Analysis of Medical Device Vigilance Reporting of Adverse Events Through the E-Watch System by Medical Device Businesses in Indonesia
1
Public Health, University of Muhammadiyah Prof DR HAMKA, Jakarta, Indonesia
Popul. Med. 2026;8(Supplement Supplement 1):A940
ABSTRACT
BACKGROUND:
Medical device vigilance, particularly adverse event reporting, is essential for post-market surveillance to ensure the safety and quality of medical devices. In Indonesia, the e-Watch Alkes system has been established to support adverse event reporting by medical device businesses. However, the level of compliance and effective utilization of this system remains limited.
METHODS:
This study aimed to assess compliance with adverse event reporting through the e-Watch Alkes system and to identify factors influencing compliance among medical device businesses in Indonesia. A sequential mixed-methods design was applied. The quantitative phase employed a cross-sectional survey involving 178 licensed medical device businesses selected through simple random sampling. Data were analyzed using descriptive statistics, chi-square tests, and logistic regression. The qualitative phase consisted of structured interviews and focus group discussions to obtain a comprehensive understanding of reporting practices and barriers. Qualitative data were analyzed through data reduction, data display, and conclusion drawing.
RESULTS:
Quantitative analysis showed that 28.7% of respondents were non-compliant with adverse event reporting, and only 8.5% had used the e-Watch Alkes system. No significant association was found between compliance and business profile (p = 0.80) or level of knowledge (p = 0.11). Attitude toward reporting was significantly associated with compliance (p = 0.02) and was the strongest predictor (Exp(B) = 2.24). Qualitative findings indicated that compliance could be improved through enhanced regulatory socialization, regular training, enforcement of sanctions, and strengthening a proactive and systematic vigilance reporting system. Limited human resources, communication barriers with authorities, and low awareness were identified as key obstacles.
CONCLUSIONS:
Attitude plays a critical role in determining compliance with medical device adverse event reporting. Strengthening regulatory enforcement, capacity building, and optimization of the e-Watch Alkes system are necessary to improve vigilance implementation and ensure medical device safety in Indonesia.
Medical device vigilance, particularly adverse event reporting, is essential for post-market surveillance to ensure the safety and quality of medical devices. In Indonesia, the e-Watch Alkes system has been established to support adverse event reporting by medical device businesses. However, the level of compliance and effective utilization of this system remains limited.
METHODS:
This study aimed to assess compliance with adverse event reporting through the e-Watch Alkes system and to identify factors influencing compliance among medical device businesses in Indonesia. A sequential mixed-methods design was applied. The quantitative phase employed a cross-sectional survey involving 178 licensed medical device businesses selected through simple random sampling. Data were analyzed using descriptive statistics, chi-square tests, and logistic regression. The qualitative phase consisted of structured interviews and focus group discussions to obtain a comprehensive understanding of reporting practices and barriers. Qualitative data were analyzed through data reduction, data display, and conclusion drawing.
RESULTS:
Quantitative analysis showed that 28.7% of respondents were non-compliant with adverse event reporting, and only 8.5% had used the e-Watch Alkes system. No significant association was found between compliance and business profile (p = 0.80) or level of knowledge (p = 0.11). Attitude toward reporting was significantly associated with compliance (p = 0.02) and was the strongest predictor (Exp(B) = 2.24). Qualitative findings indicated that compliance could be improved through enhanced regulatory socialization, regular training, enforcement of sanctions, and strengthening a proactive and systematic vigilance reporting system. Limited human resources, communication barriers with authorities, and low awareness were identified as key obstacles.
CONCLUSIONS:
Attitude plays a critical role in determining compliance with medical device adverse event reporting. Strengthening regulatory enforcement, capacity building, and optimization of the e-Watch Alkes system are necessary to improve vigilance implementation and ensure medical device safety in Indonesia.
| eISSN: | 2654-1459 |
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