Standards Development

Scope

This document specifies requirements, recommendations and test methods for the design of sharps containers intended to hold only secured sharps medical waste possessing a passive/automatic sharps injury protection mechanism remaining active until recycling. Other medical wastes and especially liquid, have to be disposed in other appropriate containers.

It provides instruction for the labelling and the instruction for use of the container so as guidance for evaluating the secure medical waste it can hold safely. 

This document is applicable to containers for secure sharps medical waste 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) and reusable sharps container (refer to ISO 23907-2) that can hold potentially hazardous sharps medical waste without functional sharps injury protection mechanisms.

Purpose

Nowadays, due in part to the use of standard precautions, engineering controls (safer medical devices), sharps containers and PPE, frequency of sharps injuries have declined. Given the risks of transmission (hepatitis C, hepatitis B, HIV…) that hazardous sharps medical waste can transmit, it is crucial to keep adopting procedures, trainings, PPE, medical devices and containers that can collectively ensure the minimisation of blood borne exposure risk in the various care contexts (Healthcare setting, homecare, labs…) and the waste stream.

Medical device that includes a sharp injury protection mechanism (SIPM) can play a role to reduce the risk of an exposure incident: the non-access to the sharps providing an important post use protection. ISO/TC 84 has recently revised ISO 23908 “Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods” to provide a trustful framework for designing and evaluating the performance of SIPM. However, discrepancies exist in such device, some requiring an additional action for activating the safety mechanism (Active or nonautomatic SIPM) while other are automatically deployed after the device’s use for the intended purpose (Passive or automatic SIPM). Reported injuries despite using device with SIPM mainly occurs prior to activation of a safety feature, underlining the importance of employing safe work practices when using the devices so as the need to adopt preferably device with passive SIPM when the possibility exists.

While the use of device with SIPM is increasing over the years, the practice related to disposal, recovery or recycling varies among countries and frequently rely on single use or reusable sharps containers without distinction between secure medical device wastes and regular sharps medical wastes. Few countries such as France, has and is experiencing different process aiming to recycled some of the MD waste and reduce the environmental footprint of the sector:

- Separation of electric sharps medical waste with passive SIPM from the regular MD sharps waste

- MD waste without needles or with a passive SIPM remaining efficient during the waste stream transportation until entering the recycling or recovery process.

Those different waste stream pathways have been largely promoted and supported by manufacturers that have identified the environmental, financial and reputational benefits of this waste separation. Such distinction permits also the use of different container than ISO 23907-1 or ISO 23907-2 ones, because of the lower risk level justified by the absence of accessible sharps in the MD waste collected plus the automatic deployment of the safety feature (no Human factor).

This proposal is aiming to define collectively the requirement, criteria, test method of container intended to hold only secure MD waste with passive SIPM in a similar framework than ISO 23907-1 and ISO 23907-2 (Performance’s criteria and testing methods but not restricted to a specific material). Relevant criteria and tests methods from the ISO 23907 series have been implemented in this proposal. This standard proposal aims also to provide guidance for selecting the waste than can be stored safely with this new container. Such containers are less costly and presents lower environmental footprint than the current single use and reusable one. In addition to contribute to the necessary changes of the sector to make it sustainable, it is reducing the container cost for the healthcare system and indirectly encouraging to adopt more largely device that present the highest level of safety in term of post use sharp injury protection.

To conclude we believe that this proposal can contribute to promote the use of device with passive SIPM and at the same time contributing to reducing the container costs and the environmental footprint promoting the creation, in a near future, of safe working condition and virtuous circular economy for medical device