Statistics from Altmetric.com
The size of the medical new-device and reuse markets
Evaluate MedTech estimated that worldwide sales of medical devices in 2017 were US$386.8 billion. Cardiology was among the largest groups, with $44.6 billion in sales.1 The Emergo Group estimated US sales to be $147.7 billion and sales in India to be $3.5 billion.2 The average annual growth of the device market since 2009 has been about 16%.3
Although many devices have been labelled as ‘single-use’ by the original manufacturers, some of these have nonetheless been reprocessed and used again. Some device manufacturers have warned against this practice,4 5 ostensibly because of the potential risks of infection or breakdown. For some time, hospitals have been reprocessing SUDs in-house. Also, since about the year 2000 a thriving third-party reprocessing industry has emerged in North America and Europe. Only about 2%–3% of all devices can be safely reprocessed.6 By 2016, global revenue of independent SUD reprocessors was estimated to be $1.054 billion.7 Estimated sales of third-party reprocessors in the USA was $848.5 million.8 In-house hospital activities are generally not included when considering the size of the reprocessing marketplace. In India, there is considerable in-house activity in device reprocessing in hospitals,9 10 but there is no large-scale SUD third-party market.
Economic approach to analysis of reuse
We compare the difference in cost with the difference in harm between new and reused SUDs. The variables included in this comparison are shown in table 1. These variables are defined differently between countries because the markets and regulatory systems are so different.
Regulation and the risks of reprocessing
The risk of harm is the major clinical outcome for reprocessing activity. To help regulate the safety of brand new and reprocessed devices, The US Food and Drug Administration (US FDA) developed a three-class licensing system.11 Devices in the …
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.