Hygienic Management of Medical Devices in/for Health Care Facilities. The Austrian Way. Wolfgang Ecker Fed. Min. of Health, Family and Youth
|
|
|
- Emmeline Stephens
- 6 years ago
- Views:
Transcription
1 Hygienic Management of Medical Devices in/for Health Care Facilities The Austrian Way May 3 rd 2007, Baden Wolfgang Ecker Fed. Min. of Health, Family and Youth
2 EU Medical Device - Directives Directive 90/385/EEC Active Implantable Medical Devices Directive 93/42/EEC Medical Devices Directive 98/79/EC In-vitro-Diagnostic- Medical Devices Pacemakers; ICD s Impl. Infusion pumps Artificial hearts... + software and accessories NMR, US, X-ray, Hip-implants, ECG, EEG, Intravascular catheters, Stent, syringes, IOL, RR, med. laser, Sterilizers, Washer/disinfectors... HIV-tests, Hepatitis-tests, Pregnancy-tests, Lab-Automats, Reagents, Calibrators, Control materials Prim. specimen receptacles...
3 Important documents for medical devices Harmonised Standards EU Law System New Approach Global Approach Medical Device Directives Nat. Medical Device Act Decrees, Ordinancies
4 Hygienic Management of Medical Devices The hygienic management (Cleaning, Disinfection, Sterilization) of Medical Devices in/for Health Care Institutions is now essentially determined by the new European and Global Standards!
5 Hygienic Management of Medical Devices CEN / ISO-Standards Standards Product-related Processes Procedures Sterilizers Washer/Disinfectors (Indicators) (Sterile Packaging) Manufacturer s Info on Reprocessing.. Development, Validation and Routine Control of Sterilization Methods Bioburden...
6 Early Developments I 1991 a group of hygienists/biologists involved in regular control of sterilizers pointed to the forthcoming new European standardisation and informed the Health Ministry and the Health Authorities of the provinces 1992 a Ministerial Decree addressed to all hospitals informed on the new developments, favoured central sterilization and guided procurement of large steam sterilizers to the new requirements 1992 an Expert Group was set up to guide the necessary changes in hospitals, develop educational concepts, disseminate the new developments and help in the creation of new regulations
7 Transposition of Medical Device Directives in Austria AIMDD MDD Medical Device Act MPG BGBl. Nr. 657/1996 BGBl. I Nr. 153/2005 IVDD Ordinancies
8 Austrian Medical Device Act Transposition of EU-Directives Supplementary Life Cycle Regulation Essential Requirements Harmonised Standards Placing on the market Putting into service Conformity assessment Clinical Investigations Market surveillance Vigilance... Health care facilities Maintenance Cleaning, disinfection, sterilisation Quality management Others Distribution Advertising...
9 Medical Device Act: Hygienic Management of Medical Devices in/for Health Care Institutions 93 Suitable Devices and Systems Validated Procedures Appropriate Organization Success of Procedures must be reproducibly assured Health and Safety of Patients,, Users and Others must not be compromized
10 Early Developments II 1997 Foundation of the Austrian Society for Sterile Supply comprising relevant stakeholders and experts platform for education and training driving the sector helping in developing regulation close cooperation with European colleagues, organisations and standardisation has to a large extent brought to reality the forthcoming Ordinance in hospitals
11 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions under 94 Medical Device Act
12 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions General requirements Validated Procedures Health and Safety must not be compromised Function/Performance of devices not to be compromised State of the Art Principles of Quality Management
13 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Responsibilities General Responsibility of Health Care Institution Responsibilities for specific tasks to be attributed Minimum requirements for Outsourcing contracts
14 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Risik analysis, Assessment, Procedures Risk Groups (based on Robert Koch Institute) Determination of Processes by Institution Instructions, which products may be reprocessed, how often, under which conditions Documentation
15
16
17 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Procedures General presumption of conformity (European, nat. or internat.. Standards, Guidelines..) Presumptions of conformity for specific processes (Guidelines:: CJD, Endoscopy, Low temperature...)
18 Ordinance EN ISO :2006, (former EN 554) Sterilization of health care products -Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Part 2: Guidance on the application of EN ISO Part 1: 2006 ON-Rule (technical specification): Guideline V+RC of Steam Sterilization with Annexes, for Hospitals
19 EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
20 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Organisation, QM, Validation, Routine Control, Documentation Adaequate Organisation, Personal, Equipment, Building, Outsourcing; contingency planning QM-principles over all relevant processes Controls by Owner / external institutions Depending on kind/size of health care institution: Presumption of conformity when Organisation acc. To Annex 3 Provisions for Documentation
21 Doctor s offices Dentists Nursing homes ambulatories Hospitals without Surgery Hospitals with Surgery
22 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Qualification of Personnel Differentiated presumptions of conformity acc. to Units I III (PUMD) Equivalency of experiences/trainings Transitional regimes
23 Doctor s offices Dentists Nursing homes ambulatories Hospitals without Surgery Hospitals with Surgery Anmerkung: Die bis 2004 abgehaltenen Fachkundelehrgänge I und II entsprechen den neuen Lehrgängen II und III, werden dementsprechend anerkannt.
24
25 Planned Ordinance for the Hygienic Management of Medical Devices in/for Health Care Institutions Outsourcing Maintenance of health care not to be endangered Contingency provisions Notification requirement for external reprocessors External reprocessor: certif.. QM-system system, Surveillance by inspection system Minimum requirements for contracts
26 Thank You!
Special Rules of Accreditation for Certification Bodies of Quality Systems
Attachment 4 Attachment 4 MEDDEV 2.10-2 Rev 1 April 2001 Special Rules of Accreditation for Certification Bodies of Quality Systems Scope "Sterile Medical Devices" Inofficial Translation of Spezielle Akkreditierungsregeln
Changes in the Medical Device Legislation; the day after. Jan Bart Hak 1
PPN Najaarsbijeenkomst 21 November 2017 Changes in the Medical Device Legislation; the day after. How much time do we have left? Jan Bart Hak Jan Bart Hak 1 Company Leading consultancy and project management
European IVD Regulations and Risk Based Classification. An Overview for Global Quality Professionals
European IVD Regulations and Risk Based Classification An Overview for Global Quality Professionals Anna Sadio IVD Technical Expert/Project Manager Oct 2013 Caution The new regulations are draft and subject
Raad voor Accreditatie (Dutch Accreditation Council RvA) Specific Accreditation Protocol for Certification according to ISO/IEC 13485
Raad voor Accreditatie (Dutch Accreditation Council RvA) Specific Accreditation Protocol for Certification according to ISO/IEC 13485 Document code: RvA-SAP-C021-UK Version 2, 6-6-2017 A Specif ic Accreditation
IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices. Med-Info. TÜV SÜD Product Service GmbH
Med-Info International expert information for the Medical Device industry IVDD revision changes to the European regulation of in-vitro diagnostic (IVD) Medical Devices The current regulatory framework
EUROPEAN PARLIAMENT Committee on the Environment, Public Health and Food Safety
EUROPEAN PARLIAMT 2009-2014 Committee on the Environment, Public Health and Food Safety 2012/0266(COD) 12.4.2013 ***I DRAFT REPORT on the proposal for a regulation of the European Parliament and of the
IAF Mandatory Document for the Application of ISO/IEC in Medical Device Quality Management Systems (ISO 13485)
IAF MD 8:2011. International Accreditation Forum, Inc.(IAF) IAF Mandatory Document IAF Mandatory Document for the Application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO (IAF MD
Medical devices briefing for patients: Patient safety in the new Regulation
Medical devices briefing for patients: Patient safety in the new Regulation 20/12/2016 Patient safety is an important priority for the European Patients Forum, and it was also our main priority in our
WFHSS. Reprocessing of Medical Devices in/for Healthcare Establishments
WFHSS world forum for hospital sterile supply education group Guideline No.04 June 2012 Reprocessing of Medical Devices in/for Healthcare Establishments TABLE OF CONTENTS 1 General requirements 3 2 Competencies
Medical Device and Health Software
Medical Device and Health Software Standards and regulations now and in the future Justin McCarthy Introduction I was head of Clinical Engineering in Cardiff till 2009. I have been chair of BSI committee
Meeting with Professional Organisations on the evaluation of the Professional Qualifications Directive. 29 October 2010
Meeting with Professional Organisations on the evaluation of the Professional Qualifications Directive 29 October 2010 1 Introduction Single Market Act State of play of the evaluation of the Directive
Sterile Supply Specialist Training Course Level II. Constructional Requirements for a Reprocesing Unit for Medical Devices
Sterile Supply Specialist Training Course Level II Constructional Requirements for a Reprocesing Unit for Medical Devices T. Miorini, M. Gehrer 2010 TABLE OF CONTENTS 1 Introduction... 5 2 Category I
COMMISSION IMPLEMENTING REGULATION (EU)
L 253/8 Official Journal of the European Union 25.9.2013 COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council
Egyptian Organization for Standardization & Quality. Egyptian Organization for Standardization & Quality. Welcome to EOS
Egyptian Organization for Welcome to EOS 1 EOS Establishment 2 1957 EOS was established in 1957 by Presidential Decree no. 29/1957 1979 In 1979 the recently established Quality Control Centre was annexed
Free movement of professionals and recognition of professional qualifications in the EU
Free movement of professionals and recognition of professional qualifications in the EU Meeting between EU-Commission and Representatives from Reparis Countries in cooperation with the World Bank Brussels,
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY Directorate F-Consumer Good Unit F3- Cosmetic and Medical Devices MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 6 December 2009 GUIDELINES ON A MEDICAL
Brussels, 12 June 2014 COUNCIL OF THE EUROPEAN UNION 10855/14. Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD)
COUNCIL OF THE EUROPEAN UNION Brussels, 12 June 2014 Interinstitutional File: 2012/0266 (COD) 2012/0267 (COD) 10855/14 PHARM 44 SAN 232 MI 492 COMPET 405 CODEC 1471 NOTE from: General Secretariat of the
New EU legislation on Medical Devices. Erik Hansson Deputy Head of Unit European Commission DG Health and Consumers 1
New EU legislation on Medical Devices Erik Hansson Deputy Head of Unit European Commission DG Health and Consumers 1 Drivers for change Presentation Commission proposals State of play in negotiations What
Regulatory Control of Diagnostics in Tanzania. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority
6 th Consultative Stakeholders Meeting on UN PQ of Medicines, Diagnostics and Vaccines 4-5 April, 2011, Geneva, Switzerland Regulatory Control of Diagnostics in Tanzania Hiiti Sillo Ag. Director General
Healthcare-Associated Infections
Healthcare-Associated Infections A healthcare crisis requiring European leadership Healthcare-associated infections (HAIs - also referred to as nosocomial infections) are defined as an infection occurring
QUALITY MANAGEMENT IN HEALTHCARE A EUROPEAN CHALLENGE THE GERMAN EXPERIENCE AMBULATORY SURGERY - HYGIENE FRAMEWORK CONDITION
Cercetãri Experimentale & Medico-Chirurgicale Anul XIV Nr.2-3/2007 Pag. 115-119 Cercetari ) experimentale & medico-chirurgicale QUALITY MANAGEMENT IN HEALTHCARE A EUROPEAN CHALLENGE THE GERMAN EXPERIENCE
CMS REQUIREMENTS: ESSENTIAL ELEMENTS FOR ASCS
CMS REQUIREMENTS: ESSENTIAL ELEMENTS FOR ASCS Luci Perri, RN, MSN, MPH, CIC, FAPIC Infection Control results OBJECTIVES Identify three areas frequently cited by surveyors State how to avoid two common
Topic Points Introduction Gesundheit Österreich GmbH Definition and evolution of Quality Total Quality Management Quality Management Systems used in h
Quality Management Brigitte Domittner Gesundheit Österreich GmbH Topic Points Introduction Gesundheit Österreich GmbH Definition and evolution of Quality Total Quality Management Quality Management Systems
Decontamination of Medical Devices:
Decontamination of Medical Devices: a development plan for healthcare organisations January 2016 Crown copyright 2016 WG27312 Digital ISBN 978 1 4734 5431 6 Foreword Eliminating preventable healthcare
Reprocessing of Flexible Endoscopic Instruments
Contents Purpose... 1 Policy... 1 Scope... 1 Definitions... 2 Roles and responsibilities... 2 Associated documents... 2 1 Personnel... 2 2 Reprocessing facilities... 3 3 High level disinfection / sterilisation...
