ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to en ISO 15883, parts 1, 4, and ISO/TS 15883-5

Endoscopy

Volumn 49, Issue 12, 2017, Pages 1262-1274

  Beilenhoff, Ulrike ^a   Biering, Holger ^b   Blum, Reinhard ^c   Brljak, Jadranka ^d   Cimbro, Monica ^e   Dumonceau, Jean Marc ^f   Hassan, Cesare ^g   Jung, Michael ^h   Neumann, Christiane ⁱ   Pietsch, Michael ^j   Pineau, Lionel ^k   Ponchon, Thierry ^l   Rejchrt, Stanislav ^m   Rey, Jean François ⁿ   Schmidt, Verona ^o   Tillett, Jayne ^p   Van Hooft, Jeanin ^q  

^a ESGENA   (Germany)

^b Centre for Radiology and Nuclear Medicine   (Germany)

^c Olympus Winter and Ibe   (Germany)

^d KBC Zagreb   (Croatia)

^e CBC (Europe)   (Italy)

^f Diagnostic and Therapeutic Gastroenterology and Endoscopy   (Argentina)

^g CATHOLIC UNIVERSITY   (Italy)

^h Katholisches Klinikum   (Germany)

ⁱ ESGENA Past President   (United Kingdom)

^j UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^k Biotech Germande   (France)

^l EDOUARD HERRIOT HOSPITAL   (France)

^m UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

ⁿ INSTITUT ARNAULT TZANCK   (France)

^o Microbiology and Hygiene Department   (Germany)

^p Aneurin Bevan University Health BoardClinical Research and Innovation Centre St Woolos Hospital   (United Kingdom)

^q ACADEMIC MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DEVICE SAFETY; INSTRUMENT VALIDATION; MANUFACTURING INDUSTRY; PRIORITY JOURNAL; PROCESS CONTROL; QUALITY CONTROL; STANDARD; DEVICES; DISINFECTION; DOCUMENTATION; ENDOSCOPE; MEDICAL DEVICE CONTAMINATION; MICROBIOLOGY; PRACTICE GUIDELINE; PROCEDURES; RECYCLING; STANDARDS; VALIDATION STUDY;

DISINFECTION; DOCUMENTATION; ENDOSCOPES; EQUIPMENT CONTAMINATION; EQUIPMENT REUSE; GUIDELINES AS TOPIC; QUALITY CONTROL; VALIDATION STUDIES AS TOPIC;

EID: 85034611860     PISSN: 0013726X     EISSN: 14388812     Source Type: Journal    
DOI: 10.1055/s-0043-122073     Document Type: Article

References (14)

1. Beilenhoff U. Neumann C. S. Biering H. ESGE Guidelines Committee et al. ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5. Endoscopy: 2007; 39 85 94
2. International Organization for Standardization ISO 15883-1:2006. Washer-disinfectors - Part 1: General requirements, terms and definitions and tests. Available from: 2017; https://www.iso.org/standard/41076.html Accessed: September 6 2017
3. International Organization for Standardization ISO 15883-4:2008. Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes. Available from: 2017; https://www.iso.org/standard/42060.html Accessed: September 6 2017
4. International Organization for Standardization ISO/TS 15883-5:2005. Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy. Available from: 2017; https://www.iso.org/standard/41175.htm Accessed: September 6 2017
5. DGKH, AKI, DGEA, DGSV Leitlinie zur Validierung maschineller Reinigungs- Desinfektionsprozesse zur Aufbereitung thermolabiler Endoskope, Zentralsterilisation Suppl. 3/2011. Available from: 2017; http://www.krankenhaushygiene.de/pdfdata/leitlinien/VamaReDeZuAuThEn-weiss.pdf Accessed: October 18 2017
6. Department of Health (England and Wales) Health Technical Memorandum [HTM] 01-06). Part D: Decontamination of flexible endoscopes: validation and verification (including storage/drying cabinets). 2016. Available from: 2017; https://www.gov.uk/government/publications/management-and-decontamination-of-flexible-endoscopes Accessed: September 6 2017
7. Österreichische Gesellschaft für Sterilgutversorgung (ÖEGSV) (Austrian Society for Supply of Sterile Goods) Leitlinie für die Prüfung, Validierung und Überwachung von maschinellen Reinigungs-/ Desinfektionsverfahren für flexible Endoskope 2013. Available from: 2017; http://www.oegsv.com/guidelines/guidelines2014.htm Accessed: October 18 2017
8. Steering Group for Flexible Endoscope Cleaning and Disinfection (SFERD) Professional standard handbook cleaning and disinfection flexible endoscopes. Version 4.1, September 2017. Available from: 2017; http://www.infectiepreventieopleidingen.nl/downloads/SFERDHandbook4-1.pdf Accessed: October 18 2017
9. Deutsche Gesellschaft für Sterilgutversorgung (DGSV) Qualification requirements for persons entrusted with validation. Zentralsterilisation: 2005; 13 375 376
10. ESGE-ESGENA Guideline Cleaning and disinfection in gastrointestinal endoscopy. Endoscopy: 2008; 40 939 957
11. Kommission für Krankenhaushygiene und Infektionsprävention Anforderungen der Hygiene an die baulich-funktionelle Gestaltung und apparative Ausstattung von Endoskopieeinheiten. Bundesgesundheitsblatt: 2002; 45 412 414
12. International Organization for Standardization ISO 17664:2004. Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. Available from: 2017; https://www.iso.org/standard/31456.html Accessed: September 6 2017
13. ESGE Newsletter Definition of endoscope families as used in EN ISO 15883. Endoscopy: 2013; 45 156 157
14. ESGE-ESGENA guideline for quality assurance in reprocessing Microbiological surveillance testing in endoscopy. Endoscopy: 2007; 39 175 181