A prospective multicenter randomized controlled clinical trial study of a domestic single-use digital flexible ureteroscope versus a reusable digital flexible ureteroscope for the treatment of upper urinary tract stones / 中华泌尿外科杂志

Objective:To compare the performance and surgical outcomes of domestic single-use digital flexible ureteroscopes with reusable digital flexible ureteroscopes in treatment of upper urinary stones.Methods:A prospective, single-blind, multicenter and randomized controlled study was performed from September 2018 to June 2019. Eligible patients were randomly assigned, in a ratio of 1∶1, to either experimental group or control group. The inclusion criteria for the study were: aged 18-75 years, solitary upper urinary stone with stone size between 0.8 and 2.0 cm and CT value less than 1 400 HU, negative preoperative urine culture and normal renal function. Exclusion criteria included: patients with acute urinary tract infection, intransitable urethral strictures, impassable ureteropelvic junction obstructions, systemic hemorrhagic disease, coagulation function abnormalities or bleeding tendency, severe hypertension or cardiopulmonary insufficiency, severe hip malformation and difficulty in meeting the demand of operation position and pregnant and lactation women. The device used in the experimental group was a domestic single-use digital flexible ureteroscope, and the device used in the control group was an imported Olympus digital flexible ureteroscope. The qualified rate of clinical comprehensive evaluation (including image quality and operational performance), the rate of device failure, the stone-free rate and the occurrence rate of adverse events (including increase in urine red blood cell and white blood cell counts, postoperative hematuria, nausea, vomiting, dizziness, and fever) in the two groups were recorded.Results:A total of 186 eligible study cases were collected from the People's Hospital of Wuhan University, the First Affiliated Hospital of Xiamen University, and the First Affiliated Hospital of Guangzhou Medical University. 90 cases in the final experimental group and 88 cases in the control group completed the trial and were included in the evaluation. There were no statistically significant differences among age [(48.40±11.36) vs. (47.40±12.53)years old, P=0.594], male to female ratio (62/28 vs. 56/32, P =0.874), BMI [(24.8±2.1) kg/m 2 vs. (25.1±2.0)kg/m 2,P =0.331], hydronephrosis (no/slight vs. mild/severe) (62/28 vs. 65/23, P =0.874), stone location and stone size [(12.8±4.7) mm vs. (11.9±5.2) mm, P =0.227]. There were no significant differences in terms of qualified rate of clinical comprehensive evaluation [98.9% (89/90) vs. 100.0% (88/88), P =0.991], lithotripsy success rate [84.4% (76/90) vs. 84.1% (74/88), P =0.888], device failure/defect rate (both 0%), and the incidence of adverse events [50.0% (45/90) vs. 52.0% (51/88), P =0.894]. The highest incidence of adverse events in two groups was the increase of red blood cells and white blood cells of routine urine after operation. There was no serious adverse event in the experimental group and 1 serious adverse event in the control group. Conclusions:There was no significant difference in image quality, device failure/defect rate, lithotripsy success rate, and adverse event rate between single-use digital flexible ureteroscopes and reusable digital flexible ureteroscopes for lithotripsy of upper ureteral and pelvic stones. Domestic single-use digital flexible ureteroscopes have good safety and effectiveness in the treatment and microscopy of upper urinary tract stones.

Assessing Hemocompatibility of Transfusion Sets for Single Use / 中国输血杂志

【Objective】 To investigate the blood compatibility of transfusion sets for single use, the loss, damage and activation of blood components after passage through the transfusion sets. 【Methods】 Transfusion sets (sample A and B) were assessed by comparing samples of blood component taken prior to and after passage through. The following makers of damage/activation were evaluated: Red blood cells (RBCs)-supernatant free hemoglobin (FHb) and potassium(K+ ) amount; platelet concentrates (PCs)-pH, hypotonic shock response (HSR), supernatant lactate dehydrogenase(LDH), CD62P; fresh frozen plasma(FFP) – prothrombin fragments 1 and 2 (F1+ 2), fibrinopeptide A (FPA), coagulation factor Ⅻa (FⅫa), Thrombin-antithrombin complex (TAT). 【Results】 After passing through two types of transfusion sets, the loss of RBCs, PCs and FFP were less than 5%. There is no statistic difference for the change of FHb and K+ of RBCs(P>0.05). There were no statistics for pH, LDH(U/L) and CD62P(%) after platelet concentrates passing through both transfusion sets. There was no statistics for the HSR after passing through the sample A, while there was a small but statistically significant increase in the HSR of sample B (37.17±6.49 vs 40.75±6.24, P<0.05). After FFP passing through the transfusion giving sets, there were no statistical difference for F1+ 2, FPA, FⅫa and TAT (P>0.05). 【Conclusion】 Two types of transfusion sets caused negligible effects on RBCs, platelet concentrates and FFP.

Single-use Medical Devices Re-processing: Regulatory Status Quo / 中国医疗器械杂志

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.

Single-use Medical Devices Re-processing: Risk Assessment and Quality Control Technologies / 中国医疗器械杂志

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.

Effects on Quality of Life in Patients with Neurogenic Bladder treated with Clean Intermittent Catheterization: Change from Multiple Use Catheter to Single Use Catheter

PURPOSE: To evaluate changes in quality of life (QoL) in patients with neurogenic bladder treated with clean intermittent catheterization (CIC), who changed from a multiple use catheter (MUC) to single use catheter (SUC). METHODS: The Modified Intermittent Self-Catheterization Questionnaire (mISC-Q) was used to determine potential changes in patients'QoL as a result of switching from MUC to SUC. The mISC-Q consists of questions within four categories: ease of use, convenience, discreetness, and symptomatic benefit. Answers were graded as Strongly agree (+2), Agree (+1), Not sure (0), Disagree (−1), and Strongly disagree (−2). Overall patient QoL, as well as by sex, disease (presence of augmentation cystoplasty), and catheterization route (via urethra or urinary diversion), were analyzed. RESULTS: Thirty-eight patients (21M:17F; mean age: 21.7±5.3 y) submitted questionnaires. For ease of use, SUC was significantly better than MUC (score: 0.364, P=0.002) in all patients. Patients with catheterization via the urethra showed significant favor for SUC in ease of use (score: 0.512, P<0.001) and convenience (score: 0.714, P=0.011), but patients with catheterization via the abdominal stoma of urinary diversion gave negative scores in all categories, though no categories were significant. CONCLUSION: This study suggested that changing from MUC to SUC may lead to improvements in QoL, especially regarding ease of use. This benefit was clearly found in patients with catheterization via urethra rather than abdominal stoma of urinary diversion.

Effects on Quality of Life in Patients with Neurogenic Bladder treated with Clean Intermittent Catheterization: Change from Multiple Use Catheter to Single Use Catheter

PURPOSE: To evaluate changes in quality of life (QoL) in patients with neurogenic bladder treated with clean intermittent catheterization (CIC), who changed from a multiple use catheter (MUC) to single use catheter (SUC). METHODS: The Modified Intermittent Self-Catheterization Questionnaire (mISC-Q) was used to determine potential changes in patients'QoL as a result of switching from MUC to SUC. The mISC-Q consists of questions within four categories: ease of use, convenience, discreetness, and symptomatic benefit. Answers were graded as Strongly agree (+2), Agree (+1), Not sure (0), Disagree (−1), and Strongly disagree (−2). Overall patient QoL, as well as by sex, disease (presence of augmentation cystoplasty), and catheterization route (via urethra or urinary diversion), were analyzed. RESULTS: Thirty-eight patients (21M:17F; mean age: 21.7±5.3 y) submitted questionnaires. For ease of use, SUC was significantly better than MUC (score: 0.364, P=0.002) in all patients. Patients with catheterization via the urethra showed significant favor for SUC in ease of use (score: 0.512, P<0.001) and convenience (score: 0.714, P=0.011), but patients with catheterization via the abdominal stoma of urinary diversion gave negative scores in all categories, though no categories were significant. CONCLUSION: This study suggested that changing from MUC to SUC may lead to improvements in QoL, especially regarding ease of use. This benefit was clearly found in patients with catheterization via urethra rather than abdominal stoma of urinary diversion.

