Gastrointestinal (GI) endoscopy is an important tool for diagnosing and treating disorders of the GI tract. With the extension of the National Cancer Screening Program, the frequency of endoscopic examination has increased. Endoscopic equipment is not disposed of after use. Most of the time, it will be reused in another patient, and therefore requires reprocessing. However, the complex structure of an endoscope, the narrow biopsy channel, the presence of various accessories, and the humid environment during use increase the chance of contamination by infectious organisms.

Most cases of endoscopy-mediated infection can be attributed to inappropriate reprocessing.1,2,3,4 However, lack of data hinders any conclusion of a causal relationship between endoscopy and pathogen transmission. There is no specific reported case of an infection caused by endoscopic examination in Korea. In a recent review of the published medical literature and the Food and Drug Administration database, the reported incidence of an infection caused by endoscopic examination was only 35 cases in the last decade, which is extremely low considering the estimated 340 million procedures performed over this period.5 However, a causal relationship between an endoscopy procedure and pathogen transmission is difficult to prove for several reasons including the long latent period and subclinical symptoms. The actual prevalence of infection transmission may be higher.6,7

Guidelines for reprocessing flexible endoscopes have been published in many countries to prevent endoscope-mediated pathogen transmission.8,9,10,11 However, their complexity and the high cost of reprocessing can reduce compliance. In 1995, the Korean Society of Gastrointestinal Endoscopy established endoscopic cleaning and disinfection guidelines to prevent endoscopic examination-mediated transmission paths of infection. The first and second revised guidelines were released in August 2009 and August 2012, respectively. There has been no standard method of evaluating the reprocessing procedure. In some countries, surveys on endoscope reprocessing were conducted.12,13,14,15,16,17 In Korea, endoscope reprocessing surveys were implemented in 2002 and 2004, but these were not practitioner-oriented surveys.18 Therefore, we undertook an endoscope reprocessing survey targeting actual practitioners to determine whether the reprocessing guidelines have been properly followed and to determine the precise current status of endoscope reprocessing.

A survey commissioned by the Disinfection Management Committee of the Korean Society of Gastrointestinal Endoscopy was conducted during a 1-week period starting on June 3, 2013. The survey targeted nurses and nursing auxiliaries from the endoscopy units of eight secondary or tertiary hospitals belonging to the society. The initial content of the survey was developed based on the previous endoscope reprocessing surveys conducted in 2002 and 2004 as well as those conducted in other countries. Since then, the content has been modified by the committee. The final survey comprised 33 self-filled questions and was distributed to 101 employees working in the various digestive endoscopy units by committee members (Appendix 1). The anonymous responses were collected after 1 week either by post or in person by committee members. All statistical analyses were performed with the statistical program R version 2.9.2 (R Foundation for Statistical Computing, Vienna, Austria). For detailed analysis, differences were compared using the chi-square test and judged statistically meaningful at p<0.05.

Overall, 100 of the 101 nurses and nursing auxiliaries responded.

This survey was the first to target nurses and nursing auxiliaries who actually participate in endoscope reprocessing. Prior surveys conducted in 2002 and 2004 queried physicians. Most of the reprocessing processes showed high compliance rates. On the questionnaire item that inquired about the rate of compliance with the reprocessing guidelines, the majority of respondents (98.9%) indicated high compliance, in comparison to 27% and 50% of respondents, respectively, in the 2002 and 2004 surveys.18

Among the several steps involved in endoscope reprocessing, transporting the contaminated endoscope in a sealed container to the disinfection area had the lowest compliance (56.0%) and was selected as the most difficult step to comply with. The compliance rates with this step in the United States and Portugal were 26% and 44%, respectively.12,13 Concerning the endoscopy unit environment, most subjects (88.0%) replied that the disinfection and procedure areas were separate. Compared to the percentages reported in the United States (85%), Portugal (92%), Spain (47%), Italy (12.3%), Germany (80%), and Romania (27.6%), the percentage in our survey is relatively high.12,13,14,15,16,19 AER was available in all hospitals that participated in our survey, compared with 32% and 49% of the hospitals surveyed in 2002 and 2004, respectively.18 On the other hand, surveys conducted in the United States, Portugal, and Italy reported 9.5%, 4%, and 9.1% implementation rates for manual disinfection, respectively. In a survey conducted in Germany, AERs were available in most hospitals, while in Spain, Romania, and China only a respective 23%, 34.5%, and 22.1% had AERs.12,13,14,15,16,17,19 AERs have important roles, such as replacing some manual reprocessing steps or manual disinfection, reducing user exposure to hazardous reprocessing chemicals and contaminated equipment, and highly reliable reprocessing.20 A previous study reported that microorganisms were detected on more than 40% of endoscopes after manual/semi-automatic reprocessing compared with 14% to 16% of instruments after automatic reprocessing.21 Therefore, a high AER penetration rate and an increasing dependency on AERs indicate good quality management as compared with the 2002 and 2004 surveys.18 In addition, questionnaire results regarding the reprocessing time of a single endoscope, indicate an increase in reprocessing time more so than in manual disinfection despite the incremental change in examination numbers. In general, the quality management of endoscopes is good.

Concerning disinfectants, surveys conducted in other countries found that glutaraldehyde was used most often. However, in domestic surveys, ortho-phthaldehyde was used most often (43.9%), followed by peracetic acid (35.0%), glutaraldehyde (16.3%), electrolyzed acid water (4.1%), and hydrogen proxide (0.8%).12,17,22 There are several reasons for the preference of ortho-phthaldehyde or peracetic acid over glutaraldehyde in Korea. First, glutaraldehyde has a relatively lengthy immersion time compared with other disinfectants.23 Second, glutaraldehyde may cause serious irritation to the eyes or respiratory system, and can cause allergic reactions of the skin, conjunctiva, nose, and pharynx.24,25 Therefore, a reprocessing area must include a ventilator to avoid vapor inhalation. These are significant disadvantages to the endoscope reprocessing process in Korea, where a relatively high number of endoscopic examinations are done compared with similar-sized hospitals in other countries. Most subjects (96.0%) replied that they have experienced occupational hazards. Concerning personal protective equipment, the majority of subjects replied that they wore most of the personal protective equipment, with the exception of eyewear. The latter is a concern. Moreover, surveys on occupational hazards should target all practitioners in endoscopy units, including doctors.

The qualitative evaluation and education by the Korean Society of Gastrointestinal Endoscopy aims to improve the quality management of endoscope reprocessing. However, several problems, such as reuse of disposable accessories, transport of the contaminated endoscope in a sealed container, and the wearing of eyewear need improvement. Most subjects (87.8%) selected financial problems such as the medical insurance fee for endoscopic procedures and the high number of endoscopic examinations as the two most common reasons for difficulty in complying with the guidelines. More than half of the subjects (50.5%) replied that a higher medical insurance fee for endoscopic procedures or a newly introduced disinfection cost were needed to comply with the guidelines, while others replied that education, employment security, or periodic surveillance were needed. Reconsideration of the endoscopic examination fee is needed for future quality management to resolve these problems. Moreover, periodic surveillance and education directed towards practitioners should be continued.

This survey has some limitations. Since it targeted hospitals that are members of the Disinfection Management Committee under the Korean Society of Gastrointestinal Endoscopy, the present survey excluded primary clinics. Compliance with the endoscope reprocessing procedure could be higher than is apparent in Korea. However, there are financial hurdles to satisfying all the conditions such as labor costs, purchase of the AER, and reuse of disposable accessories designed for single-time use that can lower the quality of endoscope reprocessing.

In conclusion, this survey demonstrates that the quality management of endoscope reprocessing has improved compared with surveys conducted in 2002 and 2004. To improve endoscope reprocessing quality management, medical insurance fees should be raised and adequate endoscope reprocessing should be bolstered by the periodic surveillance of healthcare quality and continuous education. A national survey that includes primary clinics will be necessary.