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 of a product as an SUD is in most cases arbitrary and made by the manufacturer, not the FDA.

Rapidly escalating costs of healthcare in the USA, as well as the growth of medical waste of disposable devices, lead to an interest among hospitals and physicians in reprocessing medical equipment that had been approved for single use. Hospitals recognised that the ‘single-use’ label was often motivated by economic objectives, rather than patient safety concerns, and they began the reprocessing of select SUDs under the oversight of physicians, nurses, infection control specialists, risk managers and hospital lawyers.4 In order to assure standardised and safe reprocessing, the FDA issued Compliance Policy Guide in 2000, which effectively began FDA oversight over reprocessing SUDs in the USA.5 The cost of quality assurance, complexity of the devices and concerns about the liability have led to the outsourcing of SUD reprocessing to third-party reprocessors.

According to the Compliance Policy Guide, any reprocessor, whether it be a hospital or a third party, is treated as the OEM in terms of assuring that the product adheres to initial specifications. Reprocessors are required to file premarket submissions to the FDA, which include validation data regarding cleaning, sterilisation and functional performance. They must show that the reprocessed device will remain ‘substantially equivalent’ to the original device. With the passage and enactment of the Medical Device User Fee and Modernization Act of 2002, the reprocessing of SUDs became codified and legally supported in USA. In the last 3 years, several national and transnational regulatory agencies began oversight of the reprocessing of SUDs: Canada (2015), Japan (2017) and European Union (2017). WHO issued a position statement recommending regulation of reprocessing in 2016.6 7

Despite this changing regulatory environment, in much of the world, particularly in Africa and Asia, reprocessing of SUDs is outside the law.8 In countries where there is no legal framework on reuse of SUDs, reprocessing occurs in an unregulated manner in hospitals, rather than third-party reprocessors. Last year in India, the state government of Maharashtra filed complaints against dozens of hospitals for reusing SUDs and charging patients as if the cardiac catheters and guidewires had been new. This unscrupulous practice of a few private hospitals has brought the concept of SUD resterilisation and reuse into focus and criticism. In this article, we argue for creating a legal and regulatory framework to allow the reuse of catheters and other SUDs.

Appraisal of evidence on SUD reprocessing

There is a fair number of publications suggesting safety and efficacy of interventional angiographic catheters,9–13 electrophysiology catheters,14–20 pacemakers21–26 and implantable cardioverter defibrillators.27 The literature, however, is of variable methodology and quality. Most of the studies examining the safety and efficacy of the catheters were carried out in the 1980s and 1990s, and some in early 2000s. Because changes in materials likely have an impact on the durability of catheters, one cannot assume that prior safety data are applicable to new catheter designs. Most studies were observational, either prospective or retrospective, included a limited number of catheters and were often survey based. Clinical studies in general do not describe the refurbishing process in much detail. Studies involving patients were usually small and not powered to detect small, but significant increases in risk.

Creating a framework for the regulatory environment

As shown in the medical literature and the experience in the USA with selected SUDs, reuse of SUDs may, when properly carried out, be safe and provide effective treatment in cardiovascular disease. In order to assure the public that the use is safe, however, the governmental agencies should provide oversight. The reprocessors should provide sufficient evidence that the SUD maintains mechanical and functional integrity, is sterile and free of endotoxins. Interventional catheters pose some challenges given their complex design. After reprocessing, SUDs should be encased in validated packaging including double sterility pouches and box and labelled as reused with the date of reprocessing and a use by date, and should be stored under appropriate environmental conditions. The reprocessor should establish a set of validated protocols, which would stipulate the maximum number of times the devices may be reused. The reprocessor should track the number of times the device is reused. Hospitals or hospital systems could become the reprocessors; however, it would potentially be more difficult for them to acquire and maintain competency in the world of ever-changing device re-designing. The burden of updating and validating protocols and regulatory compliance would likely result in outsourcing of this role to

third-party reprocessors. Oversight of adherence to the reprocessing protocol could be performed by a governmental or an independent organisation of hospitals, if government fails to lead this effort. The reprocessing standards and protocols should be reviewed and endorsed by relevant professional societies in a transparent manner. Responsible reuse would also include mandatory reporting of catheter and device failures. While this complicated system is not the simplest one could design, it is likely that it would withstand constructive criticism of naysayers and the test of time.

Ethics of reuse

Given the special moral importance of health, meeting health needs at some level is required for a just society. If these essential needs cannot be met due to insufficient resources in the healthcare system, as in purchasing new catheters, pacemakers or ICDs, one should seek another solution which would offer the possibility of equitable healthcare delivery with devices which can reasonably be expected to perform similarly as new devices. If inequalities in access to new devices remain insurmountable due to socioeconomic conditions in the country, safe reuse of medical devices with the goal of improving access of the least advantaged appears to be well justified ethically, as it attempts to create conditions of equality of opportunity, recovery of health and well-being. An argument in favour of reusing medical devices can be made based on the principles of egalitarianism, utilitarianism and justice.37 In order for the practice of reuse to be justified ethically, it must be transparent, and the benefits of cost savings should be forwarded to the patients. Patients should be able to opt out of reconditioned catheters and implantable devices with proper informed consent.