Residues Determination of 5 Heavy Metal Elements in Single Use and Gravity Feed Infusion Sets and Intra-venous Infusion Needles by ICP-MS / 中国药师

Objective:To establish a method for the determination of residual 5 heavy metal elements in single use and gravity feed infusion sets and intravenous infusion needles, including Cd, Cr, Cu, Sn and Pb. Methods:After the pre-preparation,the sample was dissolved in 1% nitrate. The 5 heavy metal elements in the sample solution were determined by inductively coupled plasma mass spec-trometry (ICP-MS). Results:Under the ICP-MS assay conditions, each element showed good linearity within the range of 0-50 ng· ml-1(r>0. 999 0). The average recoveries were within the range of 92%-116% and 1. 6%-2. 9%, respectively (RSD<3,n=9). Conclusion:The operation is simple and can meet the demand for the analysis of heavy metal elements in single use and gravity feed infusion sets and intravenous infusion needles.

Study on the Management Policy Situation of the Re-use of Single-use Device at Home and Abroad / 中国药房

OBJECTIVE:To provide reference for the management of re-use of single-use devices (SUDs) in China. METH-ODS:The management situation of SUDs use in China and the management policy of SUDs re-use in America and Germany were introduced,the published literature of SUDs re-use was researched and the safety and ethicality were analyzed and discussed. RE-SULTS:China had no regulation for the clear definition of the range,standards and requirements of SUDs re-use;America and Germany had well-management for the SUDs re-use with different modes. Literature analysis showed that there were 3 results for the SUDs re-use,including supporting,opposition and classified management. In terms of safety,SUDs re-use needs the base of specific species and disinfection operations;in terms of ethicality,SUDs re-use should focus on the right to know of patients and the effects on cost savings and environment. CONCLUSIONS:China should establish and improve the management policy of SUDs re-use,develop the classification assessment of re-use,encourage third-party organizations participating in the recycling of SUDs and strengthen the monitoring of adverse reactions,etc.

Resereach on management of reprocess and reuse of Single-use sterile medical devices / 国际生物医学工程杂志

The ever increasing use of the Single-use medical devices(SUD) in clinic has brought safety and convenience to people, while the management of SUD waste also put pressure on the environment. Reprocess and reuse of SUD has become the issue of social concerns. This paper will describe the management manner of FDA for reprocess and reuse of SUD, and then give some suggestion on China's management combining the national conditions of our country.

Evaluation of Single-use Blood Donor Arm Antiseptic Kits / 대한수혈학회지

BACKGROUND: Transfusion-associated bacterial contamination (TABC) have become one of the major hazards of transfusion and the donors' normal skin flora is considered to be the most important source of contamination. We therefore evaluated the effectiveness of single-use blood donor arm antiseptic kits available on the Korean market. METHODS: Forty-eight antiseptic kits of two manufacturers consisting of 70% isopropyl alcohol swab stick and 10% povidone iodine swab stick were evaluated for their performance in reducing the bacterial load of the skin before and after disinfection. Staff response about ease of use was also evaluated. RESULTS: Whereas before disinfection the mean bacterial count was 5 CFU/plate or less, after disinfection bacterial growth was hardly observed. Overall both antiseptic kits showed a percent reduction of more than 98% compared to predisinfection. The amount of antiseptic solution of one manufacturers' kit was excessive and leakage of the antiseptic solution was also observed. CONCLUSION: The effectiveness of both antiseptic kits evaluated in this study was satisfactory to be used for blood donors, but an improvement to the packaging of one manufacturers' kit is required before it can be used in the field.

Proposta metodológica para análise dos custos do reprocessamento de pinças de uso único utilizadas em cirurgia vídeo-assistida / Methodological proposal for reprocessing costs analysis of single use instruments used in video-assisted surgeries

O trabalho teve como objetivo desenvolver uma proposta metodológica para análise dos custos de reprocessamento de pinças de dissecção, apreensão e corte, de uso único, utilizadas em cirurgia vídeo-assistida. O reuso desses artigos é prática frequente, no Brasil e em diversos países, tendo como justificativa seu alto custo, embora sua viabilidade técnica não tenha sido comprovada. O reuso de artigos de uso único ainda é controverso e tem sido discutido e estudado sob os aspectos técnicos, legais, éticos e de segurança. Apesar da preocupação econômica, poucos estudos foram desenvolvidos sobre o real impacto econômico do reuso e reprocessamento. Neste trabalho, foi desenvolvida proposta metodológica para cálculo de custos e aplicada em três hospitais do Estado de São Paulo, seguindo o método de estudo de casos múltiplos. Foram coletados dados referentes a três meses nas instituições pesquisadas, por meio de observação e mensuração dos tempos das diversas fases do reprocessamento, revisão de registros da Central de Materiais e Esterilização e informações do Departamento de Recursos Humanos, Almoxarifado e Lavanderia. O custo do reprocessamento mensurado foi de R$9,374 no hospital Caso nº 1, de R$6,591 no Caso nº 2 e de R$3,312 no Caso nº 3. O baixo custo verificado deve ser analisado com grande cautela para que não seja interpretado como uma justificativa ao reuso desenfreado. Ao contrário, o baixo custo é motivo de preocupação, sobretudo quando se ---------------------------------|a observa que o controle de qualidade, nos três casos analisados, tem pequena participação na composição do custo final. Nenhuma das instituições adota os controles de qualidade recomendados para garantir a segurança do reprocessamento. Segundo a Associação Canadense de Assistência à Saúde (Canadian Healthcare Association), devem ser realizadas a validação do reprocessamento e a avaliação anual que incluem inspeções da limpeza dos artigos, testes de esterilidade e ) e análise de pirógenos e de resíduos dos agentes esterilizantes. Com os dados obtidos no estudo, foi elaborada uma estimativa do custo do reprocessamento, caso fossem realizadas a validação e a avaliação anual do reuso, empregando os testes de controle de qualidade. O custo do reprocessamento, considerando a possibilidade de dez reúsos do artigo, passaria a ser de R$185,19 no Caso nº 1 e R$363,10 no Caso nº 3. No Caso nº 2, em razão da baixa utilização das pinças do estudo, somente haveria vantagem econômica se o número de reúsos fosse restrito a três reutilizações; o custo do reprocessamento passaria a R$595,82 o que corresponderia a 58% do preço do artigo novo. A economia anual obtida pelo reuso da pinça de corte de uso único seria de R$577.818,36 no Caso nº 1, de R$51.501,60 no Caso nº 2 e de R$275.350,40 no Caso nº 3. A grande diferença observada na economia dos casos analisados está diretamente relacionada ao número de artigos empregados anualmente e aos gastos referentes à validação e avaliação anual do reprocessamento. A economia possível não elimina a necessidade de serem analisados outros aspectos relacionados ao reuso, em especial, os técnicos e de segurança

This study aimed to develop a methodological proposal for reprocessing cost analysis of dissection, apprehension and cutting single use instruments used in video-assisted surgeries. Reuse of such articles is a frequent practice in Brazil and many other countries, justified by their high cost, although technical viability of the process hasn't been established. Single use articles reuse is still a controversial issue and technical, legal, ethical and safety aspects have been discussed and studied. In spite of the financial concern involved, few studies have approached the real economic impact of reuse and reprocessing of single use items. In this study a methodological proposal developed for cost calculation was applied in three hospitals in São Paulo State, according to the multiple cases study method. Data was collected comprising a three month period in the researched institutions, through observation and time measuring of the various reprocessing phases, record revision from Central Supply and Sterilization Unit and information gathered at the Human Resources Department, Articles Supply and Laundry Units. Reprocessing costs measured were of R$9,374 in hospital Case number 1, R$6,591 in Case number 2 and R$3,312 in Case number 3. Low reprocessing costs found in this study should be analyzed with great care in order to avoid interpretation as a justification for unrestrained reuse. On the contrary, the low reprocessing cost gives reason to concern when it is observed that quality control, in all three analyzed cases, has little participation in the final cost. Neither one of the institutions adopts quality control protocols recommended for reprocessing safety assurance. According to the Canadian Healthcare Association, reprocessing process validation must be undertaken as well as annual evaluations which includes cleanliness inspection of the articles, pirogenic substances analyses, sterility testing and sterilizing agents residue analysis. An estimate of the reprocessing cost was elaborated considering a scenario where process validation and annual evaluations were performed, through quality assurance tests. Reprocessing costs, considering the possibility of 10 article reuses, would then be of R$ 185,19 in Case number 1 and of R$ 363,10 in Case number 3. Regarding Case number 2, due to the low rate of usage of the article, there would only be a financial advantage if the number of reuse would be restricted to 3 reutilizations: reprocessing costs would then be R$ 595,82 which corresponds to 58% of the price of a new article. Annual economic saving obtained through reuse of the single use cutting instrument would be of R$ 577.818,36 in Case number 1, of R$51.501,60 in Case number 2 and of R$ 275.350,40 in Case number 3. The great difference observed in the savings for the analyzed cases is directly related to the number of articles used annually and to the expenses related to validation processes and the reprocessing protocol annual evaluation. Financial saving obtained does not eliminate the need to analyze other aspects related to reuse, mainly those concerning technical and safety aspects

Reprocessamento e reutilização de material odonto-médico-hospitalar de uso: busca de evidências pela revisão sistemática de literatura científica / Single-use medical devices reprocessing and reuse: search of evidences through systematic reviews of scientific literature

Este estudo é baseado no fato inegável de que a prática do reprocessamento e reutilização de artigos odonto-médico-hospitalares é ampla no país e no mundo, apesar de não existir consenso científico para tal, principalmente pela enorme variedade de materiais e de artigos disponíveis no mercado. Neste trabalho foi aplicada metodologia de revisão sistemática de literatura científica, cuja investigação partiu de uma questão específica e utilizou fontes abrangentes com estratégias de busca explícitas, baseada em critérios aplicados uniformemente, com avaliação reprodutível. O objetivo foi selecionar publicações sobre o reprocessamento e reuso de artigos odonto-médico hospitalares de uso único de acordo com uma questão de pesquisa específica, revisar a qualidade metodológica destes estudos e discutir evidências para aplicação prática e de pesquisa deste conhecimento. A questão de pesquisa foi: Qual a efetividade e a segurança da prática de reprocessamento e reutilização de materiais odonto-médico hospitalares de uso único? Os dados foram coletados de estudos selecionados, sendo 20 estudos básicos e 01 de revisão não sistemática. Para análise e avaliação dos estudos básicos selecionados utilizou-se, como sistematização, a seguinte categorização inicial: escopo; tipo de pesquisa; sujeitos ou objetos da pesquisa; população; procedimentos da pesquisa; análise dos dados; resultados; conclusão; comentários da analisadora. Devido à epecificidade dos conteúdos obtidos das -------------------------|a pesquisas analisadas sob esta categorização, foram acrescentadas novas categorias, com a finalidade de refinar, agregar e correlacionar as informações obtidas, em quadros e tabelas, com a seguinte configuração final: tipos de artigos investigados; escopos; tipos de investigação; tipos de análises realizadas; resultados; conclusões. Os resultados mostraram que grande parte dos artigos é composta de plásticos, possui lumens e tem conformação complexa, significando que são artigos de difícil limpeza e descontaminação, cujos resultados podem, sob circunstâncias comparativas controladas, ser também considerados para artigos menos complexos e com menor dificuldade para seu reprocessamento. A finalidade foi obter informações que suportem ou não a prática de reprocessamento e reutilização de artigos odonto-médico-hospitalares de uso único. A conclusão é de que, com base no conhecimento atual, não é possível propor o reprocessamento e reuso de todos os artigos de uso único indiscriminadamente, mas é possível selecioná-los para testar e validar protocolos de reprocessamento e reuso de artigos odonto-médico-hospitalares baseados em conhecimentos científicos com graus de evidência bem estabelecidos, utilizando este conhecimento para a construção de políticas nacionais de saúde menos restritivas de recursos altamente tecnológicos para a Saúde Pública.

