The European Biosafety Network is the home for information and resources to support the rapid implementation of the European Commission Directive on the prevention from sharp injuries in the hospital and healthcare sector.
Webinar on updating the ISO 23908 standard on safety mechanisms and the prevention of sharps injuries. 22/06/2022
Agenda
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Introduction to the MDR/IVDR standardisation request on ISO 23908 and interpretation of 11.1 and 22.2 of Annex I of the MDR
Presentation by Mario Gabrielli Cossellu, Policy and Legal Officer, Medical Devices, DG SANTE.
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The scope of ISO Technical Committee 84 and how sharps protection fits in the broader context of TC84’s work
Presentation by Robert Nesbitt, chair of TC84 and Director of Abbvie.
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Overview of progress with the Working Group 8 of TC84 to revise ISO 23908
Presentation by Francois Thomassin, convenor of WG8 and Health, hygiene and medical devices, ISOPERM.
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The current state of play with the technical work of Working Group 8
Presentation by Dr Philip Bickford Smith, project leader of WG8 and medical device consultant.
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Interpretation guidance on Annex I, Points 11.1 and 22.2 of the MDR
Presentation by Dr Jose Luis Cobos, Vice Secretary General of the Spanish General Council of Nursing.
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EBN Roundtable, Belgian Federal Parliament, 25.03.2022
EBN Roundtable on the prevention of exposure to hazardous medicinal products and other substances in Belgium and Europe. Hosted in Belgian Federal Parliament.
Agenda
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France Duvivier - Presentation
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Daniel Schuermans - Presentation
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Ian Lindsley - Presentation
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Eline Versheure - Presentation
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Marijke Quaghebeur - Presentation
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Consensus Document Presentation - FR
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Consensus Document Presentation - NL
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Summary
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EBN Resources
Cancer risks in healthcare workers: identification of Hazardous Medicinal Products
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The ETUI’s list of hazardous medicinal products (HMPs)
Including cytotoxics and based on the EU CLP classification system of Carcinogenic, Mutagenic and Reprotoxic (CMR) substances
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EBN Report: World Patient Safety Day 2022
On 17th September 2022, World Patient Safety Day is focussed on ‘Medication Safety’, with the slogan ‘medication without harm’.
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Prevention from Sharp Injuries in the Hospital Sector
An Italian National Observatory on the Implementation of the Council Directive 2010/32/EU before and during the COVID-19 Pandemic
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Online Workshops - Guidance document for the safe management of hazardous medicinal products at work (HMPs)
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EBN Position Paper on Preventing Medication Errors
Preventing Medication Errors by improving the mental health and wellbeing of healthcare workers, and implementing traceability systems and a just culture, July 2021.
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ANSES Expert Advice (FR)
This document provides expert advice on occupational exposure to cytostatics.
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ANSES Expert Advice Summary (EN)
This document summarises the work of the Expert Committee on “Health reference values” and the Working Group on “Carcinogenic processes”
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Stop Cancer at Work Statement 30/06/2021
Stop Cancer at Work Campaign calls on European Commission to approve
legislation now to protect workers and patients from getting cancer
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PRACTICE GUIDELINES OF THE SPANISH SOCIETY OF HOSPITAL PHARMACISTS (SEFH)
Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments
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Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. Farmacia Hospitalaria (Hospital Pharmacy). March-April 2021. Vol 45 No 2.
Guidance by the Spanish Society of Hospital Pharmacists on surface monitoring of hazardous medicinal products
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ECDP guidance on Infection Prevention Control
European Center for Disease Prevention and Control guidance on IPC prepardness for COVID-19
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Guidance on Preventing Sharps Injuries in the MDR
Interpretation Guidance on Annex I, Points 11.1 and 22.2 of EU Regulation 2017/45 of the European Parliament and of the Council
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EBN Webinar: Preventing sharps injuries, MDR and safety mechanism in medical devices
The European Biosafety Network hosted a webinar on preventing sharps injuries, the MDR and safety mechanisms in medical devices. The webinar gave participants a chance to hear from and engage with a range of expert speakers covering the prevention of sharps injuries, the impact of COVID-19 on sharps injuries, the application and guidance on the clauses in the MDR which require the design, manufacture and use of medical devices to prevent sharps injuries and the new/updated standard for safety mechanisms in medical devices.
Webinar Summary Notes
Detailed notes of the EBN webinar on preventing sharps injuries, MDR and safety mechanism in medical devices. 15th June 2021.
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HOSPEEM-EPSU Presentation
Follow-up on and implementation of the Directive 2010/32/EU on the prevention from sharps injuries in the hospital and healthcare sector
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Paul van Wijk Presentation
How sharps injuries are managed in the Netherlands and how governmental institutions are dealing with them
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EBN Presentation
The impact of COVID-19 on sharps injuries – Ipsos MORI survey
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SGCN Presentation
Sharps injury prevention and compliance in Spain and Interpretation guidance on preventing sharps injuries in the Medical Devices Regulation (MDR)
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Notified Bodies Presentation
Implementation of the Medical Device Regulation post May 2021, sharps injuries and new standard on safety mechanisms in medical devices
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European Commission Presentation
Standardisation Request for MDR/IVDR and new harmonised European standards, including sharp injury protection, and interpretation of points 11.1 and 22.2 of Annex I of the MDR
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DASTRI Presentation
New standard on sharp injury protection on sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (EN ISO 23908:2013)
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Sharps Directive
Directive
The proposal for a Council Directive implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU.
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OJEU
The Directive as published in the Official Journal of the European Union 1st June 2010.
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European Biosafety Network Practical Toolkit for Implementation
Toolkit for the Implementation of European Directive on Prevention from Sharps Injuries (Council Directive 2010/32/EU) in Member States
European Biosafety Network Toolkit 2011
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Implementation Guidance
Prevention of Sharps Injuries in the Hospital and Healthcare Sector Implementation Guidance for the EU Framework Agreement, Council Directive and Associated National Legislation.
EU Sharps Injuries Implementation Guidance
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Implementation Guidebook
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Summary of the EU Directive and Implementation Guidance
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Achieving Rapid and Comprehensive Implementation
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Implementation Updates
Implementation Update 1 – Injection Safety
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Hazardous Drugs Exposure Prevention Case Study
Hazardous Drugs Exposure Prevention Guidelines - Castile-La Mancha, Spain
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Carcinogens and Mutagens Directive
Amendments to CMD3 and implications
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