GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
This document provides an overview of the regulatory process and classification rules for medical devices in the European Union according to the 2017 EU Medical Device Regulation. It discusses the classification of devices as Class I, IIa, IIb or III based on factors such as duration of use, invasiveness, and purpose. It also summarizes the key steps in the regulatory process, including appointing a Notified Body for review and certification, preparing a technical file, and designating an Authorized Representative in Europe.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
Academic Report on Singapore HSA Class D and Australia TGA Class III Medical ...Asia Medical Supplies
This document provides an overview of the regulatory requirements for registering the Vivace VX-1 medical device in Australia and Singapore. Key points include:
- Vivace VX-1 is a transcatheter mitral valve implantation device classified as high-risk Class D in Singapore and Class III in Australia.
- Risk management documentation must follow ISO 14971 standards for both countries.
- English language labeling is required, though GMDN codes are only mandatory for registration in Australia.
- A sponsor/registrant is needed in each country to register the device and facilitate the application process.
- Submission documents for Australia include design examination and declaration of conformity, while Singapore requires a Common Submission Dossier Template
The document discusses medical device regulation, including:
- Why regulation is needed due to past issues like thalidomide
- The definition of a medical device and what is/isn't included
- An overview of the regulatory framework and requirements in countries like Australia, Europe, and the US
- Key parts of the regulatory process include classifying devices based on risk, meeting regulatory requirements through conformity assessments, maintaining quality management systems, and providing technical documentation
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
This document provides an overview of the regulatory process and classification rules for medical devices in the European Union according to the 2017 EU Medical Device Regulation. It discusses the classification of devices as Class I, IIa, IIb or III based on factors such as duration of use, invasiveness, and purpose. It also summarizes the key steps in the regulatory process, including appointing a Notified Body for review and certification, preparing a technical file, and designating an Authorized Representative in Europe.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
Academic Report on Singapore HSA Class D and Australia TGA Class III Medical ...Asia Medical Supplies
This document provides an overview of the regulatory requirements for registering the Vivace VX-1 medical device in Australia and Singapore. Key points include:
- Vivace VX-1 is a transcatheter mitral valve implantation device classified as high-risk Class D in Singapore and Class III in Australia.
- Risk management documentation must follow ISO 14971 standards for both countries.
- English language labeling is required, though GMDN codes are only mandatory for registration in Australia.
- A sponsor/registrant is needed in each country to register the device and facilitate the application process.
- Submission documents for Australia include design examination and declaration of conformity, while Singapore requires a Common Submission Dossier Template
The document discusses medical device regulation, including:
- Why regulation is needed due to past issues like thalidomide
- The definition of a medical device and what is/isn't included
- An overview of the regulatory framework and requirements in countries like Australia, Europe, and the US
- Key parts of the regulatory process include classifying devices based on risk, meeting regulatory requirements through conformity assessments, maintaining quality management systems, and providing technical documentation
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
The document provides information on the development and importance of pharmaceutical documentation. It discusses different types of documents including commitment documents like New Drug Applications and Drug Master Files, directive documents like specifications and standard operating procedures, and record documents like batch production records and protocols. The document also outlines general requirements and guidelines for designing documentation systems in accordance with cGMP.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.
The document summarizes key aspects of clinical trial protocols, including:
1) Protocols include sections like the title page, objectives, study design, safety reporting, and informed consent. Well-written protocols use clear, unambiguous language and define all abbreviations.
2) Eligibility criteria should be minimized but ensure scientific validity and safety. Criteria must be clearly defined and verifiable.
3) Institutional review boards (IRBs) are responsible for protecting human subjects. IRBs must have at least five members from varied backgrounds to review protocols and ensure ethical standards are followed.
CMC regulatory affairs provides regulatory leadership and strategy to achieve approval of drug formulations. It ensures the proper characterization, quality, purity and potency of drugs through testing and compliance with regulatory requirements. CMC regulatory submissions contain detailed information on manufacturing, analytical methods, quality control and stability testing to support clinical trials and marketing applications for drugs. Regulatory agencies like the FDA and EMA evaluate CMC data at various stages of IND and approval processes to ensure patient safety.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
Process validation-and-critical-regulatory-requirements-in-manufacturing-of-i...Ahmed Hasham
Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
Process validation and critical regulatory requirements in manufacturing of i...Ahmed Hasham
Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.
This document discusses the design, construction, identification, cleaning, and maintenance of equipment used in pharmaceutical manufacturing. It covers topics such as:
- Designing equipment based on user requirements and material being processed. Size is determined by batch size and capacity needs.
- Equipment must be properly identified with batch number and processing stage. Major equipment are numbered and recorded.
- An equipment log tracks all operations, cleaning, and maintenance done on equipment along with batch numbers and personnel.
- Cleaning and maintenance is important for preventing contamination and ensuring product quality. Standard operating procedures outline cleaning and maintenance procedures.
Scale up process and post marketing survilenceKAVITAAGRE
This document discusses scale up process approval changes and post marketing surveillance. It defines scale up as increasing batch size from research to production. It describes SUPAC guidelines which define levels of changes (minor, moderate, major) and required tests and documentation. The guidance provides recommendations for changes to composition, manufacturing site, batch size, and process. It also discusses post marketing surveillance methods like controlled trials, spontaneous reporting, cohort and case control studies to identify adverse drug effects. Manufacturers must establish standard operating procedures for post marketing surveillance.
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...RUSHIKESHSHINDE80
This document discusses key pharmaceutical documentation including the Master Formula Record (MFR), Drug Master File (DMF), and distribution records. It provides definitions and outlines the essential contents of each document type. The MFR is the master document for any pharmaceutical product and contains manufacturing process details. A DMF provides confidential information to support regulatory submissions and includes administrative and technical information. Distribution records track products shipped to ensure adequate tracing for potential recalls.
Drug Master Files (DMFs) provide confidential information to support drug applications and are submitted voluntarily to the FDA. There are 5 types of DMFs covering manufacturing sites (Type I), drug substances and products (Type II), packaging materials (Type III), excipients (Type IV), and reference information (Type V). DMFs require authorization letters for reference and annual updates to remain open. Distribution records must allow tracing batches and facilitate recalls, with requirements for storage conditions, oldest stock distribution, and records of further distribution by consignees.
El documento describe al científico como un hombre solitario y de mediana o avanzada edad que trabaja de forma inteligente y metódica en laboratorios ocultos para desarrollar un conocimiento secreto y casi mágico.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
The document provides information on the development and importance of pharmaceutical documentation. It discusses different types of documents including commitment documents like New Drug Applications and Drug Master Files, directive documents like specifications and standard operating procedures, and record documents like batch production records and protocols. The document also outlines general requirements and guidelines for designing documentation systems in accordance with cGMP.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.
The document summarizes key aspects of clinical trial protocols, including:
1) Protocols include sections like the title page, objectives, study design, safety reporting, and informed consent. Well-written protocols use clear, unambiguous language and define all abbreviations.
2) Eligibility criteria should be minimized but ensure scientific validity and safety. Criteria must be clearly defined and verifiable.
3) Institutional review boards (IRBs) are responsible for protecting human subjects. IRBs must have at least five members from varied backgrounds to review protocols and ensure ethical standards are followed.
CMC regulatory affairs provides regulatory leadership and strategy to achieve approval of drug formulations. It ensures the proper characterization, quality, purity and potency of drugs through testing and compliance with regulatory requirements. CMC regulatory submissions contain detailed information on manufacturing, analytical methods, quality control and stability testing to support clinical trials and marketing applications for drugs. Regulatory agencies like the FDA and EMA evaluate CMC data at various stages of IND and approval processes to ensure patient safety.
The document discusses Chemistry, Manufacturing and Controls (CMC) and its role in pharmaceutical product development and regulatory approval. It provides details on:
- The key functions of CMC including process development, facility inspections, and ensuring compliance.
- CMC content requirements for different application types like NDAs, ANDAs, and INDs.
- How the CMC section evolves over clinical trial phases from laboratory to commercial scale.
- Procedures for developing and submitting post-approval study protocols to regulatory agencies.
Process validation-and-critical-regulatory-requirements-in-manufacturing-of-i...Ahmed Hasham
Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation. The objective of regulated computer systems includes systems
used to manage data or support descion making subject to review by regulated authorities whether they are being
submitted because its impact on quality or on business. Investments in computer systems supporting the quality controls
to ensure that the process is followed correctly, reducing human error and the need to conduct manual checks,
Standardization of practices to build consistent ways of working, Speed-up of process cycle times by reducing wait times
and by improved scheduling...etc.Computer systems shouldn't be enforced only for restrictive compliance; operational
advantages must always be exploredas well. “U.S. Code of Federal Regulation 21 CFR Part 600, 606, and 610” and “EU
Directive 2003/94/EEC” are the prominent regulations reqested CSV, while “Volume 4 Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems” considered the main guidlines for
CSV in biopharmaceutical industries in European Union. This paper aims to provide simplifed guidance on the basic
requireents for computer system validation (CSV) based on the latest regulatory developments and industry trends. In
conclusion, CSV has the great impact on the processes improvement. Also the critical parameters of computer systems
validation for biopharmaceutical indsutries are highlighted.
#AHMED_HASHAM
https://medwinpublishers.com/OAJPR/computerized-systems-validation-csv-in-biopharmaceutical-industries.pdf
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
The biopharmaceutical industries has more and more used computers to support and accelrate producing of their
products. Computer systems also are accustomed support routine offer of high quality products to boost production
process performance, scale back production prices, and improve product quality. it's vital that these systems square
measure suitable purpose from a business and restrictive perspective. Regulatory authorities treat a lack of regulatory
computer system compliance as a serious GxP deviation.
Process validation and critical regulatory requirements in manufacturing of i...Ahmed Hasham
Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.
This document discusses the design, construction, identification, cleaning, and maintenance of equipment used in pharmaceutical manufacturing. It covers topics such as:
- Designing equipment based on user requirements and material being processed. Size is determined by batch size and capacity needs.
- Equipment must be properly identified with batch number and processing stage. Major equipment are numbered and recorded.
- An equipment log tracks all operations, cleaning, and maintenance done on equipment along with batch numbers and personnel.
- Cleaning and maintenance is important for preventing contamination and ensuring product quality. Standard operating procedures outline cleaning and maintenance procedures.
Scale up process and post marketing survilenceKAVITAAGRE
This document discusses scale up process approval changes and post marketing surveillance. It defines scale up as increasing batch size from research to production. It describes SUPAC guidelines which define levels of changes (minor, moderate, major) and required tests and documentation. The guidance provides recommendations for changes to composition, manufacturing site, batch size, and process. It also discusses post marketing surveillance methods like controlled trials, spontaneous reporting, cohort and case control studies to identify adverse drug effects. Manufacturers must establish standard operating procedures for post marketing surveillance.
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...RUSHIKESHSHINDE80
This document discusses key pharmaceutical documentation including the Master Formula Record (MFR), Drug Master File (DMF), and distribution records. It provides definitions and outlines the essential contents of each document type. The MFR is the master document for any pharmaceutical product and contains manufacturing process details. A DMF provides confidential information to support regulatory submissions and includes administrative and technical information. Distribution records track products shipped to ensure adequate tracing for potential recalls.
Drug Master Files (DMFs) provide confidential information to support drug applications and are submitted voluntarily to the FDA. There are 5 types of DMFs covering manufacturing sites (Type I), drug substances and products (Type II), packaging materials (Type III), excipients (Type IV), and reference information (Type V). DMFs require authorization letters for reference and annual updates to remain open. Distribution records must allow tracing batches and facilitate recalls, with requirements for storage conditions, oldest stock distribution, and records of further distribution by consignees.
El documento describe al científico como un hombre solitario y de mediana o avanzada edad que trabaja de forma inteligente y metódica en laboratorios ocultos para desarrollar un conocimiento secreto y casi mágico.
Este documento describe nuevas formas de realizar investigación y docencia en enfermería utilizando tecnologías como la publicación y evaluación en línea. Se argumenta que estas nuevas formas de trabajo colaborativo son más rápidas y eficientes. También se menciona la necesidad de un cambio hacia modelos de investigación 2.0 y docencia 2.0 que aprovechen mejor estas herramientas digitales.
Este documento explora los nuevos escenarios y actores en la relación y comunicación en enfermería debido al aumento del uso de Internet y las redes sociales. Menciona que el 68% de los hogares en España tienen acceso a Internet y el 70% de los internautas usan Internet como fuente de información sobre salud. También discute el papel creciente de los pacientes informados (ePacientes) y las nuevas herramientas digitales como aplicaciones móviles y sitios web que facilitan la difusión y el trabajo colaborativo en enfermería
Este documento ofrece consejos para escribir un blog exitoso y sostenible a largo plazo. Recomienda que los contenidos del blog sean útiles, de calidad, fáciles de entender y leer, entretenidos y eviten material sin valor. También sugiere planificar objetivos y estrategias, evaluar el progreso mediante métricas como visitas y seguidores, y mantener la paciencia, constancia, enfoque, honestidad y originalidad.
Ponencia del IX Congreso Nacional de la FAECAP (Federacion de Asociaciones de Enfermeria Comunitaria y Atencion Primaria). Santiago de Compostela (España)
En las X Jornadas Tecnica de la AIISCYL (Asociación de Informáticos de Instituciones Sanitarias de Castilla y León) querían conocer casos de profesionales 2.0. Yo les conté mi vida... y les gustó.
La práctica basada en la evidencia implica el uso explícito de la mejor evidencia científica disponible para tomar decisiones clínicas. Este proceso incluye construir una pregunta clínica específica, buscar evidencia a través de bases de datos y revistas científicas, evaluar críticamente la literatura encontrada, aplicar la evidencia a la situación clínica, y evaluar los resultados obtenidos. La evidencia científica se categoriza en diferentes niveles, siendo los metaanálisis y revisiones sistemáticas la evid
VII encuentro metis avila 2014. LAS NUEVAS TECNOLOGÍAS DE LA INFORMACIÓN AL S...Carmen Villar Bustos
El documento describe cómo las tecnologías de la información y la comunicación (TIC) pueden usarse para apoyar la investigación. Explica que las TIC permiten compartir información, recursos y resultados entre investigadores. También menciona algunas herramientas TIC útiles como las redes sociales, entornos personales de aprendizaje y software para gestionar y analizar datos. El documento enfatiza que lo más importante es el uso que se haga de estas herramientas para avanzar en la investigación.
Este documento resume las ideas principales sobre la Web 2.0 y su aplicación en el campo de la salud. Define conceptos como Web 2.0, Salud 2.0 y eHealth que implican el uso de aplicaciones web para promover la colaboración entre profesionales y pacientes. También destaca las ventajas del uso de herramientas sociales como wikis, blogs y redes sociales para mejorar la educación, difusión de información y trabajo en red entre los agentes del sector salud.
Conferencia Inaugural: Carlos Segovia Pérezinvestenisciii
Este documento describe la investigación en servicios de salud en Europa a través del Instituto de Salud Carlos III de España. Detalla las actividades de investigación en servicios en el 7o Programa Marco y Horizonte 2020 de la UE, así como las actividades del ISCIII para aumentar la participación española y estructurar su presencia en la investigación europea de servicios de salud.
