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Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries. Refurbished medical devices are restored devices that are rebuilt to meet safety and performance requirements comparable to their condition when new, without changing the intended use of the original device. While new medical devices are controlled by well-established and stringent safety and quality regulations, a great variation in the regulations of refurbished medical devices exists across countries. Here we discuss the different regulations and practices specific to refurbished medical devices in countries of major markets. We also explore the opportunities and challenges for expanding the refurbished medical device market. Finally, we suggest that regulatory guidelines pertaining to the import, sale, labelling and use of a refurbished medical product are needed, and authorities should implement these guidelines to ensure a high quality and safety standard of refurbished devices., ((c) 2023 The authors; licensee World Health Organization.)

Background: In China, reprocessing and reuse of single-use medical devices (SUDs) are banned. However, the actual situation has not been reported so far. The study aims to clarify the perceptions and concerns of various sectors of the community on the reuse of SUDs, and whether such practice exists. In addition, we are also wondering how acceptable the respondents are on this matter., Methods: A cross-sectional study based on a national survey which was conducted on the professional online questionnaire survey platform ( www.wjx.cn ) from July 26 to August 4, 2015. We analyzed the data according to the work fields, sex, age, education level, professional background and participants' answers to 49 other questions., Results: Five hundred forty-four nationwide respondents belong to nine different work fields. In general, participants had positive attitudes towards the reprocessing and reuse of SUDs. However, many respondents doubted the hygienic and functional safety of the reprocessed SUDs. They also tended to think that the reuse of SUDs should have lower prices and more technical training as well as patient advocacy. Further analysis demonstrated the work fields, education level and professional background of respondents were statistically associated with their responses to certain questions., Conclusions: The research indicated that although the reuse of SUDs is prohibited legally in China, there were extensive reprocessing and reuse in hospitals. Most responses tended to accept reprocessed SUDs if safety and low prices were guaranteed. These existing contradictions and the lack of relevant research led to policy makers in China will confront numerous challenges in building and improving this use system of medical devices to meet escalating demands of social sectors.

Purpose: Since the Brazilian current legislation permits the reuse of single-use devices under a validated processing protocol, the main purpose of our study was to develop and validate a method for reusing non-irrigated electrophysiology catheter (EC)., Methods: Manual and mechanical processing by ultrasonic washer was associated with the use of enzymatic solution and hydrogen peroxide with a final rinse with filtered water. Validation of the cleaning process, as well as catheter integrity, was done by observing the ECs in stereoscopic microscope at ×60 magnification, followed by HemoCheck-S® (HCS) test to monitor the presence of residual blood on their surfaces. Ethylene oxide (EO) was used for sterilization, and the final validations of the processing were performed by assays of sterility, pyrogenicity, and EO residuals. Lastly, a cost-minimization study was performed., Results: Cleaning process demonstrated absence of organic material detectable by HCS at the surfaces of the ECs. Assays for sterility were negative, and assays of EO residuals and endotoxins showed levels under established standards. The number of reuses was settled to a maximum of seven uses for the ECs with handle and ten uses for ECS without handle. The cost-minimization study showed an 84% savings, when considering seven reuses., Conclusions: Processing of ECs was validated at all stages. Therefore, reuse of ECs under the conditions that we designed was considered safe for patients and cost-effective for our institution.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high., Competing Interests: Interessenkonflikt: Die Autoren geben an, dass kein Interessenkonflikt besteht., (Georg Thieme Verlag KG Stuttgart · New York.)

This article discusses property rights in recyclable artificial implants such as pacemakers. These implants can remain useful and valuable after the death of the first user, but it is not clear who owns the devices when they are removed. The article explains how property rights are transferred consensually and by the operation of law. It then applies these principles to the problem of recyclable implants and argues that the central question is whether the device in any given case accedes to its host human body. If it does not, then on removal the device is owned by the same person who owned it when it was first implanted: this may be the first user or their estate, or a hospital, or even a manufacturer. On the other hand, if the device does accede to the host body, then it ceases to exist as an independent object. The thing into which it has merged, a living human body, cannot be the subject of property rights. This means that any earlier rights in the implant are lost, and would not revive on removal. Instead, new property rights may attach to an explanted device.

Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices., (Copyright © 2013 Longwoods Publishing.)

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon’s ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices.

