Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.
Expert Rev Med Devices
; 21(9): 819-828, 2024 Sep.
Article
de En
| MEDLINE
| ID: mdl-39119692
ABSTRACT
INTRODUCTION:
Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety. AREAS COVERED This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks. EXPERT OPINION The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Équipement et fournitures
/
Union européenne
Limites:
Humans
Pays/Région comme sujet:
Africa
/
America do norte
/
Asia
Langue:
En
Journal:
Expert Rev Med Devices
/
Expert rev. med. devices
/
Expert review of medical devices
Sujet du journal:
DIAGNOSTICO POR IMAGEM
/
TERAPEUTICA
Année:
2024
Type de document:
Article
Pays d'affiliation:
Inde
Pays de publication:
Royaume-Uni