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Safety On Point - Safety Legislation

Among clinicians, healthcare workers and staff, accidents involving "medical sharps" occur frequently, at an estimated rate of 3.5 million incidents per year worldwide. Many of these cases can be attributed to mishaps wih IV catheters, hypodermic needles, blood collection devices and vascular access needles.

A needlestick injury or case of blood exposure can devastate the healthcare institution, the practice and the victim, who needs to be tested for possible transmission of blood-borne infection. For a victim who contracts an infection or a disease, there is medical care and even the prospect of long-term health consequences.

Taking measures to avoid needlestick and blood exposure is the best defense, and it makes good sense.

Safety On Point

Austria

On May 11th 2013, Austria's needlestick regulation (Nadelstichverordnung, NastV) came in to effect. The NastV implements guidelines from the EU Sharps Directive 2010/32/EU into national law and demands the safe handling of medical sharps in the health sector, as well as in other similar workplaces such as laboratories and nursing homes.

NastV complements and further defines the existing work safety regulations (Arbeitsschutzgesetz, ASchG) and the regulation on biological agents (VbA) across the nation, and has the goal to prevent injuries with medical sharps such as needles.

Sharps safety is a particularly prominent issue for Austrian healthcare workers, as more than a third of all workplace accidents in Austrian hospitals were needlestick injuries. NastV aims to minimise the risk of injury when workers come into contact with medical sharps and outlines the responsibilities of the employer and workers themselves. The legislation also recommends that employers should establish written instructions and other measures with any subcontractors, cleaning crews and sharps disposal services) in order for these workers to observe the law.

The required measures of NastV

NastV requires employers in the healthcare sector to assess and determine the specific risks of injury from medical sharps. They must consider various situations in which workers could injure themselves and consequently come in contact with potentially infectious or hazardous materials. These situations include, for example, taking blood samples or disposing of instruments.

In general, medical devices incorporating safety and protection mechanisms should replace traditional instruments, apart from those that don't have such safety devices available.
The recapping of needles breaches the guidelines in all circumstances and is prohibited.
Disposal containers should be placed close to the workstation and special instrument racks should be established on which all pointed or sharp instruments are consistently aligned.

The legislation also outlines the obligation of the employer to provide information and training for employees who have to deal with medical sharps. The training must be provided before the start of the activity and be repeated at regular intervals. NastV stipulates that employers must have a process to ensure that staff can meet their legal health and safety obligation to report any injury or near- injury. Furthermore, measures to reduce time pressure and shifts that are overly long are to be analysed.

Regions:

Europe

Countries:

Austria

Belgium

For Belgian health sector employees, preventing the risk of biological agents became subject to more specific rules in April 2013. The already established rule, Article 3 of the Royal Decree of 4 August 1996, was given further clarification surrounding the use of medical sharps.

The updated legislation gives more responsibilities to the employer and explains that they are now obliged to manage, organize and deliver health care and the services directly related to their employees, contractors and subcontractors who may be at risk of sharps injuries. The information to the contractors must provide clarity on the risks of working with sharp instruments as well as preventative measures taken. The employer must also ensure that employees of contractors and subcontractors receive the right training and instructions in connection with medical sharps.

Risk analysis and prevention

Concerning risk analysis, the employer must examine all situations where employees can become injured by a sharp medical instrument during the work day.

During the risk assessment, the employer shall take into account:

The technology and the material used;
The organization of the work;
Working conditions;
The level of qualification;
Work-related psychosocial factors;
The influence of environmental factors at work.

On the basis of this risk assessment, the employer will take preventive measures, including information provision and providing user manuals for medical sharps.

The employee continues to be committed to the following measures if the risk assessment shows that there is a danger of injury and/or infection by medical sharps:

Ending the unnecessary use of medical sharps by changing the way in which work is conducted. Based on the findings of the risk assessment, the employer is also required to incorporate safety-engineered protection mechanisms in the tools;
Ban the recapping of needles;
Establishing and implementing safe procedures for using and disposing of medical sharps and contaminated medical waste. These procedures should be regularly reviewed;
Employing clearly marked and technically safe containers for disposing of sharp medical instruments and contaminated medical waste, as close to the areas where these tools are used;
Highlight the various risks associated with the use of a medical sharp devices;
Creating awareness by developing activities and promotional materials.

The employer is also responsible for explaining the risks and the preventive measures during the induction period. Compliance with the measures on the prevention of injury and/or infection by a sharp medical instrument is the responsibility of the employer.

Regions:

Europe

Countries:

Belgium

EU Directive 2010/32/EU Legislation Overview

The EU Directive 2010/32/EU is implementing a Framework Agreement on the prevention from sharp injuries in the hospital and healthcare sector.

The scope of the Directive applies to all workers in the hospital and healthcare sector who are exposed to a risk of injury from medical sharps while at work on the healthcare premises. Employers and employees have a responsibility to ensure safe working practices which includes following guidelines and directives set out by the EU.

The purpose of the Directive is to achieve the best possible working practices by the introduction of safer sharps systems as well as dedicated reporting procedures and staff training.

The Directive requirements build on existing requirements such as the Health and Safety at Work Act 1974 and the Provision and Use of Work Equipment Regulations 1998.

The deadline for member states of the European Union to implement appropriate changes in needlestick and medical sharp protection was May 11th 2013. Now this has passed and the UK, along with other EU states, has had to ensure its policy comes in line with the EU Directive 2010/32/EU in order to comply and reap the benefits for its healthcare workers.

Helpful Links/Guidance:

href="http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:134:0066:0072:EN:PDF">Official Journal of the European Union L/134/66 (2010) Council Directive 2010/32/EU

Health & Safety Website

Health & Safety Information Sheet

Health & Safety at Work Act 1974

Safer Needles Network

Royal College of Nursing guidance

European Biosafety Network

Regions:

Europe

Countries:

United Kingdom, Germany, France, Spain, Belgium, Portugal, Australia, Austria, Italy

France

Before the EU Directive 2010/32/EU came into effect, France had some needlestick legislation under the Decree No. 2001-1016 of 5 November 2001, which concerns the creation of a risk assessment document on the evaluation of hazards for the safety and health of workers. The legislation mandated that this log be updated at least once a year, as well as whenever there were significant changes in the workplace affecting workers' health and safety conditions.

Code du travail; Decree 2001-1016 had three requirements for risk prevention:

  1. General safety requirement for the employer>: The employer must transcribe into a single document the results of the risk assessment for safety and health of workers in the entire property.
  2. Obligation to carry out risk assessment
  3. Implementation of the general principles of prevention

The key elements of Decree No. 2013-607

France enacted Decree No. 2013-607 on 9 July 2013, which protects workers who are at risk of biological infections due to their contact with medical sharps. This decree introduced a new Article R4424-11 in the Labour Code, requiring the employer to follow a risk assessment for sharps safety and, where appropriate, to take the necessary steps to remove them.

The objectives of the Directive are to strengthen the obligations of employers in the prevention and protection of workers within inpatient and outpatient sectors.

  • Ensure maximum safety in the workplace;
  • Prevent injuries to medical workers by sharp object;
  • Defines a strategy to develop an evaluation policy, risk prevention, training and awareness.

The three key steps include:

  • Evaluation in order to prevent and eliminate risk to protect health and safety of workers;
  • Identify workers at risk;
  • Eliminating the risk by implementing a series of measures, when the results reveal a risk of injury from sharps and / or infection.

Helpful Links/Guidance:

Directive 2010/32/UE du Conseil – Français

Arrêté du 9 juillet 2013 relatif à la prévention des risques – Français

Regions:

Europe

Countries:

France

Germany

Since 2007, needlestick regulations have been in place under TRBA250 (Technische Regeln für Biologische Arbeitsstoffe; Technical Rules for Biological Agents). One of the main components of TRBA250 is the call for protective measures, which includes the replacement of medical sharps with safer devices.

TRBA 250 mandates that needle safety devices include the following properties:

  1. One-handed activation
  2. No change in technique
  3. Safety mechanism prevents re-use

Ordinance on Biological Substances (BioStoffV)

In July 2013, the EU sharps directive was signed into Germany's national law, the Ordinance on Biological Substances (BioStoffV). It aims to reduce the risk associated with needlestick injuries, while expanding the law concerning biological agents in the hospital and healthcare sector.

The new version of BioStoffV outlines basic obligations for the employer which, if ignored, would put them at risk of fines. Among the regulations, organizations must conduct a risk assessment, develop the occupational health and safety requirements regarding activities with biomaterials and integrate them into the organisation, planning and design of work.

German law dictates that the STOP principle must be followed, which means that sharps must be substituted by safety devices as a priority, followed by technical, organisational and personnel measures. In order to avoid infection, medical sharps must be replaced by those with no or less risk of sharps injuries, as far as technically possible.

Helpful Links/Guidance:

Richtlinie 2010/32/EU Des Rates - Deutsch

Verordnung über Sicherheit und Gesundheitsschutz bei Tätigkeiten mit Biologischen Arbeitsstoffen (Biostoffverordnung - BioStoffV) - Deutsch

TRBA 250 - Technische Regeln für Biologische Arbeitsstoffe - Deutsch

TRBA 250 - Biological agents in health care and welfare facilities - English

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) – (Federal Institute for Occupational Safety and Health)

Regions:

Europe

Countries:

Germany

Italy

In Italy, there was already some needlestick safety legislation under law 81/2008, known as the “Consolidated Law on Safety at Work” (Testo Unico Sicurezza Lavoro). It reads: "The employer is under an obligation to provide employees with all general information on the risks present in the workplace and specific information on the risks associated with performance of the tasks assigned to individuals."

The Italian government has now enacted Legislative Decree of February 19, 2014, n. 19 to implement the European Directive 2010/32/EU across the nation. This means that Italian hospitals will not only be encouraged to buy safety devices, but also risk being penalised if they opt to use conventional devices.

The provision applies to all workers who operate in the health sector, both public and private, who may be affected by sharps injuries, including employees, trainees, apprentices, temporary workers, students, and sub-contractors.

The legislation's objective is to apply measures to prevent injury and transmission of infection in the provision of services in the hospital and healthcare setting, in relation to the risks and methods of use and disposal for medical sharps. It aims for the use of equipment considered to be technically more secure, such as medical devices incorporating sharps mechanism protection and security that can protect your hands.

The key elements of Decreto legislativo 19 febbraio 2014

The employer has an obligation to ensure the health and safety of workers in every aspect related to their professional life, including psychosocial factors and the organization of work, in particular:

  • To ensure that health personnel are adequately trained and provided with resources to operate in safe conditions to avoid needlestick injury and subsequent infection;
  • To adopt appropriate measures to eliminate or contain more than the risk of injury and occupational infections through the elaboration of a comprehensive prevention policy which takes account of the most advanced technologies, organization and working conditions, psychosocial factors related to exercise of the profession and of the influence on workers from the workplace;
  • To create conditions which encourage participation from active workers and their representatives in the drafting of comprehensive prevention policies;
  • To never assume a non-existent risk;
  • To ensure adequate awareness-raising measures through a mutual degree of employee involvement and their representatives;
  • To plan and implement prevention initiatives, awareness, information and training and monitoring to assess the degree of impact of sharps injuries in workplaces involved;
  • To promote the reporting of accidents, in order to highlight the systemic causes.

The employer, during risk assessment, must ensure that it includes determining the level of risk of exposure to diseases that can be contracted in relation to working methods, so as to cover all situations of risk involving injuries and contact with blood or other potential carriers of infection.

During risk assessment, employers must identify necessary technical, organizational and procedural rules regarding working conditions, the level of professional qualifications, work-related psychosocial factors and the influence of factors related to the working environment, to eliminate or reduce occupational risks assessed.

Through the risk assessment, the employer shall take the following measures:

  • Define and implement procedures for safe use and disposable of medical sharps and waste contaminated with blood and biological materials;
  • Install containers that are properly marked and technically safe for disposal of medical sharps, with the containers placed as close as possible to the areas in which they are used;
  • Procedures must be periodically subject to an evaluation process to test effectiveness and are an integral part of the programs of information and training of workers;
  • Eliminate the use of sharps when such use is not strictly necessary:
    • Introduce medical devices incorporating protection and security mechanisms;
    • Immediate ban on the practice of manual recapping of the needles in the absence of protective devices and safety for punctures;
  • Conduct training:
    • Proper use of medical devices incorporating sharps safeguards and security;
    • Procedures to be implemented for notification, response and monitoring post-exposure;
    • Prophylaxis to be implemented in case of wounds or punctures on basis of the assessment of the source of the risk and the ability to infect.
  • Awareness-raising activities and the dissemination of information that promote:
    • Support programs be put in place as a result ofinjuries;
    • Different risks associated with exposure to blood and body fluid resulting from use of medical sharps;
    • Standard precautions should be taken towork in safe conditions;
    • Proper procedures and use ofdisposal of medical devices used;
    • Importance of reporting in the case of injury the relevant information about the details of the sharps injury occurrence.
    • The importance of immunization - advantages and disadvantagesvaccination or non- vaccination, be it preventiveor in the case of exposure to biological agents for which there areeffective vaccine. These vaccines should be dispensed free of chargeto all workers and students who provide health care and activities related to it in the workplace.
    • Evaluations of the procedures that need to be taken in case of injury to the worker:
      • To provide immediate care to the injured, including post-exposure prophylaxis and the necessary medical tests and, where appropriate, psychological assistance;
      • Ensure proper notification and subsequent monitoring for the identification of appropriate prevention measures to be implemented through the recording and analysis of the causes, mode and circumstances that led to the occurrence of accidents resulting from sharps injuries, ensuring confidentiality for the worker.
  • Failure to follow the legislative requirement can lead to sanctions for the employer and is punishable with imprisonment and / or fines.

Helpful Links/Guidance:

Direttiva 2010/32/UE del Consiglio - Italiano

Regions:

Europe

Countries:

Italy

Portugal

Portugal implemented Decree-Law no. 121/2013, of 22nd August 2013. This decree establishes the legal framework for the prevention of injuries caused by medical cutting-perforating devices constituting work equipment in the sectors of hospital and health care, transposing into national law the Directive 2010/32/EU. It encompasses employers, workers, subcontractors, students and trainees of hospitals and health care. According to the legislation, employers must create measures to be carried out to ensure that subcontractors comply with the law.

All medical devices that cut or perforate the skin or can cause wounds, sores or infections in healthcare workers, defined under Article 3 of the Decree-Law n. 145/2009, come under the directive.

"Specific preventive measures" include anything taken to prevent injury or infection transmission in the workplace. This encompasses the use of safety equipment, based on risk assessment and the education of staff on safe methods of handling and disposal of medical devices, which could cause them harm.

The employer shall ensure health and safety in all aspects of the work, though professionals in the sector are responsible for their own safety after comprehensive training and education has taken place.

Employers

The employer shall provide specific information about the risk of injury caused by medical sharps in the following aspects:

  • Disclose, comply with and ensure compliance with the rules of use or instructions issued by the manufacturer;
  • Disclose annually a list of incidents, accidents and adverse events that occurred in the last three years;
  • Sensitize the workers' representatives for the development of activities and materials to prevent incidents and accidents.

Employees

In order to minimize the risk of injury and / or infection caused by the use of medical sharps, workers, contractors, students and trainees shall:

Know and comply with the technical standards of Direção-Geral da Saúde (Portuguese Directorate-General for Health) in relation to:

  • Prevention and control of infection associated with health care;
  • Basic precautions for infection control;
  • Good practices to prevent incidents and accidents;
  • Know and comply with the rules of use or instructions issued by the manufacturer.

The employer shall have a system for reporting incidents and adverse events, according to the National System of Incident Reporting and Adverse Events of Direção-Geral da Saúde. The reporting of incidents, adverse events and accidents involves researching the causes and circumstances in which they occurred and taking the resulting corrective measures, in conjunction with representatives of the workers in the fields of health and safety.

Helpful Links/Guidance:

Directiva 2010/32/UE do Conselho - Portugués

Regions:

Europe

Countries:

Portugal

Spain

The Spanish Official Gazette announced on July 31, 2013 the implementation of the Directive ESS/1451/2013, which sets up provisions for the prevention of injuries caused by sharp medical instruments in the hospital and healthcare sector.

The key elements of ESS/1451/2013

The objective of these new rules is to create the safest working environment possible for health professionals:

  • To prevent injuries resulting from the use of a sharp medical instruments;
  • To establish an integrated approach defined by policy evaluation, prevention, training, information, awareness-raising and monitoring;
  • To implement responses and follow-up procedures.

These new rules apply to all workers in the hospital and healthcare sector and those who are under the direction and supervision of employers. All medical facilities, whether in the public or the private sector, must comply with this directive.

A special emphasis is placed on "specific preventive measures" that should be taken seriously by hospitals. This set of measures was designed to provide better training for health professionals along with adequate resources.

The directive specifies that active staff participation in matters of health and safety is crucial. In the context of risk analysis, the employer must examine all situations where employees can become injured in the course of their work and/or may be infected by a sharp medical instrument or as a result of exposure to blood or other potentially infectious material. The protocol of action is based on three fundamental pillars: elimination, prevention and protection.

Article 6 ensures that the unnecessary use of sharp instruments is eliminated through changes in practice. In addition, the text calls for a reduction in exposure to these materials to adequately protect the security of workers. The directive encourages the use of a good practice guide in order to develop a comprehensive and coherent prevention policy which covers technology, work organization and working conditions.

It also advises that vaccination should be free to all workers and students engaged in health activities. The hospital or medical centre should inform them of the pros and cons of vaccination, including the possible impact on their health and the environment.

Article 8 of the directive also ensures that adequate training on policies and procedures for the use of sharp medical instruments is offered. Non-compliance with the new rules will be punished in accordance with the provisions of the revised text of the law on offences.

The directive concludes with an appendix of 10 recommendations on how to use sharp materials, with an emphasis on a careful approach, the importance of hygiene and the implementation of a good policy for throwing away used needles.

Recommendations on the use of sharps

  1. Needles and sharp instruments used shall be handled with extraordinary care.
  2. Precautions shall be taken during and after use to cleaning and disposal.
  3. Once used, the needles should not be subjected to any manipulation.
  4. For disposal, needles, syringes and other sharps should be placed in sharps containers, which will be located in the area where they are to be used.
  5. Never completely fill the containers, since the needles protruding from the containers constitute a significant risk to the people who handle them.
  6. Whenever possible, health workers using sharps must personally place them in the appropriate container.
  7. Never leave sharps on a surface, because of the risk that other workers may have accidents.
  8. This is especially necessary after interventions at the bedside of the patient as the individual who manages an instrument knows the situation and number of sharps used, thus avoiding the risk of exposure to other workers.
  9. Particular care that no sharps or pointed objects in clothes go to the laundry, as they can cause accidents to workers who handle it.
  10. No sharps shall be placed in plastic bags placed in garbage cans.

Helpful Links/Guidance:

Directiva 2010/32/UE del Consejo - Español

Regions:

Europe

Countries:

Spain

The Netherlands

The European Directive 2010/32/EU was implemented into the Netherlands through the Working Conditions Decree, Article 4.97 in January 2012. It states that:

  • Safe needle systems must be built with safety and protection mechanisms available;
  • Recapping is prohibited.

Employers

Employers are required to take action to prevent needlestick injury through measures of using safety needle devices and using needle containers for the safe disposal of sharp materials.

Employers are required to educate, train, and supervise on safe needle practices, as well as what to do if an injury occurs. This includes drawing up an emergency plan that is required by the Working Conditions Decree (Article 4.97) and is posted in the workplace.

The Emergency Plan includes:

  • Perform a risk assessment within two hours after any injection accident and, if necessary, the employee may undergo treatment. If there is a risk of HIV infection, the employee must receive PEP (post-exposure prophylaxis).
  • Record the risk of needlestick injuries in the risk assessment and evaluation.
  • Providing hepatitis B vaccination to all staff that any risk of a needlestick injury.

Employees

Employees are also responsible for their safety and should follow safe needle procedures and instructions of use and ask their employers for safe needle systems.

Helpful Links/Guidance:

Richtlijn 2010/32/EU Van de Raad – Nederlands

ArboPortaal

Regions:

Europe

Countries:

The Netherlands

The United Kingdom

The directive serves as an addition to working standards for those employed in medical and healthcare sectors across the European Union. As a product of this, it demands that healthcare organisations can demonstrate that they are "providing medical devices incorporating safety-engineered protection mechanisms which encompases both needles and intravenous catheters.

In the UK, many of the requirements contained in the directive were already addressed in the Health and Safety at Work Act 1974. However the legislation provides specific details on requirements which must be introduced in order to bring the country in-line with the new regulations. The new legal requirements, of both employer and employee, indicate that they must work together to ensure the "effective safe management of sharps, across all sectors, flows from the existing health and safety legislation. In particular, the needs to assess the risks, provide appropriate information and training, and consult with employees", according to a leaflet distributed by the Health and Safety Executive (HSE). This will be achieved by adjusting the current health and safety standards to explicitly meet the requirements of the legislation protocol.

Britain's biggest trade union, Unison, has supported the need for safer needlestick regulation with its Safer Needles Network and is pleased the EU has enforced appropriate legislation. Robert Baughan, National Officer for Health & Safety for the union, said that workers had welcomed the introduction of the new policies.

He said: "The feedback we have had is positive for those affected by sharps injuries." However he added that it only "applies to healthcare workers" and Unison would like to see "the directive to extend to all workers who are working with sharps".

Benefits

A number of benefits can be attributed to the implementation of such legislation for medical workers in the UK. Financially, it is thought that needlestick injuries cost £500,000 per NHS Trust every year, according to a Memorandum submitted by the Safer Needle Network. Compare this to the £136,000 annual cost of introducing the safety-engineered devices and you can see it is a logical monetary step for state-funded organisations.

However it will be the ethical considerations that drive many employers to support the legislation. A safer working environment will surely boost loyalty, job satisfaction and productivity among staff.

Mr Baughan said that the legislation makes it very clear for employers about what they need to do to make work environments safe. It specifies the need for higher arbitrary controls which means they have to consider engineering controls and collective measures like the use of safe needle stick devices above measures which are aimed at individual behaviour which is always harder to enforce, according to the official.

He said that a possible drawback would be that the legislation required a change in behaviour for many people which can't always be guaranteed. There is always the chance for human error so the union is always looking for measures that can reduce this as much as possible, according to Mr Baughan.

Helpful Links/Guidance:

Official Journal of the European Union L/134/66 (2010) Council Directive 2010/32/EU

Health & Safety Website

Health & Safety Information Sheet

Health & Safety at Work Act 1974

Safer Needles Network

Royal College of Nursing Guidance

European Biosafety Network

Regions:

Europe

Countries:

United Kingdom

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