How to improve regulatory practices for refurbished medical devices.

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.

Les établissements de soins de santé modernes dépendent d'équipements et dispositifs médicaux. Pour nombre de ces établissements, il est toutefois impossible de suivre l'évolution des nouvelles technologies, surtout dans les lieux manquant de ressources. La demande en dispositifs médicaux remis à neuf est donc en hausse partout dans le monde, en particulier dans les pays à revenu faible et intermédiaire. Il s'agit de dispositifs restaurés, remaniés pour répondre aux mêmes exigences de sécurité et de performances que lorsqu'ils sont neufs, sans que l'usage prévu du dispositif d'origine ne soit modifié. Alors que les dispositifs médicaux neufs sont soumis à des normes de qualité et de sécurité strictes et bien établies, leurs équivalents restaurés font l'objet de règles nettement plus variables d'un pays à l'autre. Dans le présent document, nous évoquons les différentes réglementations et pratiques spécifiques aux dispositifs médicaux remis à neuf dans les pays qui abritent les principaux marchés. Nous nous intéressons en outre aux opportunités et aux défis liés à un développement du marché des dispositifs médicaux remis à neuf. Enfin, nous suggérons l'adoption de lignes directrices réglementaires concernant l'importation, la vente, l'étiquetage et l'utilisation de tels dispositifs; ces lignes directrices sont à faire appliquer par les autorités afin de garantir les normes les plus élevées en matière de qualité et de sécurité.

Los centros sanitarios modernos dependen de dispositivos y equipos médicos. Sin embargo, mantenerse al día en el desarrollo de las nuevas tecnologías no es viable para muchos centros sanitarios, sobre todo en los de escasos recursos. Por este motivo, la demanda de dispositivos médicos renovados está aumentando en todo el mundo, especialmente en los países de ingresos bajos y medios. Los dispositivos médicos renovados son dispositivos restaurados que se reconstruyen para que cumplan unos requisitos de seguridad y rendimiento comparables a los que tenían cuando eran nuevos, sin cambiar el uso previsto del dispositivo original. Mientras que los dispositivos médicos nuevos están sujetos a reglamentos estrictos y bien establecidos en materia de seguridad y calidad, los reglamentos de los dispositivos médicos renovados varían mucho de un país a otro. En este artículo, se analizan los diferentes reglamentos y prácticas específicos de los dispositivos médicos renovados en los países de los principales mercados. También se exploran las oportunidades y los desafíos que plantea la expansión del mercado de dispositivos médicos renovados. Por último, se propone que se establezcan directrices reglamentarias relativas a la importación, venta, etiquetado y uso de los dispositivos médicos renovados y que las autoridades las apliquen para asegurar su calidad y seguridad.

Reprocessing and reuse of single-use medical devices in China: a pilot survey.

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.

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

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.

Property in recyclable artificial implants.

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.

Legal implications of single-use medical device reprocessing.

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.

MRSA contaminated venepuncture tourniquets in clinical practice.

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.

[Effect of quality assessment assurance in 2002 (before starting the German colorectal cancer screening programme by colonoscopy) on the quality of reprocessing of flexible endoscopes--a nationwide analysis]. / Effekt der Qualitätssicherungsvereinbarung von 2002 (bei Einführung der Vorsorgekoloskopie) auf die Qualität der Aufbereitung flexibler Koloskope - eine bundesweite Analyse.

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.

Conception and validation of a protocol for reuse of non-irrigated electrophysiology catheters in a Brazilian teaching hospital.

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.

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

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.

The implications of reusing single-use medical devices.

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.

[Recycling and reuse of disposable products in radiology]. / Aufbereitung und Wiederverwendung medizinischer Einmalprodukte in der Radiologie.

Legitimacy and appropriateness of recycling and reuse of single-use disposable medical devices is a common issue in many areas of medicine. Advocates of reprocessing claim economic savings and environmental benefits. From the manufacturers' point of view, the single use is a characteristic property of their products. Moreover, they warn that using of recycled instruments makes the procedure more difficult and increases the rate of adverse events. As comparative tests demonstrate, reused products are sometimes inferior to the genuine ones with respect to mechanical properties, but these differences may have relatively little consequence for the performance of the products and the success rate of the interventions. With rigorous cleaning and sterilizing of the instruments, patients do not run an increased risk of infection. Sterile single-use products are subject to the German Medical Products Act (1994) and the German Medical Devices Ordinance (1998). New legal provisions (in force since January 1st 2002) have restricted professional recycling of used devices further. Companies reprocessing medical products for the original users are free from certification liability. CE can no longer be issued for devices newly placed on the market. Lawyers controversially discuss whether patients must be informed about the use of recycled products. In view of the otherwise strict regulations concerning the information given to patients, it seems imperative to obtain a written informed consent when reprocessed devices are used. This might interfere with the confidential relationship of patients and physicians. The combination of increased risk, strict legal regulations, ethical concern and adverse publicity demand to refrain from reprocessing and reusing disposable equipment in diagnostic and interventional radiology.