Reprocessing single-use devices: A new season in a long-running show? A European perspective

The series “Reprocessing single-use devices” emerged in endoscopy in the 1990 s, and rapidly became a “cliffhanger,” when single-use biopsy forceps were launched. Argon plasma coagulation probes, ERCP devices and, more recently, endoscopic ultrasound needles [1] have also featured; the study by Visrodia and colleagues [2] published in this issue of Endoscopy is dedicated to some components of the endoscopic band ligation device. Many editorials on the subject were published in the 1990 s with provocative titles. And the study results were controversial. Some demonstrated that devices remained contaminated after cleaning and sterilization and that furthermore, cleaning could disseminate contaminants in small channels [3] [4] [5]. Some studies demonstrated the opposite [6] [7] [8] [9]. As with endoscopes, the quality of cleaning for removing materials and reducing the bioburden was considered to be the key factor.

There is also abundant literature on orthopedics materials, cardiovascular catheters, and urologic devices etc. [10].

A single-use device is by definition recommended for use once (namely, in only one patient for only one procedure). The designation of a medical device as “single-use” is solely the decision of the manufacturer, and there is no need for the manufacturer to validate this designation. Manufacturers qualify a device as “single-use” when they have not conducted studies to demonstrate that the device can be labeled as reusable. “Single-use” means the device is not intended to be disassembled and cleaned. Concerning endoscopic band ligation, the device should be first assembled by the medical team and thus disassembly is easy to allow; cleaning/disinfection is another story.

There are several arguments for reprocessing single-use devices. Cost-saving is the first. In the paper by Visrodia et al., no economic analysis has been conducted but the authors acknowledge that this must be done prior any implementation. The device seems to cost between 221 and 450 dollars in the USA, whereas in French institutions the price is 100 euros. The waste costs of medical devices should also be considered. On the other hand, as also stated by the authors, we need to calculate in our own institutions the direct and indirect costs related to high level disinfection and to the microbial controls (sampling and culture), including traceability as for the endoscope, plus the cost of reloading the new bands. Another reason for reprocessing single-use devices in some developing countries is simply the paucity of medical supplies and suppliers. Other reasons are environmental, concerning the reduction of toxic waste. Finally an argument that is less frequently expressed is simply the lack of consistency concerning the respective definitions of single-use and reusable, as indicated above. Especially when medical staff see no change in design between a single-use and a reusable device.

“This paper is an excellent opportunity to re-emphasize the lack of uniform guidance in Europe concerning the reprocessing of single-use devices.”

If the reprocessing of single-use devices is common in developing countries, surveys show that, at least 10 years ago, it was also frequent in the USA, Canada, and Europe [11].

Since 2000, the US Food and Drug Administration (FDA) has regulated reprocessors of single-use devices: medical institutions and third-party reprocessors must follow the same regulatory framework as the manufacturers. This new policy reduced the rate of reprocessing of single-use devices and also changed where reprocessing is performed [12]: less in medical institutions, and more in third-party company sites. In 2011, the FDA permitted the reuse of 70 devices, dividing them into three categories of risk with three different recommended approaches.

The European Union (EU) does not have a single policy, despite new regulations. In April 2017, two new regulations on medical devices were adopted (2017 /745 and 2017 /746) [13] [14]. These were enacted by the European Commission because the previous three directives (of 1990, 1993, and 1998) had allowed diverging interpretations, and also because of serious incidents (concerning breast implants, metal hips) that had been extensively reported in the lay press. These new regulations in particular reinforce the rules concerning assessment performed by “notified bodies.” But they are still vague concerning the reprocessing of single-use devices [13]:

“The reprocessing and further use of single-use devices should only take place where permitted by national law …. The reprocessor of a single-use device should be considered to be the manufacturer of the reprocessed device and should assume the obligations incumbent on manufacturers under this Regulation. Nevertheless, Member States should have the possibility of deciding that the obligations relating to reprocessing and re-use of single-use devices within a health institution or by an external reprocessor acting on its behalf may differ from the obligations on a manufacturer described in this Regulation …”

Ultimately, these EU regulations are not far from the long-standing FDA regulation, and national laws or regulations predominate.

In 2009 Eucomed published a white paper that clearly advises against the reuse of single-use devices [15]. The document identifies and analyzes all the problems related to reuse of such devices:

1. First, of course, the potential risk of cross-contamination, in particular because the geometry of some devices, especially the presence of narrow lumens, prevents adequate cleaning and because of the presence of heat-sensitive materials that prevent the use of steam sterilization.

2. The toxic risk caused by residues of decontamination agents that can be absorbed by plastics.

3. Alteration of materials by heating and/or chemical agents.

4. Mechanical failure due to repeated use.

5. Reactions to endotoxins that are present in biofilms and are not inactivated by sterilization.

The document also emphasized the risk of virus transmission.

Other considerations were also expressed in the white paper: the ethical and the legal liability issues. The ethical issues are very challenging: which patient will receive a single-use device that has never been used and which will receive an already used one? Who should choose? Can the patient have the choice? More simply, should the patient be informed? Information about the reprocessing of single-use devices can of course scare the patient, but it is necessary, just as it is concerning the reprocessing of endoscopes. More sensitive is the information is that endoscopes are theoretically designed to be disinfected and reused but this is not the case for single-use devices. The legal liability aspects are more obvious: the medical institution bears responsibility for the reuse of single-use devices that is contrary to the indications of the manufacturer, as the manufacturer is only responsible for the quality and the efficacy of the device when it is used in accordance with its intended purpose. Of course, in developing countries, the responsibility also lies with the national health care system in general and the decision may take into account the shortage of resources. Is this the case for European countries? Certainly not if the reimbursement covers the cost of the single-use device, as in France through the public welfare system: reusing single-use devices is a faulty practice (see below) but can also be considered to be fraud.