This study is based on the undeniable fact that single-use medical devices reprocessing and reuse is a large practice in the country and also the world, although there is no scientific consensus for such, mainly due to the enormous variety of materials and available articles in the market. In this study, methodology of systematic review of scientific literature was applied. The inquiry started up as a specific question and used wide sources with explicit strategies of search, based in criteria applied uniformly. The objective was to select publications in accordance to the single-use medical devices reprocessing and reuse using a specific question research, to revise the methodological quality of these studies and to discuss evidences for practical application and also for research of this knowledge. The research question was: Are the single-use medical devices reprocessing and reuse a safe and effective practice? The data was collected from selected studies, being 20 basic studies and 01 narrative review. For analysis and evaluation of the basic studies as systematization, the following initial categories are used: target; type of research; research's objects; population; research's procedures ; data analysis; results; conclusion; author's analysis. The results have shown that a great part of articles is composed of plastics, possesses lumens and has complex conformation, meaning that they are articles of difficult cleanliness and decontamination, which results can, under controlled comparative circumstances, also be considered for less complex articles and with lesser difficulty for reprocessment. The aim was to get information that supports or not SUDS reuse. The conclusion is that, according to the current knowledge, it is not possible to consider reprocess and reuse of all single-use devices indiscriminately. It is possible to select them for testing and to validate reprocess and reuse guidelines based in scientific evidences and using this knowledge for the construction of less restrictive National Health Policies for the Public.

Reprocessamento e reutilização de cateteres de hemodinâmica: a busca da qualidade nesta prática / Haemodynamic catheters reprocessing: search of quality in that practice

Este estudo teve como objetivos identificar e analisar os aspectos que implicam na decisão em reprocessar e reutilizar cateteres de hemodinâmica originalmente para um único uso as condições gerais do seu reprocessamento. Os dados foram coletados em 13 instituições hospitalares do município de São Paulo que aceitaram participar da pesquisa e que realizavam procedimentos hemodinâmicos, por meio de entrevista com enfermeiros do setor de hemodinâmica e da Comissão de Controle de Infecção Hospitalar (CCIH). O instrumento utilizado para a coleta de dados foi de múltipla escolha abrangendo as diversas etapas do reprocessamento. Constatamos que a causa principal para decidir pela reutilização dos cateteres é o aspecto econômico, mas nem todos os enfermeiros concordavam com a reutilização. A responsabilidade na decisão pelo reprocessamento e reutilização desses cateteres não era conhecida ou estava diluída entre um único profissional (médico ou enfermeiro), exceto a CCIH em duas instituições. As etapas de execução dessa prática não ocorriam em um só setor, distribuindo-se principalmente entre o serviço de hemodinâmica e serviço terceirizado de esterilização. O enfermeiro da Central de Materiais e Esterilização não estava envolvido e esse setor participava de algumas das etapas do processo na minoria das instituições. Apesar de constatarmos que as mesmas utilizavam mecanismos de controle, a principal problemática foi identificada na diversidade das ações, com bases empíricas na maioria das vezes não correspondendo às recomendações encontradas em literatura científica. Tendo em vista que a prática de reprocessamento reutilização de artigos originalmente de uso único é uma realidade nacional e internacional, concluímos pela necessidade de mais pesquisas que forneçam subsídios cientificamente comprovados para sua qualificação, assim como um maior comprometimento das instituições, associações profissionais e órgãos governamentais

The main objective of this study was to identify and analyze which aspects would imply in taking the decision of reprocessing and reusing haemodynamic catheters originally designed for single use and general reprocessing conditions. The data were collected in 13 hospital entities in São Paulo district, which accepted to take part in the research, and used to realize haemodynamic procedures through interviews with Haemodynamic Section Nurses and Hospital Infection Control Committee (HICC). The instrument used for collecting data was multiple choices comprising the different steps of the reprocessing. We stated that the main reason for deciding for reusing the catheters is the savings aspect, although not all the nurses agreed with the reusing. The responsibility in deciding for reprocessing and reusng those catheters was unknown or had been dissolved in a single professional (doctor or a nurse), except the HICC in two entities. The steps in the accomplishment of that practice did not happen in a single section, being mainly shared between the haemodynamic service and thirth-party sterilization service. The Central Supply nurse was not involved, and that section used to take part in some of the steps of the process only in few entities. Although we stated that they used control mechanisms, the main difficulty was identified in the diversity of the actions, most of the times with empiric basis, and not corresponding to the recommendations retrieved in scientific literature. Having in mind that the reprocessing and reuse of devices originally designed for single use is a national and international reality, we came to the conclusion that more researches are necessary to provide scientifically certified endowments for its qualification, as well as a major commitment of the entities, professional associations and governamental organs