SANS 373-1-2009 Reprocessing of endoscopes Part 1 Flexible endoscopes and accessories《内窥镜再加工 第1部分 灵活内窥镜及附件》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22936-8 SANS 373-1:2009Edition 2 SOUTH AFRICAN NATIONAL STANDARD Reprocessing of endoscopes Part 1: Flexible endoscopes and accessories Pu

4、blished by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 373-1:2009 Edition 2 Table of changes Change No. Date Scope Acknowledgement The SABS Standards Division wishes to acknowledge the valuable

5、assistance derived from the publications of Standards Australia and Standards New Zealand. Foreword This South African standard was approved by National Committee SABS SC 1039E, Medical devices Healthcare devices and materials for use in clinics and hospitals, in accordance with procedures of the SA

6、BS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in July 2009. This document supersedes SANS 373-1:2006 (edition 1). A reference is made in 3.1.18 to water that complies with “the local regulations for drinking water“. In South Africa this means

7、 the Water Services Act, 1997 (Act No. 108 of 1997). A reference is made in 4.3(g) to systems and procedures instituted in accordance with “the current relevant national legislation“. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993) and the Health Act, 197

8、7 (Act No. 63 of 1977). A reference is made in 4.5.2.1(g) to high-level disinfectants that comply with the requirements of “the current relevant national legislation“. In South Africa this means the Standards Act, 1993 (Act No. 29 of 1993). A reference is made in 4.5.2.1(l) to “legislated control li

9、mits“ for concentrations of airborne hazardous chemicals in the reprocessing area. In South Africa this means the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993). SANS 373 consists of the following parts, under the general title Reprocessing of endoscopes: Part 1: Flexible endoscopes a

10、nd accessories. Part 2: Rigid endoscopes, associated components and accessories. Annex C forms an integral part of this standard. Annexes A and B are for information only. SANS 373-1:2009 Edition 2 1 Contents Page Acknowledgement Foreword 1 Scope . 3 2 Normative references . 3 3 Definitions and abbr

11、eviations 3 4 Requirements 7 4.1 Reprocessing environment . 7 4.2 Storage 7 4.3 Training of personnel 8 4.4 Personal protective equipment 8 4.5 Responsibilities of the healthcare facility 9 5 Structure of flexible endoscopes . 11 5.1 Types. 11 5.2 Main external components 11 5.3 Internal features 13

12、 6 Manual reprocessing of flexible endoscopes 14 6.1 Preparation. 14 6.2 Pre-cleaning after an endoscopic procedure. 14 6.3 Manual cleaning in a designated area . 15 6.4 Rinsing and purging with air. 16 6.5 High-level chemical disinfection. 16 6.6 Rinsing after disinfection 17 6.7 Drying . 17 6.8 St

13、orage and reuse . 17 6.9 Biological monitoring of reprocessed endoscopes 18 7 Automated reprocessing of flexible endoscopes 18 7.1 Requirements for an AER 18 7.2 Procedure. 19 7.3 Biological monitoring of AER final rinse water . 20 8 Reprocessing of reusable EAs used with flexible endoscopes. 20 8.1

14、 Preparation. 20 8.2 Manual cleaning. 20 8.3 Ultrasonic cleaning. 21 8.4 Rinsing, drying and purging with air. 22 8.5 High-level disinfection or chemical sterilization of thermolabile EAs. 22 8.6 Sterilization of autoclavable EAs 23 8.7 Storage 23 SANS 373-1:2009 Edition 2 2 Contents (concluded) Pag

15、e Annex A (informative) Biological monitoring of endoscopes after high-level disinfection 24 Annex B (informative) Biological monitoring of the final rinse water from the AER 25 Annex C (normative) Information to be supplied by the manufacturer of the endoscope and EAs 26 Bibliography. 27 SANS 373-1

16、:2009 Edition 2 3 Reprocessing of endoscopes Part 1: Flexible endoscopes and accessories 1 Scope 1.1 This standard provides a code of practice for the preparation of flexible fiber-optic endoscopes, video endoscopes and the reusable endoscopic accessories used with flexible endoscopes, for reuse, ei

