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1.
J Hazard Mater ; 470: 134219, 2024 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-38615647

RESUMO

Disposable surgical masks undeniably provide important personal protection in daily life, but the potential health risks by the release of microplastic fibres from masks should command greater attention. In this study, we conducted a microplastic fibre release simulation experiment by carrying masks in a pocket and reusing them, to reveal the number and morphological changes of microfibres released. Fourier transform infrared spectrometry, scanning electron microscopy, and optical microscopy were employed to analyse the physical and chemical characteristics of the mask fibres. The results indicated that the reuse of disposable masks led to a significant release of microplastic fibres, potentially leading to their migration into the respiratory system. Furthermore, the release of microplastic fibres increased with prolonged external friction, particularly when masks were stored in pockets. The large-scale release of microplastic fibres due to mask reuse raises concerns about potential health risks to the human respiratory system. The reuse of disposable masks should be also strictly avoided in daily life in the future. Furthermore, the current study also established a robust foundation for future research endeavours on health risks associated with microplastic fibres entering the respiratory system through improper mask usage.


Assuntos
Máscaras , Microplásticos , Humanos , Microplásticos/análise , Microplásticos/toxicidade , Equipamentos Descartáveis , Reutilização de Equipamento , Espectroscopia de Infravermelho com Transformada de Fourier
4.
PLoS One ; 19(2): e0296871, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38319932

RESUMO

The Coronavirus Disease 2019 (COVID-19) pandemic has induced a critical supply of personal protective equipment (PPE) especially N95 respirators. Utilizing respirator decontamination procedures to reduce the pathogen load of a contaminated N95 respirator can be a viable solution for reuse purposes. In this study, the efficiency of a novel hybrid respirator decontamination method of ultraviolet germicidal irradiation (UVGI) which utilizes ultraviolet-C (UV-C) rays coupled with microwave-generated steam (MGS) against feline coronavirus (FCoV) was evaluated. The contaminated 3M 1860 respirator pieces were treated with three treatments (UVGI-only, MGS-only, and Hybrid-UVGI + MGS) with variable time. The virucidal activity was evaluated using the TCID50 method. The comparison of decontamination efficiency of the treatments indicated that the hybrid method achieved at least a pathogen log reduction of 4 logs, faster than MGS and UVGI. These data recommend that the proposed hybrid decontamination system is more effective comparatively in achieving pathogen log reduction of 4 logs.


Assuntos
Respiradores N95 , Vapor , Micro-Ondas , Descontaminação/métodos , Reutilização de Equipamento , Raios Ultravioleta , Pandemias
5.
Int J Prosthodont ; 37(1): 109, 2024 02 21.
Artigo em Inglês | MEDLINE | ID: mdl-38381989

RESUMO

PURPOSE: To determine and compare the frequency of contamination on different sites of healing abutments (HAs) after sterilization with Phloxine B dye on unused and used HAs after sterilization. MATERIALS AND METHODS: A total of 60 HAs were divided into two test groups: (1) used and sterilized and (2) a control group (unused). The test group was evaluated for contamination after sterilization; the control group did not undergo any procedure. Data were analyzed using SPSS version 22 (IBM). Descriptive statistics were used to determine the frequency of contamination in the different groups and at the different HA sites. Chi-square test was used to evaluate the association of frequency of contamination with the HA site and design. The level of significance was kept at P ≤ .01. RESULTS: The test group showed more contamination compared to the control group. The most contaminated sites were the screw thread and the screwdriver engagement location. CONCLUSIONS: HA reuse is cost-effective, but cleaning and sterilization was not effective for these components; thus, HAs need to be reused with caution because they were heavily contaminated when compared to new HAs. Among the different sites, the screw thread and screwdriver engagement sites were more prone to contamination. HA type did not influence the frequency of contamination.


Assuntos
Dente Suporte , Implantes Dentários , Propriedades de Superfície , Reutilização de Equipamento , Esterilização/métodos , Contaminação de Equipamentos
7.
Ann R Coll Surg Engl ; 106(2): 167-172, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37051744

RESUMO

INTRODUCTION: After excluding anaesthetic gases, around one-third of carbon emissions from surgical procedures are from consumables. This sustainable quality improvement project revised the laparoscopic appendicectomy surgical set at a large teaching hospital, with the aim of reducing unnecessary usage of disposable laparoscopic ports and surgical instruments. METHODS: A prospective audit of 25 consecutive laparoscopic appendicectomies (5% of annual appendicectomies performed at the Trust) was conducted to assess use of disposable instruments. The financial and environmental costs of the five most commonly used disposable instruments were calculated and annual cost of current practice determined. A revised surgical set was created to include additional reusable instruments and new reusable ports. A reaudit of disposable surgical instrument usage was conducted and the financial and environmental impact of the new set compared with the results from the initial audit. RESULTS: A total of 109 disposable instruments were opened in 25 appendicectomies, costing an estimated £49,656 and 692kg CO2 equivalent (CO2e) annually. Following rollout of the revised appendicectomy set, there was a significant reduction in disposable instrument usage (median four versus one instruments per case, p<0.00001). The revised set is predicted to reduce annual disposable instrument usage from 2,180 to 705 instruments (68% reduction), saving £219,452 and 3.02 tonnes CO2e over the estimated seven-year lifecycle of the reusable instruments. CONCLUSIONS: Updating a laparoscopic appendicectomy set to include additional/new reusable instruments can lead to a marked reduction in disposable surgical instrument usage. This results in significant projected financial and CO2e savings.


Assuntos
Equipamentos Descartáveis , Laparoscopia , Humanos , Reutilização de Equipamento , Instrumentos Cirúrgicos , Apendicectomia/métodos
8.
J Endourol ; 38(1): 68-76, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37885229

RESUMO

Introduction: Single-use medical devices (SUDs) are labeled for single use only, but rising health care costs along with the absence of visible deterioration in the quality of SUDs after one use have led to their reprocessing and reuse. In the past, SUDs mainly consisted of equipment such as guidewires and catheters. However, SUDs have now expanded to flexible endoscopes and energy devices that are much more expensive. Reuse of such devices raises concerns of infection transmission, safety, and lack of effectiveness. We reviewed the disinfection process, cost benefits, potential harms, and legal status of the reuse of SUDs in endourology. Materials and Methods: PUBMED, Embase, and the Cochrane Library databases were searched for articles published between 1970 and March 2023 that reported the reuse of SUDs using the search terms "reuse"; "single-use device"; "disposable medical devices"; "reprocessing of single-use device"; "endourology"; and keywords related to cost, safety, sterilization, and legal status. Online resources were found using Google search engines. Articles on cost savings, device malfunction, disinfection, or legal status in different countries were reviewed. Results and Conclusions: Reusing SUDs has financial, environmental, and practical advantages. The potential savings on medical expenses is the most compelling argument for reprocessing disposable devices. Reusing medical equipment also contributes to the reduction of toxic biodegradable waste. However, there is a scarcity of data on the safety and efficacy of reused SUDs. For patient safety and to avoid complications, the practice must be regulated with established reprocessing standards.


Assuntos
Equipamentos Descartáveis , Esterilização , Humanos , Custos de Cuidados de Saúde , Análise Custo-Benefício , Reutilização de Equipamento
9.
BJU Int ; 133(1): 14-24, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37838621

RESUMO

OBJECTIVE: To compare clinical outcomes of single-use endoscopes with those of reusable endoscopes to better define their role within urology. METHODS: A systematic search of electronic databases was performed. All studies comparing the clinical outcomes of participants undergoing urological procedures with single-use endoscopes to those of participants treated with reusable endoscopes were included. Results are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. RESULTS: Twenty-one studies in 3943 participants were identified. Six different single-use flexible ureteroscopes and two different single-use flexible cystoscopes were assessed. There were no differences in mean postoperative infection rates (4.0% vs 4.4%; P = 0.87) or overall complication rates (11.5% vs 11.9%; P = 0.88) between single-use and reusable endoscopes. For patients undergoing flexible ureteroscopy there were no differences in operating time (mean difference -0.05 min; P = 0.96), length of hospital stay (LOS; mean difference 0.06 days; P = 0.18) or stone-free rate (SFR; 74% vs 74.3%; P = 0.54) between the single-use and reusable flexible ureteroscope groups. CONCLUSION: This study is the largest to compare the clinical outcomes of single-use endoscopes to those of reusable endoscopes within urology, and demonstrated no difference in LOS, complication rate or SFR, with a shorter operating time associated with single-use flexible cystoscope use. It also highlights that the cost efficiency and environmental impact of single-use endoscopes is largely dependent on the caseload and reprocessing facilities available within a given institution. Urologists can therefore feel confident that whether they choose to 'use' or to 'reuse' based on the financial and environmental implications, they can do so without negatively impacting patient outcomes.


Assuntos
Ureteroscopia , Urologia , Humanos , Ureteroscopia/métodos , Reutilização de Equipamento , Desenho de Equipamento , Ureteroscópios
10.
J Hosp Infect ; 145: 88-98, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38103694

RESUMO

A central tenet in infection prevention is application of the Spaulding classification system for the safe use of medical devices. Initially defined in the 1950s, this system defines devices and surfaces as being critical, semi-critical or non-critical depending on how they will be used on a patient. Different levels of antimicrobial treatment, defined as various levels of disinfection or sterilization, are deemed appropriate to reduce patient risk of infection. However, a focus on microbial inactivation is insufficient to address this concern, which has been particularly highlighted in routine healthcare facility practices, emphasizing the underappreciated importance of cleaning and achieving acceptable levels of cleanliness. A deeper understanding of microbiology has evolved since the 1950s, which has led to re-evaluation of the Spaulding classification along with a commensurate emphasis on achieving appropriate cleaning. Albeit underappreciated, cleaning has always been important as the presence of residual materials on surfaces can interfere with the efficacy of the antimicrobial process to inactivate micro-organisms, as well as other risks to patients including device damage, malfunction and biocompatibility concerns. Unfortunately, this continues to be relevant, as attested by reports in the literature on the occurrence of device-related infections and outbreaks due to failures in processing expectations. This reflects, in part, increasing sophistication in device features and reuse, along with commensurate manufacturer's instructions for use. Consequently, this constitutes the first description and recommendation of a new cleaning classification system to complement use of the traditional Spaulding definitions to help address these modern-day technical and patient risk challenges. This quantitative risk-based classification system highlights the challenge of efficient cleaning based on the complexity of device features present, as an isolated variable impacting cleaning. This cleaning classification can be used in combination with the Spaulding classification to improve communication of cleaning risk of a reusable medical device between manufacturers and healthcare facilities, and improve established cleaning practices. This new cleaning classification system will also inform future creation, design thinking and commensurate innovations for the sustainable safe reuse of important medical devices.


Assuntos
Anti-Infecciosos , Reutilização de Equipamento , Humanos , Desinfecção , Instalações de Saúde
11.
Ann Pharm Fr ; 82(2): 292-305, 2024 Mar.
Artigo em Francês | MEDLINE | ID: mdl-38135038

RESUMO

OBJECTIVES: Sterilized reusable medical devices have a use-by date, after which sterility is no longer guaranteed. There is currently no consensus on how this should be determined. The aim is to re-evaluate the expiry date of reusable medical devices, by means of a risk analysis and an assessment of the maintenance of the sterile state of reusable medical devices over time. METHODS: The risk analysis focused on the stages whose malfunction could compromise the sterility of reusable medical devices over time: packaging, transport and storage. Risk mapping was carried out in accordance with the methodology recommended by the French Health Authority. Based on standard NF EN ISO 11737, the assessment of the maintenance of the sterile state was checked on reusable medical devices after two, four and six months storage and on reusable medical devices that had expired more than a year previously. RESULTS: The risk analysis identified four failures and sixty-eight potential causes. The most sensitive stage was storage, which accounted for most of the critical and major causes. Improvement actions were proposed, such as the definition of a container maintenance plan. At the same time, 256 reusable medical devices were tested. The cultures remained sterile for all the containers, for folded products tested at 6 months and more and for the sachets tested at 2 and 4 months and at more than one year of storage. CONCLUSIONS: The DLU has been extended to 4 months for sachets, 6 months for folded products and maintained at six months for containers.


Assuntos
Reutilização de Equipamento , Infertilidade , Humanos , Esterilização , Embalagem de Produtos , Embalagem de Medicamentos
13.
Zhongguo Zhong Yao Za Zhi ; 48(17): 4545-4551, 2023 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-37802795

RESUMO

It has become a common consensus that resource conservation and intensive recycling for improving resource utilization efficiency is an important way to achieve carbon peak and carbon neutrality(dual carbon). Traditonal Chinese medicine(TCM)resources as national strategic resources are the material basis and fundamental guarantee for the development of TCM industry and health services. However, the rapid growth of China's TCM industry and the continuous expansion and extension of the industrial chain have exposed the low efficiency of TCM resources. Resource waste and environmental pollution caused by the treatment and discharge of TCM waste have emerged as major problems faced by the development of the industry, which has aroused wide concern. Considering the dual carbon goals, this paper expounds the role and potential of TCM resource recycling and circular economy industry development. Taking the typical model of TCM resource recycling as the case of circular economy industry in reducing carbon source and increasing carbon sink, this paper puts forward the suggestions for the TCM circular economy industry serving the double carbon goals. The suggestions mainly include strengthening the policy and strategic leading role of the double carbon goals, building an objective evaluation system of low-carbon emission reduction in the whole industrial chain of TCM resources, building an industrial demonstration park for the recycling of TCM resources, and promoting the establishment of a circular economy system of the whole industrial chain of TCM resources. These measures are expected to guide the green transformation of TCM resource industry from linear economic model to circular economy model, provide support for improving the utilization efficiency and sustainable development of TCM resources, and facilitate the low-carbon and efficient development of TCM resource industry and the achievement of the double carbon goals.


Assuntos
Reutilização de Equipamento , Medicina Tradicional Chinesa , Objetivos , Poluição Ambiental , Desenvolvimento Econômico , Carbono , China
14.
Environ Sci Technol ; 57(43): 16153-16165, 2023 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-37861439

RESUMO

China's enterprises of waste electrical and electronic equipment (WEEE) recycling suffer from low profitability that is highly dependent on government subsidies. This low economic gain impedes the sustainable growth of China's WEEE-recycling sector and also adds to the government's financial burden. Prior life-cycle studies have approved the carbon reduction potentials or net carbon credit of recycling WEEE. However, policymakers fail to know whether the revenue from selling carbon credits can offset the government's financial subsidy. We performed life-cycle and cost-benefit analyses for a case recycling enterprise that processes six categories of household appliances. The results show that the reduction potentials of greenhouse gases range from 930-3450 kgCO2e by recycling per ton of household appliances and materials substitution. The recycling enterprise would gain extra revenue ranging from 32 to 160 RMB per ton of appliance if the carbon credits were sold at China's current carbon price, i.e., 45-60 RMB tCO2e-1. Recycling waste refrigerators exhibits the highest carbon revenue, offsetting 6-17% of the government's financial subsidy. Microcomputers, by contrast, indicate the lowest carbon revenue, equivalent to 1-3% of its highest government subsidy. For each household appliance category, when the carbon price reaches 270-600 RMB tCO2e-1, selling carbon credits can fully offset the government's financial subsidy. Constrained by the processing capacity of the case enterprise, optimizations for appliance-recycling composition contribute a 15-25% profit growth to the current economic gains. Interpreting the specific profit depends on the predefined scenarios of carbon price and the substitution rate of the regenerated materials for the virginal ones. Our findings show that raising the profitability of WEEE recycling enterprises through the carbon trading policy contributes to the sustainable growth of China's WEEE-recycling sector while alleviating the government's financial burden.


Assuntos
Resíduo Eletrônico , Gerenciamento de Resíduos , Reutilização de Equipamento , Resíduo Eletrônico/análise , Eletrônica , China , Reciclagem/métodos , Financiamento Governamental
15.
Gastroenterol Nurs ; 46(6): 455-464, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37700439

RESUMO

Contamination due to failures or omissions in the reprocessing steps of gastrointestinal endoscopes is common in clinical practice. Ensuring the proper execution of each step is a challenge for reprocessing personnel. This cross-sectional study was conducted in an endoscopy setting between March and May 2021. We performed interviews about reprocessing practices, analyzed the life history of the equipment, and performed inspections through a borescope video of gastrointestinal endoscope channels that were stored and ready for use. A borescope is a complementary tool used to validate endoscope reprocessing, evaluate the internal visualization of channels, and identify changes that can compromise the safety of its use, which are often not detected in the leak test. Thirteen biopsy channels from stored gastrointestinal endoscopes were inspected. We found that 85% had stains and grooves, 69% contained moisture, and 46% had debris. There was at least one noncompliance issue in all of the channels inspected.


Assuntos
Desinfecção , Reutilização de Equipamento , Humanos , Estudos Transversais , Endoscópios , Endoscópios Gastrointestinais , Contaminação de Equipamentos/prevenção & controle
16.
Int J Infect Dis ; 136: 151-157, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37758170

RESUMO

BACKGROUND: Early in the COVID-19 pandemic, there was a global shortage of masks. Although mask reprocessing was practiced, no clinical study has assessed systematically the impact of repeated cycles of wear and decontamination on the integrity of N95 filtering facepiece respirators (FFRs). METHODS: We evaluated mask fit assessed by qualitative respirator fit test (QRFT) after each cycle of wear and decontamination, as well as four measures of mask integrity-bacterial filtration efficacy, particle filtration efficacy, differential pressure, and splash resistance through five cycles of wear and decontamination using one of the four modalities (moist heat, steam, ultraviolet-C irradiation, and hydrogen peroxide plasma). RESULTS: A total of 60.6% (hydrogen peroxide plasma) to 77.5% (moist heat) of the FFRs passed five cycles of wear and decontamination, as assessed by the wearers passing QRFT all five times. Moist heat-decontaminated FFRs retained all technical measures of integrity through all five cycles. CONCLUSIONS: This is the first large-scale study to assess systematically the impact (clinically and quantitatively) on N95 FFR integrity of repeated cycles of wearing followed by decontamination. Our results suggest that moist heat is a promising method for decontaminating N95 FFRs. Performing QRFT after every cycle of wear and decontamination ensures wearer safety. Although there is currently no mask shortage, reprocessing may reduce medical waste and improve sustainability.