Australian/New Zealand Standard
AS/NZS 4815:2001 AS/NZS 4815 Australian/New Zealand Standard Office-based health care facilities not involved in complex patient procedures and processes Cleaning, disinfecting and sterilizing reusable
EL_07_04_07_218
European Federation of National Associations of Measurement, Testing and Analytical Laboratories 28-06-2007 EL070407218 Position Paper on the Proposed Regulation setting out the Requirements for Accreditation
DG(SANCO)/ MR
1 Ensure efficient and effective coordination between all CAs involved in official controls on food according to Article 4(3) of Regulation (EC) No 882/2004. GFSD organized on August 10 th, 2010 a videoconference
DECONTAMINATION OF REUSABLE MEDICAL DEVICES Annual Report 2009/10
Quality care for you, with you DECONTAMINATION OF REUSABLE MEDICAL DEVICES Annual Report 2009/10 Version 0_1 Presented to Board of Directors September 2010 Author of report: Sandra McLoughlin Presented
IVD Regulatory Update February 2015
IVD Regulatory Update February 2015 Sue Spencer Head of IVD Notified Body Copyright 2015 BSI. All rights reserved. Content IVD proposals Expected timelines Impacts: Re-classification Clinical evidence
EUROPEAN PARLIAMENT Plenary sitting
EUROPEAN PARLIAMT 2009-2014 Plenary sitting A7-0324/2013 9.10.2013 ***I REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive
WHTM Welsh Health Technical Memorandum. Decontamination of medical devices within acute services. Part A: Management and environment
WHTM 01-01 Welsh Health Technical Memorandum Decontamination of medical devices within acute services Part A: Management and environment Welsh Health Technical Memorandum 01-01 - Decontamination of medical
Current and future standardization issues in the e Health domain: Achieving interoperability. Executive Summary
Report from the CEN/ISSS e Health Standardization Focus Group Current and future standardization issues in the e Health domain: Achieving interoperability Executive Summary Final version 2005 03 01 This
Law on Medical Devices
Law on Medical Devices The Law is published in the Official Gazette of the Republic of Montenegro, no. 79/2004 on 23.12.2004. I GENERAL PROVISIONS Article 1 Manufacturing and distribution of medical devices
NBOG Report for the period
NBOG Report for the period 2005 2008 1 Introduction...2 2 Background...2 3 Work Programme, Activities, Achievements...2 3.1 Overview...2 3.2 Guidance documents...3 3.3 Review of NB-MED Recommendations...6
Harmonizing national legislation on Food Safety
OIE 12th Conference of the OIE Regional Commission for the Middle East Harmonizing national legislation on Food Safety Alberto Mancuso Amman (Jordan) 23 September 2013 CONTENTS Evolution of food safety
Medical Device Reimbursement in the EU, current environment and trends. Paula Wittels Programme Director
Medical Device Reimbursement in the EU, current environment and trends Paula Wittels Programme Director 20 November 2009 1 agenda national and regional nature of EU reimbursement trends in reimbursement
Compounded Sterile Preparations Pharmacy Content Outline May 2018
Compounded Sterile Preparations Pharmacy Content Outline May 2018 The following domains, tasks, and knowledge statements were identified and validated through a role delineation study. The proportion of
Charles Hughes. Instrument Reprocessing Update: What s New?
