Speech Recognition Systems 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    554
  • 날짜
    2002-03-08
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA