MONITORING DAN EVALUASI CARA DISTRIBUSI ALAT KESEHATAN YANG BAIK (CDAKB) PADA PEDAGANG ALAT KESEHATAN PT.X DI KOTA BATAM

Authors

  • Yan Yan Universitas Abdurrab
  • Mona Asiah Universitas Syiah Kuala, Aceh, Indonesia
  • Ovalina Sylvia Br. Ginting Universitas Haji Sumatera Utara

DOI:

https://doi.org/10.51771/fj.v2i2.392

Keywords:

Alkes, distribusi, CDAKB

Abstract

Distribution is an important aspect in ensuring the quality of the preparation. Medical Device Distributors must have adequate facilities and infrastructure to ensure the implementation of distribution, management, procurement, and storage. The purpose of this study was to determine Medical Device Distributors compliance with CDAKB requirements in the distribution of medical devices. This study uses the direct observation method on the research object to see the activities carried out and compare them with the CDAKB requirements listed in the Draft Technical Instructions for Supervision of Medical Device Distribution Facilities. Monitoring objects are documents, officers, facilities/infrastructure, and distribution activities. The results of the observations are the percentage of the level of fulfillment of the CDAKB requirements by dividing the total score achieved by the maximum number of scores and then multiplying by 100%. The results of the analysis of the level of CDAKB compliance show that PT. X meets 59 of 84 points (70.24%) requirements divided into 4 aspects, namely quality management system, resource management, product storage, and handling, and corrective actions, returns, and product destruction. In conclusion PT. X meets the CDAKB requirements and is in a good category.

References

Afqary, M., Ishfahani, F., & Mahieu, M. T. R. (2018). Evaluasi Penyimpanan Obat Dan Alat Kesehatan Di Apotek Restu Farma. Jurnal Farmamedika (Pharmamedica Journal), 3(1), 10–20. https://doi.org/10.47219/ath.v3i1.21

Anandani, G. I., Fauziah, R., & Rusmana, W. E. (2022). Evaluasi Sistem Penyimpanan Obat Antibiotik dengan Menggunakan Metode Fifo dan Fefo di Gudang Farmasi Rumah Sakit X. Cerdika: Jurnal Ilmiah Indonesia, 2(3), 364–372. https://doi.org/10.36418/cerdika.v2i3.355

Anonim. (2005). Rencana Strategi Departemen Kesehatan. Kementerian Kesehatan Republik Indonesia. Jakarta.

Anonim. (2010). Peraturan Menteri Kesehatan Republik Indonesia Nomor 1192/Menkes/Per/VIII/2010 Tentang Penyaluran Alat Kesehatan. Kementerian Kesehatan Republik Indonesia.

Anonim. (2014). Peraturan Menteri Kesehatan RI Nomor 4 Tahun 2014 Tentang Cara Distribusi Alat Kesehatan yang Baik. Kementerian Kesehatan Republik Indonesia. Jakarta.

Anonim. (2017). Peraturan Menteri Kesehatan RI Nomor 62 Tahun 2017 tentang Izin Edar Alat Kesehatan, Alat Kesehatan Diagnostik In Vitro dan Perbekalan Kesehatan Rumah Tangga. Kementerian Kesehatan Republik Indonesia. Jakarta.

Dianita, P. S., Kusuma, T. M., & Septianingrum, N. M. A. N. (2017). Evaluasi Penerapan Standar Pelayanan Kefarmasian di Puskesmas Kabupaten Magelang Berdasarkan Permenkes RI No.74 tahun 2016. University Research Colloquium (URECOL), 74, 125–134. http://journal.ummgl.ac.id/index.php/urecol/article/view/1631

Patty, L. J., Lolo, W. A., & Sudewi, S. (2016). Evaluasi Penyimpanan Dan Pendistribusian Alat Kesehatan Di Pedagang Besar Farmasi Suramando. Pharmacon, 5(2), 290–296.

Downloads

Published

2022-07-31