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

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.

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.

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.

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.

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.

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

France Duvivier - Presentation

Daniel Schuermans - Presentation

Ian Lindsley - Presentation

Eline Versheure - Presentation

Marijke Quaghebeur - Presentation

Consensus Document Presentation - FR

Consensus Document Presentation - NL

Summary

EBN Resources

Cancer risks in healthcare workers: identification of Hazardous Medicinal Products

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

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’.

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

Online Workshops - Guidance document for the safe management of hazardous medicinal products at work (HMPs)

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.

ANSES Expert Advice (FR)

This document provides expert advice on occupational exposure to cytostatics.

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”

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

PRACTICE GUIDELINES OF THE SPANISH SOCIETY OF HOSPITAL PHARMACISTS (SEFH)

Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments

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

ECDP guidance on Infection Prevention Control

European Center for Disease Prevention and Control guidance on IPC prepardness for COVID-19

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

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.

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

Paul van Wijk Presentation

How sharps injuries are managed in the Netherlands and how governmental institutions are dealing with them

EBN Presentation

The impact of COVID-19 on sharps injuries – Ipsos MORI survey

SGCN Presentation

Sharps injury prevention and compliance in Spain and Interpretation guidance on preventing sharps injuries in the Medical Devices Regulation (MDR)

Notified Bodies Presentation

Implementation of the Medical Device Regulation post May 2021, sharps injuries and new standard on safety mechanisms in medical devices

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

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)

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.

OJEU

The Directive as published in the Official Journal of the European Union 1st June 2010.

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

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

Implementation Guidebook

Summary of the EU Directive and Implementation Guidance

Achieving Rapid and Comprehensive Implementation

Call For Action

A Call For Action

Implementation Updates

Implementation Update 1 – Injection Safety

Hazardous Drugs Exposure Prevention Case Study

Hazardous Drugs Exposure Prevention Guidelines - Castile-La Mancha, Spain

Carcinogens and Mutagens Directive

Amendments to CMD3 and implications

The Network is supported by the following organisations: