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We Set the Standard for ISO-Compliant Reusable Sharps Containers

The introduction of reusable sharps containers has been widely accepted within the healthcare industry due to the inherent benefits they provide, which include a reduction in plastics manufacture and disposal, a significant decrease in CO2e (when compared with the use of single-use containers), and in many cases, a reduction in sharps injuries as a result of the engineered safety features that can be incorporated into reusable sharps containers. 

However, until recently there had been no official standards or regulations governing the design and construction of reusable containers in the UK. That changed in 2019 with the introduction of BS EN ISO 23907-1 and BS EN ISO 23907-2, covering single-use and reusable containers, respectively. 

This page briefly describes the requirements and test methods for Reusable Sharps Containers and will reference the differences between BS EN ISO 23907 Part 1 and Part 2. Use this page as a resource to: 

  • Understand the standards associated with sharps injury protection as they relate to reusable sharps containers 
  • Understand the main differences between BS EN ISO 23907-1:2019 (single-use sharps containers) and BS EN ISO 23907-2:2019 (reusable containers) 
  • Have a basic understanding of the specification requirements and test methods associated with reusable sharps containers 

 

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What is BS EN ISO 23907-2:2019?  


BS EN ISO 23907-2:2019 specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g., scalpel blades, trocars, hypodermic needles and syringes. It is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to single-use sharps containers (refer to ISO 23907-1:2019 for such containers). This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring, and performance testing. 

 

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A Brief History of UK Sharps Container Standards

When reusable sharps containers were introuced into the UK, the technical requirements and test methods for single-use sharps containers were outlined in BSI Standard 7320, which was released in 1990. The BSI standard was not applicable to reusable sharps containers at the time of launch, so it was typical for reusable container suppliers to mirror the tests performed within BSI 7320-1990 as a ‘claim of safety’. Whilst this was deemed acceptable by some procurement professionals, it did not go as far as other international standards (e.g., Canadian, Australian, and New Zealand standards) where additional performance testing was required to prove that reusable containers would meet the performance criteria of a single-use container throughout its reuse lifespan. 


One UK provider of reusable sharps containers (Sharpsmart Ltd) also mirrored the test methods outlined in the more stringent international standards to provide comfort to NHS procuring authorities that the containers were safe to use throughout the expected life of the reusable container. The lack of standards control related to reusable sharps containers has, however, enabled some providers to supply containers that have not routinely undertaken lifecycle and cleaning validation tests under the claim that ‘single use or international standards do not apply to UK Reusable containers’. This vacuum in standards availability has, in some instances, allowed non-compliant and poor-quality reusable containers to enter the global market. The introduction of ISO 23907-2:2019 was developed to ensure that safety and quality was incorporated into the global healthcare market, where healthcare worker and patient safety is an absolute priority. 

 

 

For single-use containers

  • In 2012 a new single-use sharps container standard was launched and adopted by BSI which superseded the old BSI 7329-1990. EN ISO 23907 Part 1 was introduced and adopted by BSI. It included globally harmonised, modernised, and more stringent design criteria and test methods than what was in the 1990 British Standard. Again, this standard did not include reference to the requirements for reusable sharps containers. This standard was updated again in 2019 and the new standard reference for single-use sharps containers is now BS ISO 23907-1:2019 

For reusable containers

  • During the production of the ISO single-use container standard, it was agreed by the ISO working group that a completely new standard for reusable sharps containers was required. In 2019 the BS ISO 23907-2:2019 was launched. This new standard not only covered the design functionality for user safety outlined in ISO 23907 Part 1 (single-use containers), but it also included requirements for lifespan simulation, cleaning & decontamination, microbial validation, quality monitoring, and performance testing for reusable standards. The goal of the new standard was to ensure that cleanliness and quality was inherent each time the container was reused and also to ensure that the container performed ‘as designed’ and compliantly after each use. 

Engineered Safety Features of Reusable Containers

Explanation of Additional Testing for Reusable Containers

Unique Testing Requirements for Reusable Containers  

Reusable sharps container manufacturers have validated their containers for many hundreds of uses, and the reusable sharps standard outlines the pre-conditioning processes that should be carried out to ensure that containers continue to perform after each use. Tests are performed to validate that the resistance to penetration, stability, handle strength, and resistance to damage/leakage would be maintained following the expected lifecycle use expiration of the container.  

Lifespan Transport & Processing Simulation Testing 

Section 5 of BS EN ISO 23907-2:2019 outlines the rigorous conditioning that the reusable sharps containers will undergo before the standard sharps container testing (as outlined in BS EN ISO 23907-1:2019) will take place. The Part 2 standard outlines the procedures for temperature conditioning, tumbling with representative sharps simulation, transportation, and processing (opening, decanting decontamination, and closing). 

Test procedures for Cleaning & Decontamination 

Section 4.5 of BS EN ISO 23907-2:2019 outlines the stringent requirements of the cleaning and validation process that must be achieved to render the containers clean (i.e., aesthetic and visibly free of soil, debris, and organic matter, and decontaminated to a level that renders them safe for handling and reuse). 

Test Procedures for Microbial Validation 

Annex A within BS EN ISO 23907-2:2019 shows an example of a procedure suitable for the validation of the microbiological efficacy of the decontamination process and for establishing the validation parameters during automated processing, showing an example test report.


How Can Reusable Sharps Containers Be Purchased? 

Reusable sharps containers can be purchased through competitive tendering processes and procurement frameworks. The reusable sharps container service can include the supply and collection of the containers, including or excluding the sharps disposal element of the service. The reusable sharps container service can be procured on a ‘per-turn’ basis (where the supplier charges by the number of containers delivered/collected) or as a fixed monthly service fee which is calculated based on the prior year sharps disposal weights and single-use bin procurement volumes. 
 

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