Assuntos
Respiradores N95 , Dispositivos de Proteção Respiratória , Humanos , Vapor , Peróxido de Hidrogênio , Temperatura Alta , Descontaminação/métodos , Pandemias/prevenção & controle , Reutilização de Equipamento , Máscaras
17.
Eur Urol Focus ; 9(6): 859-860, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37748949

RESUMO

Reprocessing of endoscopic equipment generates greenhouse gas emissions, releases toxic substances into the environment, and consumes large quantities of water. The use of alternative materials, such as single-use devices with a low carbon footprint and recycled materials, and reprocessing without the use of water and toxic products represent sustainable solutions.


Assuntos
Reutilização de Equipamento , Esterilização , Humanos , Endoscopia , Água
18.
J Osteopath Med ; 123(12): 557-561, 2023 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-37552797

RESUMO

CONTEXT: A 25-pound weight limit is currently set on containerized instrumentation sets by the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI), in order to reduce strain on the staff and ensure that the sets are not too crowded in order to preserve sterilization and drying of the instruments. This is pushing companies to reduce the weight and number of instrumentation sets for the operating room. One solution has been to explore the viability of new, lighter materials such as Onyx. OBJECTIVES: The goal of this study is to evaluate the novel material Onyx as a viable material utilized in reusable total knee arthroplasty (TKA) instrumentation sets utilizing traditional steam sterilization as the sterilization method. METHODS: Mechanical and biocompatibility tests according to the American Society for Testing Materials (ASTM) and International Organization for Standardization (ISO) 10,993 were run to evaluate the Onyx Material to see if it would be a viable alternative to the stainless and martensitic steel that is currently being utilized. RESULTS: Gross warping and cracking after 10 rounds of sterilization was observed. This was qualitatively worse in the Onyx without a carbon fiber component. The Onyx material did not meet biocompatibility standards for its application. CONCLUSIONS: Onyx was determined to not be a viable material for TKA instruments regarding multiple high-pressure and -temperature sterilizations and cytotoxic cell testing.


Assuntos
Artroplastia do Joelho , Esterilização , Equipamentos Cirúrgicos , Artroplastia do Joelho/instrumentação , Reutilização de Equipamento , Esterilização/instrumentação
19.
PLoS One ; 18(7): e0287664, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37498861

RESUMO

The COVID-19 pandemic resulted in many supply chain issues, including crippling of essential personal protective equipment (PPE) needed for high-risk occupations such as those in healthcare. As a result of these supply chain issues, unprecedented crisis capacity strategies were implemented to divert PPE items such as filtering facepiece respirators (FFRs, namely N95s) to those who needed them most for protection. Large-scale methods for decontamination were used throughout the world to preserve these items and provided for their extended use. The general public also adopted the use of non-specialized protective equipment such as face coverings. So, the need for cleaning, decontamination, or disinfection of these items in addition to normal clothing items became a necessary reality. Some items could be laundered, but other items were not appropriate for washing/drying. To fill research gaps in small-scale, non-commercial cleaning and disinfection, this bench-scale research was conducted using small coupons (swatches) of multiple PPE/barrier protection materials inoculated with virus (non-pathogenic bacteriophages Phi6 and MS2) and tested against a range of decontamination methods including bleach-, alcohol- and quaternary ammonium compound (QAC)-based liquid sprays, as well as low concentration hydrogen peroxide vapor (LCHPV) and bench-scale laundering. In general, non-porous items were easier to disinfect than porous items, and the enveloped virus Phi6 was overall easier to inactivate than MS2. Multiple disinfection methods were shown to be effective in reducing viral loads from PPE coupons, though only laundering and LCHPV were effective for all materials tested that were inoculated with Phi6. Applications of this and follow-on full-scale research are to provide simple effective cleaning/disinfection methods for use during the current and future pandemics.


Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , SARS-CoV-2 , Pandemias/prevenção & controle , Desinfecção/métodos , Equipamento de Proteção Individual , Reutilização de Equipamento , Descontaminação/métodos
20.
Bull World Health Organ ; 101(6): 412-417, 2023 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-37265675

RESUMO

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.


Assuntos
Equipamentos Médicos Duráveis , Reutilização de Equipamento , Regulamentação Governamental , Equipamentos Médicos Duráveis/normas , Reutilização de Equipamento/legislação & jurisprudência , Reutilização de Equipamento/normas
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