Gestion clinica de los cuidados a través de Gacela Care: experiencias de impl...Azucena Santillan García
Presentación utilizada en la 8ª Teleconferencia del Programa "Teleenfermería 2013" del Grupo Regional de Informática de la Salud para América Latina y El Caribe.
La enfermería basada en la evidencia utiliza las mejores pruebas disponibles para tomar decisiones sobre el cuidado del paciente. Se basa en tres elementos: la investigación, que permite intervenciones mejoradas; la experiencia profesional, que mejora las decisiones a lo largo del tiempo; y los recursos disponibles para evaluar la validez de las intervenciones. El método científico y la investigación complementan la práctica de enfermería para lograr los mejores resultados para los pacientes.
Ponencia de la III Jornada de eSalud Enfermeria Castilla Leon (Segovia Mayo 2014).
Sobre la importancia de la evaluacion de la calidad de las APP en salud.
This document outlines the requirements for a quality management system for manufacturers of notified medical devices and in-vitro diagnostics in India. It specifies requirements in areas such as documentation, management responsibility, resource management, product realization, measurement and improvement. The quality management system must ensure that products meet regulatory and customer requirements. Top management is responsible for establishing the quality policy and quality objectives, reviewing the quality system, and providing necessary resources. Personnel must be properly trained and competent. The system requires control of documents, records, outsourced processes, management reviews and corrective/preventive actions to continually improve the effectiveness of the quality system.
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
Post-Market Clinical Follow Up Studies Under EU MDR and IVDREMMAIntl
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD) were replaced by the Medical Device Regulations (MDR) 2017/745, and the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD) was replaced by the In-Vitro Diagnostic Regulations (IVDR) 2017/746.
Both of these new regulations put a heavy emphasis on post-market surveillance activities for a product. Post-market clinical follow-up studies, or performance studies as called in the IVDR, are an integral part of the post-market surveillance requirements of the newly released regulations. PMCF studies must be initiated by the manufacturer...
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
This document provides an overview of GMP requirements for equipment used in pharmaceutical manufacturing. It discusses factors to consider when selecting equipment, as well as guidelines for equipment design, identification, cleaning, maintenance, and record keeping. The document outlines qualification processes like design, installation, operational, and performance qualification. It also covers specific equipment types like filters, balances, and automated or electronic devices. The goal is to help ensure equipment is suitable for its intended use and does not compromise product quality.
A Clinical Evaluation Report is a critical document required for the regulatory approval of medical devices in Australia and many other countries. It provides a comprehensive analysis of the safety and performance of the medical device based on clinical data and relevant scientific literature. Manufacturers should ensure compliance with the latest regulations set by the TGA and other relevant authorities. Additionally, consulting with regulatory experts, clinicians, and medical writers is recommended to create a robust and accurate Clinical Evaluation Report.
https://mavenprofserv.com/clinical-evaluation-report/
We prepare and maintain a clinical evaluation report that complies with the requirements of MEDDEV and EU MDR. Clinical evaluation report (CER) summarizes and concludes the clinical evaluation of medical devices. Clinical evaluation is responsibility of the manufacturer and is a critical step in process of CE Marking. Many manufacturers struggle and find it tedious to comply with the requirements of CER.
https://mavenprofserv.com/clinical-evaluation-report/
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
2010 Medical Equipment Management Plan Medical Equipment Management PlanNat Rice
The document outlines the medical equipment management plan for MCG Health, Inc. It details (1) the purpose of managing medical equipment maintenance and safety, (2) the scope of services provided by the Biomedical Engineering Department including equipment inventory, acquisition, inspections, maintenance and repairs, and (3) the fundamentals of the equipment management program including inventory, acquisition, selection, inspections, planned maintenance, and repair services. The plan defines criteria to assess equipment risk and assign maintenance frequencies, with life support equipment receiving highest priority and inspections.
This document provides guidelines on validation and qualification processes. It discusses the relationship between validation and qualification, and defines key terms. Validation and qualification should follow a structured approach according to documented protocols and procedures. A validation master plan should be in place reflecting the scope and approach to validation. Qualification and validation protocols and reports are required documentation. The scope and extent of qualification and validation should be based on quality risk management principles. Change control and periodic review are important aspects of ensuring continued validation. The appendices provide additional guidance on specific validation activities.
American radiology accreditation reqmts 2013Bhanu Sharadha
The American College of Radiology has established a Diagnostic Imaging Centers of Excellence program to recognize facilities that demonstrate high quality imaging services through accreditation, participation in quality registries, and an on-site review. Facilities must be accredited in all modalities, participate in ACR registries, and undergo an on-site survey covering areas such as governance, safety, quality management, and patient rights. The survey team evaluates whether the facility meets standards for personnel, equipment, safety policies, and a quality improvement system. Facilities that pass this comprehensive assessment receive designation as a Diagnostic Imaging Center of Excellence.
Clinical Evaluation Report for Medical DevicesI 3 Consulting
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau luc...Brajesh Kumar
This presentation provides an overview of medical device validation. It discusses the categories of medical devices and regulatory requirements for validation. The presentation covers validation concepts for medical devices including process validation and risk assessment. Analytical and clinical validation methods are described for in vitro diagnostic tests. Finally, the FDA regulatory perspectives on medical devices based on risk classification are summarized.
TGA Presentation: Potential reforms for the regulation of system and procedur...TGA Australia
This document discusses potential reforms to the regulation of system and procedure pack medical devices in Australia. It provides background on the current legislative provisions and international approaches. Common findings that impact patient health and safety are presented, such as inclusion of devices without appropriate conformity assessment or compatibility issues. Key factors associated with the current framework are identified, including a lack of clarity around definitions and responsibilities. The purpose of the workshop is to gather stakeholder feedback on reforms that could address these issues and better ensure the safety of systems and procedure packs.
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Este documento propone un manifiesto para hacer más visible la profesión de enfermería en España. Plantea que la atención sanitaria depende de todo un equipo de profesionales, incluyendo enfermeras, pero que existe poca visibilidad y reconocimiento de su labor. Pide a las enfermeras que dignifiquen su profesión usando la mejor evidencia disponible, y a organizaciones sanitarias y medios de comunicación que reconozcan más el importante papel de las enfermeras en el sistema de salud.
Presentación realizada durante el IV Congreso de Socinorte realizado en Burgos los días 27 y 28 de Marzo de 2014
En este enlace podreis visitar todas las demás: http://www.socinorte.com/ponencias-del-iv-congreso-socinorte-burgos-27-y-28-de-marzo-de-2014/
Este documento describe las fases de implementación de un sistema de trazabilidad en la Central de Esterilización del Hospital Real Nuestra Señora de Gracia en Zaragoza. Inicialmente en 2000, el hospital reconoció la necesidad de mejorar la gestión del instrumental quirúrgico y la trazabilidad. Entre 2003-2004 se desarrollaron los procedimientos de la central y en 2005 se completó el inventario y marcado del instrumental. En 2006, se codificó todo el instrumental mediante códigos alfanuméricos y data-matrix para permitir la trazabilidad
Protocolo de vigilancia y control de microorganismos multirresistentes Carmen Villar Bustos
Este documento presenta un protocolo de vigilancia y control de microorganismos multirresistentes en el Complejo Hospitalario de Cáceres. Describe la justificación y objetivos del protocolo, así como tres protocolos específicos para Staphylococcus aureus meticilin-resistente, Acinetobacter baumannii y otros microorganismos multirresistentes. Finalmente, incluye información sobre la epidemiología de las infecciones nosocomiales y la resistencia a los antimicrobianos en España.
Dificultades para la Investigación en Enfermería. Artículo de Cristina QuesadaCarmen Villar Bustos
Dificultades para la Investigación en Enfermería. Artículo de Cristina Quesada publicada en la revista OIÑARRI del COLEGIO DE ENFERMERÍA DE BIZKAIA durante el segundo semestre del año 2012
Elaborating and implementing an infection control and hospital hygiene programme
Area 2. Quality improvement Implementing quality improvement initiatives
Area 3. Surveillance and investigation of healthcare-associated infections Surveillance and investigation
Area 4. Infection control activities Implementing infection control activities
Table A2. Areas, domains and competencies in infection control and hospital hygiene for junior and senior
specialists (introductory and expert levels)
Area 1. Programme management
Domain: Elaborating and implementing an infection control and hospital hygiene programme
Introductory level (junior specialist)
1.1 Describe the basic principles of infection control and hospital hygiene programmes
1.2
Control de Calidad en Esterilización en los centros de Castilla y LeónCarmen Villar Bustos
El documento describe el control de calidad en la esterilización de instrumentos médicos en Castilla y León de acuerdo con la norma ISO 17665-1. Se realizó un estudio en 190 centros que muestra que la mayoría realiza esterilización siguiendo los protocolos, aunque se necesita mejorar los controles rutinarios. La formación del personal también requiere más atención para asegurar procesos de esterilización seguros.
El documento habla sobre el Complejo Asistencial de Zamora. Brevemente describe que es un centro hospitalario ubicado en la ciudad de Zamora, España. El texto se enfoca en presentar a Carmen Villar, una enfermera que trabaja en el control del hospital.
Este documento describe un estudio sobre la importancia de la trazabilidad en el proceso de esterilización de materiales quirúrgicos para mejorar la seguridad del paciente. El estudio encontró que los hospitales que tenían un sistema de trazabilidad digital registraban más parámetros de control de calidad que los que no lo tenían. La implantación de un sistema de trazabilidad en un hospital mejoró la adecuación del proceso de esterilización a criterios de calidad mediante la estandarización, formación y cultura de seguridad entre el personal.
Este documento presenta una revisión de la situación actual de la investigación en enfermería en España. Resume que la investigación en enfermería se centra en el desarrollo del conocimiento sobre la profesión y el cuidado de personas sanas y enfermas, aunque existen barreras como la falta de costumbre, apoyo y recursos. También propone líneas prioritarias de investigación como el cuidado de ancianos y la promoción de hábitos saludables.
