Events

Alerta De Seguridad para Speech Recognition Systems

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
    554
  • Fecha
    2002-03-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Ecri has found that in some cases, speech recognition software can replace one drug name with another (eg clonidine by quinidine). if a physician dictates a report using a failed speech recognition system, if there is a substitution, a patient may receive the wrong medication, or the patient's medical record may appear to be the wrong medication, creating a risk to patient safety.
  • Acción
    ECRI recommends the following to prevent substitution of the drug name when using speech recognition system; these recommendations also apply to the use of traditional transcription methods: (1) To alert clinicians to the potential for misinterpretation of drug names when using speech recognition systems. When appropriate, provide in-service training for staff on how and why this problem occurs, and how this can be avoided, such as speaking clearly and slowly or spelling words when dictating drug names. (2) Remind clinicians that they should always check drug names before signing the final report. (3) If you are using a speech recognition system, to report dictation, make sure this instrument provides a pharmaceutical vocabulary or dictionary. If not, most systems will provide specific vocabularies to be imported or downloaded into it. In some cases, the user may need to train the system to recognize this imported vocabulary. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Speech Recognition Systems
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA