|FORMAT:||PDF EPUB MOBI TXT|
ERLAUTERUNG:Qm handbuch transport
Click words or phrases color for definitions and descriptions When a word or phrase is the title of a chapter, a link is provided to give direct access to the chapter Close or expand to hide or show functions : Display a window with additional information Close a window Using icons : Provides explanations or examples Provides additional indications on international standards Are regulatory insights Provides WFHSS advice or recommendations In the flowchart Move the cursor on colored cells to open an explanation or tool tips.
Click a link for direct access to a paragraph Guidelines Partners Guidelines World Europe North America South and Central America Asia Oceania World World Decontamination and Reprocessing of Medical Devices for Health care facilities — — World Health Organization — WHO.
Good practices for the sterilisation of medical devices — — Superior Health Council. Good practices voor sterilisatie van medishe hulpmiddelen — Herziening van de aanbevelingen voor sterilisatie — — Hoge Gezondheidsraad. Hygiene Requirements for the Reprocessing of Medical Devices — RKI — — BfArM.
Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices — — DGKH — DGSV — AKI. Recommendations by the Quality Task Group — Low-temperature sterilization processes — — Central Service. Recommendations by the Quality Task Group 98 — Recommendations for validation preparation of steam sterilization processes in large sterilizers — — Central Service.
Recommendations by the Quality Task Group 99 — Recommendations for validation preparation of steam sterilization processes in large sterilizers — Part 2 — — Central Service. Recommendations by the Quality Task Group 89 — Programme Controls Part 2: Endoscope washer-disinfectors with chemothermal disinfection — — Central Service. Guideline for the validation of packaging processes according to ISO — — Central Service — DGSV. Guidelines for validation of manual cleaning and manual chemical disinfection of medical devices — — DGSV — DGHK — AKI — VAH.
Professional Standard Handbook Cleaning and Disinfection Flexible Endoscope — — SVN — DSMH — VHIG — VOVN. Buone pratiche di ricondizionamento di dispositivi medici — — SSSH — SSHH — Swissmedic. Schweizerische Leitlinie für die Validierung und Routineüberwachung von Reinigungs- und Desinfektionsprozessen für Medizinprodukte — — SSSH — SSHH — Swissmedic. Turkish guideline for the sterilization and disinfection in healthcare settings — DAS. Health Technical Memorandum Management and decontamination of surgical instruments medical devices used in acute care — Part A: Management and provision — — Department of Health.
Health Technical Memorandum Management and decontamination of surgical instruments medical devices used in acute care — Part A: Common elements — — Department of Health. Health Technical Memorandum Management and decontamination of surgical instruments medical devices used in acute care — Part D: Washer-disinfector — Part A: Common elements — — Department of Health.
Health Technical Memorandum Management and decontamination of surgical instruments medical devices used in acute care — Part E: Alternatives to steam for the sterilization of reusable medical devices — Part A: Common elements — — Department of Health. Reprocessing Medical Devices in Health Care Settings: validation, methods and labeling — Guidance for industry and Food and Drug Administration staff — — Food and Drug Administration.
High-Level Disinfection HLD and sterilization BoosterPak — — The Joint Commission. Multisociety guideline on reprocessing flexible GI endoscopes — — SGNA — APIC — SHEA — AASLD — ASGE — ACG — AGA — ASCRS. Guidelines for disinfection and sterilization in Healthcare facilities — — CDC. AAMI Standards and Technical Information Reports — Association for the Advancement of Medical Instrumentation.
The APSIC guidelines for disinfection and sterilization of instruments in health care facilities — — APSIC. Guidelines for the evaluation of sterilants and disinfectants — Therapeutic Goods Administration — TGA — — Therapeutic Goods Administration — TGA. Decontamination and Reprocessing of Medical Devices for Health care facilities — — World Health Organization — WHO.
Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities — — Standard Australia. Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities — — Standard New Zealand. Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices — — Health Canada.
Guidance document — Safety and Effectiveness Requirements for High-Level Disinfectants and Sterilants for use on Reusable Semi-Critical and Critical Medical Devices — — Health Canada. AST Standards of Practice for Packaging Material and Preparing Items for Sterilization — — Association of Surgical Technologies.
Guidelines for disinfection and Syerilization in Healthcare facilities — — CDC. Combination of all technical and associated administrative actions intended to keep equipment at a state in which it can perform its required function, or restore it to such a state ISO : Packaging is intended to preserve the sterility of teh reusable medical device RMD until its use. For the puropose of these guidelines, International Standard means standardsor guidance published by international standardization organizations such as ISO or CEN.
Go to the international standards paragraph or Regulation and standards chapter. Prion is a small proteinaceous infectious unit that appear in a variety of neurodegenerative diseases, including bovine spongiform encephalopathy, Creutzfeldt-Jakob disease, and scrapie. They derive from a normal body protein that becomes irreversibly misfolded and proliferates primarily in the central nervous system.
Prions are highly resistant to disinfection and sterilization. Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces. Processing operation performed at point of use of the Reusable Medical Device i. Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives.
They also include quality planning, quality control, quality assurance, and quality improvement. In the present guide the quality management chapter includes a description of the processus approach, performance evaluation, risk and non-conformity management, documentation management and traceability. The Spaulding classification qualify the RMD as non critical when they touch intact skin, semi-critical when they are brought in contact with mucous membranes and critical when they enter sterile body cavities.
