Objective:
A new guide has been introduced to standardize the creation of medical device safety information using voice and sign language conversion codes. This ensures accessibility for visually and hearing-impaired individuals.

Key Guidelines:

  • Manufacturers and importers must incorporate accessibility features in safety content.
  • QR codes can be used for easy access to voice and sign language video instructions.
  • Safety information must be clear, avoiding ambiguous terms and including detailed usage instructions and precautions.
  • Patients with severe blood circulation disorders or blood diseases should consult a physician before using devices that may cause internal bleeding due to pressure.
  • Implementation:
  • The guide outlines the selection of relevant safety information and appropriate methods for delivering it to individuals with impairments. Certified sign language interpreters must be used to ensure accurate communication.

This initiative enhances inclusivity, ensuring that all users can access critical medical device safety information effectively.

Region: East Asia

Source: https://www.mfds.go.kr/brd/m_1060/view.do?seq=15634&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

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