Sentinal™ & Samplar™: Winners of the UK Lab Consumables Innovation Award 2022 and Best Consumer Innovation Award 2023.
Regulatory Information
Sharps Legislation & Regulation
Implementation of Safety Engineered Devices (SED)
Reduce 70% Injuries
Governments around the world have recognised the enormous unnecessary costs of accidental needlestick injuries (NSI) in the medical and healthcare sector.
They have enacted legislation to ensure that those responsible for healthcare workers are actively seeking to reduce NSI risks.
Key Principles of Workplace Safety Regulations
All Regulations Espouse The Basic Principles
Workplace safety regulations universally uphold fundamental principles aimed at safeguarding the health and well-being of employees. Regardless of jurisdiction or industry, these principles serve as guiding standards for employers and organizations to create safe work environments and prevent accidents. These regulations are founded upon principles such as the employer’s responsibility for the health and safety of their workers, the proactive identification and elimination of potential hazards, and the implementation of safer procedures and equipment. By adhering to these basic principles, employers can ensure the safety of their workforce and mitigate the risk of workplace injuries and accidents.
Employer Responsibility for Workplace Safety
Workplace safety regulations emphasize the paramount importance of employer responsibility for the health and safety of their workers. Employers bear the ultimate duty to ensure the well-being of employees in all aspects of their work, cultivating a culture of safety and accountability throughout the organization.
Proactive Hazard Identification and Prevention
These regulations prioritize the proactive identification and elimination of potential hazards in the workplace. Employers are encouraged to implement measures to prevent accidents before they occur, rather than reacting after incidents happen. This proactive approach helps create safer work environments and reduces the risk of occupational injuries.
Implementation of Safer Practices and Equipment
Implementation of safer procedures and the use of modern safety-engineered devices. Employers should invest in training, enforce safety protocols, and utilize devices with engineered control of sharps exposure (SED) to protect workers from occupational hazards can significantly reduce the risk by prioritizing safer practices and equipment, employers.
Safety Engineered Devices (SED)
Safety Regulations Enacted
USA
OSHA Bloodborne pathogen standard (29 CFR 1910.1030) – 1991 Amended 2000.
EU
Directive 2010/32/EU – Prevention from sharp injuries in the hospital and healthcare sector.
UK
Health and Safety (Sharp Instruments in Healthcare) Regulations 2013.
Australia
Work Health and Safety Act 2011 (WHS Act) and Work Health and Safety Regulation 2017 (WHS Regulation).
Safety Engineered Devices (SED)
Essential Regulatory Standards
Safety Engineered Devices (SED) are designed to meet stringent regulatory standards to ensure maximum protection and usability in healthcare settings. These regulations mandate that SEDs incorporate advanced safety features, provide ease of use, and maintain reliable performance to prevent needlestick injuries and other hazards. By adhering to these rigorous standards, SEDs offer the highest level of safety for both healthcare workers and patients, ensuring that safety measures are seamlessly integrated into everyday medical practices.
Single-Handed or Automatic Activation
Safety Engineered Devices (SED) should feature mechanisms that can be activated with one hand or automatically. This ensures that healthcare professionals can maintain control and efficiency during procedures, reducing the risk of needlestick injuries.
Irreversible Safety Mechanisms
Once activated, the safety mechanisms of SEDs must not be easily reversible. This prevents accidental exposure and ensures that the device remains safe throughout its use, unlike devices with lids that can be easily reopened.
Ease of Use
SEDs must be user-friendly, requiring little to no change in technique for healthcare professionals. This ease of use ensures that safety protocols can be seamlessly integrated into routine practices without additional training or disruption.
Integrated Safety Mechanisms
The safety mechanism of an SED must be an integral part of the device itself, not a separate accessory. This integration ensures consistent performance and reliability, enhancing the overall safety of the device.
Uncompromised Patient Care
SEDs must not compromise patient care in any way. They should provide the same or improved levels of care as traditional devices while offering enhanced safety features for both patients and healthcare professionals.
Reliable Performance
SEDs must perform reliably under various conditions. Consistent and dependable performance is crucial to ensuring the safety and effectiveness of these devices in clinical settings.
Convenient Activation
The activation of the safety mechanism in SEDs must be convenient, allowing healthcare professionals to maintain appropriate control over the procedure. This ensures that safety measures do not interfere with the efficiency and effectiveness of patient care.
No Additional Safety Hazards
SEDs must not create other safety hazards or sources of blood exposure. The design and functionality should enhance safety without introducing new risks to healthcare workers or patients.
Clear Activation Indication
Activation of the safety mechanism must be indicated by an audible, tactile, or visual sign. This clear indication ensures that healthcare professionals are aware when the device is safely engaged, providing an additional layer of assurance during use.
Safety Resources
Needlestick Injuries
The World’s First Safety Engineered Needlestick Safe Blood Sampling Adaptor, Samplar is the first Safety Engineered Device (SED) for transferring samples of platelet or blood from a bag into a test or culture bottle. It is used in quality control of platelets or other blood products.