Managing medical devices end of life cycle – August 2023

Premarket requirements and placing products on the market are typically the focus of medical device businesses. But managing the end of lifecycle of medical devices – safe disposal and recycling – has increasingly become a compliance issue, both in relation to latest medical device regulations and local environmental and health regulations.

By Val Theisz

Once ownership of medical devices changes hand from manufacturers or distributors to healthcare organisation and end consumers, manufacturers no longer have control on what happens to used medical devices and how these are discarded or recycled. But does that mean manufacturers have no responsibility for managing the end of lifecycle of their products? Not quite. Medical device regulations include requirements for managing the product end of life.

For example, the EU Medical Devices Regulation or MDR and the In Vitro Diagnostic Medical Devices Regulation or IVDR include requirements for the safe disposal of medical devices in Annex I General Safety and Performance Requirements or GSPRs (emphasis added):

EU MDR:

13.3. For devices manufactured utilising non-viable biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.

14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.

23.4. Information in the instructions for use

The instructions for use shall contain all of the following particulars:

(v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:

— infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and

— physical hazards such as from sharps.

If in accordance with the point (d) of Section 23.1 [General requirements regarding the information supplied by the manufacturer] no instructions for use are required, this information shall be made available to the user upon request;

EU IVDR:

13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.

20.4.1. The instructions for use shall contain all of the following particulars:

(ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any. This information shall cover, where appropriate:

(i) infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin;

(ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation);

(iii) physical hazards such as explosion.

Similar requirements are defined in the Australian Medical Device Regulations, in Schedule 1 Essential Principles:

9.2 Minimisation of risks associated with use of medical devices

(h)  the risks associated with disposal of any waste substances.

13.4  Instructions for use

26 Information about precautions that should be taken by a patient and the user if there are special or unusual risks associated with the disposal of the device

In the U.S., the FDA regulation 21 CFR Part 801 Labeling does not cover instructions for safe disposal of medical devices, as waste handling including safe disposal of medical devices is managed at State level.

In addition to medical device regulations, manufacturers need to be aware of state and national environmental, packaging labelling and waste disposal regulations in the market they place their devices on.

In the EU, the key environmental Directives are:

• Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) – The RoHS aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste by restricting the use of certain hazardous substances such as heavy metals, flame retardants or plasticizers, that can be substituted by safer alternatives.
• Waste from Electrical and Electronic Equipment (WEEE) – The WEEE aims to address environmental and sustainability issues caused by the growing number of discarded electronics, also referred to as electronic waste or e-waste, by preventing e-waste where possible, and setting targets for re-use, recycling and other forms of recovery.
• Batteries Directive and New EU regulatory framework for batteries – The Battery Directive aims to minimise the negative impact of batteries and waste batteries on the environment, by setting limits to hazardous substances in batteries such as mercury, cadmium and lead, and to set rules for the proper management of waste batteries.
• Packaging Waste – The Packaging Waste Directive aims to prevent the generation of packaging waste, reducing it in quantity, and promoting reuse and refill and increase the use of recycled plastics in packaging, thus enabling more high quality (“closed loop”) recycling and substituting virgin materials.

In Australia, attempts were made to introduce recycling schemes such as the Australian Packaging Covenant and REDcycle, with limited success (to put it mildly). An official review in April 2023 found Australia was recycling just 18% of plastic packaging and would fall well short of a target of 70% by 2025. In June 2023, the States and Territories environment ministers issues a Communiqué in which they agreed to:

• Take shared action to address the biodiversity crisis by setting ambitious national targets, in line with the Global Biodiversity Framework, by mid-2024
• By 2024 develop a roadmap to protect and conserve 30% of Australia’s land
• Strengthen Australia’s marine protection, and identify shared marine and coastal protection, pollution abatement and restoration actions to include in a national Sustainable Ocean Plan

An alignment with EU environmental regulations, or at least avoiding a completely divergent Australian environmental regulatory framework, would be beneficial to medical device manufacturers and importers as it would mean designing and labelling medical devices including packaging to meet a set of convergent if not harmonised environmental regulations (Australian medical device regulations are aligned with EU MDR and IVDR after all).

Here are a few strategies that developers of medical devices can adopt:

• Train systems engineers to identify applicable regulatory requirements, including environmental requirements, early into the product development process
• Wherever possible, use fewer materials, select materials that are attractive in terms of recovery, choose design solutions that allow materials to be easily separated from each other
• Wherever possible, choose design solutions that allow easy decontamination of products after use, so that materials can be cleaned and recovered or recycled
• Apply recycling and disposal labels, as appropriate; include instructions in the user manual to remind users to dispose of the medical device in accordance with the local environmental regulations.

Further information on waste and recycling: Waste and recycling – DCCEEW

Power tools are available everywhere, both to professional tradespeople and laypersons alike. Australian law protects consumers against injury and property damage caused by electrical devices. Before supplying power tools in Australia, importers and distributors need to be aware that there are laws and regulations they must comply with such as electrical and mechanical safety, and electromagnetic compatibility (EMC).

While all electric power tools must be safe before being supplied to the market, many power tools such as portable consumer tools also require mandatory safety certification and equipment Level 3 registration on the Electrical Equipment Safety System (EESS) database. This also applies to any supplied battery chargers for the consumer or DIY market.

In addition, electric power tools must also comply with the Australian Communications and Media Authority’s (ACMA) EMC regulations before marking the tools with the RCM and signing the RCM Supplier’s Declaration of Conformity (SDoC). Some tools may have radiofrequency functions such as Bluetooth, NFC or Wi-Fi, these functions are also regulated by ACMA and supplier declarations must show compliance to radiofrequency (RF) standards.

Tools that include button or coin batteries are subject to safety and information standards mandated by the Australian Competition & Consumer Commission (ACCC) since June 2022.

Failure of importers or responsible suppliers to comply with regulatory requirements and ACCC standards may lead to costly market recalls. The ACCC is proactive and checks compliance with safety standards, performance claims or button/coin mandatory standards. Some typical product failures that can lead to increased risks for consumers and users of power tools are lack of compliance with electrical standards and mechanical guarding of tools, incorrect wiring or earthing, exposed live parts, overheating and risk of fire.

Below link to ACCC’s Product Safety webpage provides useful resources, news and information related to product safety laws and market recalls:

https://www.productsafety.gov.au/

What can I do to get assistance?

Market Access can assist you with meeting your regulatory obligations. We can provide customised regulatory training sessions for your company and the specific power tools you import into Australia or New Zealand. We can conduct due diligence and review your available test reports, certificates and information provided to the user such as rating/warning labels and user safety instructions for compliance in order to reduce your risk before the power tools are supplied to the market.

Market Access AUS Pty Ltd is an independent provider of product compliance services to manufacturers and distributors of electrical and electronic devices. Our specialist and highly experienced team will ensure your products conform with all applicable Australian regulatory requirements to not only minimize any risk of liability but assist your rapid time to market.

If you would like to discuss how Market Access can assist you with your regulatory requirements, please contact our general enquiries email Gunther Theisz at gtheisz@marketaccessaus.com.au or call our office on +61 2 9099 1557.