Regulating Environmental Impact of Medical Devices in the United Kingdom—A Scoping Review

Abstract

Medical devices are highly regulated to ensure safety and efficacy of the products and minimize the risk of harm to users and patients. However, the broader impacts of these devices on the environment have scarcely been questioned until recently. The United Kingdom National Health Service intends to achieve a “net zero” emissions service by 2040 and has identified specific targets to achieve through this process. However, medical device manufacturers do not see sufficient incentives to invest in reducing greenhouse gas emissions unless enforced by legislation. Furthermore, there is little evidence on the legislation required to reduce emissions from medical devices. This study addresses the relationship of medical device regulations and the environmental impact of the devices throughout their lifecycle. A scoping review was conducted on academic literature on the topic, followed by a critical review of the current medical device regulations and associated guidelines in the United Kingdom. The challenges to regulating environmental impact of medical devices were identified under seven themes. These challenges were contextualized with the National Health Service target of achieving zero emissions by 2040. The review indicates that current guidelines support single-use disposal of devices and equipment as the best approach to prevent pathogen transmission and landfilling and incineration are the most used waste management strategies. Manufacturers need to be guided and educated on reducing their emissions while ensuring the development of safe and effective devices.