17、ther manually or using automatic endoscope reprocessors. It covers the requirements for personnel responsible for reprocessing endoscopes and for the reprocessing environments in healthcare facilities. 1.2 It does not cover: items intended by the manufacturer to be destroyed after single patient use

18、; procedures to handle spillages of chemicals used for sterilization or disinfection; details of commercially available products used for high-level disinfection or chemical sterilization; and validation and routine control of various sterilization methods or procedures. 2 Normative references The f

19、ollowing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Information on currently valid national and internatio

20、nal standards can be obtained from the SABS Standards Division. SANS 17664/ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices. 3 Definitions and abbreviations 3.1 Definitions For the purposes of this documen

21、t, the following definitions apply. 3.1.1 autoclavable suitability for sterilization by steam within an autoclave without deterioration of functional or structural integrity of the item being sterilized SANS 373-1:2009 Edition 2 4 3.1.2 autoclave enclosure designed to generate or control the process

22、 whereby devices placed inside are sterilized by steam 3.1.3 automatic endoscope reprocessor washer-disinfector designed to clean, leak test and sterilize (or high-level disinfect) flexible endoscopes and accessories, as relevant, to render them ready for reuse 3.1.4 bacterial-free water water that

23、has been processed to render it free of bacteria (for example, by filtration) 3.1.5 cleaning solution solution capable of breaking down biological soils such as proteins, lipids, carbohydrates and mucopolysaccharides and has no protein-fixing effect (for example, an enzymatic cleaning solution) 3.1.

24、6 clean potable water unused potable water that is free from visible suspended matter or sediment 3.1.7 critical medical device device that normally enters sterile tissue or the vascular system 3.1.8 disinfection reduction of the number of viable micro-organisms on a product to a level previously sp

25、ecified as appropriate for its intended further handling or use SANS 15883-1:2008 3.1.9 endoscope optic instrument used to visually examine the interior of a bodily organ or to perform therapeutic interventions or minimal access surgery 3.1.10 endoscopic accessories devices used directly within or u

26、pon endoscopes to facilitate their diagnostic or interventional capability 3.1.11 healthcare facility place (site) where professional health services are dispensed to patients or where biological research is carried out 3.1.12 high-level disinfectant chemical agent, which, when used for a shorter ex

27、posure time than would be required for sterilization, kills all micro-organisms with the exception of high numbers of bacterial spores SANS 373-1:2009 Edition 2 5 3.1.13 insufflation distension of a body cavity with clear gas so that internal organs can be visualized more clearly during endoscopic p

28、rocedures 3.1.14 leak test test intended to establish that the surface covering a device or lining a device channel (or both) is intact to the extent necessary to maintain a slight positive pressure SANS 15883-4:2008 3.1.15 list names and details of patients scheduled for endoscopic procedures in ea

29、ch endoscopic procedure room NOTE The endoscopic procedure room can be an operating theatre. 3.1.16 load all the goods, equipment and materials that are put into a washer-disinfector at any one time for the purpose of cleaning and disinfecting it by an operating cycle SANS 15883-1:2008 3.1.17 minimu

30、m effective concentration concentration of disinfectant which, under the stated conditions of temperature and time, will meet the required microbial performance 3.1.18 potable water water that complies with the local regulations for drinking water (see foreword) intended for human consumption 3.1.19

31、 reprocessing cleaning and high-level disinfection or cleaning and sterilization necessary to render an endoscope and reusable accessories ready for reuse 3.1.20 self-disinfection cycle operating cycle under the control of the automatic controller, for use without any load in the washer- disinfector

32、, which is intended to disinfect all liquid transport systems piping, chamber(s), tanks and other components that come into contact with the water or solutions (or both) used for cleaning, disinfecting and rinsing the load NOTE This does not include disinfection of pipework between the disinfectant

33、supply and the control valve, where single-use, multi-dose containers are used to provide process chemicals for use in the washer-disinfector. SANS 15883-4:2008 SANS 373-1:2009 Edition 2 6 3.1.21 semi-critical medical device device that comes into contact with intact mucous membranes and does not or

34、dinarily penetrate sterile tissue 3.1.22 sterilant antimicrobial agent capable of achieving sterilization by chemical means 3.1.23 sterilization reduction of more than 99,9999 % or 6 log10of micro-organisms present by means of physical, chemical, or mechanical methods, or by irradiation SANS 10248-1