Processing requirements increase with level of risk involved in their use. OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards WHO : Go to Occupational health and safety.
The reprocessing of single use medical device is outside the scope of theses guidelines. Medical device regulations vary between regions. Some items may not be registered as medical devices in some regions. Sterilization is intended to renders the reusable medical device free from viable microorganisms. Sterilization is implemented on a clean RMD. Most common Sterilization process is steam. Low temperature sterilization processes are available for heat sensitive RMD. Process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose ISO : Removal of contaminants to the extent necessary for its further processing or for intended use ISO : Other definition: The first step required to physically remove contamination by foreign material, e.
It will also remove organic material such as blood, secretion, excretion and microorganisms, to prepare a medical device for sterilization or disinfection WHO : Process used to render product free from viable microorganisms ISO : They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices RMD used in Health Care facilities.
They are the result of a consensus from a review of national practices, standards, regulations. They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies. Your feedback is essential to contribute to the improvement of the Guidelinesfeel free to use the form to send your comments or suggestions. We wish you interesting reading! Some sterilizing, cleaning and disinfecting formulations are known to favor the anchorage of proteins, including prion on RMD surfaces.
For instance, dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such formaldehyde or glutaraldehyde, alcohol used to accelerate drying of some RMD. For this reasons, some national guidelines recommend to avoid use of this subtances or require specific precautions for instance thorough cleaning. Non terminal sterilization is a process whereby product is not sterilized in a sterile barrier system and hence not protected from environmental and handling contamination after the sterilization cycle.
For the needs of the present guidelines outsourcing means a process in which a healthcare facility employs another organization to perform some or all reusable medical device reprocessing tasks. The organization can be another healthcare facility, a shared reprocessing unit or a private service company.
The services can be perfomed within the healthcare facility or externalized. Pyrogen are substances that induces fever. Endogenous pyrogen are low-molecular weight protein produced by phagocytic leukocytes in response to stimulation by exogenous pyrogens. Exogenous pyrogens are produced by bacterial endotoxins and other microbial product such as antigen, antibody complexes, virus.
Endotoxins are lipopolysaccharide components of the cell wall of Gram-negative bacteria that are heat stable and elicits a variety of inflammatory responses in animals and humans ISO Ability to trace the history, application, use and location of an item products, parts, materials, and services or its characteristics through recorded identification data. For the purpose of theses guidelines, training means the certified acquisition of the theoricital, practical skills and behavior adapted to the assignment.
Skills are periodically controlled and updated as needed. Routine control check that performances of process or equipment are maintained over time between 2 process validations. Routine controls can be systematic at each cycle or at predefined periodicities.
For instance, for the sterilization process, at end of each cycle, it is checked that process parameterare are within the validated tolerances, leak tests are performed daily or at periodicity defined by local recommandations. Written indication provided by the manufacturer to ensure correct and safe use of a products including but not limited to reusable medical device, reprocessing equipment and consumables.
IFU of RMD include the instruction for reprocessing. IFU are also available for reprocessing equipment and consumables. Identification and analyzis of potential issues that could negatively impact a given process. Risk analysis includes an evaluation of the consequence and likelihood.
The issues with the more severe consequences and higher likelihood of occurence are addressed in priority. As needed measure are then to minimize the occurence or consequence. Methods are available to improve the reliability of the risk analysis.
Storage concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions. Process validation means establising, by objective evidence that a process consistently produces a results or product meeting its predeternined objective. Process validation applies to all steps of RMD reprocessing from point of use processing to storage.
When equipments are used validation include their installation qualification IQoperational qualification OQ and performance qualification PQ.
Engineering Books Pdf. Browse A B C D E F G H I J K L M N O P Q R S T U V W X Y Z A B C Aerospace Engineering Articles AutoCAD Automobile Engineering Chemical Engineering Civil Engineering Computer Engineering. D E F Electrical Books Electronics Engineering Engineering Books. M N O Mathematics MCQs Mechanical Engineering Online MCQs. P Q R Past Papers PDF Petroleum Engineering Physics.
Engineering Books PdfDownload free Books related to Engineering and many more. Automobile Engineering. Aerospace Engineering. Engineering Books. Computer Engineering. Chemical Engineering. Civil Engineering. Electronics Engineering. Electrical Books. Mechanical Engineering. Petroleum Engineering. Telecommunication Engineering. Bridge to Abstract Mathematics Mathematical Proof and Structures by Ronald P.
Graduate Texts in Mathematics Graph Theory BY J. Bondy and U. Excel Formulas and Functions 5th Edition by Ken Bluttman. Orthogonal Sets And Polar Methods in Linear Algebra Applications to Matrix Calculations, Systems of Equations, Inequalities, and Linear Programming By Enrique Castillo, Angel Cobo, Francisco Jubete and Rosa Eva.
The IIT Foundation Series Chemistry Second Edition Class 10 by Trishna Knowledge Systems. Numerical Algebra, Matrix Theory, Differential Algebraic Equations and Control Theory Festschrift in Honor of Volker Mehrmann By Peter Benner, Matthias Bollhofer, R Daniel Kressner, Christian Mehl and Tatjana S. Mathematics Science and Technology by A H Siddiqi, R C Singh and P Manchanda. Differential Equations with Applications and Historical Notes, Third Edition by George F. An Introduction to Hamiltonian Mechanics by Gerardo F.
Torres del Castillo. Home DMCA Contact Us. All rights reserved.