In the large majority of countries, reprocessing of single-use devices is discouraged. It has been clearly prohibited in France since 2001. Germany has had since 2001 a regulatory framework that does not distinguish between reusable and single-use devices concerning reprocessing. There is strict regulation by two official commissions, and medical institutions should adopt a quality management system which is audited annually by accredited “notified bodies.” In the UK, the Medicines and Heathcare Products Regulatory Agency (MHRA) issued a document in 2013 [16]: it states that a device designated as single-use must not be reused, as the reuse can affect its safety, performance, and effectiveness, exposing patients and staff to unnecessary risk. The document emphasizes the legal implications and liability issues and the risk of transmission of abnormal prion proteins. In parallel, in 2016 the MHRA published a guide on re-manufacturing single-use devices [17]; the guide ranges from A to Z, including decontamination, but also performance assessment, labelling, risk management, and post-market surveillance. All critical medical devices (see below) are excluded from this policy.

Concerning the paper by Visrodia et al., there is not too much debate with regard to EU countries. First, the target is not so much Europe but more the developing regions of other continents where economic constraints are greater. In this regard, a well-balanced consensus article has recently been published by Indian cardiologists [18]: reuse is not encouraged but is a pragmatic approach. Kapoor and colleagues conclude that: (a) the devices should clearly designated; (b) standard operating procedures for decontamination should be written; (c) informed consent should be obtained; and (d) cost-savings should be passed on the patient [18].

Secondly, the Endoscopy study by Visrodia et al. relates to only one product, the endoscopic ligation device. And of course the study does not concern the bands themselves but only the cap, the handle, and the cord. Thirdly, there were multiple study limitations that were well-discussed by the authors: the small sample size; the potential role of antibiotic use which was considered to be an exclusion criterion and which could have influenced device contamination; the absence of virus isolation (viruses being frequent in the relevant patients but highly sensitive to disinfectants); the use of automated high level disinfection, whereas manual disinfection is still common in developing countries; and the exclusion of bleeding varices.

Nevertheless, some uncertainties concerning the efficacy of the reprocessing method must be underlined. First, cleaning is certainly easier than for a papillotome but is cleaning a cord as effective? Secondly, decontamination is done by high level disinfection and not by sterilization. One issue concerns knowing how to classify the components of this product within the Spaulding scheme: are they critical devices (devices that enter the sterile tissues) which need sterilization, or semi-critical devices (that come in contact with the mucous membranes) which can be reprocessed by high level disinfection? Thirdly, the authors observed microbial organisms on 6 endoscopic ligation devices out of 14 and Gram-negative bacilli on 2 components out of 41. The level of contamination was low at 1 colony forming unit (CFU). But the study did not analyze the effects of prolonged storage of the devices on potentially pathogenic microbial recolonization. Fourthly and finally, the mechanical effects of reuse and of disinfection were not analyzed, as acknowledged by the authors: breaking of the cord during band ligation of a bleeding varix would render the procedure more difficult.

In conclusion, this paper is an excellent opportunity to re-emphasize the lack of uniform guidance in Europe concerning the reprocessing of single-use devices. There are many arguments for banning this policy in Europe. We could first conduct a survey concerning the different practices and regulations in the various European countries. In developing countries, given the shortage of financial resources and medical supplies, reprocessing of single-use devices is a pragmatic approach that cannot be ignored but should be better regulated, following an evaluation of the effects of decontamination on single-use devices. As acknowledged by Visrodia et al., their study is a pilot; it may open the route for more precise assessment (of the effect of storage, of function, etc.). The study is also limited to a very specific device that can be easily dismantled, and it seems unrealistic to assess the reprocessing of all endoscopic single-use devices. More debate is thus anticipated – a cliffhanger series…

• References

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• 2 Visrodia K, Haseeb A, Hanada Y. et al. Reprocessing of single-use endoscopic variceal band ligation devices: a pilot study. Endoscopy 2017; 49: 1202-1208
• 3 Alfa MJ, Nemes R, Olson N. et al. Manual methods are suboptimal compared with automated methods for cleaning of single-use biopsy forceps. Infect Control Hosp Epidemiol 2006; 27: 841-846
• 4 Alfa MJ, Nemes R. Inadequacy of manual cleaning for reprocessing single-use, triple-lumen sphincterotomes: simulated-use testing comparing manual with automated cleaning methods. Am J Infect Control 2003; 31: 193-207
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• 11 Polisena J, Hailey D, Moulton K. et al. Reprocessing and reuse of single-use medical devices: a national survey of Canadian acute-care hospitals. Infect Control Hosp Epidemiol 2008; 29: 437-439
• 12 Alfa MJ, Castillo J. Impact of FDA policy change on the reuse of single-use medical devices in Michigan hospitals. Am J Infect Control 2004; 32: 337-341
• 13 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
• 14 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
• 15 Eucomed. Eucomed white paper on the reuse of single use devices. December 2009. Available from: http://archive.eucomed.org/key-themes/patients-safety/reuse-of-single-use-devices Accessed: 23 October 2017
• 16 Medicines and Healthcare Products Regulatory Agency (MHRA). Single-use medical devices: implications and consequences of reuse. December 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/403442/Single-use_medical_devices__implications_and_consequences_of_reuse.pdf Accessed: 23 October 2017
• 17 Medicines and Healthcare Products Regulatory Agency (MHRA). Single-use medical devices: UK guidance on re-manufacturing. June 2016. Available at: http://www.remanufacturing.org.uk/pdf/story/739crr1.pdf Accessed: 23 October 2017
• 18 Kapoor A, Vora A, Nataraj G. et al. Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document. Indian Heart J 2017; 69: 357-363