Development of a checklist as self-assessment tool to evaluate the reprocessing of endoscopic instruments in an Italian teaching hospital.

OBJECTIVE: The present study aims to develop a checklist, as a self-assessment tool, for evaluating all the items involved in the endoscope reprocessing that could be useful for the improvement and/or development of a safety endoscope reprocessing system. MATERIALS AND METHODS: A three-step modified Delphi method, with an embedded qualitative component, was adopted to develop the checklist. According to it, corrective actions were performed before its further re-administration. Contextually, the microbiological surveillance of the endoscopes and of the wash disinfector machine was carried out. RESULTS: Five areas were included in the checklist. After the 1st checklist application, only one of three wards reached the excellent scores in all the items. The other two wards showed an improvement in the Traceability and Endoscope Reprocessing areas after corrective actions. The McNemar's test reported significant difference in the proportion of satisfactory results before and after the 1st and 2nd checklist application. The microbiological surveillance, conducted after the 1st administration, showed unsatisfactory results for the 2 bronchoscopes available in the Intensive Care Unit and for 2 automated endoscope reprocessors. The analysis performed after the 2nd administration showed good results. CONCLUSIONS: The periodic administration of the checklist is functional for a self-assessment of quality reprocessing procedures carried out in the large endoscopic services and in the wards occasionally providing those services, according to the good practice guidelines and for any corrective actions to increase the safety.

Assessment of endoscope cleaning and disinfection efficacy, and the impact of endoscope storage on the microbiological safety level.

AIMS: The aim of the study was microbiological evaluation of the efficacy of cleaning and disinfection of endoscopes carried out with the use of endoscope washer-disinfector EndoCleaner and evaluation of the endoscope storage cabinet providing a controlled environment. METHODS AND RESULTS: The efficacy evaluation of endoscope cleaning and disinfection using the endoscope washer-disinfector EndoClener (AORT) was carried out in accordance with the PN-EN ISO 15883 standard, and the validity of endoscope storage cabinet (TRIBO LLC) was evaluated in accordance with the PN-EN 16442 standard. The micro-organism tested used in the study were as follows: Pseudomonas aeruginosa ATCC® 15442™, Enterococcus faecium ATCC® 12952™, Clostridium sporogenes ATCC® 19404™ (spores), Candida albicans ATCC® 90028™ and Aspergillus brasiliensis DSM® 1988™ (surrogate for Asperigllus niger ATCC® 16404™). It was demonstrated that the endoscope reprocessing carried out in the washer-disinfector EndoCleaner guaranteed the elimination of the micro-organism tested, and the tested endoscope storage cabinet met the microbiological criteria defined by the Polish standard PN-EN 16442 in the scope of tests. CONCLUSION: The obtained results showed that usage of washer-disinfector EndoCleaner and endoscope storage cabinet ensures the microbiological safety of using endoscopes. SIGNIFICANCE AND IMPACT OF STUDY: The increase in the frequency of procedures applying endoscopes contributes to the increased risk of transmission of potentially pathogenic micro-organisms remaining after insufficient cleaning and disinfection of these devices. Research allows assessing the effectiveness of antimicrobial cleaning and disinfection of endoscopes and the safety of storing this equipment in an endoscope cabinet. A particularly innovative aspect is equipping the cabinet with a module generating the phenomenon of radiant catalytic ionization, which is a unique solution on the market. This is one of the very few works involving the assessment of each stage, that is contamination, washing and disinfection, drying and storage of endoscopes.

Worldwide practices on flexible endoscope reprocessing.

Background: Endoscopy related infections represent an important threat for healthcare systems worldwide. Recent outbreaks of infections with multidrug resistant micro-organisms have highlighted the problems of contaminated endoscopes. Endoscopes at highest risk for contamination have intricate mechanisms, multiple internal channels and narrow lumens that are especially problematic to clean. In light of raised awareness about the necessity for meticulous reprocessing of all types of endoscopes, a call for international collaboration is needed. An overview is presented on current practices for endoscope reprocessing in facilities worldwide. Method: An electronic survey was developed and disseminated by the International Society for Antimicrobials and Chemotherapy. The survey consisted of 50 questions aimed at assessing the reprocessing of flexible endoscopes internationally. It covered three core elements: stakeholder involvement, assessment of perceived risks, and reprocessing process. Results: The survey received a total of 165 completed responses from 39 countries. It is evident that most facilities, 82% (n = 136), have a standard operating procedure. There is, however a lot of variation within the flexible endoscope reprocessing practices observed. The need for regular training and education of reprocessing practitioners were identified by 50% (n = 83) of the respondents as main concerns that need to be addressed in order to increase patient safety in endoscope reprocessing procedures. Conclusion: This international survey on current flexible endoscope reprocessing identified a large variation for reprocessing practices among different health care facilities/countries. A standardised education and training programme with a competency assessment is essential to prevent reprocessing lapses and improve patient safety.

Assessment of occupational exposure to airborne chlorine dioxide of healthcare workers using impregnated wipes during high-level disinfection of non-lumened flexible nasoendoscopes.

Routine flexible nasoendoscopy in otolaryngology clinics is well established, the rate-limiting step of which being the speed of the nasoendoscopes reprocessing method used. Non-lumened flexible nasoendoscopes are expensive, heat-sensitive, delicate instruments that cannot be sterilized in an autoclave but must be disinfected by means of high level disinfection (HLD). In one of the public hospitals in Singapore, the method of disinfection was recently changed to the use of commercial impregnated wipes which generates less than 1% chlorine dioxide upon activation. An exposure assessment was performed to assess the potential exposure of healthcare workers (HCWs) to airborne chlorine dioxide during nasoendoscope disinfection. A total of 14 long-term personal samples, four short-term personal samples and 16 long-term area samples were collected over 8 days in midget impingers containing 0.02% potassium iodide in sodium carbonate/sodium bicarbonate buffer during the nasoendoscope disinfection. The samples were then analyzed by ion-chromatograph. The chlorine dioxide concentrations and upper confidence limit at 95% confidence level (UCL95%) for personal and area samples collected were all below the occupational exposure limits (OEL) for chlorine dioxide (Singapore Workplace Safety and Health PELs, ACGIH TLVs, U.S. OSHA PELs). The study presented evidence that the exposure of HCWs to chlorine dioxide during high-level disinfection of flexible nasoendoscopes were deemed insignificant.

Assessment of test methods for evaluating effectiveness of cleaning flexible endoscopes.

BACKGROUND: Strict adherence to each step of reprocessing is imperative to removing potentially infectious agents. Multiple methods for verifying proper reprocessing exist; however, each presents challenges and limitations, and best practice within the industry has not been established. Our goal was to evaluate endoscope cleaning verification tests with particular interest in the evaluation of the manual cleaning step. The results of the cleaning verification tests were compared with microbial culturing to see if a positive cleaning verification test would be predictive of microbial growth. METHODS: This study was conducted at 2 high-volume endoscopy units within a multisite health care system. Each of the 90 endoscopes were tested for adenosine triphosphate, protein, microbial growth via agar plate, and rapid gram-negative culture via assay. The endoscopes were tested in 3 locations: the instrument channel, control knob, and elevator mechanism. RESULTS: This analysis showed substantial level of agreement between protein detection postmanual cleaning and protein detection post-high-level disinfection at the control head for scopes sampled sequentially. CONCLUSIONS: This study suggests that if protein is detected postmanual cleaning, there is a significant likelihood that protein will also be detected post-high-level disinfection. It also infers that a cleaning verification test is not predictive of microbial growth.

The cost of being clean: A cost analysis of nasopharyngoscope reprocessing techniques.

OBJECTIVE: Nasopharyngoscopes are an essential instrument to otolaryngologists; reprocessing them in a high-value manner is paramount. Although several different techniques for reprocessing exist, all methods yield similar effectiveness. Given equivalent effectiveness outcomes, a cost analysis of four nasopharyngoscope reprocessing techniques was performed. STUDY DESIGN: Cost-minimization analysis. METHODS: Four techniques were evaluated: 1) an automated reprocessor using peracetic acid (Steris System 1; Steris Canada Inc., Mississauga, Canada), 2) an automated reprocessor using ortho-phthalaldehyde (OPA) (Cidex OPA; Advanced Sterilization Products, Johnson and Johnson Inc., Markham, Canada), 3) a manually performed accelerated hydrogen peroxide bath (Revital-Ox; Steris Canada Inc.), and 4) a chlorine dioxide wipe (Tristel Trio Wipes System; Tristel plc, Cambridgeshire, U.K.). The costing perspective was a third-party payer that was adjusted to 2014 Canadian dollars. The base-case scenario used an annual volume of 4,153 reprocessing events in a tertiary care setting, and a scenario analysis assessed the impact of volume and capital expense. RESULTS: The cost per reprocessing event for the Steris (Steris Canada Inc.) automated endoscope reprocessing, Cidex OPA (Advanced Sterilization Products), Revital-Ox (Steris Canada Inc.), and Tristel Trio Wipes (Tristel plc) were $20.58, $14.20, $9.57, and $13.14, respectively. Scenario analysis demonstrated the Tristel Trio Wipes System (Tristel plc) was the least expensive method in practices with low reprocessing volumes (a threshold of less than 6 events per day, or 22 per week), whereas the Revital-Ox (Steris Canada Inc.) system was least expensive at higher volumes and became substantially more so as volumes increased. CONCLUSION: A manual accelerated hydrogen peroxide bath offers the least costly approach to nasopharyngoscope reprocessing. The convenience and portability of the Tristel Trio (Tristel plc) system may be a good alternative for low reprocessing volumes, or when rapid turnaround is necessary. LEVEL OF EVIDENCE: NA. Laryngoscope, 128:64-71, 2018.

Risk-assessment-based approach to patients exposed to endoscopes contaminated with Pseudomonas spp.

Patients exposed to bronchoscopes contaminated with Pseudomonas aeruginosa are at increased risk of pseudomonal infection. The optimal methods for management and mitigation of risk following exposure are controversial. This article describes a two-phase risk assessment following pseudomonal contamination of a family of 75 endoscopes, detected through routine surveillance and attributed to one endoscope washer-disinfector. An initial risk assessment identified 18 endoscopes as high risk, based on the presence of lumens used for irrigation or biopsy. Exposure was communicated to the patients' clinical teams and a further clinical risk assessment of the exposed patients was performed. No patients developed complications due to pseudomonal infection.

Endoscope storage time: assessment of microbial colonization up to 21 days after reprocessing.

BACKGROUND: Insufficient data exist for how long endoscopes can be stored after reprocessing. Concern about possible microbial colonization has led to various recommendations for reprocessing intervals among institutions, with many as short as 5 days. A significant cost savings could be realized if it can be demonstrated that endoscopes may be stored for as long as 21 days without risk of clinically significant contamination. OBJECTIVE: To demonstrate whether flexible endoscopes may be stored for as long as 21 days after reprocessing without colonization by pathogenic microbes. DESIGN: Prospective, observational study. SETTING: Tertiary care center. ENDOSCOPES: Four duodenoscopes, 4 colonoscopes, and 2 gastroscopes. INTERVENTION: Microbial testing of endoscope channels. MAIN OUTCOME MEASUREMENTS: Culture results at days 0, 7, 14, and 21. RESULTS: There were 33 positive cultures from 28 of the 96 sites tested (29.2% overall contamination rate). Twenty-nine of 33 isolates were typical skin or environmental contaminants, thus clinically insignificant. Four potential pathogens were cultured, including Enterococcus, Candida parapsilosis, α-hemolytic Streptococcus, and Aureobasidium pullulans; all were likely clinically insignificant as each was only recovered at 1 time point at 1 site, and all grew in low concentrations. There were no definite pathogenic isolates. LIMITATIONS: Single center. CONCLUSION: Endoscopes can be stored for as long as 21 days after standard reprocessing with a low risk of pathogenic microbial colonization. Extension of reprocessing protocols to 21 days could effect significant cost savings.

Sequential cohort study comparing chlorine dioxide wipes with automated washing for decontamination of flexible nasendoscopes.

INTRODUCTION: Flexible nasoendoscope is an important tool in otorhinolaryngology practice. The endoscope needs to be decontaminated prior to use in the next patient. The 2005 ENT-UK guidance for cleaning fibre-optic laryngoscopes stated that the ideal disinfecting agent and process should be effective and have low capital and maintenance costs. OBJECTIVE: To compare the efficacy and cost-effectiveness of chlorine dioxide wipes versus automated washer, for decontamination of flexible nasendoscopes. METHODS: A sequential cohort, in vitro study was performed to test the efficacy of chlorine dioxide wipes and automated washer. Costs were also calculated. RESULTS: After deliberate bacterial contamination of the nasendoscope and subsequent decontamination, swab samples from the endoscope showed Staphylococcus epidermidis growth in 2 per cent (1/50 swabs) of the chlorine dioxide wipe group and in 28 per cent (14/50 swabs) of the automated washer group (p = 0.00). Based on a projected 10-year cost calculation, the automated washer was cheaper. CONCLUSION: Further studies are required to test whether these results are replicable. A similar study should be performed using real patients, to check the significance of improper decontamination.

Assessment on experimental bacterial biofilms and in clinical practice of the efficacy of sampling solutions for microbiological testing of endoscopes.

Opinions differ on the value of microbiological testing of endoscopes, which varies according to the technique used. We compared the efficacy on bacterial biofilms of sampling solutions used for the surveillance of the contamination of endoscope channels. To compare efficacy, we used an experimental model of a 48-h Pseudomonas biofilm grown on endoscope internal tubing. Sampling of this experimental biofilm was performed with a Tween 80-lecithin-based solution, saline, and sterile water. We also performed a randomized prospective study during routine clinical practice in our hospital sampling randomly with two different solutions the endoscopes after reprocessing. Biofilm recovery expressed as a logarithmic ratio of bacteria recovered on bacteria initially present in biofilm was significantly more effective with the Tween 80-lecithin-based solution than with saline solution (P = 0.002) and sterile water (P = 0.002). There was no significant difference between saline and sterile water. In the randomized clinical study, the rates of endoscopes that were contaminated with the Tween 80-lecithin-based sampling solution and the saline were 8/25 and 1/25, respectively (P = 0.02), and the mean numbers of bacteria recovered were 281 and 19 CFU/100 ml (P = 0.001), respectively. In conclusion, the efficiency and therefore the value of the monitoring of endoscope reprocessing by microbiological cultures is dependent on the sampling solutions used. A sampling solution with a tensioactive action is more efficient than saline in detecting biofilm contamination of endoscopes.

Microbiologic assessment of disposable sterile endoscopic sheaths to replace high-level disinfection in reprocessing: a prospective clinical trial with nasopharygoscopes.

BACKGROUND: Conventional reprocessing of endoscopes with high-level disinfection is labor intensive, expensive, delays the turnover of instruments, and involves potential exposure of personnel to toxic chemicals. We report a prospective clinical trial with rigorous microbiologic assessment of a novel disposable, sterile, polyurethane sheath, which can be easily and snugly applied over a nasopharyngoscope before performing the endoscopic procedure, with enzymatic cleansing and disinfection of the instrument with 70% ethanol following the procedure to determine whether the use of the novel sheath can provide reliable protection against bacterial contamination and obviate the need for routine high-level disinfection in reprocessing. METHODS: Baseline cultures were obtained at 3 time periods from the control heads and insertion shafts of nasopharyngoscopes used in 100 clinical examinations: before application of the protective sheath and execution of the procedure; immediately after the procedure and removal of the sheath; and after enzymatic cleaning, disinfection with 70% ethanol, and drying. All 100 used sheaths and 20 unused sheaths were subjected to high-pressure leak testing to assess barrier integrity. RESULTS: Bacteria were detected on 16 control heads and 6 shafts prior to the procedure; from 13 heads and 1 shaft immediately following the nasopharyngoscopic procedure and sterile sheath removal; and none of the instruments following cleaning, ethanol disinfection, and drying. No sheath showed loss of barrier integrity on leak testing. CONCLUSION: Use of a high-quality, snugly fitting, sterile, disposable polyurethane sheath on a nasopharyngoscope during a clinical examination, combined with enzymatic detergent cleaning and disinfection with 70% ethanol, can provide a reliably decontaminated, patient-ready instrument, eliminating the need for high-level disinfection of endoscopes.

Microbiological monitoring of endoscopes: 5-year review.

