Reuse of catheters and devices labelled for single use: evidence, recommendations and oversight.

Abstract

Cardiovascular disease has become the most common cause of death and morbidity throughout the world, not just the affluent societies. In 2015, there were 422 million prevalent cases of cardiovascular disease worldwide, and it accounted for an estimated 30% of deaths.1 2As most people live in low-income and middle-income countries, the burden of cardiovascular disease is the greatest in resource-poor countries. The cardiovascular epidemic has a direct impact on the health of the patients and also on the welfare of the economies in which those patients live and work. Poverty can be both a contributing cause and a consequence of cardiovascular disease. It is in the context of oppressive burden of healthcare spending that the discussion about reusing catheters and devices should be considered. ### Historical context In the mid-20th century, most medical devices were made of metal, glass or rubber and were generally reusable. Technological developments in the 1960s and 1970s brought out a wave of new polymers, which could be harnessed and which would eventually transition a multiuse medical industry into a single-use paradigm. Many open surgical procedures were gradually replaced by laparoscopic or endovascular procedures. In the 1980s and 1990s, new concerns regarding transmission of bloodborne pathogens such as hepatitis B and C, and HIV coincided with the explosive development of new technologies. Advances in manufacturing techniques, and expectation of improved product performance and predictability deepened interest in single-use devices (SUDs). The confluence of all these factors led to the evolution and dramatic expansion of the SUD concept. Original equipment manufacturers (OEMs) began to submit applications to the United States Food and Drug Administration (FDA) asking for approval of their products as SUDs. In some instances, the manufacturers changed the labelling from multiuse to single use only without making significant structural changes to the devices.3 The designation …