Creating a Circular Eco-System for Medical Devices: Single-Use vs Reuse

This is the latest blog in the Creating a Circular Eco-System for Medical Device series that aims to highlight different aspects and challenges of a circular economy in the healthcare and medical device industries. It addresses the principle of reuse and the struggle with choosing single-use or reusable devices, focusing on four (of many) areas that a manufacturer must consider.

Designing a device to be single-use or reusable is a critical eco-design decision for medical device and healthcare product manufacturers. Healthcare organizations like the UK’s National Health Service (NHS) Supply Chain[1] are implementing sustainability initiatives to achieve their Net Zero goals by reducing their use of and reliance on single-use items. Manufacturers need to support these initiatives by providing more sustainable, reusable options.

This is not a simple task and manufacturers must identify and assess the risks associated with both disposable and reusable options. They need to consider the environmental impacts and benefits of sustainable alternatives, ensure the reusable device performs as well as or better than the single-use option, and that it does not impact patient safety – all while maintaining costs and product availability.

Impact of Single-Use Plastics on Waste Stream

The key objective of shifting from single-use to reusable devices is to reduce the plastic materials and packaging entering the healthcare system, as well as the amount of waste leaving it. It is estimated that medical plastics, including single-use items such as syringes, IV bags, gloves, catheter tubing and tourniquets contribute between 5-10% of global plastic waste. The NHS generates over 540,000 tonnes of waste per year in England, at a cost of £115 million to dispose of – 30% of this waste is from plastic products.

But not all single-use devices are plastic.

Single-Use Steel Instruments

Single-use steel surgical instruments (SSI) such as scalpels, forceps, and scissors have become increasingly common. Estimates indicate that over 2 million single-use SSI were used by the UK’s NHS, most of which were discarded after a single procedure. Hospitals and surgery centres in the US are major consumers of SSI, especially for minor procedures and procedures in outpatient settings or emergency departments.

This reliance on single-use instruments, whether they are plastic or steel, has been historically driven by cost savings and concerns about patient safety stemming from increases in occurrences of hospital acquired infections (HAI) attributed to incorrectly reprocessed medical devices like duodenoscopes and bronchoscopes.

Considerations for Reusable Alternatives

Material Change

Single-use devices are often made of lower quality, inexpensive materials that cannot withstand the harsh chemicals and cleaning processes necessary for reusable devices. Changing the material can make a device more durable and reusable, but this requires extensive, rigorous testing to ensure the new material is safe for use in humans, as well as being environmentally friendly.

Materials used in medical devices require unique properties such as durability, heat and chemical resistance, and non-stick characteristics that repel bioburdens, water, and oil. However, many commonly used materials contain PFAS (per- and polyfluoroalkyl substances), also called ‘forever chemicals’. Due to increased regulations restricting the use of PFAS, manufacturers are already having to consider alterative materials for their devices.

These alternative materials must comply with emerging environmental and health regulations, requiring innovation in material science to develop new substances that offer similar benefits as PFAS without the long-term environmental and health risks.

Related standards:

ASTM E3027-23 Standard Guide for Making Sustainability-Related Chemical Selection Decisions in the Life-Cycle of Products

BS EN 16760:2015 Bio-based products – Life Cycle Assessment

BS EN ISO 22526-3:2021 Plastics. Carbon and environmental footprint of biobased plastics - Process carbon footprint, requirements and guidelines for quantification

BS EN ISO 10993 series on biological evaluation of medical devices

Safe and Effective Processing of Reusable Devices

There are many challenges with rendering a contaminated device safe for reuse. As such, when exploring a reusable option, the manufacturer must consider the ability to disassemble and effectively clean and disinfect or sterilize the device for reuse and prevent contamination or the spread of infections. Ensuring that this process is reliable across multiple uses can be technically complex and expensive.

As most single-use devices are not intended to be reused, they are not designed for disassembly and cleaning, or constructed of materials that are durable enough to withstand repeated use, cleaning, and sterilization. Reusable devices must retain their functionality and integrity over time, which can be difficult to achieve without increasing costs or compromising performance. Further complexity is added for limited-use devices that require tracking of how many use cycles they have gone through.

Additionally, manufacturers are required to provide validated instructions for cleaning, disinfection, and sterilization that can be effectively repeated by or for the healthcare facility. These instructions have historically been included in every package of a device, but there are proposed changes to regulations in the US and EU to allow the use of electronic instructions for use (e-IFU).

Healthcare facilities must also prepare for the shift to reusable devices by ramping-up capabilities, resources, and infrastructure to support the increased volume of devices requiring processing.

Related standards:

ASTM F3357 – 19 Standard Guide for Designing Reusable Medical Devices for Cleanability

BS EN ISO 17664-1:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices — Critical and semi-critical medical devices

BS EN ISO 17664-2:2023 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices — Non-critical medical devices

BS ISO 8887-1:2017 Technical product documentation. Design for manufacturing, assembling, disassembling and end-of-life processing — General concepts and requirements

HTM-01-01 Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care

Regulatory and Compliance Issues

Regulatory frameworks are often more complex for reusable devices because they need to meet specific safety and quality standards over the entire life cycle of the device. This requires testing, certification, and ongoing compliance with health and safety regulations, which can be more demanding than those for single-use devices.

However, there is an increasing number of environmental regulations and guidelines impacting the medical device industry – specifically the reuse, remanufacture, waste handling, and materials recovery processes in the healthcare ecosystem. These apply to both single-use and reusable devices, and present another set of challenges, considerations, and risks that will be addressed later in another blog.

Related standards:

AAMI TIR65:2015 Sustainability of medical devices. Elements of a responsible product life cycle.

BS EN 13429:2004 Packaging. Reuse

BS 8887-3:2018 Design for manufacture, assembly, disassembly and end-of-life processing (MADE) — Guide to choosing an appropriate end-of-life design strategy

Economic Viability and Product Availability

The final area of focus is that of economic viability and product availability. While reusable devices can offer long-term savings, the initial costs can be significantly higher compared to single-use devices. This includes not only the cost of the reusable items but also the infrastructure needed for cleaning, disinfection, sterilization, storage, and transportation. Moving from single-use to reusable options is an investment, not only for healthcare systems but also the device manufacturers.

Additionally, the transition from single-use to reusable devices can have several impacts on product availability and service of care.

Single-use devices are often ordered in bulk, and the supply chain can operate on a predictable, one-time use model. Switching to reusable devices requires changes to the inventory management system, and the time needed for cleaning, sterilization, and restocking needs to be accounted for. This can create potential delays if a sufficient supply of reusable devices is not available, affecting product availability and potentially causing delays in hospital procedures and patient care.

The switch from single-use to reusable devices may also require additional training for personnel, leading to a temporary increase in errors and impact on service efficiency, as new protocols are implemented.

These are just a few of the challenges the medical device and healthcare industries face when considering reusable options for devices, and none of them are insignificant. However, proper planning and understanding of the risks associated with each device by all stakeholders is crucial for a successful transition to a circular economy.