ANALISIS MANAJEMEN RISIKO KEAMANAN DAN KUALITAS PENGGUNAAN PERALATAN MEDIS DI RUMAH SAKIT UMUM DAERAH ARIFIN ACHMAD PROVINSI RIAU

Nani  Lasiyah; Romi Mulyadi; Okta Nola Yolanda iriani

doi:10.35328/kesmas.v13i1.26931

Authors

Nani Lasiyah Institut kesehatan dan Teknologi Al Insyirah, Pekanbaru, Indonesia
Romi Mulyadi Institut kesehatan dan Teknologi Al Insyirah, Pekanbaru, Indonesia
Okta Nola Yolanda iriani Institut kesehatan dan Teknologi Al Insyirah, Pekanbaru, Indonesia

DOI:

https://doi.org/10.35328/kesmas.v13i1.26931

Keywords:

Service Quality, Puskesmas, An Outpatient

Abstract

Electro-medical equipment plays an important role in providing public health services. Health services must be supported by devices that are available and function in accordance with Republic of Indonesia Law Number 56 of 2014. This research aims to analyze risk management related to electro-medical equipment to ensure safe use and no work accidents during use for both patients and other medical personnel in accordance with ISO 14971:2019. Qualitative research method with a document study approach, checklist sheets and interviews. Based on the results of research conducted, risk management for electro-medical equipment has been carried out well and in accordance with ISO 14971:2019 standards. It was found that the percentage of suitability for electro-medical equipment risk management was 100%. There are low, medium and high risk classifications for electro-medical equipment. Risk evaluation is carried out by labeling dangerous medical devices, and risk control is carried out through preventive measures, routine maintenance and calibration of medical devices. Risk documentation: There are budget and cost constraints in the electro-medical equipment risk management process. Based on the data obtained, it can be concluded that the risk management of electro-medical equipment is in accordance with ISO 14971:2019 which is 100% compliant

References

Auliani, Istiana. 2021. “Evaluasi Sistem Pelaksanaan Manajemen Pemeliharaan Alat Medis Di Instalasi Pemeliharaan Dan Perbaikan Peralatan Medis Rumah Sakit (Ip3Mrs) Rsud Arifin Achmad Provinsi Riau Tahun 2020.” Jurnal Pengabdian Kesehatan Komunitas 1 (1): 38–53. https://doi.org/10.25311/jpkk.vol1.iss1.729.

Daniel Aditya. 2021. “Prinsip-Prinsip Manajemen Risiko Ala ISO 31000:2018.” Risk Management Plus. 2021. https://rwi.co.id/prinsip-prinsip-manajemen-risiko-ala-iso-310002018/.

Fanny, Nabilatul, and Anindiya Soviani. 2020. “9_Analisis_Manajemen_Resiko_Di_Ruang_Filing_RSUD.” Infokes 10 (2): 12–19.

Giovaningrum, Putri, and Muhammad Firdaus. 2022. “Pengaruh Kualitas Pelayanan Terhadap Kepuasan Dan Loyalitas Pasien Rawat Jalan Di Rsud Arifin Achmad Provinsi Riau.” Journal of Hospital Administration and Management 3 (2): 50–57. https://doi.org/10.54973/jham.v3i2.289.

Haryania, Dwi Septi, and Octojaya Abriyosob. 2020. “Proses Manajemen Risiko Dengan Pendekatan Enterprise Risk Management (ERM) Pada Usaha Pembuatan Tahu,” no. 34: 270–81.

Hutagalung, Louis Eberhard. 2022. “Analisa Manajemen Risiko Sistem Informasi Manajemen Rumah Sakit (Simrs) Pada Rumah Sakit Xyz Menggunakan Iso 31000.” TeIKa 12 (01): 23–33. https://doi.org/10.36342/teika.v12i01.2820.

Imam, Waqas. 2021. “ISO 14971 – Tinjauan Singkat Standar Manajemen Risiko Alat Kesehatan.” Tsqasia. 2021. https://tsqasia.com/iso-14971-quick-review-of-medical-devices-risk-management-standard/.

Indragiri, Suzana, and Triesda Yuttya. 2020. “Risiko Menggunakan Identification Risk Assessment and Risk (Hirarc).” Jurnal Kesehatan 9: 1080–94.

KILIÇ, CENK. 2022. “Pembaruan ISO 14971:2019.” Linked In. 2022. https://tr.linkedin.com/in/cenkkalkan?trk=article-ssr-frontend-pulse_publisher-author-card.

Kruszynska, Małgorzata. 2021. “ISO 14971: Manajemen Risiko Alat Kesehatan Dijelaskan.” Spyrosoft. 2021. https://spyro-soft.com/blog/healthcare/iso-14971-risk-management-for-medical-devices-explained.

Lelani. n.d. “8 Prinsip Manajemen Risiko ISO 31000.” Laboratorium Mutu. https://www.labmutu.com/2023/06/prinsip-manajemen-risiko-iso-31000.html.

Mahendra, Rendi. 2017. “11 Prinsip Manajemen Risiko Berdasarkan ISO 31000.” ISO CENTER INDONESIA. 2017. https://isoindonesiacenter.com/11-prinsip-manajemen-risiko-berdasarkan-iso-31000/.

Nichols, Etinne. 2023. “Manajemen Risiko ISO 14971 Untuk Alat Kesehatan: Panduan Definitif.” Green Light. 2023. https://www.greenlight.guru/blog/iso-14971-risk-management.

Rangkuti, Maksum. 2023. “Manajemen Risiko Pengertian, Ciri, Tujuan, Manfaat, Dan Prinsip.” UMSU Fakultas Ekonomi Dan Bisnis. 2023.

Sanjay Dhal, MS, MBA. n.d. “Manajemen Risiko Dalam QMS Dan Desain Produk Baru (NPD).” Qualcy System. https://qualcy.com/blog/medical-device-quality-risk-management/.

Sulistyawati, Rr Laeny. 2023. “Ada Ledakan Di RS Eka Hospital BSD Tangerang, Diduga Gara-Gara Alat MRI Overheat.” Rejabar Republika. 2023. https://rejabar.republika.co.id/berita/s1c5ph282/ada-ledakan-di-rs-eka-hospital-bsd-tangerang-diduga-garagara-alat-mri-overheat.

Suparmin, Asyari. 2019. “Manajemen Resiko Dalam Perspektif Islam.” El-Arbah: Jurnal Ekonomi, Bisnis Dan Perbankan Syariah 2 (02): 27–47. https://doi.org/10.34005/elarbah.v2i02.551.

Ulfianinda, Tika. n.d. “ISO 31000: Sistem Manajemen Risiko.” Maserp. https://www.mas-software.com/blog/iso-31000-manajemen-risiko.

ZENO, PINSENSIUS RICHARD. 2021. “Pemahaman Manajemen Resiko Tujuan Manajemen Risiko.” Lmsspada Kemdikbud. 2021. https://lmsspada.kemdikbud.go.id/mod/forum/discuss.php?d=8429.