Related Experiment Video
Updated: Nov 3, 2025

Automatic Separation and Collection of Cancer-Related Substances from Clinical Samples
Published on: January 13, 2023
Which Health Impacts of Medical Device Adverse Event Should Be Reported Immediately in Korea?
Sooin Choi1, Soo Jeong Choi2, Jin Kuk Kim2
1From the Departments of Laboratory Medicine and Genetics.
Objective:
Immediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, and congenital malformation or abnormalities. With the advent of new codes from the International Medical Device Regulators Forum, a study was undertaken to explore the applicability of health impact codes as immediate MDAE reporting indications in the Republic of Korea.
Method:
This domestic cross-sectional survey study was conducted for members from Medical Device Safety Information Monitoring Center in November 2019. For the annex F (health impact) codes defining health impact of an MDAE, we checked whether each code matched with the current indication and asked experts whether they agreed with each code as an indication of immediate reporting. Consensus was reached when ≥70% of experts agreed.
Results:
A total of 28 experts from 19 centers responded to the survey. Of a total of 64 codes, 29 matched with the current indication. However, in an expert survey, 17 of 29 codes were not agreed for immediate reporting and 5 codes were found to be unmatched codes. For these 5 codes, experts agreed that they would need reporting immediately. Finally, only 17 codes achieved consensus for immediate reporting.
Conclusions:
There is a discrepancy between the code matched to the current immediate MDAE reporting indication and experts' consensus. Sufficient discussion and agreement would be needed to apply health impact codes for immediate reporting.
Related Concept Videos
Types of Reports II: Incident or Occurrence Report
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Bacterial Signaling
Types of Reports III: Telephone and Verbal Reports
Here's an overview of each type:
Telephone Orders
Healthcare Associated Infections II: Preventive Measures
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
Data Reporting and Recording

