Education - Recommendations
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General Guidelines and Recommendations
- Anke Carter:
Guideline for the Validation of the Sealing Process according to DIN EN ISO 11607-2
[in English; PDF File; 130 KB] - United Kingdom Department of Health
ACDP TSE Working Group:
Transmissible spongiform encephalopathy agents: safe working and the prevention of infection
Guidance from the Advisory Committee on Dangerous Pathogens' TSE Working Group
[in English; Web Link: www.advisorybodies.doh.gov.uk/acdp/tseguidance/] - Pan American Health Organization (PAHO)
Silvia I. Acosta-Gnass, Valeska de Andrade Stempliuk:
Manual de esterilización para centros de salud
["Sterilization Manual for Health Centers"; in Spanish; PDF File; 3.0 MB] - ANSM - Agence nationale de sécurité du médicament et des produits de santé:
L Recommendations de l’agence nationale de sécurité du médicament et des produits de santé
Creutzfeldt-Jakob et produits de santé - Protocole Standard Prion
[in French; Web Link: http://ansm.sante.fr/Dossiers-thematiques/Creutzfeldt-Jakob-...]
- Anke Carter:
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Recommendations by the Quality Task GroupTransport
- [2] Transport from the OR to the CSSD
(NOTE: This recommendation is replaced by Recommendation [73] from Central Service 6/2011 "Medical device reprocessing logistics") - [73] Medical device reprocessing logistics
(NOTE: This recommendation replaces Recommendation [2] from Central Service 6/1998 "Transport from OR to CSSD")
Cleaning- [8] Cleaning and Disinfection in the Ultrasonic Bath (Part 1)
- [9] Cleaning and Disinfection in the Ultrasonic Bath (Part 2)
- [11] Programmes for Automated Processing
(NOTE: This recommendation is replaced by Recommendation [86] from Central Service 4/2014 "Programme Controls Part 1: Washer-disinfectors with a thermal and chemothermal disinfection cycle") - [12] Programmes for Automated Processing (Part 2)
(NOTE: This recommendation is replaced by Recommendation [86] from Central Service 4/2014 "Programme Controls Part 1: Washer-disinfectors with a thermal and chemothermal disinfection cycle") - [14] Thermal Washer-Disinfectors - Investigating the Disinfection Effect with Thermologgers
- [17] Quality Assurance on the Unclean Side of a CSSD (Part 2)
(NOTE: Revised by Recommendation 84) - [19] Cleaning (Part 1) - Instruments Causing Problems
- [20] Cleaning (Part 2) - Validation of Cleaning Efficacy
- [25] Water for Operating Washer-Disinfectors
(NOTE: This recommendation is replaced by Recommendation 87 from Central Service 4/2014 "Water for reprocessing medical devices (Part 1)") - [26] Water for Operating Washer-Disinfectors (Part 2)
- [28] Daily Check of Washer-Disinfectors Before Placing Them in Operation
- [29] Verification of the Performance of Washer-Disinfectors Used for Thermal Disinfection
- [35] Loading Pattern and Its Implications for Successful Cleaning in the Washer-Disinfector
- [40] Automated Processing of Ophtalmologic Instruments
- [42] Using Process Challenge Devices To Verify Cleaning Performance for Validation of Washer-Disinfector Processes
- [45] Decontamination of Narrow-Lumened Medical Devices
- [46] Manufacturer's Instructions for Decontamination
- [47] Insights Gleaned from Workshops at the 10th DGSV Congress: Manufacturer's Instructions for Decontamination
- [49] Decontamination of Plastic Sterilisation Containers and Plastic Supports
- [51] Decontamination of Anaesthesia and Respiratory Accessories
- [53] Verification of Completeness of Validation Protocols for WD Processes
- [55] Performance Requalification on Changing the Process Chemicals
- [56] Decontamination of Motor Systems
- [57] Physical Data for Routine Control in Washer-Disinfectors
- [62] Manual Reprocessing of Medical Devices (wish-wash workshop, DGSV Cogress, Fulda)
- [63] Outlook of DGSV Quality Task Group's Activities for 2010
- [64] Decontamination of Containers
- [66] General Principles for Using Ultrasound for Cleaning Medical Devices - Part 1
- [67] Using Ultrasonic Basins to Reprocess Medical Devices - Part 2
- [69] Problem instruments when it comes to reprocessing - Part 1
- [70] Reprocessing ophthalmologic medical devices (Part 1)
- [71] Reprocessing ophthalmologic medical devices (Part 2)
- [72] Reprocessing ophthalmologic medical devices (Part 3)
- [86] Programme Controls Part 1: Washer-disinfectors with a thermal and chemothermal disinfection cycle
(NOTE: This recommendation replaces Recommendation [11] from Central Service 3/2000 "Programmes for Automated Processing" and Recommendation [12] from Central Service 4/2000 "Programmes for Automated Processing (Part 2)") - [87] Water for reprocessing medical devices (Part 1)
(NOTE: Recommendation [87] replaces Recommendation [25] from Central Service 3/2000 "Programmes for Automated Processing")
Packaging- [13] Quality Assurance on the "Clean Side" of a CSSD
