Alerta De Seguridad para Connectors and Connections - SAFETY ALERT

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
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  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
  • Causa
    Recent events linked by the media point out that due to the administration of solutions by erroneous routes, unfavorable outcomes have occurred, with a serious consequence for the patients. examples disclosed in brazil were deaths in health services associated with intravenous feeding. however, it is known that this is not a problem only in brazil, but it is world wide. several factors contribute to this and all must be considered, since the objective is to evaluate how the chain of triggering of such errors occurs and to propose systemic interventions in order to prevent such errors and to provide safety to the patient and the user of the product . this vision refers to the importance of knowing in what context these errors occur, hence the stimulus to their notification. in practice, what is observed is that such situations are not notified, but are publicized in the media in such a way that it is limited to finding "the culprit", usually the professional who administered the product or who advised the family member to administer (in this case of probe power). in these cases, the actions seem to be punitive, strengthened by the appeal of public opinion. merely punitive stances inhibit reporting within the health service itself and the competent health authorities and make it difficult to analyze the problem and identify "root cause" and, consequently, to propose effective measures to address the problem.
  • Acción
    From the knowledge of some situations that can trigger this problem, initiatives already exist to minimize the risk of its occurrence. Among these initiatives, one is specifically concerned with the production of health products, the elaboration and revision of Technical Norms regarding connectors. The first published Technical Standard was ISO 594-1: 1986 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. Currently, the ISO 80369 (7 parts) series of standards is currently being reviewed and internalized in Brazil, which will replace ISO 594-1. Besides this series, there are others that refer to the connection with other devices, such as anesthesia devices, for example. This is a timely initiative, but the problem must be faced by noting also the other factors that involve risk with connectors. Hence the Recommendations to Avoid Misconnections, presented by the Secretary¹ of CE 26.150.01 of ABNT - Quality Management and related general aspects of health products: (i) To identify and emphasize, through training, the risks related to connection errors and to guide ways of avoiding them (2, 8, 9, 11, 12); (1), (2), (2), (3), (4), (5), (6), (7), (8) 12); (iii) .Do not modify or adapt the connector in its use. This may compromise their safe use (1, 4, 6, 7, 10); (iv). Tubes and catheters that have different purpose for use or are applied to different systems should be secured in opposite positions (eg central venous catheter positioned towards the patient's head and nasoenteral catheter positioned towards the patient's feet) (2, 4, 7, 11) This guidance is especially important in the case of neonatal units. (v). High-risk catheters (eg epidural, intrathecal, arterial) should be labeled and should not have secondary injections (2, 11, 12); (vi). Do not force any connection. If a connection is difficult to make - it requires a lot of effort - one should consider the possibility of a connection error. Likewise, if a connection seems unsecured, check if the components are correct (3, 9, 10); (vii). Only make connections under suitable lighting conditions. (5, 6, 7); (viii) .Reconnect the connections and track all tubes and catheters of a new patient in the industry (2, 5, 6, 7, 11, 12); (ix). Inform non-clinical collaborators, patients and their families to request assistance from the nursing or medical staff, whenever there is a need to connect or disconnect devices or infusions (1, 2, 5, 6, 7, 8, 11); (x). Identify and manage environmental conditions and practices that may contribute to the fatigue of the health professional and take appropriate actions to avoid them. (2, 5, 6, 7, 11); (xi). To notify adverse events arising from connection errors to the competent authority (3, 5). In addition to these Recommendations, we suggest reading materials available at the following addresses: (i) .http: // (ii) .http: // www. (iii) .https: // ¹ Recommendations for Avoiding Misconnections - Systematized by Elaine Koda, nurse, risk management specialist (ISO 14971 and ISO 31000). Secretary of CE 26.150.01 - "Quality management and related general aspects of health products", WG 6 Rapporteur and member of ISO / TC 210 JWG4.


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