Periodic microbiological monitoring of endoscopes is a recommendation of the Gastroenterological Society of Australia (GENSA). The aim of monitoring has been to provide quality assurance of the cleaning and disinfection of endoscopes; however, there is controversy regarding its frequency. This lack of consensus stimulated a review of the experience within our health service. At Southern Health, routine microbiological sampling has involved 4-weekly monitoring of bronchoscopes, duodenoscopes and automated flexible endoscope reprocessors (AFER), and 3-monthly monitoring of all other gastrointestinal endoscopes. Records of testing were reviewed from 1 January 2002 until 31 December 2006. A literature review was conducted, cost analysis performed and positive cultures investigated. There were 2374 screening tests performed during the 5-year period, including 287 AFER, 631 bronchoscopes for mycobacteria and 1456 endoscope bacterial screens. There were no positive results of the AFER or bronchoscopes for mycobacteria. Of the 1456 endoscopic bacterial samples, six were positive; however, retesting resulted in no growth. The overall cost of tests performed and cost in time for nursing staff to collect the samples was estimated at $AUD 100,400. Periodic monitoring of endoscopes is both time-consuming and costly. Our review demonstrates that AFER (Soluscope) perform well in cleaning endoscopes. Based on our 5-year experience, assurance of quality for endoscopic use could be achieved through process control as opposed to product control. Maintenance of endoscopes and AFER should be in accordance with the manufacturer's instructions and microbiological testing performed on commissioning, annually and following repair. Initial prompt manual leak testing and manual cleaning followed by mechanical leak testing, cleaning and disinfection should be the minimum standard in reprocessing of endoscopes.

Endoscope decontamination incidents in England 2003-2004.

An Endoscope Task Force was established following the report of an endoscope decontamination failure in May 2004. The Task Force reviewed endoscope decontamination incidents in England from 2003 to 2004 and made recommendations to prevent further recurrences. Twenty-one incidents were reported from 19 National Health Service (NHS) Trusts, 18 of which matched the Task Force definition of an incident. Eight incidents involved failures to decontaminate auxiliary endoscope channels, seven incidents highlighted problems with automated endoscope reprocessors, and the remaining three involved disinfection practices not recommended by the British Society of Gastroenterology Guidelines. Following an assessment of the risk of transmission from blood-borne viruses, the Task Force recommended that look-back exercises were not indicated. The nature of the incidents suggested that there were problems associated with defining roles and responsibilities for endoscope decontamination, staff training and incompatibility between endoscopes and reprocessors. The Medicines and Healthcare Products Regulatory Agency subsequently issued recommendations to all NHS Trusts carrying out endoscopies.

Endoscope disinfection by ortho-phthalaldehyde in a clinical setting: an evaluation of reprocessing time and costs compared with glutaraldehyde.

Ortho-phthalaldehyde provides high-level disinfection in 12 minutes at room temperature (20 degrees C). To determine whether the endoscopy unit at Massachusetts General Hospital could cost-effectively increase endoscope throughput and decrease delayed procedures while maintaining biocidal efficacy with heavy use, ortho-phthalaldehyde solution (0.55% w/v) was used for high-level disinfection in place of glutaraldehyde in the unit's five automatic endoscope reprocessors. During this 38-day study, 1,839 endoscopes were processed in 1,201 cycles. Each machine ran an average of 80 disinfection cycles in each of three consecutive periods. The shorter disinfection time of ortho-phthalaldehyde (12 minutes) resulted in an average savings of 53 hours in disinfection time per study period for the five processors when compared with glutaraldehyde's 20-minute disinfection time.Ortho-phthalaldehyde costs more per gallon than glutaraldehyde ($31.03 versus $13.20). This higher cost would be offset, however, by additional time savings resulting from the fact that compared with glutaraldehyde, ortho-phthalaldehyde is faster-acting and a mixing and activation step is not required. In addition, testing prior to each cycle verified that despite heavy use, ortho-phthalaldehyde solution remained efficacious, lasting through an average of 80 cycles, whereas glutaraldehyde only lasts for an average of 40 cycles. Test strips showed the concentration of ortho-phthalaldehyde in the reprocessors remained above the minimum effective concentration for the entire 14-day maximal reuse period. Additional microbiological efficacy testing of spent solution diluted to its minimum effective concentration demonstrated the solution remained tuberculocidal in tests with Mycobacterium bovis.