(NOTE: Revised by Recommendation 84) - [27] Packaging Systems
- [30] Packaging Systems - Part 2: Hard Packaging
(NOTE: This recommendation is replaced by Recommendation [83] from Central Service 1/2014 "Reprocessing sterilization containers with synthetic components used for sterile supplies and for contaminated medical devices") - [33] Mesh Trays and Their Implications for Successful Cleaning in the Washer-Disinfector
- [34] Packaging Part 3: Summary
- [41] Production of Heat Sealing Seams for Packing Medical Devices (based on the currently valid standards, ISO 11607, EN 868, DIN 58953)
- [60] Instrument Identification
- [79] Sterile barrier and packaging systems
- [83] Reprocessing sterilization containers with synthetic components used for sterile supplies and for contaminated medical devices
(NOTE: This recommendation replaces Recommendation [30] from Central Service 5/2003 "Packaging Systems - Part 2: Hard Packaging")
SterilizationValidation- [3] Validation (Part 1)
- [4] Validation (Part 2)
- [6] Deciding How to Process a New Medical Device
- [7] Validation of Older Steam Sterilisers
- [16] Quality Assurance on the Unclean Side of a CSSD
(NOTE: Revised by Recommendation 84) - [18] Bowie Dick Test
- [32] How Quality Management is Structured in CSSD Practice
- [37] Guide to Compilation of Standard Operating Procedures
- [54] Performance Requalification for No Particular Reason
- [65] Computer-Assisted Batch Documentation
Storage- [15] Release and Storage of Medical Devices after Sterilisation
(NOTE: This recommendation is replaced by Recommendation [82] from Central Service 6/2013 "Release of medical devices after sterilization") - [39] Recommendations for the Storage Period for Sterile Medical Devices
- [82] Release of medical devices after sterilization
(NOTE: This recommendation replaces Recommendation [15] from Central Service 1/2001 "Release and storage of medical device after sterilization") - [85] Recommendations for the storage period for sterile medical devices
Miscellaneous- [1] Recommendations
- [5] Cooperation with the OR and other Departments
(NOTE: This recommendation is revised by Recommendation [75] from Central Service 2/2012 "Cooperation with the operating room and other departments") - [21] Why Computerised Documentation? - Reflections from the Field
- [22] Classifying Medical Devices before Processing (Part 1)
- [23] Classifying Medical Devices before Processing (Part 2)
- [24] Classifying Medical Devices before Processing (Part 3)
- [31] Updating the Decision Tree on Risk Assessment and Classification of Medical Devices
- [36] Risk Management in the CSSD
- [38] Checklist for Preparation of Visits by the Competent Inspection Authorities
- [44] Compilation of Procedures
- [50] Requirements for Construction or Conversion of a Hospital Central Sterile Supply Department
- [52] Requirements for Construction or Conversion of a Hospital Central Sterile Supply Department Part 2 - Staff and Material Routes
- [58] Requirements for Construction or Conversion of a Hospital Central Sterile Supply Department Part 3 - Technical and Functional Fittings and their Installation
- [61] Requirements for Construction or Conversion of a Hospital Central Sterile Supply Department Part 4 - Room Ventilation Systems in the CSSD
- [68] Problems today - tomorrow, how can we solve them?!
- Commentary by the Quality Task Group of the German Society of Sterile Supply (DGSV) on the topic of the «Hygiene Scandal»
- [74] Transmission Instruments - Hand and Angled Pieces and Turbines - Part 1
- [75] Cooperation with the operating room and other departments
(NOTE: Revision of Recommendation No. 5 from Issue 3/1999 "Cooperation with the OR and other Departments") - [76] Reprocessing Transmission Instruments in Dentistry
(NOTE: Continuation of Recommendation 74 - Reprocessing Transmission Instruments) - [77 Revised Version] DGSV Flow Chart 2013 for Classification of Medical Devices
- [78] Management of Loan Instruments (Part 1)
- [80] Quality assurance in reprocessing
- [81] Management of Loan Instruments (Part 2)
- [84] Quality assurance in reprocessing (Part 2)
(NOTE: Revision of Recommendations 13, 16 and 17)
Recommendations by the Committee for Hygiene, Construction and Technology- Committee for Hygiene, Construction and Technology of the German Society of Sterile Supply (DGSV):
Requirements for construction or reconstruction of a Reprocessing Unit for Medical Devices (RUMED)
Part 1 - Basics
[PDF File; 1.6 MB]
Recommendations and Publications by the AFS Working Group
AFS - Association Française de Stérilisation
- Recommendations and Publications in English:
- Sterilisation Premises Architecture and Layout
[PDF File; 381 KB]
- Sterilisation Premises Architecture and Layout
- Recommendations and Publications in French:
- Architecture et Locaux en Sterilisation
[PDF File; 1.9 MB]
We wish to thank the AFS - Association Française de Stérilisation for the contribution of this article.
