O perfil de queixas técnicas relacionadas a equipos comercializados no Brasil e o impacto na segurança do paciente / The profile of technical complaints related to infusion sets sold in Brazil and the impact on patient safety / El perfil de las quejas técnicas relacionadas con los equipos vendidos en Brasil y el impacto en la seguridad del paciente

Equipos são dispositivos médicos que, ao apresentarem desvios de qualidade, podem ocasionar agravos a elevado número de pessoas. Este estudo objetivou avaliar o perfil das notificações de queixas técnicas realizadas no Sistema Notivisa, desenvolvido pela Agência Nacional de Vigilância Sanitária, para discussão sobre o seu impacto na segurança do paciente. Por meio de metodologia quantitativa foram avaliados equipos comercializados no período de 2016 a 2017, cinco anos após a instituição da certificação metrológica compulsória. As principais queixas técnicas se referiram a problemas na integridade (82,70%): defeito mecânico, vazamentos, problemas no corta-fluxo, oclusão de fluido e descolamento, problemas na embalagem ou rotulagem (8,54%) e presença de corpo estranho e sujidades (7,97%). Tais falhas podem interferir nos procedimentos diagnósticos e/ou de tratamento, como a administração de medicamentos quimioterápicos, de antibióticos e também a realização de transfusões. Assim, a tecnovigilância é fundamental para a segurança sanitária no mercado a partir da identificação dos riscos e da possibilidade de mitigá-los, promovendo a segurança do paciente.

Infusion sets are medical devices that, when presenting quality deviations, can cause harm to a large number of people. This study aimed to evaluate the profile of technical complaint notifications made on the Notivisa System, developed by Anvisa ­ Agência Nacional de Vigilância Sanitária (National Agency for Health Surveillance), so as to discuss its impact on patient safety. By means of quantitative methodology, devices sold from 2016 to 2017 was evaluated, five years after the establishment of compulsory metrological certification. The main technical complaints referred to integrity problems (82.70%): mechanical defect, leaks, flow shutdown issues, fluid obstruction and detachment, packaging or labeling problems (8.54%) and presence of foreign bodies and dirt (7.97%). Such failures can interfere with diagnostic and/or treatment procedures such as the administration of chemotherapy drugs, antibiotics and also the transfusion process. Thus, the technovigilance is essential for health safety in the market, based on the identification of risks and the possibility of mitigating them, thus promoting the patient safety.

Los equipos son aparatos médicos quepueden resultar en daños a un gran número de personas por si acaso presentan desviaciones de calidad. El objetivo de esta investigación ha sido evaluar el perfil de notificacio-nes de quejas técnicasregistradas en el Sistema Notivisa, desarrollado por Anvisa ­ Agência Nacional de Vigilância Sanitária (Agencia Nacional de Vigilancia Sanitaria) con miras a la discusión de su impacto en la seguridad del paciente. Valiéndose de la metodología cuantitativa se evaluaron los equipos comercializadosdesde 2016 hasta 2017, que coincide con los cinco años tras la institución de la certificación metrológica obligatoria. Las principales quejas técnicas (82,70%) se refirieron a problemas de integridad: defecto me-cánico, fugas, problemas en el corta flujo oclusión y despegue de fluidos, dificultades en el embalaje o en la rotulación (8,54%) además de la presencia de cuerpo extraño y suciedades (7,97%). Dichos desperfectospueden obstaculizar los procedimientos de diagnóstico y/o de tratamiento, como la administración de fármacos quimioterapéuticos, antibióticos y también la realización de trasfusiones. De ahí que la tecnovi-gilancia sea fundamental para la vigilancia sanitaria en el mercado a partir de la identificación de riesgos sumada a la posibilidad de paliarlos, fomentando la seguridad del paciente.

Design of Gas Detection System Based on STM32 Infusion Set / 中国医疗器械杂志

Aiming at the low efficiency and low quality detection level of the manual infusion set, a gas detection system for infusion set based on STM32 single-chip microcomputer was designed. The detection system includes hardware system design and software system design. The hardware system is based on the STM32F103 single-chip microcomputer. It mainly designs the gas pressure sensor acquisition circuit and the multi-way solenoid valve control circuit. The software system uses a C ++ real-time operating system to ensure system monitoring's real-time performance and validity. Test data is transmitted to the upper computer and displayed via USB serial communication. The experiment proves that the infusion set gas detection system can perform gas detection on the infusion set. The system has the characteristics of stability and high accuracy. The relative error of the experimental measurement is within ±5%, and the detection efficiency is better than manual detection.

Study on the Migration Resistance of Additives in Disposable Photophobic Infusion Set / 中国医疗器械杂志

The disposable photophobic infusion was used to simulate clinical infusion under different conditions. The simulated liquid was collected every 30 min (total 4 h),and detected the additives (Fe, MDA and antioxidant 1076) in simulated liquid by spectroscopic method and chromatography method. The method is simple and stable, and can be used for the technical monitoring of the disposable photophobic infusion set in the future.

Analysis of Volatile Constituents in Disposable Infusion Set and Nasal Cannula by Gas Chromatography-Mass Spectrometry / 中国药师

Objective:To characterize the volatile compounds in 10 batches of disposable infusion sets and 6 batches of nasal can-nulas by GC-MS and determine the main odor-active compounds. Methods:The volatile components were extracted using a headspace sampler. An HP-5MS capillary column (30 m × 0. 25 mm,0. 25 μm) was adopted, and the qualitative analysis was performed by total ion chromatography ( TIC) of full scan with temperature programmer. Results:A total of 19 major volatile compounds were identified, which were hydrocarbon, alcohol and carbonyl compounds (such as aldehyde and ester). Based on the combination of odor test and GC-MS, the concentration of alcohol compounds (2-ethyl hexanol, 2-EH) had the most notable effect on the odor of samples. Conclu-sion:The samples with unacceptable order contain 2-EH with relatively high content, which should be paid more attention.

Adsorbability Study of Plastic Transfusion Bottle and Infusion Set to Diazepam / 中国药房

OBJECTIVE:To study the adsorbability of plastic transfusion bottle and infusion set to diazepam. METHODS:With the reference of plastic-bottled 5% glucose injection,HPLC was used to determine the changes of mass concentration of diazepam adding into plastic-bottled 5% glucose injection at different time;disposable plastic infusion set was connected to simulate intrave-nous infusion and determine the changes of mass concentration of diazepam in the liquid effluent at different time. RESULTS:The mass concentration of diazepam in glass infusion bottles group was higher than in plastic transfusion bottles group. The adsorbabili-ties of solutions showed the strongest at the time of 15-20 min. The mass concentration of the effluent liquid from the glass bottle group was about 80% of the original concentration and plastic bottle group was about 67%. As the time went on,the adsorbability was gradually saturated at 60 min and the concentration rose again;the mass concentration of the effluent liquid from the glass bot-tle group returned to 95%of the original concentration at 80 min and the plastic bottle group was about 75%of the original concen-tration. CONCLUSIONS:Both plastic infusion bottle and infusion set have strong adsorbability to diazepam. It is suggested that the dosage of diazepam should be increased by 25% to 33% while plastic-bottled 5% glucose injection is used as solvent for intrave-nous drip.

Study on Adsorbability of Disposable Infusion Set on Puerarin Injection / 中国药房

0 05) CONCL_USION:The adsorption of infusion set will not result in obvious changes of drug concentration