Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., Title of Report: Laboratory Evaluation of Endoscope Waterbottles

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1 Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., 2005 Title of Report: Laboratory Evaluation of Endoscope Waterbottles Author: Paul J. Pearce, Bachelor of Science (BS), Master of Science (MS), Doctor of Philosophy (PhD)/Microbiology; Specialist in Microbiology - American Society of Clinical Pathologists (SM/ASCP) Author s Institutional Affiliation: President - Nova Biologicals, Inc. Author s Contact Information: Nova Biologicals, Inc.; 1775 East Loop 336, Suite 4; Conroe, TX 77301; ; Fax ; ppearce@novatx.com Report Preparation Date: 2005 Nova Biologicals, Inc.: U.S. Food and Drug Administration Registration Number A Report on the Widespread Inadequate Reprocessing of Endoscope Air/Water and Suction Valves by Healthcare Facilities P/N Rev A 1 of 10

2 Abstract Endoscope manufacturer s water bottles are attached to endoscopes and used during every endoscopic procedure. 2 Water bottles are complex, reusable medical devices that must be reprocessed and disinfected before being used on subsequent patients. Reprocessing and disinfection is intended to result in high-level disinfection. 3 Currently, all published episodes of pathogen transmission related to gastrointestinal endoscopy have been associated with the failure to follow established reprocessing and disinfection guidelines or use of defective equipment. 4 The U.S. Center for Disease Control and Prevention (CDCP) and the U.S. Food and Drug Administration (USFDA) classify endoscopes and their components as semi-critical medical devices. As such, these devices should receive at least high-level disinfection, defined as the destruction of all vegetative microorganisms, mycobacteria, small or nonlipid viruses, medium or lipid viruses, fungal spores, and some, but not all, bacterial spores. 4 The Association for Professionals in Infection Control and Epidemiology (APIC) issued a Special Communication in the year 2000 regarding guidelines for infection prevention and control in flexible endoscopy. These guidelines highlight the need to use sterile water to fill the water bottle. Additionally, the guidelines noted that the water bottle and connecting tubes are difficult to clean and disinfect and are often colonized with Pseudomonas species and may serve as important reservoirs of cross infection. 3 Finally, in many ambulatory care settings, there can be confusion about what must be sterilized and a lack of knowledge and training about the proper steps required to appropriately reprocess and disinfect endoscopes. 1 This paper presents the initial study results of a laboratory evaluation of re-useable endoscope water bottles. Each bottle is defined as a water reservoir (bottle), O-ring, and lid assembly. Laboratory evaluation of each bottle included isolation and identification of bacteria, yeasts, and fungi, determination of pyrogen/endotoxin levels, and determination of eluate ph. Reprocessed, disinfected, and patient-ready endoscope water bottles were submitted by endoscopy suites located throughout the United States. A total of twenty-five (25) bottles were tested. Included in this total were seventeen (17) Olympus bottles 10, seven (7) Pentax bottles, and one (1) Fujinon bottle 11. Bacteria and/or fungi were detected in twenty-three (23) of the bottles; pyrogen/endotoxin levels greater than the Method Detection Limit (MDL) was detected in seven (7) of the bottles; and out-of-range ph levels were detected in two (2) of the bottles. Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

3 Introduction With studies showing medical errors, including nosocomial infections, responsible for 44,000 to 98,000 deaths in the United States annually, infection control practitioners are intensifying their efforts to identify problem areas within healthcare facilities. Endoscopy suites are being assessed and evaluated as potential reservoirs for pathogenic microorganisms. Infection control practitioners are finding that detailed manufacturer s guidelines for equipment reprocessing and disinfection are not being followed and that the potential for patient cross infection has increased. 2 The current design of re-useable endoscope water bottles makes them difficult to reprocess and disinfect. These difficulties are manifested by the presence of valves and complex tubing arrangements that impede or prevent proper cleaning prior to high-level disinfection or sterilization. 9 With this in mind, laboratory studies were initiated with the intent of accomplishing the following: 1. Isolate and identify bacteria, yeast, and fungi present on twenty-five (25) re-useable endoscope water bottles that had been reprocessed, disinfected or sterilized, and deemed patient-ready by endoscopy practitioners. 2. Determine the level of pyrogen/endotoxin in eluates from these bottles. 3. Determine the ph level of eluates from these bottles. Methods and Materials Endoscope Water Container Bottles A total of twenty-five (25) re-useable water bottles were tested. Included in this total were seventeen (17) Olympus units, seven (7) Pentax units, and one (1) Fujinon unit. Each unit consisted of a bottle, O-ring, and lid assembly that were tested separately. Units were shipped via overnight express delivery to Nova Biologicals, Inc., Conroe, TX. Nova conducted all of the testing reported in this paper. Endoscopy suites in Texas, New Jersey, California, Alabama, Ohio, Michigan, Mississippi, Indiana, North Carolina, Louisiana, Oregon, Wyoming, and Maryland submitted water bottles for evaluation and testing. Isolation and identification of bacteria, yeasts, and fungi Microorganism isolation and identification was conducted according to methods found in U.S. Pharmacopeia/National Formulary 28/23, 2005, Chapter <61> and Manual of Clinical Microbiology, American Society for Microbiology, 8 th Edition, Pyrogen/Endotoxin Determinations Endotoxin testing was conducted according to U.S. Pharmacopeia/National Formulary 28/23, 2005, Chapter <85> ph Determinations ph determinations were conducted according to U.S. Pharmacopeia/National Formulary 28/23, 2005, Chapter <791> Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

4 Results Table 1: Microorganisms Identified from Endoscope Water Container Units Endoscope Water Bottle Unit ID Manufacturer Cleaning/Disinfection Method Microorganism(s) Identified M17351 Pentax Steam Staphylococcus Bacillus brevis M17352 Olympus Gluteraldehyde & Steam Staphylococcus M17353 Pentax Steris machine Pseudomonas aeruginosa M17382 Olympus Steam Micrococcus species Mold M17426 Olympus Steam Staphylococcus warneri M17427 Pentax Gluteraldehyde Staphylococcus Staphylococcus capitis M17428 Olympus Weekly Clean & Rinse M17429 Olympus Steam Staphylococcus saprophyticus Staphylococcus aureus M17430 Olympus Ethylene Oxide Staphylococcus saprophyticus Staphylococcus aureus Micrococcus luteus M17452 Olympus Steam Staphylococcus Staphylococcus pasteuri M17453 Olympus Not Indicated Staphylococcus Staphylococcus hominis M17492 Olympus Enzyme Rinse/Steam Staphylococcus M17539 Pentax Steam Providencia rettgeri M17600 Olympus Steam None M17601 Olympus Steam Proteus vulgaris M17609 Olympus Ethylene Oxide Proteus mirabilis M17672 Pentax Not Indicated Staphylococcus M17673 Olympus Enzyme Rinse/Steam Staphylococcus capitis Bacillus species M17674 Olympus Enzyme Rinse/Steam Proteus mirabilis M17728 Olympus Steam Staphylococcus aureus Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

