Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology

Tessarolo, Francesco; Caola, Iole; Nollo, Giandomenico

doi:10.5772/13582

Cited by 9 publications

(11 citation statements)

References 45 publications

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“…According to the European Association for the Reprocessing of Medical Devices, this practice can be performed in almost all European countries, and especially without requiring quality standards. [32][33][34] However, high quality standards are required by regulations in Germany, the Netherlands, Denmark, Sweden, Belgium, Slovakia and Finland. Austria, Luxembourg, the Czech Republic and Slovenia are still undergoing evaluations of the procedure, where [30][31][32][33][34] In France, reprocessing is prohibited and in the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA), which is a union of The Medicines Control Agency, and The Medical Devices Agency issued a statement in 2003 against the practice, claiming that the practice may compromise the safety, performance and effectiveness of the devices, and that the risk to patients outweighs any benefit.…”

Section: Resultsmentioning

confidence: 99%

“…[32][33][34] However, high quality standards are required by regulations in Germany, the Netherlands, Denmark, Sweden, Belgium, Slovakia and Finland. Austria, Luxembourg, the Czech Republic and Slovenia are still undergoing evaluations of the procedure, where [30][31][32][33][34] In France, reprocessing is prohibited and in the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA), which is a union of The Medicines Control Agency, and The Medical Devices Agency issued a statement in 2003 against the practice, claiming that the practice may compromise the safety, performance and effectiveness of the devices, and that the risk to patients outweighs any benefit. 28 One of the countries with the highest quality control of the catheter reuse process is the United States, which has a disposable medical device reuse rate in about 25% of hospitals.…”

Section: Resultsmentioning

confidence: 99%

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Legal and biological safety of legal reprocessing of medicalhospital materials

Pinto

Massini

2021

BJHBS

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Introduction: Procedures using disposable materials in thehealth area began to be performed, for example in cardiaccatheterization, which has a high prevalence of morbidity andmortality. Objective: To justify and reaffirm the reuse of single-use catheters in surgeries, as it is justified by the economicbenefit gained from replacing the purchase of new materialsby reusing them. Materials and methods: A bibliographic anddocumentary narrative review was carried out using LILACSand NCBI as database, with previously defined filters andselection criteria. Resultados: Decontamination, disinfection,conditioning, sterilization, and quality control tests are criticalstages and, therefore, require training. Each of these stages alsohas characteristic risks, which must be minimized. In order toensure the quality of the catheter reuse process, after the cleaningand sterilization process, techniques beyond microscopicand visual evaluation of the device are required. A diversityof techniques is addressed so that the quality of the process isassured. Although legislation and supervision are divergentaround the world, many countries choose to adopt reprocessingwith economic justification in most cases. The reuse ofhospital devices involves several physico-chemical processes,which must be performed with quality and safety. Conclusion:The need for greater rigor in the norms and guidelines thataddress this practice is clear and urgent, as well as the greaterintensity and rigidity of the responsible inspection agencies.The use of luminol as an indicator of organic contaminantsmay generate a false positive result. Therefore, 3M™ Clean-Trace ™ is the best instrument found in the world market toensure that the material that has been reused is free of organicwaste, and thus fit for use in hospitals.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Legal and biological safety of legal reprocessing of medicalhospital materials

Pinto

Massini

2021

BJHBS

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“…In Italy it was found that the very high demands placed on in the reprocessing single-use instruments can hardly be met by small- and mid-scale health care institutions [ 42 ]. The health authority in UK warns of reprocessing single-use medical devices due to the occurrence of events with negative consequences for the patient [ 43 ].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners‘ offices within the European context – consequences for European harmonization

Thiede¹,

Krämer²

2013

GMS Hygiene and Infection Control; 8(2):Doc20; ISSN 2196-5226

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“…With the development of newly fabrication materials such as plastic polymers the single-use medical devices (SUDs) have been booming since the late 1970s [1]. The original intention of SUDs stemmed from a desire to improve product performance and minimize the potential for disease transmission.…”

Section: Introductionmentioning

confidence: 99%

“…However, the increasing number of interventions and the consequent economic burden on health-care systems had led many countries to consider a reprocessing policy. Although there were controversial results associated with the safety and effectiveness of SUDs reprocessing and reuse [2–5], little evidence so far on its safety and efficacy has been published [6, 7], and the practice remains common in the most countries worldwide [1, 8–12].…”

Section: Introductionmentioning

confidence: 99%

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

Wang

2019

BMC Public Health

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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. Electronic supplementary material The online version of this article (10.1186/s12889-019-6835-9) contains supplementary material, which is available to authorized users.

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Critical Issues in Reprocessing Single-Use Medical Devices for Interventional Cardiology

Cited by 9 publications

References 45 publications

Legal and biological safety of legal reprocessing of medicalhospital materials

Legal and biological safety of legal reprocessing of medicalhospital materials

Evaluation of reprocessing medical devices in 14 German regional hospitals and at 27 medical practitioners‘ offices within the European context – consequences for European harmonization

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

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