35、:2008 3.1.24 thermolabile damaged by exposure to temperatures within the range used for thermal disinfection NOTE The minimum temperature for thermal disinfection specified in SANS 15883-1 is 65 C. SANS 15883-4:2008 3.1.25 viable micro-organism micro-organisms, including viruses, which are capable o

36、f multiplication under specified culture conditions SANS 15883-1:2008 3.1.26 washer-disinfector machine intended to clean and disinfect medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice SANS 15883-1:2008 3.2 Abbreviations AER: automatic

37、 endoscope reprocessor CCD: charged coupled device EAs: endoscopic accessories ERCP: endoscopic retrograde cholangio-pancreatography GI: gastrointestinal HLD: high-level disinfectant LSCA: light source connector assembly MEC: minimum effective concentration SANS 373-1:2009 Edition 2 7 MSDSs: materia

38、l safety data sheets WD: washer-disinfector 4 Requirements 4.1 Reprocessing environment A reprocessing environment shall be provided to include: a) separate designated areas for performing endoscopic procedures, the manual cleaning of endoscopes and EAs, and the high-level disinfection or automated

39、sterilization of endoscopic equipment; b) adequate ventilation that will exhaust toxic vapors and airborne pathogens; c) area for manual processing that includes tight-fitting lids over basins containing large volumes of chemical disinfectants (for example, glutaraldehyde), utility sinks or basins l

40、arge enough to totally immerse endoscopes without coiling them too tightly, a supply of clean potable water for rinsing after manual cleaning and high-level disinfection or for use in an approved AER, and a supply of sterile water for rinsing after chemical sterilization; d) designated facility equi

41、pped for hand washing and drying; and e) storage cabinets or cases appropriate for the instruments. 4.2 Storage 4.2.1 Storage cabinets 4.2.1.1 Storage cabinets used to store reprocessed endoscopes shall: a) be enclosed and have support structures that permit full-length hanging of endoscopes; b) be

42、sufficiently spacious so that stored endoscopes are not in contact with other endoscopes or flat surfaces; c) have interior surfaces that are easily washable and are not water absorbent; and d) not be padded with foam rubber or any other absorbent padding at the base as this could make them retain w

43、ater and thus provide a favourable environment for bacterial growth. SANS 373-1:2009 Edition 2 8 4.2.1.2 Storage cabinets shall be cleaned at least weekly, or more frequently if visibly soiled, by washing thoroughly with detergent, disinfectant and water, and allowed to air-dry before storing reproc

44、essed equipment. 4.2.2 Customized padded carry cases 4.2.2.1 Customized padded carry cases shall not be used for the storage of nor for the transport of contaminated endoscopes sent for repair. 4.2.2.2 Used or contaminated endoscopes that cannot be reprocessed without further damage to the endoscope

45、 shall be at least pre-cleaned and wiped externally before being sent for repair. NOTE It is recommended that the interior of carry cases should be washed and autoclaved, or exposed to ethylene oxide when there is reason to suspect contamination of the carry cases. 4.3 Training of personnel Institut

46、ionally developed, competency-based training dedicated to the reprocessing of endoscopes shall include: a) complete familiarization with the mechanical aspects of endoscopic equipment; b) information on the safe handling of endoscopes; c) thorough background knowledge of the potential chemical and i

47、nfectious hazards for patients and healthcare personnel associated with the reprocessing of endoscopes; d) thorough background knowledge of the potential for negative patient and healthcare personnel outcomes that result from lapses in compliance with written reprocessing guidelines; e) thorough ins

48、truction on the technique for the handling and reprocessing of EAs for specific procedures; f) information on the safe handling of body fluid spills or spillages of the chemicals used for reprocessing; and g) information on systems and procedures instituted in accordance with the current relevant na

49、tional legislation (see foreword). NOTE 1 Endoscopes and EAs should be the responsibility of a specific person or persons and should not be delegated to person(s) who do not have the appropriate credentials or training for the position. NOTE 2 Training of person(s) responsible for endoscope reprocessing should be documented and reviewed regularly. NOTE 3 When an emergency endoscopic procedure is done outside of normal working hours, someone with knowledge of the process for endoscope decontamination should be available to prepare and clean