El documento describe la transición hacia una nueva era de la información en la atención médica donde los pacientes y sus cuidadores son cada vez más considerados como recursos importantes de salud. Se argumenta que cuando los pacientes participan más activamente en su atención médica, se pueden crear sistemas de salud con mejores resultados, menor costo y errores, y pacientes más satisfechos y saludables. El objetivo principal debe ser pacientes más felices y saludables, no sistemas médicos más sofisticados.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
WFHSS Guideline on Reprocessing Medical Devices in / for Healthcare Establishments
1. WFHSS world forum for hospital sterile supply
education group
Guideline No.04 June 2012
Reprocessing of Medical Devices
in/for
Healthcare Establishments
2. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 2 of 15
TABLE OF CONTENTS
1 General requirements 3
2 Competencies 3
3 Risk analysis, evaluation, selection and definition of suitable reprocessing methods 4
4 Organisational measures, quality management (QM), validation, monitoring 4
5 Personnel qualification 5
6 Documentation 6
7 External reprocessing (outsourcing) 6
8 Authors 7
ANNEX 1: STANDARD OPERATING PROCEDURES (SOPS) 8
ANNEX 2: CLASSIFICATION OF MEDICAL DEVICES INTO RISK GROUPS 10
ANNEX 3: REQUIREMENTS FOR RUMEDS IN HEALTHCARE ESTABLISHMENTS 14
3. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 3 of 15
WFHSS Guideline on Reprocessing Medical
Devices in / for Healthcare Establishments
This Guideline has been compiled pursuant to the Medical Devices Directive of the EU.
1 General requirements
Medical device (MD) reprocessing in or for healthcare establishments must be con-
ducted with validated processes that demonstrate that a process continually meets
the given specifications.
This does not apply for MDs belonging to the non-critical group, as defined by the
Robert Koch Institute (RKI) (see Annex 2.)1
Note: “Validation serves to furnish documented proof of the ongoing effectiveness of the reprocessing
process under the operating conditions prevailing at the installation site, using the medical devices
encountered in routine operation in their respective packaging and with the reference loads used (i.e. to
ensure clean, disinfected or sterile devices).”
The functions of a MD, as dictated by its intended purpose, or compliance with the
relevant safety requirements must not be adversely affected when the device is re-
processed.
Medical device reprocessing must be conducted in accordance with the state of the
art in science and technology.
Note: The state of the art in science and technology is dictated by pertinent harmonised standards and by
relevant national or international standards and guidelines, such as those published by specialist
associations.
2 Competencies
Overall responsibility for medical device reprocessing in prescribed form is borne by
the proprietor or authorities in charge of the respective establishment.
Before MDs are procured, those parties responsible for their reprocessing must be
aware of the attendant reprocessing conditions and the requisite equipment must be
available in the establishment (see wfhss guideline No 02: “Check List for Procure-
ment of Medical Devices pursuant to EN ISO 17664”).
The manufacturer of a reusable MD must supply instructions on how to reprocess the
1
The RKI scheme rather than the Spaulding scheme takes into account the consequences for reprocessing of assigning
MDs to risk groups.
4. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 4 of 15
device, using (pre-) validated2
processes as per EN ISO 17664.
Competencies and working practices related to all steps of the reprocessing chain
must be set out in writing in the form of standard operating
3 Risk analysis, evaluation, selection and definition of
suitable reprocessing methods
To ensure that they are reprocessed in prescribed form, medical devices must be
classified into risk groups in accordance with Annex 2.
Based on this classification, it must be set out in writing
• whether,
• how often,
• with which process
• and under what conditions
medical devices are to be reprocessed and stored.
The following aspects, in particular, must be borne in mind:
• the manufacturer’s instructions, if relevant,
• the resistance profiles of the microorganisms and potentially infectious agents
(e.g. prions) expected on the MDs,
• expected intervals between the time the MDs are used and the time repro-
cessed, with correspondingly more challenging reprocessing demands as well
as
• special risks posed by the MD when using and/or reprocessing it.
4 Organisational measures, quality management (QM),
validation, monitoring
Reprocessing Units for Medical Devices (RUMEDs) entrusted with medical device re-
processing are divided into three categories on the basis of the highest risk group to
which the medical devices they reprocess are assigned (see Annex 3).
Competencies and responsibilities within the RUMED must be defined (e.g. in the
form of an organogram). RUMED managers must have corresponding deputy manag-
ers.
2
The term “prevalidation” is understood to mean tests conducted for the purpose of identifying a suitable
reprocessing procedure; these are carried out on behalf of the manufacturer and should preferably be
performed by an independent test body
5. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 5 of 15
The structural conditions must permit high quality reprocessing in line with the state
of the art in science and technology.
The equipment, fittings and adjuncts needed for MD reprocessing must be available
and comply with the state of the art (see Annex 3).
For medical device reprocessing all precautions and measures must be taken to as-
sure a demonstrable and continually high quality of reprocessing, in line with the vali-
dation specifications.
Reprocessing of medical devices subject to ultra stringent reprocessing demands
(“Critical C” devices as per Annex 2) must be conducted in line with a QM system
pursuant to EN ISO 13485 (see Annex 3).
The quality of automated reprocessing (cleaning, disinfection and sterilisation) must
be assured by the following measures:
• installation qualification
• validation of reprocessing procedures
• periodic (at least annual) revalidation
• routine daily tests on each day the RUMED is in operation
• batch-related routine tests
• monitoring and testing of process parameters using measurement technology.
5 Personnel qualification
Reprocessing in general, or any reprocessing task, may only be conducted by persons
who by virtue of their training, knowledge and practical experiences are able to as-
sure proper execution of such tasks (see Annex 3):
• All persons entrusted with MD reprocessing must have successfully attended
Specialist Training Course 1 (series of training courses specifically designed for
sterilisation assistants), or be in possession of an equivalent qualification.
• Managers and deputy managers of Category II RUMEDs must additionally have
successfully attended Specialist Training Course 2
• Managers and deputy managers of Category III RUMEDs must additionally
have successfully attended Specialist Training Course 3
Knowledge and skills must be acquired by attendance at appropriate continuing pro-
fessional development seminars based on the state of the art in science and technol-
ogy.
6. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 6 of 15
6 Documentation
When reprocessing MDs belonging to Semi-Critical B as well as to Critical B and C risk
groups, the measured values recorded for the process parameters and underlying the
decision-making process for MD release must be documented, while indicating the
batch name and name of the person responsible for release. These values must fur-
nish proof that the reprocessing procedure was carried out in compliance with the
standard operating procedures (SOPs), using the parameters set out in the validation
protocol. This batch documentation must comprise at least:
• Date
• Equipment serial number
• Programme
• Serial batch numbers
• Designation of reprocessed load or similar code
• Operator’s name
• Release by responsible person
• Printout of measured values in analog or digital form (actual values)
• If applicable, results of batch control (e.g. cleaning indictors, chemical indicators)
Documentation of reprocessing MDs belonging to the non-critical risk group is not re-
quired, while that of Semi-Critical A and Critical A risk groups must be adapted to the
intended use on the basis of risk assessment and the mode of reprocessing inferred
from that.
Category I RUMED documentation, as per Annex 3, must be archived in a well-
assured readable form for at least five years, and Category II and III RUMED docu-
mentation for at least 10 years. Electronic documentation, including release docu-
mentation, is permitted provided that readability and data safety are assured for the
specified period.
7 External reprocessing (outsourcing)
The term “external reprocessing” is used to describe a situation where healthcare es-
tablishments outsource reprocessing in general, or parts thereof, to an authorised
external service provider. The same requirements refer to insourcing.
Outsourcing of reprocessing to a third party must not in any way negatively impact
on the healthcare establishment’s ability to meet the terms of its own service con-
tract.
Reprocessing service providers or healthcare establishments that conduct MD repro-
7. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 7 of 15
cessing for other healthcare institutions must use validated reprocessing procedures.
Commercial service providers conducting MD reprocessing for healthcare establish-
ments with Category II and III RUMEDs as per Annex 3 must have in place a certified
QM system as per ÖNORM EN ISO 13485.
The following aspects, in particular, must be contractually regulated between the ex-
ternal service providers and the person (s) responsible for the respective healthcare
establishment (Category II and III RUMEDs as per Annex 3):
• The conditions to be met to assure running operations (e.g. emergency measures as well
as regulations on coping with bottle necks, breakdowns, standby);
• Duties, responsibilities and competencies of contract awarder and contractor (interfaces);
• Ownership rights as regards the MDs;
• Condition and quality of MDs to be reprocessed;
• Liability for (transport) damage;
• Handover conditions;
• Feedback system;
• Quality assurance measures (if necessary, certification as per ÖNORM EN ISO 13485, see
above);
• Transport logistics, including protected transport of contaminated instruments;
• Maximum time interval before soiled MDs are reprocessed;
• Whether and how any pre-treatment measures are to be conducted for MDs already within
the respective establishment, while taking account of specific types of soils;
• (Special) release regulations;
• Loaned instruments;
• Validation obligations of contract awarder and contractor;
• Qualifications of managers and staff in both premises (as per Annex 3);
• Nature, frequency and scope of checks to be conducted by contract awarder;
• Nature and scope of documentation to be provided by the contract awarder (validation, re-
validation reports, if applicable batch release documentation).
• Compatibility with the quality management system of the hospital
• Compatibility with the documentation system of the hospital
8 Authors
A. Blacky, V. Buchrieser, T. Freundlinger, M. Gehrer, H. Getreuer, A. Gruber, M. Hell, W. Koller,
P. Lachner, T. Miorini, A. Percht, G. Palmisano, U. Prüfert-Freese, M. Suchomel, A. Steinhardt, B.
Weinmayr
The guideline has been proof read and authorized by the wfhss education group
8. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 8 of 15
ANNEX 1: Standard operating procedures (SOPs)
The RUMED management must ensure that standard operating procedures are availalble and
clearly displayed for the persons entrusted with the respective tasks. The RUMED manage-
ment, or a person explicitly designated in writing to that effect by the latter, must ensure that
RUMED employees are also able to understand the content of such SOPs.
This applies in particular for the following:
1. All partial steps, such as:
• Measures conducted immediately after using an MD, e.g. pretreatment, dis-
mantling, collection and intermediate storage
• Transport
• Cleaning
• Rinsing
• Disinfection
• Drying
• Verification of steps conducted hitherto (cleaning results, etc.)
• Maintenance and care
• Functional testing
• Packaging
• Arrangement of supplies for sterilisation
• Sterilisation
• Labelling
• Release
• Transport of sterile supplies
• Storage of sterile supplies
• Measures conducted immediately before use (e.g. checking that sterile sup-
plies are undamaged)
2. Special processes
2.1 Reprocessing MDs that have not been used
These medical devices include:
- MDs which were supplied in an unsterile condition but must be
sterile when put to use,
- Sterilised MDs whose packaging was damaged or opened without the
MD having been used and which, as specified by the manufacturer’s in-
structions, can be reprocessed.
- MDs whose sterile storage period has expired before the expiry date
9. wfhss Guideline on Reprocessing Medical Devices
Status:June 2012 Page 9 of 15
and which, in terms of their composition, are amenable to reprocessing.
2.2 Reprocessing of MDs which may be used or reprocessed only for a limited number
of times
2.3 Reprocessing of textile materials
2.4 Patient-related specific forms of reprocessing.
3. Critical processes
3.1. Reprocessing of heat-sensitive MDs (e.g. endoscopes)
3.2. Reprocessing of MDs with poorly accessible sites (e.g. minimally invasive surgical
(MIS) instruments)
3.3. Reprocessing of MDs posing a risk of injury to users, personnel or patients (e.g.
faulty electrical currents, pointed/sharp implements)
3.4. Reprocessing of MDs subject to more stringent reprocessing requirements (e.g.
residues that are difficult to remove)
3.5. Reprocessing of MDs made of special materials or technical configuration (e.g.
kinks, liable to scratches, antimagnetic, cannot be immersed in liquid, alumini-
um)
3.6. Manual reprocessing steps
3.7. Reprocessing of MDs subject to special reprocessing requirements because of
specific infectious agents (e.g. prions)
10. wfhss Guideline on Reprocessing Medical Devices
Status: June 2012 Page 10 of 15
ANNEX 2: Classification of medical devices into risk groups
(modified as per RKI)
Classification of MDs into risk groups is done on the basis of previous and subsequent
use, transport and storage conditions, design and materials. If there is any doubt
about the risk group to which the MD belongs, assign it to the higher group.
Preference must be given to automated reprocessing in a washer-disinfector because
it assures better standardisation and occupational protection. Disinfection should
preferably be performed with a thermal process.
Classification Description
Medical
device
Example
Pretreat-
treat-
ment
a
Cleaning /
Disinfec-
tion
Spec.
label
Sterili-
sation
Critical process
steps, special re-
quirements
NON-CRITICAL Contact with
intact skin
ECGelectrode,
Kidney dish
X ( X
1
) Inspection:visual cleanli-
ness
SEMI-
CRITICAL Contact with mucosa or pathologically altered skin
A
No special repro-
cessing require-
ments
b
Specula ,
Oral mirror,
dental scoop,
endoscopes
without lumens
(X
2
) X (X
3
)
Preferablyautomated
cleaning (C)and disinfec-
tion (D),atleastdisinfec-
tion withsuitableagents/
process
B
Subjecttomore
stringentrepro-
cessing require-
ments
Flexible endo-
scopeswith
lumens
c
,
Hand and
angled
pieces
c,d
,,
X
4 X (X
3
) Automated C/D
CRITICAL Skin or mucosa penetration, contact with open wounds, drugs, blood or blood products
that must be administered in sterile condition
A
No special repro-
cessing require-
ments
Woundretrac-
tors,
Needleholders
(X
2
) X X
Automated C/Dfor
Cat.IIIRUMED,otherwise
preferablyautomated C/D
Steamsterilisation
B
Subjecttomore
stringentrepro-
cessing require-
ments
Heat--sensitive
MISinstru-
ments,
surgical drapes
X
4, e
X (X
5
) X
Forall partscominginto
directcontactwith tissue,
onlyautomated thermal
C/Din suitableWDand
steam sterilisation
C
Subjecttoultra
stringentrepro-
cessing require-
ments
Angioscopes
Epiduroscopes
X
4
X X
5
X
Fornon-thermalsterilisa-
tionprocesses,noevi-
dence ofprion inactivation
hasbeenfurnished to
date.This mustbe borne
in mindforMDs belonging
to this group
a
Pretreatment: this is understood to mean removal of course soils or a measure aimed at prevention of
incrustations, but need not be limited to these. Pretreatment is done at the site of MD use.
b
e.g. can cleanliness be checked through visual inspection
c
if it cannot be classified as “critical”;
d
preferably, automated reprocessing, if this is not possible, then steam sterilisation with suitable pro-
11. wfhss Guideline on Reprocessing Medical Devices
Status: June 2012 Page 11 of 15
cesses following manual reprocessing
e
does not apply to surgical drapes
(X) optional working step
X
1
steam sterilisation may be needed, bearing in mind specific requirements.
X
2
pretreatment immediately after use with non-protein fixing agents/process
X
3
for MDs that are not used in physiologically sterile body cavities, final disinfection suffices apart from
cases of intraoperative use.
X
4
these MDs (semi-critical B, critical B, C) must be treated immediately after use to pave the way for
subsequent cleaning and disinfection, so that final cleaning is conducted as quickly as possible us-
ing automated processes, while preventing corrosion or other form of damage to the instruments. All
factors of influence here must be defined and taken account of during validation..
X
5
A special label is used for identification, information and tracking (as required, information must be
displayed on the following: batch no., serial no., manufacturer’s name, type and number of repro-
cessing cycles., max. number of reprocessing cycles permitted, safety and warning instructions,
etc.).