- Architecture et Locaux en Sterilisation
- Recommendations and Publications in Spanish:
- Arquitectura y Servicios de Esterilización - Parte 1
[PDF File; 277 KB]
We wish to thank the AFS - Association Française de Stérilisation for the contribution of this article. - Arquitectura y Servicios de Esterilización - Parte 2
[PDF File; 531 KB]
We wish to thank the AFS - Association Française de Stérilisation for the contribution of this article.
- Arquitectura y Servicios de Esterilización - Parte 1
Recommendations by the Irish Health Service Executive (HSE)
HSE - Health Service Executive
- Health Service Executive Code of Practice for Decontamination of Reusable Invasive Medical Devices
Health Service Executive published its Code of Practice for Decontamination of Reusable Invasive Medical Devices (RIMD) on 24th October 2007. The HSE has published this Code of Practice as a guide to standards and recommended practices for decontamination of RIMD required in the Irish public health service.
You can view or download the report below. This publication has been divided for ease of download. Please consider the environment before printing this report- Part 1: Background
[PDF File; 310 KB] - Part 2: Standards
[PDF File; 296 KB] - Part 3: Recommended Practices for Central Decontamination Units
[PDF File; 1.4 MB] - Part 4: Recommended Practices for Endoscopy Units
[PDF File; 811 KB] - Part 5a & 5b : Recommended Practices for Dental Services (CDU & LDU)
[PDF File; 967 KB] - Part 6: Audit Tool
[PDF File; 545 KB] - Part 7: Additional Resources and Appendices
[PDF File; 253 KB]
- Part 1: Background
Guidelines and Recommendations by vDSMH and SVN (The Netherlands)
vDSMH - Vereniging van Deskundigen Steriele Medische Hulpmiddelen
SVN - Sterilisatie Vereniging Nederland - Sterilization Association of The Netherlands
- Professional Standard for Loaner Instrumentation
Standard for loaning or renting of surgical instruments
[in English; PDF File; 285 KB] - Professionele standaard Leeninstrumentarium
Professionele standaard vor het in bruikleen of huur nemen c.q. geven van chirurgisch instrumentarium
[in Dutch; PDF File; 166 KB]
Guidelines and Recommendations by SFERD
Stuurgroep Flexibele Endoscopen Reiniging en Desinfectie (SFERD)
(Advisory Board Cleaning and Disinfection Flexible Endoscopes)
- SFERD Professional Standard Handbook - Flexible Endoscopes Cleaning and Disinfection
[in English; PDF File; 1.6 MB]
Recommendations by Swissmedic - Swiss Agency for therapeutic products
Swissmedic - www.swissmedic.ch
- Guidelines and Recommendations in French:
- Guide pour l’achat d’un petit stérilisateur à la vapeur d’eau à l'intention des cabinets médicaux et dentaires et autres établissements de soins
[PDF File; 76 KB] - Exemple de liste de contrôle pour l'achat d'un petit stérilisateur à la vapeur d'eau
[PDF File; 44 KB] - Bonnes pratiques de retraitement des dispositifs médicaux stériles pour les cabinets médicaux, les cabinets dentaires et d'autres utilisateurs de petits stérilisateurs à la vapeur d'eau saturée
[PDF File; 712 KB]
- Guide pour l’achat d’un petit stérilisateur à la vapeur d’eau à l'intention des cabinets médicaux et dentaires et autres établissements de soins
- Guidelines and Recommendations in German:
- Leitfaden zur Beschaffung eines Dampf-Klein-Sterilisators für Arzt- und Dentalpraxen, sowie für andere medizinische Einrichtungen
[PDF File; 74 KB] - Beispiel einer Checkliste für die Beschaffung eines Dampf-Klein-Sterilisators
[PDF File; 42 KB] - Aufbereitung von sterilen Medizinprodukten in Arzt- und Zahnarztpraxen sowie bei weiteren Anwendern von Dampf-Klein-Sterilisatoren
[PDF File; 719 KB]
- Leitfaden zur Beschaffung eines Dampf-Klein-Sterilisators für Arzt- und Dentalpraxen, sowie für andere medizinische Einrichtungen
- [2] Transport from the OR to the CSSD