Introduction: Meticillin-resistant Staphylococcus aureus (MRSA) hospital-acquired infection is associated with increased patient mortality. National guidelines state that shared patient equipment must be cleaned after use. The authors sought to identify MRSA contamination in a sample of non-disposable venepuncture tourniquets and audit cleaning habits between patient contacts., Materials and Methods: Fifty tourniquets were collected from junior doctors, nursing staff and wards from two district general hospitals in Essex, UK in 2007. A questionnaire was completed at the time of collection for each tourniquet. The tourniquets were cultured using standard microbiology techniques., Findings: 18/50 (36%) tourniquets were positive for S. aureus and of these 6/50 (12%) were MRSA positive. 33/43 (77%) healthcare professionals using non-disposable tourniquets for venepuncture made no attempts at cleaning their tourniquets. 10/43 (23%) staff admitted to cleaning their tourniquets. The tourniquets were used for an average of 14 weeks on approximately three different patients per day. 30/50 (60%) tourniquets were visibly soiled and of these 13 were blood stained and 20/50 (40%) appeared 'clean'. Worn tourniquets when compared with the 'clean' tourniquets were more likely to be contaminated with S. aureus, 15/30 (50%) vs 3/20 (15%), and MRSA 5/30 (17%) vs 1/20 (5%)., Conclusion: Non-disposable venepuncture tourniquets are contaminated with MRSA and pose a risk to patients. The majority of clinical staff do not clean them between patient contacts as recommended by guidelines. The use of non-disposable venepuncture tourniquets should be abandoned. The introduction of disposable tourniquets to clinical practice should be an adjunct to current measures for MRSA prevention.

In the wealthy nations of the world, access to implantable cardiac rhythm management devices is widespread. In many underserved low- and middle-income countries (LMIC), where cardiovascular disease is fast becoming a major public health problem, access is often limited. Reuse of pulse generators was practiced regularly in some European nations in the 1990s with good results. It is performed in LMIC, although the rates of device reuse are unknown. The available literature suggests there is no increased risk of morbidity or mortality with the reuse of devices. Donations of pacemaker and defibrillator pulse generators from developed nations constitute an important source of devices for the poor in LMIC. There are opportunities to increase this supply, but logistical barriers and legal and ethical concerns must be addressed. With proper sterilization, meticulous chains of custody, and advance directives for device handling (pacemaker/defibrillator living wills), patients in LMIC who would otherwise lack access to these devices could benefit from their reuse., (Copyright © 2010 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Many communities are concerned about the reuse of potentially contaminated land (brownfields) and believe that environmental liability is a hindrance to redevelopment. However, with land price adjustments, liability might not impede the reuse of this land. This article studies state liability rules-specifically, strict liability and joint and several liability-that affect the level and distribution of expected costs of private cleanup. It explores the effects of this variation on industrial land prices and vacancy rates and on reported brownfields in a panel of cities across the United States. In the estimated equations, joint and several liability reduces land prices and increases vacancy rates in central cities. The results suggest that liability is at least partly capitalized but does still deter redevelopment.

Some charitable organizations and physicians are willing to assist in the compassionate donation of explanted pacemakers for reuse in medically underserved nations. However, healthcare organizations must recognize that the Food and Drug Administration (FDA), device manufacturers, professional societies and many physicians advocate return of explanted pacemakers to the manufacturer to ensure an accurate performance database promoting improved device reliability and safety for the patient.

Background: International studies in the 1990 s and the HYGEA study from Germany in 2002 revealed prevalences of around 50 % of microbiological contaminations in reprocessed flexible endoscopes. Before introducing the colorectal cancer screening programme by colonoscopy in Germany in 2002, the Kassenärztliche Bundesvereinigung (KBV) and the key stakeholders of the public health insurance system agreed on a quality assessment assurance for reprocessing endoscopes where the qualification for refund for colonoscopies from the public health system was made conditional on adequate qualifications of the gastroenterologist; on a minimum number of performed procedures per year; and on adequate endoscope reprocessing documented by negative surveillance cultures two times per year. This study is an implementation and outcome evaluation of the quality assessment assurance in colonoscopy in Germany., Methods: The following data - per year and per Kassenärztliche Vereinigung (KV) - were obtained from the KBV: the number of endoscopic units performing therapeutic and/or screening colonoscopies within each KV; the results of all microbiological surveillance tests of reprocessing quality (two per year per unit); the number of failed surveillance tests and re-tests; and the number of qualifications for refund from the public health system cancelled due to repeated failure of microbiological surveillance tests., Results: The percentages of actually performed hygiene control tests (out of those prescribed by the assurance system) reached 95 % already in 2004 and remained above or close to this level thereafter. After the introduction of the quality assessment assurance, the percentage of failed microbiological surveillance tests dropped significantly and steadily from close to 17 % in 2003 to below 4 % in 2007., Conclusions: This study evidences 1. the successful implementation of the quality assessment assurance in Germany and 2. a substantial improvement in the quality of reprocessing flexible endoscopes achieved by these measures with a drop from 50 % of failed tests observed before the introduction in 2000 - 2001 to below 4 % in 2007.

High-profile hepatitis C outbreaks in 2008 spurred the Centers for Disease Control and Prevention's attention toward legislative and regulatory action in several states around the practice of reuse of single-use devices. Promulgated in the interest of public safety, some of these new regulations and laws can have a potential impact on hospitals' ability to access third-party reprocessing duly regulated by the Food and Drug Administration.

Objectives: The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada., Methods: A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals., Results: Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism., Conclusions: There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.

Objective: The effective decontamination of reusable dental instruments is essential to reduce the risks from onward transmission of infectious diseases. There are therefore a number of legislative requirements placed upon manufacturers of medical devices (which includes dental instruments) to provide validated methods for the reprocessing of such devices. The aim of this study was to determine the availability and content of manufacturer's instructions for the reprocessing of reusable dental instruments., Materials and Methods: A database of reusable dental instruments with details of their manufacturers was collated from information received from three dental hospitals. A questionnaire was sent to all the manufacturers requesting information about the reprocessing instructions for their products. The response from each manufacturer was assessed for the quality of the information and compliance with the British, European and International Standard, BS EN ISO 17664 (2004)., Results: The database from the three dental hospitals included over 800 items supplied by 54 different manufacturers/suppliers. Forty protocols were available for assessing compliance with BS EN ISO 17664 (2004). These protocols accounted for 25 (46%) manufacturers covering 300 devices. The majority (90%) of the returned questionnaires did not comply with the required standard and provided insufficient information to allow for the effective decontamination of the instruments., Conclusions: Manufacturers of medical devices are legally required to supply the user with validated instructions to enable effective decontamination of these devices. The information must be in a format as specified in BS EN ISO 17664 (2004). The information obtained in this survey demonstrated that the manufacturers' instructions fall short of the required regulatory requirements. The absence of such instructions increases the risk of cross-infection arising from inadequate cleaning, decontamination and sterilisation.

Efforts to reduce both costs and medical waste have led many health systems to start reusing single-use medical devices (SUDs) after cleaning and sterilizing (i.e. reprocessing). There is a currently a wide range of SUD types being reused in many health systems. The objective of this paper is to provide a brief summary of risk issues associated with critical SUDs, based on a rapid review of the available literature. The specific focus is on risk issues, but includes discussion of economic and legal/ethical issues as well. The evidence in the literature regarding the safety of reuse of SUDs indicates that for certain devices (e.g. heart catheters) reuse can be safe (in terms of patient infection) and cost-effective as long as stringent reprocessing protocols are followed. However, potential risks associated with reusing SUDs are not just limited to infection of patients. There are staff and environmental risks, plus important legal, ethical, and financial issues to consider in a reuse policy. There are currently no Canadian guidelines on reuse or reprocessing SUDs, although a national Scientific Advisory Panel on Reprocessing of Medical Devices has made recommendations. Additionally, reuse of SUDs is interwoven with the issue of infection control and reprocessing procedures in general and as applied to multiple-use devices. With limited healthcare resources, there will always be a trade-off between the human resources and costs required to clean and sterilize reused devices with costs associated with purchasing and disposing of non-reused SUDs. Evaluation of complete operational pathways, especially for more expensive and commonly used SUDs, will be useful to properly determine the balance of benefits, risks, and costs under a reuse policy.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its advice on the implications of reusing single-use medical devices. This article discusses what constitutes a single-use device, the implications of reuse and the legal and safety issues.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.