Events

Alerte De Sécurité sur Speech Recognition Systems

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    554
  • Date
    2002-03-08
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA