Presence and Causes of Sterilization Equipment Failures with Biological Indicators in Dental Offices in Mexico: A Longitudinal Cohort.

Background/Objectives: Sterilization in dental practice is crucial for infection prevention. The aim of this study was to identify the presence and causes of bacterial growth using biological indicators in dental sterilization equipment in San Luis Potosí, S.L.P., Mexico, with different consecutive measurements over a year. Methods: This longitudinal cohort, conducted from January 2022 to January 2024 in San Luis Potosí, Mexico, aimed to identify the presence and causes of bacterial growth in dental sterilization equipment using biological indicators. A total of 207 dental offices were approached, and 175 participated, providing data through questionnaires and monitoring sterilization cycles with BIs. The checks were bimonthly for one year, with a total of six checks. Results: (a) An 11% (n = 1188) incidence of bacterial growth was observed, with a higher percentage in dry heat equipment (13%). (b) Upon analyzing the six consecutive verifications over a year, no statistically significant differences were observed in the failures of the sterilization cycles when comparing the two pieces of equipment. (c) Error in temperature and time of the equipment (OR = 4.0, 95% CI = 1.6-3.9, p = 0.0001) was significantly associated with the presence of bacterial growth during the one-year period. Conclusions: Monitoring sterilization cycles and identifying the causes of bacterial growth with different consecutive verifications decreased the presence of bacterial growth (failures) during the one-year period.

Compliance of primary and secondary care public hospitals with standard practices for reprocessing and steam sterilization of reusable medical devices in Nepal: findings from nation-wide multicenter clustered audits.

BACKGROUND: Reusable medical devices in healthcare facilities are decontaminated and reprocessed following standard practices before each clinical procedure. Reprocessing of critical medical devices (those used for invasive clinical procedures) comprises several processes including sterilization, which provides the highest level of decontamination. Steam sterilization is the most used sterilization procedure across the globe. Noncompliance with standards addressing reprocessing of medical devices may lead to inadequate sterilization and thus increase the risk of person-to-person or environmental transmission of pathogens in healthcare facilities. We conducted nationwide multicenter clustered audits to understand the compliance of primary- and secondary-care public hospitals in Nepal with the standard practices for medical device reprocessing, including steam sterilization. METHODS: We developed an audit tool to assess compliance of hospitals with the standard practices for medical device reprocessing including steam sterilization. Altogether, 189 medical device reprocessing cycles which included steam sterilization were assessed in 13 primary and secondary care public hospitals in Nepal using the audit tool. Percentage compliance was calculated for each standard practice. Mean percentage compliances were obtained for overall primary and secondary care hospitals and for each hospital type, specific hospital and process involved. RESULTS: For all primary and secondary care hospitals in Nepal, the mean percentage compliance with the standard practices for medical device reprocessing including steam sterilization was 25.9% (95% CI 21.0-30.8%). The lower the level of care provided by the hospitals, the lower was the mean percentage compliance, and the difference in the means across the hospital types was statistically significant (p < 0.01). The mean percentage compliance of individual hospitals ranged from 14.7 to 46.0%. The hospitals had better compliance with the practices for cleaning of used devices and transport and storage of sterilized devices compared with the practices for other processes of the medical device reprocessing cycle. CONCLUSION: The primary and secondary care hospitals in Nepal had poor compliance with the standard practices for steam sterilization and reprocessing of medical devices. Interventions to improve compliance of the hospitals are immediately required to minimize the risks of person-to-person or environmental transmission of pathogens through inadequately reprocessed medical devices.

[Reuse process of positive pressure powered air-filter protective hoods].

OBJECTIVE: To establish reuse process of positive pressure powered air-filter protective hoods during coronavirus disease 2019 (COVID-19) epidemic. METHODS: The procedure of pretreatment, storage, recovery, cleaning, disinfection and sterilization process of positive pressure powered air-filter protective hoods, which were used in the treatment of COVID-19 infection patients was established in Central Sterile Supply Department of the hospital. The cleaning and disinfection effects of the protective hoods after treatment were examined by magnifying glass method, residual protein detection method, real-time PCR, and agar pour plate method. RESULTS: Twenty five used protective hoods underwent totally 135 times of washing, disinfecting and sterilizing procedures. After washing, all the protein residue tests and COVID-19 nucleic acid tests showed negative results. After sterilizing, all the protective hoods met sterility requirement. All the tested protective hoods were undamaged after reprocessing. CONCLUSIONS: The established reuse procedures for used positive pressure powered air-filter protective hoods are safe.

[Quality Control of Medical Instruments and Cleaning Water].

PURPOSE: Herein we aimed to investigate the degradation of surgical instruments in our hospital and how water quality affects the rate of metal corrosion. MATERIALS AND METHODS: We observed 279 stainless steel instruments, and determined the presence of damage like metal corrosion or scale formation. We also measured the concentrations of chloride(Cl-)and silicate(SiO44-)ions in the water used for cleaning in our operating rooms, including tap water from the city water supply and reverse-osmosis(RO)filtered water. RESULT: Pitting corrosion was observed on 71% of the instruments we investigated. The concentration of Cl- was 0.7mg/L in tap water and 0.1mg/L in RO water, while the concentration of SiO44- was 0.3mg/L in both the tap and RO water. DISCUSSION: Of the dissolved ions Cl- and SiO44-, Cl- is more of a concern, as it causes pitting corrosion over time, while SiO44- causes scale formation. Considering the typical water quality in the operating-room environment, degradation must be monitored for the general maintenance of metal surgical instruments.

[ISO 9001 certification of a sterilization unit: Transition to the 2015 version]. / Certification ISO 9001 d'un service de stérilisation : passage à la version 2015.

OBJECTIVES: The sterilization unit of Pitié-Salpêtrière-Charles Foix hospital group is ISO 9001 certified on one of its sites. The purpose of this work is to describe how the unit prepared for the transition from the 2008 version to the 2015 version of the standard, as well as the conduct of the audit. METHODS: The pharmaceutical team has received prior training from French national organization for standardization (Afnor) to understand the new requirements and how to apply them to the sterilization unit. SWOT and PESTEL methods were used. A 3-month retro planning has been established. Deadlines were the annual management review and the certification audit. Audits carried out by the Quality and Risk Management Department helped to identify the priorities. RESULTS: The compliance of the quality management system (QMS) has led to the identification of internal and external challenges, relevant stakeholders and risks and opportunities. Management leadership and communication has been strengthened and control over external providers has improved. The auditor did not identify any non-compliance, but said that the system had to mature regarding the recent application of the new requirements. CONCLUSIONS: The QMS is more effective, new strengths and weaknesses have been identified and requirements of the unit and stakeholders have been better defined. The pharmaceutical investment necessary for this approach has been important. Involvement in the quality approach of all the staff of the unit lies to the success of the project.

[Subcontracting a steam sterilization activity: Impact on surgical instruments]. / Externalisation de l'activité de stérilisation : impact sur l'état des instruments chirurgicaux.

Subcontracting our institution's sterilization activity induced the implementation of an automated cleaning facility. Following this development, some of the resterilizable stainless steel needle holders started to show abnormal corrosion. Our study goal was to investigate the causes of this corrosion in order to optimize the sterilization circuit. A full sterilization process mapping and Ishikawa diagram enabled us to identify potential causes of corrosion. The needle holders' intrinsic characteristics, like steel quality and manufacturing, were analyzed as well as extrinsic factors such as the influence of preprocessing soaking conditions, steel passivation, water quality and the impact of corrosion inhibitors. Each potential factor of corrosion was tested in real conditions on needle holders' kits. The needle holders steel grade complies with medical standards and the tests showed that passivation and pre-processing conditions were not involved in the occurrence of corrosion, contrary to soaking length and use of softened rinsing water, containing more chloride than reverse osmosis water, and, thus conducive to rust formation. Moreover, corrosion inhibitors were deemed ineffective or incompatible. Due to this analysis, the incidence of corrosion was reduced by switching softened water to osmosis water and by introducing dynamic drying in the automated cleaning process. In addition, this work stresses the importance of minimizing waiting times and auditing the sterilization circuit before any subcontracting. Management Guidelines related to sterilization's outsourcing would probably have helped to limit this episode.

[Evaluation of dental medical devices: Focus on the definition of needs]. / Évaluation des dispositifs médicaux dentaires pour un appel d'offres : privilégier la haute définition des besoins.

OBJECTIVES: As a university teaching hospital, the call for tender for dental medical devices (dental implants and consumables) is done with the help of a team of hospital pharmacists and users. In order to optimize the definition of needs and evaluation criteria, an exhaustive review of the products was carried out. METHODS: Dental medical devices suppliers were consulted in 2017 for reviewing their products. Their technical, clinical and economic data were compared. The products have been gathered into categories and its results had been submitted to a commission of dental experts of our university hospital for clinical opinion. RESULTS: More than 30,000 references from 30 different suppliers were analyzed (orthodontics, dental implants, membranes and bone substitutes, various dental consumables). Relating to oral implantology, the opinions converged on clinical studies. On the contrary, diverging opinions have been proffered on the systematic use of single-use drills and customized guides for surgery and on the implant's choice. The definition of needs has been specified for orthodontics and consumables. Other criteria played a great role: single packaging (unit doses), product's sterility, paediatric needs, presence of allergens, traceability of devices and supplier diversity. CONCLUSIONS: This review led to the identification of new needs in more precise terms. The complexity and diversity of dental products and techniques requires this careful review and a better collaboration with practitioners.

Pilot study: Internally cooled orthopedic drills - standard sterilization is not enough?

Bone drilling causes focal temperature rise due to metal-to-bone contact, which may result in thermal osteonecrosis. Newly constructed internally cooled medical drill of an open type decreases temperature rise at a point of metal-to-bone contact although standard sterilization of such a drill could be inadequate due to bacteria retention within the drill lumen. The aim of this pilot study was to examine the effectiveness of sterilization and to propose sterilization recommendations for internally cooled open type bone drills. Unused internally cooled medical steel bone drills were tested. Drills were contaminated with Pseudomonas aeruginosa, Bacillus sp., beta-hemolytic Streptococcus sp., Enterobacter sp. and methicillin-resistant Staphylococcus pseudintermedius and then incubated for 24 hours at 37 °C. Afterwards, drills were autoclaved for 15, 20 and 30 minutes at 132 °C and 2.6 bar. When 15-minute sterilization was used, one out of 16 drills was contaminated with Pseudomonas aeruginosa, while the other 15 drills were sterile. Extended cycle sterilization in autoclave lasting for 20 and 30 minutes resulted in 100% sterility of all drills tested. In conclusion, lumened drills should be exposed to extended sterilization times in autoclave. Minimal recommended time for sterilization of lumened drills is 20 minutes.

Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) - Update 2018.

This Position Statement from the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology Nurses and Associates (ESGENA) sets standards for the reprocessing of flexible endoscopes and endoscopic devices used in gastroenterology. An expert working group of gastroenterologists, endoscopy nurses, chemists, microbiologists, and industry representatives provides updated recommendations on all aspects of reprocessing in order to maintain hygiene and infection control.

Application of EPR spectroscopy to examine free radicals evolution during storage of the thermally sterilized Ungentum ophthalmicum.

Free radicals formed during thermal sterilization of the Ungentum ophthalmicum were examined by an X-band EPR spectroscopy. The influence of storage time (15 min; 1, 2 and 3 days after heating) on free radical properties and concentrations in this sample was determined. Thermal sterilization was done according to the pharmaceutical norms. The first-derivative EPR spectra with g-values about 2 were measured with magnetic modulation of 100 kHz in the range of microwave power 2.2-70 mW. The changes of amplitudes (A) and linewidths (ΔBpp) with microwave powers were evaluated. Free radicals in concentration ∼1017 spin/g were formed during heating of the tested Ungentum. Free radical concentration decreased with increase in storage time, and reached values ∼1017 spin/g after 3 days from sterilization. The tested U. ophthalmicum should not be sterilized at a temperature of 160 °C because of the free radicals formation, or it should be used 3 days after heating, when free radicals were considerably quenched. Free radical properties remain unchanged during storage of the Ungentum. The EPR lines of the U. ophthalmicum were homogeneously broadened and their linewidths (ΔBpp) increased with increase in microwave power. EPR spectroscopy is useful to examine free radicals to optimize sterilization process and storage conditions of ophthalmologic samples.

Does the Use of Clean or Sterile Dressing Technique Affect the Incidence of Wound Infection?

PURPOSE: The purpose of this article is to examine the evidence and provide recommendations for the use of clean or sterile dressing technique with dressing application to prevent wound infection. QUESTION: In all persons with acute or chronic wounds, does the use of clean or sterile dressing technique affect incidence of wound infection? SEARCH STRATEGY: A search of the literature was performed by a trained university librarian, which resulted in 473 articles that examined any age group that dealt with application of a wound dressing using either sterile or nonsterile technique. A systematic approach was used to review titles, abstracts, and text, yielding 4 studies that met inclusion criteria. Strength of the evidence was rated using rating methodology from Essential Evidence Plus: Levels of Evidence and Oxford Center for Evidence-Based Medicine, adapted by Gray and colleagues. Johns Hopkins Nursing Evidence-Based Practice Nursing Research Appraisal Tool was used to rate the quality of the evidence. FINDINGS: All 4 studies reported no significant difference in the rate of wound infection when using either clean or sterile technique with dressing application. The strength of the evidence for the identified studies was identified as level 2 (1 level A, 3 level B). The study sizes were variable, and the wounds included do not represent the continuum of wounds clinically encountered across the board. CONCLUSION/RECOMMENDATION: Evidence indicates that the use of clean technique for acute wound care is a clinically effective intervention that does not affect the incidence of infection. There is no recommendation that can be made regarding type of dressing technique for a chronic wound due to the lack of evidence in the literature.

[Study of the reproducibility of the sterilization process and proposal of an sterilizer requalification protocol]. / Étude de la reproductibilité du procédé de stérilisation et proposition d'un protocole de requalification des stérilisateurs.

Unlike EN 554, and since the publication of ISO 17665-1 standard, the user of autoclaves may use methods other than those indicated in the guidelines. Outsourcing the requalification of sterilizers by an external service provider and after observing from the previous requalification reports that the thermometric data seemed reproducible, we decided to propose and validate a validation method for the reproducibility of the sterilization process. This is to exempt from the study of the repeatability of the EN 554 standard in future requalifications. Reproducibility was studied with the sensors of the sterilization service and from the production cycles. This study was carried out in three parts. First, we checked whether our sensors were reliable. Then we evaluated the sterilization process fidelity of each sterilizer. Finally, we compared our measurements performed by the service sensors with the measurements performed by the service provider during the requalifications of the previous years. This work leads us to describe a new protocol of requalification of our sterilizers.

Residual risk of bacterial contamination of platelets: six years of experience with sterility testing.

BACKGROUND: Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein. STUDY DESIGN AND METHODS: In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as "true-positives" when the same bacterium was isolated in initial and confirmatory cultures or "false-negatives" when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases. RESULTS: During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria. CONCLUSION: The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention.

'Unfit for human consumption': a study of the contamination of formula milk fed to young children in East Java, Indonesia.

OBJECTIVES: To examine levels of bacterial contamination in formula feeding bottles in Sidoarjo, East Java, and to assess the preparation practices that may have been responsible. METHODS: A cross-sectional study was conducted among 92 randomly selected households with children under the age of two who were bottle-fed formula. In each household, we carried out video observation of mothers/caregivers preparing bottles, and examined samples of formula for coliform bacteria and Escherichia coli (E. coli). In-depth interviews were conducted with a subsample of 20 mothers. RESULTS: A total of 88% of the formula feeds were contaminated with total coliforms at a level >10 MPN/ml, and 45% contained E. coli. These feeds were defined as 'unfit for human consumption'. In the video observations, none of the mothers complied with all five WHO-recommended measures of hygienic formula feed preparation. Only two mothers washed their hands with soap prior to formula preparation. Most mothers also failed to clean or sterilise the bottle and clean the preparation area. In-depth interviews confirmed that such suboptimal hygiene practices were common. CONCLUSION: The high levels of contamination found highlight that bottles are an important faecal-oral exposure pathway resulting from poor hygiene practices during bottle preparation.

Sterility of Selected Operative Sites During Total Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To describe the type and quantity of bacteria found intraoperatively on the abdomen, vagina, surgical gloves, instrument tips, and uterus at distinct time points during total laparoscopic hysterectomy (TLH). DESIGN: Observational study (Canadian Task Force classification III). SETTING: Academic affiliated hospital. PATIENTS: Thirty-one women undergoing TLH for benign indications in 2016. INTERVENTIONS: After antibiotic prophylaxis and chlorhexidine preparation, swabs were collected from the vaginal fornices and abdomen. During subsequent TLH, additional swabs were collected from the following sites: surgeon's gloves after placement of the uterine manipulator, tips of instruments used to close the vaginal cuff, uterine fundus after extraction, and surgeon's gloves after removal of the uterus. A calibrated loop was used to inoculate each specimen onto 5% blood and chocolate agars for growth of aerobes and onto Brucella blood, phenylethyl alcohol, kanamycin vancomycin, and Bacteroides bile esculin agars for growth of anaerobes. Manual colony counts were tabulated for all positive cultures and reported in colony-forming units per milliliter (CFU/mL). MEASUREMENTS AND MAIN RESULTS: Anaerobic growth was not seen on the instrument tips, in the vagina, or on the abdomen of any patient. Aerobic bacterial growth was not seen in the vagina of any patient. On the surgeon's gloves after uterine manipulator placement, no patients demonstrated sufficient bacterial growth to potentially cause surgical site infection (≥5000 CFU/mL). On the surgeon's gloves following uterine extraction, 1 patient demonstrated sufficient growth to potentially cause infection. None of the patients developed surgical site infections postoperatively. CONCLUSION: Cultures from multiple operative sites yielded bacterial growth, but the bacterial concentrations did not exceed the threshold for infection in 98.9% of cultures. Given absent growth from vaginal cultures and rare growth from abdominal cultures, chlorhexidine gluconate 4% is considered an appropriate surgical preparation for use in laparoscopic hysterectomy.

Assessing hydrogen peroxide vapor exposure from hospital sterilizers.

This study examines the hydrogen peroxide concentrations measured near four models of hydrogen peroxide sterilizers, from two manufacturers, monitored in seven hospitals across the U.S. and Canada over several years. The results showed that the majority of sterilizers do not emit hazardous levels of hydrogen peroxide and none of them exceeded the OSHA PEL of 1 ppm (8-hr time-weighted average (TWA)), however several of the sterilizers exceeded 3 ppm, the short-term exposure limit in two states: Washington and Hawaii. One hospital found brief concentrations of 25-40 ppm hydrogen peroxide from 4 hydrogen peroxide sterilizers each time they opened the sterilizer at the end of its cycle. Although not exceeding the OSHA PEL, these exposures are of concern since this concentration is roughly half the NIOSH IDLH of 75 ppm, and operators in a busy hospital environment may receive these exposures multiple times a day.

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high.

Anesthesia in patients with infectious disease caused by multi-drug resistant bacteria.

PURPOSE OF REVIEW: Up to 50% of specific bacterial strains in healthcare admission facilities are multi-drug resistant organisms (MDROs). Involvement of anesthesiologists in management of patients carrying/at risk of carrying MDROs may decrease transmission in the Operating Room (OR). RECENT FINDINGS: Anesthesiologists, their work area and tools have all been implicated in MDRO outbreaks. Causes include contamination of external ventilation circuits and noncontribution of filters to prevention, inappropriate decontamination procedures for nondisposable equipment (e.g. laryngoscopes, bronchoscopes and stethoscopes) and the anesthesia workplace (e.g. external surfaces of cart and anesthesia machine, telephones and computer keyboards) during OR cleaning and lack of training in sterile drug management. SUMMARY: Discussions regarding the management of potential MDRO carriers must include anesthesia providers to optimize infection control interventions as well as the anesthesia method, the location of surgery and recovery and the details of patient transport. Anesthesia staff must learn to identify patients at risk for MDRO infection. Antibiotic prophylaxis, although not evidence based, should adhere to known best practices. Adjuvant therapies (e.g. intranasal Mupirocin and bathing with antiseptics) should be considered. Addition of nonmanual OR cleaning methods such as ultraviolet irradiation or gaseous decontamination is encouraged. Anesthesiologists must undergo formal training in sterile drug preparation and administration.

Code Grey: Stained Surgical Instruments and Their Impact on One Canadian Health Authority.

In 2016, NL's largest RHA was faced with serious challenges stemming from the discovery of stained surgical instruments at its two largest hospitals. This discovery prompted a series of postponed surgeries, an extensive internal mobilization of labour and the purchase of millions of dollars of new equipment. In tackling these challenges, the organization not only acquired a better understanding of its surgical tools, but it also gained renewed appreciation for the resilience of its human resources. By describing this incident and the lessons learned, we hope to offer insight to providers in similar circumstances.

Outbreaks associated with duodenoscopes: new challenges and controversies.

PURPOSE OF REVIEW: Recent outbreaks of carbapenem-resistant enterobacteriaceae related to duodenoscopes in the United States and Europe have gained international attention and resulted in new regulations, especially in the United States, affecting healthcare facilities. In this review, we summarize findings from recent duodenoscope-related outbreaks, highlight what is known about the risk of transmission from these devices and discuss controversies about current recommendations to prevent transmission. RECENT FINDINGS: Between 2013 and 2015, several US and European healthcare facilities reported outbreaks of carbapenem-resistant enterobacteriaceae associated with endoscopic retrograde cholangiopancreatography procedures. Unlike prior outbreaks (attributed to lapses in cleaning and reprocessing), the recent outbreaks occurred in spite of adherence to current reprocessing guidelines. Factors associated with infection transmission include a low margin of safety for gastrointestinal endoscopic procedures and complex design features of duodenoscopes. Outbreaks were halted with enhanced cleaning and surveillance measures or by adopting gas sterilization methods. New guidance from manufacturers and federal agencies has been issued as a result of these recent outbreaks; however, concerns remain that the new measures may not eliminate risks to patients. SUMMARY: Recent duodenoscope-related outbreaks have highlighted the need for a reassessment of current guidelines for endoscope reprocessing and for new design of duodenoscope components. Although we summarize the US experience, this review has global implications for the safe cleaning and disinfection of these instruments.