5 M17729 Pentax Steam Corynebacterium kutscheri M17730 Olympus Detergent/Gluteraldehyde None M17826 Fujinon Gluteraldehyde/Peracetic Acid M17827 Olympus Steam Bacillus pumilus M17892 Pentax Cidex OPA Bacillus licheniformes Staphylococcus species, not aureus Table 1 Summary Bacteria were identified in twenty-three (23) of the bottles submitted for testing. A fungus was identified in one (1) of the bottles submitted for testing. Table 2: Brief Description of Identified Microorgansims ORGANISM Bacillus brevis Coagulase Negative Staphylococci include: S. capitis, S. ureolyticus, S. caprae,, S. cohnii, S., S. equorum, S. gallinarum, S. haemolyticus, S. hominis, S. novobiosepticius, S. hyicus, S. intermedius, S. lugdunensis, S. pasteuri, S. saccharolyticus, S. saprophyticus, S. schleiferi, S. coagulans, S. sciuri, S. simulans, S. warneri, S. xylosus Micrococcus luteus DESCRIPTION Commonly found in the general environment including soil, air, dust, water, and decaying matter. It is rarely associated with infectious disease. Commonly found in the general environment including soil, air, dust, water, and decaying matter. It is associated with food poisoning. Common members of the normal flora of skin and mucous membranes. Its large numbers and ubiquitous distribution make it one of the most commonly isolated organisms in the clinical laboratory. While at one time the appearance of Coagulase Negative Staphylococci in clinical material could be dismissed as contamination, it is now one of the most important agents of hospital acquired infections. Immunosuppressed or neutropenic patients are particularly at risk, as are individuals with indwelling catheters or prosthetic devices. It can also cause endocarditis in individuals with previous heart valve damage. The hydrophobic nature of the organism's cell surface facilitates its adherence to synthetic devices as well as damaged heart valves. Following initial colonization, a copious amount of extracellular polysaccharide or slime is synthesized, forming a protective biofilm around the colony. Because many isolates are multiple antibiotic resistant, these infections are very serious and can even be fatal. Has been isolated from human skin, animal and dairy products, and beer. It can be found in many other places in the environment, as well, like water, dust, and soil. M. luteus on human skin breaks down compounds in sweat into Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

6 Pseudomonas aeruginosa Staphylococcus aureus Micrococcus species Molds (fungus) Proteus vulgaris Proteus mirabilis Providencia rettgeri Corynebacterium kutscheri Bacillus species compounds with bad odor. M. luteus can grow well in environments with little water or high salt concentrations. An opportunistic pathogen, meaning that it exploits some break in the host defenses to initiate an infection. It causes urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Pseudomonas aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis, and burns. The case fatality rate in these patients is 50 percent. These bacteria are common inhabitants of soil and water. They occur regularly on the surfaces of plants and occasionally on the surfaces of animals. Often simply called "staph" (pronounced "staff") bacteria. Staph bacteria can live harmlessly on many skin surfaces, especially around the nose, mouth, genitals, and rectum. But when the skin is punctured or broken for any reason, staph bacteria can enter the wound and cause an infection. Staph bacteria can cause folliculitis, boils, scalded skin syndrome, impetigo, toxic shock syndrome, cellulitis, and other types of infections. Commonly found on the skin and mucous membranes of humans, mammals, and some other animals. Commonly found in the soil and environment. Implicated in diseases of humans. Proteus species are mainly soil inhabitants, particularly common in decomposing organic matter. Proteus vulgaris can cause urinary tract infections. Implicated in diseases of humans; especially urinary tract infections. Syn: Proteus rettgeri - Implicated in diseases of humans; especially urinary tract infections. Implicated in diseases of animals. In general, Corynebacterium species are bacteria commonly found on the skin and mucous membranes and in the gastrointestinal tracts of humans, mammals, and some other animals. Commonly found in the general environment including soil, air, dust, water, and decaying matter. The category Bacillus species includes several different species of Bacillus. Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

