentation led to the transmission of infectious diseases in numerous, otherwise healthy people. Today, all dental instruments are sterilized, either by sterilization or by single use devices. We believe that similar links exist between current endoscopic practices and the transmission of infectious diseases, including TB and Creutzfeld-Jacob disease (more commonly known as Mad Cow disease).
The Role of Citizens for Safe Endoscopy
Each year New Yorkers are place in a Catch—22 situation. We must have lifesaving endoscopic procedures, but these procedures are being performed with non-sterile endoscopic equipment. The endoscope has proven to be an invaluable tool in screening for deadly diseases such as colorectal cancer, as well as ameliorating the need for costly and painful invasive surgeries. However, all too often these endoscopes are used in direct violation of FDA guidelines and consequently in direct violation of federal law. The vast majority of people are not aware that the endoscope that is being used on them is not sterile. Furthermore, the FDA recently concluded that the most common method of disinfecting endoscopes, and the procedure that the CDC recommends, is wholly ineffective for killing tuberculosis and other resistant pathogens. Consequently, New Yorkers are exposed to the threat of developing highly contagious and possibly fatal diseases hundreds of times each day.
Each year New York State residents undergo 900,000 endoscopic procedures and:
- It is estimated that 2.7% of all endoscopes result in the transmission of an infectious disease
- Therefore, 24,300 New Yorkers will be needlessly infected each year by cross-contamination via endoscopes.
Documented cases of Mycobacerium tuberculosis, Mycobacterium chelonei, Mycobacterium chelonae, and Mycobaterium gordonae were traced to the inadequate cleansing of endoscopes or adherence to the CDC recommendations and not FDA guidelines. The following are documented cases of such cross-contamination”
- A veteran’s hospital experienced 13 Mycobaterium gordonae infections of 193 endoscopes performed.
- In 1983 at least one death can be linked to Mycobacterium chelonea.
- In 1990, 12 documented cases of Mycobacterium can be traced to endoscopes that were cleaned according to CDC/professional recommendations and not FDA guidelines.
- In 1995, several patients were diagnosed with multiply drug resistant TB in South Carolina, their cases were linked to a contaminated endoscope.
- In 1996 and 1998 the New York State Department of Health identified three separate clusters of infectious diseases traced to improper or insufficient cleaning methodology.
- Mycobacterium tuberculosis caused the death of two patients in a North Carolina hospital and the infection was traced to an endoscope that was not cleaned thoroughly.