The Pharmaceuticals and Medical Devices Agency (PMDA) releases Medical Device Safety Communications (MDSCs) to convey important safety information to patients and healthcare professionals. PMDA releases different types of safety communications, such as:

The Yellow Letter / Blue Letter

It is crucial to gather and analyze post-marketing reports of adverse reactions to provide prompt feedback about the information to the medical institutions. As required by Article 77-4 of the Pharmaceutical Affairs Law (Law No. 145, 1960), when the Marketing Authorization Holders (MAHs) of medical devices learn that the use of medical devices they have marketed could result in the onset or spread of hazards to public health or hygiene, they must take the necessary actions, such as recalls, sales suspensions, and information sharing, to prevent such hazards.

The Dear Healthcare Professional Letters of Rapid Safety Communications (Yellow Letter) or Dear Healthcare Professional Letters of Emergent Safety Communications (Blue Letter) are used to provide urgent safety information. Important and urgent safety information about medical device usage is provided in the Yellow Letter. Information contained in the Blue Letter should be quickly communicated to healthcare providers even though it does not call for emergency communications like the Yellow Letter.

Revisions of ‘PRECAUTIONS’

Information like Warnings, Contraindications, Important Precautions, and Clinically Significant Adverse Reactions are all included under PRECAUTIONS in package inserts. The PMDA extensively evaluates any new risks and works with experienced advisors to determine whether it is necessary to update PRECAUTIONS. This enables the PMDA to suggest taking an additional safety step to the Ministry of Health, Labour, and Welfare (MHLW). Following the findings of the PMDA inquiry, the MHLW issues a notification to revise PRECAUTIONS. Therefore, MAHs modify PRECAUTIONS to reflect the changes.

Pharmaceuticals and Medical Devices Safety Information (PMDSI)

Pharmaceuticals and Medical Devices Safety Information is issued in accordance with safety data gathered by the MHLW for healthcare workers to use medical devices more safely.

PMDA Alert for Proper Usage of the Medical Device – This alert aims to communicate to healthcare providers with clear information. The information presented here includes cases where the reporting frequencies of similar reports have not decreased despite relevant alerts provided in package inserts among medical device failure/infection cases reported.

PMDA Alert for Proper Usage of the Medical Device for Patients – This alert aims to convey to patients any significant problems with medical devices, such as malfunctions, using illustrations. It is occasionally necessary to remind patients to use the devices appropriately, even though such problems are previously mentioned in package inserts or other relevant literature.

Making a medical device safe for human use has become an increasingly difficult issue as a result of the globalization of the medical device business and the rise in medical device use. Medical device safety reporting is developed as a crucial competitive strategy for entering international markets. Appropriate safety communication methods will become more crucial as clinicians, patients, and regulators become more conscious of patient safety issues.

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