Presentation by Ian Lindsley Secretary of European Biosafety

Presentation by Ian Lindsley, Secretary of European Biosafety Network to 7 th European Biosafety Summit, National Assembly, Paris, 18 January 2018

About the EBN • Established in 2009 by the founding partners, the Spanish General Council of Nursing and the British public services union UNISON. • To help support the early, consistent and effective implementation of the Directive on preventing sharps injuries in the hospital and healthcare sector (2010/32/EU) in all European Union Member States. • The Network is an inclusive organisation made up of national and European professional institutions, representative associations, unions and other interested parties committed to biological and occupational safety in healthcare throughout the European Union.

The European Biosafety Network - Objectives • The Network's primary focus is on promoting and encouraging the implementation and compliance with the Sharps Directive 2010/32/EU in all Member States. • The EBN helps raise awareness, provide guidance, disseminates information and supports effective reporting and monitoring.

The 1 st European Biosafety Summit 1 June 2010, Madrid • Implementation Guidance • A Call for Action • Injection Safety Implementation Update

The 2 nd European Biosafety Summit 1 June 2011, Dublin • Toolkit for Implementation

The European Biosafety Network - Activity Engaging with and bringing together: • Healthcare and non-healthcare workers and their representatives at the European and national level, healthcare management, leading academics, occupational safety experts, infection control experts, national coalitions of stakeholders, the European Commission, the European Parliament, the European Agency for Safety and Health at Work, government agencies and other important stakeholders • Raising awareness, providing information, guidance on implementation, risk assessment and prevention, education and training, reporting and monitoring

Background on Sharps Injuries • Injuries caused by needles and other sharp instruments are one of the most common and serious risks to healthcare workers in Europe and represent a high cost for health systems and society in general. • It is recognised that hospital and healthcare workers (nurses, doctors, surgeons, etc. ), particularly in certain departments and activities (emergencies, intensive care, surgical operations, etc. ), frequently risk infection due to injuries caused by needles or other sharp instruments (scalpels, suture equipment, etc. ). The consequences may be very serious, possibly leading to serious diseases such as viral hepatitis or AIDS. • Some studies estimate the number of needle-stick injuries at approximately 1, 200, 000 per year in Europe. • In the Community strategy 2007 -2012 on health and safety at work, the Commission announced its intention of continuing its work, through consultation of the European social partners as provided for in Article 139 of the EC Treaty, on ways of improving risk prevention with regard to needle-stick infections, among others. • On several occasions, the European Parliament has expressed concern at the life-threatening risks faced by healthcare workers from contaminated needles.

History of Sharps Directive • The European Parliament called on the Commission to submit a legislative proposal for a Directive amending Directive 2000/54/EC (biological agents at work): European Parliament Resolution on protecting Healthcare Workers from blood-borne infections due to needlestick injuries of 6 July 2006 • November 2008: HOSPEEM (European Hospital and Healthcare Employers’ Association) and EPSU (European Federation of Public Services Unions) informed the Commission of their intention to negotiate a framework agreement on the prevention from sharp injuries in the hospital and healthcare sector. • On 17 July 2009 EPSU and HOSPEEM signed a ‘Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector’. • Biological risks due to sharp injuries: a new EU Directive adopted by the Council on 10 May 2011 and published in the Official Journal of the EU on 1 June 2010: Council Directive 2010/32/EU Implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU

Content of Sharps Directive • Purposes, Scope, Definitions • Risk Assessment • Elimination, preventation and protection • Information and awareness raising • Training • Reporting • Response and follow up • Implementation

Sharps Directive implementation • The Directive aims to achieve the safest possible working environment and prevent sharps injuries across the healthcare sector. • It establishes an integrated approach establishing policies in risk assessment, risk protection, training, information, awareness raising and monitoring. • It is legally binding across the EU and there are penalties for non compliance with its requirements. • The Directive came into legal force in all 28 EU Member States in May 2013. • However, the Directive has not been universally implemented geographically across the EU and in non-traditional settings, including primary and homecare and dental surgeries, and with agency and self-employed staff. • The Sharps Directive itself allows its application to be reviewed by the Commission after five years if requested by the parties to the agreement, EPSU and HOSPEEM.

EBN 2016 survey of implementation The online survey conducted in 2016 found a number of possible Causes for Concern • A significant number of countries reported that awareness of legislation, training 66. 30% 33. 70% 17. 46% 20. 10% 67. 90% of staff and the procurement of safety engineered devices were more limited. 35. 07% • A small number of member states had consistently lower levels of awareness and 83. 06% compliance with the Sharps Directive across all questions. 16. 94% • In a number of countries where compliance is generally good, use of some specific 32. 10% 79. 90% categories of safety engineered devices, such as injection devices, is more restricted. 26. 30% 73. 70% 82. 54% • Agency, contract and self-employed staff are either not covered or less aware of the legislation or regulations and thus more at risk of breaching the Sharps Directive. • Care homes, long-term care settings and dental practices are generally underperforming with regard to safer sharps awareness and uptake.

Inspections in United Kingdom • HSE has conducted 40 inspections in UK on compliance with Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 which derive from the Sharps Directive. 66. 30% 17. 46% 20. 10% 33. 70% • Health and safety breaches were identified in approximately 90% of the hospitals visited. 35. 07% 16. 94% 83. 06% • 83% of breaches failed to comply with the Sharps Regulations. 79. 90% 32. 10% • 10 improvement notices have been issued so far to at least a third of the hospitals 67. 90% visited. 73. 70% 82. 54% 26. 30% • Inspections were conducted over two years and formally finished at the end of 2015 but Inspectors are still picking up further breaches.

Issues identified in UK inspections • Failure to use safer sharps where reasonably practicable or inconsistent use of safer sharps across the trust • Failure to assess risks of exposure to blood borne viruses from sharps injuries 66. 30% 33. 70% 17. 46% • Failures to report RIDDORs or report correctly as dangerous occurrence when 20. 10% 35. 07% appropriate • Information and training 16. 94% 83. 06% • Not investigating thoroughly • Lack of suitable and sufficient risk assessments around the use of non-safe sharps 64. 93% 79. 90% (e. g. vaccines) 32. 10% • Sharps legislation in the UK was breached significantly more frequently in the 67. 90% inspections than any other legislation and risk is not managed as effectively as the 26. 30% 73. 70% 82. 54% Directive and the UK Regulations require.

Preliminary Conclusions on compliance with the Sharps Directive • Is the Sharps Directive actually reducing the number of injuries, risks and changing behaviour in practice? • Some member states and some sectors are lagging behind, for example in awareness 66. 30% 33. 70% of the Directive, and might therefore be less compliant. 17. 46% 20. 10% 35. 07% • The UK inspections case study shows that in a small sample of at risk hospitals there is actually very low compliance with the Sharps Directive but also that inspections and 16. 94% 83. 06% enforcement work in changing behaviour, as evidenced by inspections conducted by the HSE. • More still needs to be done on implementation and compliance for those in healthcare 64. 93% 79. 90% 32. 10% but also in non-healthcare settings, including care homes and dental practices. 67. 90% • Self-employed, contract and agency staff in healthcare and non-healthcare settings are more at risk of not complying with the Sharps Directive. 73. 70% 82. 54% 26. 30%

35. 07% 66. 30% 17. 46% 20. 10% 33. 70% 16. 94% 83. 06% 64. 93% 79. 90% www. europeanbiosafetynetwork. eu 32. 10% 67. 90% 73. 70% 82. 54% 26. 30%