1 Instrument Reprocessing Update: What s New? 2 Objectives Upon completion, participants will be able to... 1. Explain various national accreditation organizations along with their new survey methods,
Guidance on Quality Management in Laboratories
Guidance on Quality Management in Laboratories series QULAITY IBMS 1 Institute of Biomedical Science Guidance on Quality Management in Laboratories As the UK professional body for biomedical science the
INFECTION CONTROL SURVEYOR WORKSHEET
Attachment 2 Exhibit 351 INFECTION CONTROL SURVEYOR WORKSHEET Instructions: The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the infection
MAIMONIDES MEDICAL CENTER. SUBJECT: Medical Equipment Failures and Medical Device Reporting Program
MAIMONIDES MEDICAL CENTER CODE: AD-101 (Reissued) DATE: May 7, 2013 ORIGINALLY ISSUED: 4/19/1993 SUBJECT: Medical Equipment Failures and Medical Device Reporting Program I POLICY: It is the policy of Maimonides
COMMUNICATION FROM THE COMMISSION
EN EN EN COMMUNICATION FROM THE COMMISSION First stage of consultation of the social partners on protecting European healthcare workers from blood-borne infections due to needlestick injuries 1. INTRODUCTION
GUIDANCE DOCUMENT ON DIRECTIVE 2005/50/EC ON THE RECLASSIFICATION
Ref. Ares(2015)2027431-13/05/2015 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices Brussels, 12 January 2007 DG ENTR Unit F3/JB D(2006) GUIDANCE
Take a Course of Action.
Take a Course of Action. When you choose RAPS Online University, you ll be on track to expand your regulatory knowledge and advance your career. Our comprehensive learning provides an immersive experience
Consulted With Individual/Body Date Medical Devices Group August 2014
Medical Equipment Policy - Safe Use Of Medical Equipment Developed in response to: Contributes to Care Quality Commission Regulation Policy Registration No. 04066 Status: Public MHRA Guidance Regulation
Clinical staff undertaking Endoscopy and Nasendoscope interventions
DECONTAMINATION OF NON LUMENED ENDOSCOPIC EQUIPMENT ( INCLUDING CYSTOSCOPES AND NASENDOSCOPES) Version: 3 Date issued: December 2017 Review date: December 2020 Applies to: Clinical staff undertaking Endoscopy
1.2 billion ambulatory care visits in US: physician offices, outpatient hospital and ED
Overview More patients obtain healthcare in specialty clinics and physicians offices in the United States than in hospitals 1.2 billion ambulatory care visits in US: physician offices, outpatient hospital
EPF recommendations for the trilogue on the proposal for regulation on Medical Devices
EPF recommendations for the trilogue on the proposal for regulation on Medical Devices Contents 1. Introduction... 3 2. EPF recommendations for the trilogue... 3 2.1 Gaps in Patient safety and quality
GHTF SG2 Guidance: Group work output presentation
GHTF SG2 Guidance: Group work output presentation SG2 Post-market Surveillance & Vigilance SG2 is charged with the task of developing harmonized manufacturers adverse event reporting and other forms of
Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET
Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET Name of State Agency or AO (please print at right): HFAP Instructions: The following is a list of items that must be assessed during
Official Journal of the European Union
L 33/30 DIRECTIVE 2002/98/EC OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of
CENTRAL SERVICE (CS) PERSONNEL AND THEIR HEALTHCARE
by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Quality Management in Central Service Using a Systematic Approach LEARNING OBJECTIVES 1. Define the terms quality
abcdefghijklm abcde abc a From the Chief Medical Officer eé~äíü=aéé~êíãéåí= Dear Colleague
abcdefghijklm eé~äíü=aéé~êíãéåí= Dear Colleague From the Chief Medical Officer IMPORTANT INFORMATION FOR ALL PRACTITIONERS ENGAGED IN ENDOSCOPY AND DECONTAMINATION OF ENDOSCOPES A detailed survey of current
ENDOSCOPY MICROBIOLOGY ALERTS PROCEDURE STANDARD OPERATING PROCEDURE
ENDOSCOPY MICROBIOLOGY ALERTS PROCEDURE STANDARD OPERATING PROCEDURE Version Number V1 Date of Issue December 2017 Reference Number Review Interval Approved By Name: Seamus Hussey Title: Chairperson Endoscopy
Pediatric Medical Device Development and Safety. Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA
Pediatric Medical Device Development and Safety Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA This presentation represents the professional opinion of the speaker and is not an official
Richard Haggas Blood Transfusion Quality Manager Leeds Teaching Hospitals NHS Trust
Richard Haggas Blood Transfusion Quality Manager Leeds Teaching Hospitals NHS Trust MHRA Oversees compliance with Blood safety and quality regulations Annual compliance report submitted by each transfusion
Re-use of Single Use Devices Implications for Hospitals
Re-use of Single Use Devices Implications for Hospitals April 28, 2008 Sudha Kutty, Director, Patient Safety and Clinical Best Practice Ontario Hospital Association Agenda About OHA Current Drivers against
international FMD Real Time Exercise Austria June 2009
Picorna 09 international FMD Real Time Exercise Austria 3.-5. June 2009 Mag. Simon Stockreiter Dep. II/B/11 Animal Welfare, Animal Health and Zoonoses Federal Ministry of Health, Vienna, AUSTRIA legal
10 th European Development Fund (EDF) Programme. Technical Barriers to Trade
10 th European Development Fund (EDF) Programme Technical Barriers to Trade Outline of the Presentation Overview and update of the TBT project Management structure of the TBT project Standardization and
GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/3 December 2010 GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS
INFECTION PREVENTION & CONTROL, INCLUDING PROCESSING ITEMS FOR REUSE, IN GENERAL PRACTICE
INFECTION PREVENTION & CONTROL, INCLUDING PROCESSING ITEMS FOR REUSE, IN GENERAL PRACTICE Rose Griffiths May 2016 Rose.griffiths1@gmail.com M 0425 736 817 Ref: RACGP Infection Prevention and Control Standards
3M Sterilization Assurance Standards Practice. In Sterilization with the Core Four
3M Sterilization Assurance Standards Practice 1 2 3 4 Confidence In Sterilization with the Core Four 1 Equipment Monitoring Equipment Monitoring is a way to find out whether or not your sterilizer is doing
COMMISSION EUROPÉENNE DG Emploi, affaires sociales et égalité des chances
COMMISSION EUROPÉENNE DG Emploi, affaires sociales et égalité des chances Dialogue social, Droits sociaux, Conditions de travail, Adaptation au changement Dialogue social, Relations industrielles Technical
Medical Devices Technical Safety Protects Your Patients
Medical Devices Technical Safety Protects Your Patients 2 Technical safety protects your patients Experience saves lives TÜV AUSTRIA has been serving customers domestically since 1872 and is now active
WELSH HEALTH CIRCULAR
Issue Date: 6 January 2016 WELSH HEALTH CIRCULAR WHC/2015/050 STATUS: ACTION & INFORMATION CATEGORY: QUALITY AND SAFETY DECONTAMINATION OF MEDICAL DEVICES: A DEVELOPMENT PLAN FOR HEALTHCARE ORGANISATIONS
(unofficial translation)
(unofficial translation) Ordinance on Offshore Installations Seaward of the Limit of the German Territorial Sea (Offshore Installations Ordinance SeeAnlV) Dated 23 January 1997 (BGBl. I p. 57) amended
Implementing the revised recognition of professional qualifications Directive
24 February 2015 Council 12 To note Implementing the revised recognition of professional qualifications Directive Issue 1 The revised recognition of professional qualifications Directive 2013/55/EU was
SMART PROCUREMENT Going green: best practices for green procurement - AUSTRIA Vienna ÖkoKauf programme
Vienna ÖkoKauf programme AUSTRIA 1 - Vienna ÖkoKauf programme Context Public procurement expenditure of the city of Vienna amounts to EUR 5 billion annually, of which approximately 50% is spent on supplies
Administrative Policies and Procedures. Policy No.: N/A Title: Medical Equipment Management Plan
Administrative Policies and Procedures Originating Venue: Environment of Care Title: Medical Equipment Management Plan Cross Reference: Date Issued: 11/14 Date Reviewed: Date: Revised: Attachment: Page
Medical Equipment Management. Medical Equipment Management Activities (EC and EC )
Medical Equipment Management Plan 2017 I. Introduction, Mission Statement, and Scope The Medical Equipment Management Plan defines the mechanisms for interaction and oversight of the medical equipment
NJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE. 8:43G-8.1 Central service policies and procedures
NJ Dept of Health Central Service Standards SUBCHAPTER 8. CENTRAL SERVICE 8:43G-8.1 Central service policies and procedures (a) The hospital's central service shall have written policies and procedures
EU-Cofinancing in Austria
EU-Cofinancing in Austria Cofinancing of EU-funded projects for Development Communication & Education in Austria Funding Guidelines An instrument of Austrian Development Cooperation (ADC) Valid from August
U-M Hospitals and Health Centers Policies and Procedures
U-M Hospitals and Health Centers Policies and Procedures UMHHC Policy 05-02-006 Safe Medical Device Act Policy Issued: 4/00; Last Reviewed: 10/04; Last Revised: 10/04 Return to UMHHC Policies Table of
EMERGING TRENDS WHAT I WILL COVER INCREASED INTEREST DEVICES ARE MIGRATING SAFE AND RELIABLE DEVICES LEAD TO LIVING WELL
SAFE AND RELIABLE DEVICES LEAD TO LIVING WELL THE HOME AND MEDICAL DEVICE TECHNOLOGY Presented by Mary Weick-Brady, MSN, RN April 20, 2012 Great Lakes Biomedical Conference on Home and Mobile Health WHAT
Safety Surveillance for Medical Devices
Safety Surveillance for Medical Devices May 10, 2012 James P. Keller, M.S. Vice President, Health Technology Evaluation and Safety jkeller@ecri.org (610) 825-6000, ext. 5279 Presentation Overview ECRI
Mandatory accreditation of medical laboratories in France: how to best reconcile regulatory and normative requirements for cytogenetics?
Mandatory accreditation of medical laboratories in France: how to best reconcile regulatory and normative requirements for cytogenetics? Philippe LOCHU Medical Biologist - Cytogeneticist Background The
NOTICE. Re: GD207: Guidance on the Content of ISO Quality Management System Certificates Issued by Health Canada Recognized Registrars
November 13, 2007 NOTICE Our file number: 07-126340-821 To: All Stakeholders Re: GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates Issued Health Canada is pleased to announce
BASINGSTOKE AND NORTH HAMPSHIRE HOSPITALS NHS FOUNDATION TRUST
BASINGSTOKE AND NORTH HAMPSHIRE HOSPITALS NHS FOUNDATION TRUST SUMMARY This policy provides guidance for providing safe maintenance procedures for assets and buildings owned by the Trust. 1 BASINGSTOKE
Address: Tamar Science Park, Derriford, Plymouth. PL6 8BU. Telephone:
Issue Number 217 December 2011 Cardiac Output Cardiac Output Issue Number 217 December 2011 The Free Independent Job Vacancy and News Bulletin For Cardiology Technical Staff The Free Independent Job Vacancy
National Decontamination Standards for Environmental Cleaning & Monitoring
National Decontamination Standards for Environmental Cleaning & Monitoring IDI Workshop September 7 th 2013 Paschal Kent, Cork University Hospital 1 Learning objectives By the end of this presentation
Level 3 Diploma in Healthcare and Social Care Support Skills (QCF)
Level 3 Diploma in Healthcare and Social Care Support Skills (QCF) Qualification Specification ProQual 2015 Contents Page Introduction 3 The Qualifications and Credit Framework (QCF) 3 Qualification profile
Infection Prevention & Control Annual Report 2011/2012
Infection Prevention & Control Annual Report 2011/2012 Board of Directors Approval date: 1 November 2012 Infection Prevention & Control Committee Submission date: 1 August 2012 Position at 31 March 2012
Quality assurance in medical laboratories
Quality & Safety Laboratory medicine Quality assurance in medical laboratories Paths to global competence standards Prof. Dr. Egon Amann Hamm-Lippstadt University of Applied Sciences, Germany 50 www.q-more.com/en/
QUALITY MANUAL. Department of Pathology, Our Lady s Hospital Page 1 of 83 Effective Date: 14/02/2017. QMn-GEN-0001
Page 1 of 83 QUALITY MANUAL Page 2 of 83 Contents 1. INTRODUCTION... 3 1.1 Purpose... 3 1.2 Overview of Our Lady s Hospital... 4 1.3 Overview of Department of Pathology... 5 2. QUALITY MANAGEMENT SYSTEM...
Linking research and standardization. Integrating standards in your research project: a pocket guide for project proposers
Linking research and standardization Integrating standards in your research project: a pocket guide for project proposers Table of contents Things you need to know about standards... 3 Who are we?... 4
Part I AAMI ST79 Recommended Practice
Infection Prevention Division Attest Sterile U Network Part I AAMI ST79 Recommended Practice June 9, 2011 Welcome! Topic: Part I AAMI ST79 Recommended Practice Facilitator: Jamie Meilahn, 3M Marketing
Pediatric Cardiology Clinical Privileges
Name: Effective from / / to / / Initial privileges (initial appointment) Renewal of privileges (reappointment) All new applicants should meet the following requirements as approved by the governing body,
Introduction of Saudi Arabia Medical Device Regulatory System Ali Al Dalaan Executive Director, SFDA AHWP TC Chair
Introduction of Saudi Arabia Medical Device Regulatory System Ali Al Dalaan Executive Director, SFDA AHWP TC Chair IMDRF Meeting. 20-22 March,2018. Shanghai, China Saudi Food & Drug Authority ) Drug Food
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices SUR-G0004-4 02 AUGUST 2012 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
European CE Marking of Medical Devices. October 2017
European CE Marking of Medical Devices October 2017 1 2017 EU Regulations Why? Response to scandals to restore confidence in system Keep pace with scientific and technical developments Overcome divergence
Laboratory Assessment Tool
WHO/HSE/GCR/LYO/2012.2 Laboratory Assessment Tool Annex 1: Laboratory Assessment Tool / System Questionnaire April 2012 World Health Organization 2012 All rights reserved. The designations employed and
Standards for the Medical Laboratory
Clinical Pathology 21-47 High Street Feltham Middlesex TW13 4UN Registered in England & Wales No. 2675095 Tel: (020) 8917 8400 Fax: (020) 8917 8500 e-mail: office@cpa-uk.co.uk www.cpa-uk.co.uk Clinical
Education and Training Committee, 5 June 2014
Education and Training Committee, 5 June 2014 Directive 2013/55/EU the revised Recognition of Professional Qualifications (RPQ) Directive challenges and opportunities for the Health and Care Professions
Access to medical devices for Universal Health Coverage and achievement of SDGs
Access to medical devices for Universal Health Coverage and achievement of SDGs Adriana Velazquez Berumen Senior advisor on medical devices Essential Medicines and Health Products Department, WHO WHO/HIS/EMP
DG(SANCO)/ MR
1 The CA should ensure that standards applied to The INVIMA shall issue a technical regulation that will fishery products exported to the EU are fully equivalent modify Resolution 776 of 2008 through the
Slovenian legal metrology in the field of health
Slovenian legal metrology in the field of health Mojca Požar, M. Sc., Metrology Institute of the Republic of Slovenia (MIRS) Metrology Supervision Division (SMN) Zvolen, Slovakia, 27 May 2015 Milestones
European Commission s proposal for a Regulation on Medical Devices (2012/0266 (COD)) EPF Position Statement
European Commission s proposal for a Regulation on Medical Devices (2012/0266 (COD)) EPF Position Statement April 2013 Introduction: Medical devices include any apparatus, appliance, software, material
MEDICAL DEVICES SECTOR
MEDICAL DEVICES SECTOR MDS - IR4 IMPLEMENTING RULE ON ESTABLISHMENT Application Date: February 14 th 2011 Version 4 Our mission is to ensure the safety of food; the safety, quality and efficacy of drugs;
Interreg Europe: what you need to know
European Union European Regional Development Fund Sharing solutions for better regional policies Interreg Europe: what you need to know Anne-Cécile Renard Coordinator Programme Finances Interreg Europe