7 Bacillus pumilus Bacillus licheniformes Commonly found in the general environment including soil, air, dust, water, and decaying matter. This organism is an antagonist to some plant pathogens. Commonly found in the general environment including soil, air, dust, water, and decaying matter. This organism is an antagonist to some plant pathogens. Table 3: ph of Eluates from Endoscope Water Container Bottles Endoscope Water Manufacturer Cleaning/Disinfection Method ph Bottle Unit ID M17351 Pentax Steam 5.4 M17352 Olympus Gluteraldehyde & Steam 5.4 M17353 Pentax Steris machine 5.5 M17382 Olympus Steam 4.9 M17426 Olympus Steam 5.2 M17427 Pentax Gluteraldehyde 4.0 M17428 Olympus Weekly Clean & Rinse 5.0 M17429 Olympus Steam 5.0 M17430 Olympus Ethylene Oxide 5.0 M17452 Olympus Steam 6.7 M17453 Olympus Not Indicated 5.2 M17492 Olympus Enzyme Rinse/Steam 5.2 M17539 Pentax Steam 5.4 M17600 Olympus Steam 5.0 M17601 Olympus Steam 5.6 M17609 Olympus Ethylene Oxide 5.5 M17672 Pentax Not Indicated 5.8 M17673 Olympus Enzyme Rinse/Steam 5.5 M17674 Olympus Enzyme Rinse/Steam 5.3 M17728 Olympus Steam 5.6 M17729 Pentax Steam 5.3 M17730 Olympus Detergent/Gluteraldehyde 5.3 M17826 Fujinon Gluteraldehyde/Peracetic Acid 5.9 M17827 Olympus Steam 5.5 M17892 Pentax Cidex OPA 5.6 Table 3 Summary Out-of-range ph levels (less than ph 5.0) were identified in two (2) of the bottles submitted for testing. None of the bottles had a ph level greater than 7.0. Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

8 Table 4: Pyrogen/Endotoxin Levels of Eluates from Endoscope Water Container Bottles Endoscope Water Bottle ID Manufacturer Cleaning/Disinfection Method Endotoxin Unit(s) per milliliter eluate (EU/ml) M17351 Pentax Steam 1.92 M17352 Olympus Gluteraldehyde & Steam 0.24 M17353 Pentax Steris machine >30.0 M17382 Olympus Steam <0.06* M17426 Olympus Steam <0.06 M17427 Pentax Gluteraldehyde 0.12 M17428 Olympus Weekly Clean & Rinse 0.48 M17429 Olympus Steam <0.06 M17430 Olympus Ethylene Oxide <0.06 M17452 Olympus Steam <0.06 M17453 Olympus Not Indicated <0.06 M17492 Olympus Enzyme Rinse/Steam <0.06 M17539 Pentax Steam <0.06 M17600 Olympus Steam <0.06 M17601 Olympus Steam <0.06 M17609 Olympus Ethylene Oxide <0.06 M17672 Pentax Not Indicated <0.06 M17673 Olympus Enzyme Rinse/Steam 0.12 M17674 Olympus Enzyme Rinse/Steam <0.06 M17728 Olympus Steam <0.06 M17729 Pentax Steam <0.06 M17730 Olympus Detergent/Gluteraldehyde <0.06 M17826 Fujinon Gluteraldehyde/Peracetic <0.06 Acid M17827 Olympus Steam <0.06 M17892 Pentax Cidex OPA <0.06 * 0.06 EU/ml is the method detection limit (MDL) Table 4 Summary Pyrogen/endotoxin levels greater than the Method Detection Limit were found in six (6) of the bottles submitted for testing. One (1) bottle had an endotoxin level greater than 0.5 EU/ml. Discussion Test results show that 92% of the endoscope water bottles tested were contaminated with either bacteria or fungi. Contaminants included known human pathogens, documented opportunistic pathogens, and microorganisms commonly found in soil, dust, and water. Test results demonstrate that a high percentage of the water container bottles tested failed to meet CDCP and USFDA criteria for high level disinfection. 4 Test results also support the report of Gorse and Messner 8 that showed noncompliance with various aspects of endoscope reprocessing guidelines ranged from 7% to 33%. Additionally, the data reported herein demonstrates that the level of non-compliance with various aspects of water bottle reprocessing may be significantly greater than previously reported. Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

9 Failure to comply with accepted guidelines for the reprocessing of endoscope water bottles results in the use of microbiologically contaminated equipment for patient care. The use of such equipment establishes a known and deliberate pathway for the transfer of pathogenic microorganisms from one patient to another with the distinct possibility of initiating an infectious disease in an otherwise healthy patient. ph testing of water bottle eluate was used to determine the presence of alkaline or acid chemicals on the bottles. The ph of sterile purified water used for extraction of the bottles is between 5.0 and 7.0. Results that are less than 5.0 or greater than 7.0 may indicate sanitizing, disinfecting, or sterilization chemicals have not been completely removed from the bottle. Test results show that 8% of the bottles tested had ph levels of less than 5.0, indicating the presence of acidic residues on the bottles. These findings support the position that showed non-compliance with various aspects of endoscope reprocessing guidelines ranged from 7% to 33%. 8 Additional studies are required to determine the causes of low eluate ph. Pyrogen/endotoxin testing was used to detect and quantify bacterial endotoxins that may be present on water bottles. Endotoxins are bacterial toxins with the capability to elicit a febrile reaction in a patient. The Method Detection Limit was 0.06 Endotoxin Units per milliliter of eluate. Endoscope water bottles, as properly processed, semi-critical medical devices, are expected to have endotoxin levels of less than 0.5 endotoxin units per milliliter (EU/ml) of eluate. Test results show that 24% of the endoscope water bottles tested had pyrogen/endotoxin levels greater than the Method Detection Limit. 4% of the bottles tested had pyrogen/endotoxin levels greater than 0.5 EU/ml. The presence of pyrogens/endotoxins on water bottles creates the potential for introducing these agents into a patient, resulting in a febrile reaction. Febrile reactions may occur naturally following an endoscopic procedure and are a recognized side effect of these procedures. Additional research is needed to determine the link between the incidence of febrile reactions in patients and the use of endotoxin-contaminated endoscope water bottles. The use of endotoxin contaminated water bottles establishes a known and deliberate pathway for the transfer of endotoxins to a patient, potentially resulting in a febrile reaction. Conclusion Microbiologically contaminated, endotoxin contaminated, and improperly processed endoscope water bottles are routinely used in the United States by practitioners conducting endoscopic examinations. Test results demonstrate that the majority of patient-ready, re-usable endoscope water bottles do not meet the high-level disinfection criteria for semi-critical medical devices as established by the U.S. Center for Disease Control and Prevention (CDCP) and the U.S. Food and Drug Administration (USFDA). Additional research is indicated to determine the reasons and causes for the observed levels of microbiological contamination and variations in detected endotoxin and ph levels. Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10

10 References 1. McLachlan EA. Proper Sterilization of Instruments is Essential to Patient Safety. sterilization.html 2. Donley KM. Endoscopic Water Bottles May Hide Dangerous Pathogens Alvarado CJ. APIC Guideline for Infection Prevention and Control in Flexible Endoscopy. Am J Infect Control 2000:28: Nelson DB; Jarvis WR; Rutala WA; Foxx-Orenstein AE; Isenberg G; Dash GP; Alvardo CJ; Ball M; Griffin-Sobel J; Peterson C; Ball K; Henderson, J; Stricof RL. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes. Infection Control and Hospital Epidemiology July 2003: Sehulster L; Chinn RYW. Guidelines for Environmental Infection Control in Health-Care Settings. Morbidity and Mortality Weekly Report June 6, 2003 / 52(RR10); U.S. Pharmacopeia/National Formulary 28/23, 2005, Chapters <61><85><791> 7. Manual of Clinical Microbiology, American Society for Microbiology, 8 th Edition, Gorse GJ, Messner RL. Infection control practices in gastrointestinal endoscopy in the United States: A national survey. Infect Control Hosp Epidemiology 1991;12: Jackson FW, Ball MD. Correction of deficiencies in flexible fiberoptic sigmoidoscope cleaning and disinfection technique in family practice and internal medicine offices. Arch Fam Med1997;6: Olympus Operations Manuals; G ; G ; Q ; R ; QR Fujinon Operation Manual; FG201A 12. Pentax Water Bottle Product Information. PMA-024 (2/03) OLYMPUS is a registered trademark of Olympus Corporation PENTAX is a registered trademark of Hoya Corporation FUJINON is a registered trademark of Fujifilm Corporation Nova Biologicals, Inc., Conroe, TX Report prepared on behalf of Medivators Inc. by Nova Biologicals, Inc., of 10