The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare?

Abstract

Policies for health technologies such as medical devices are essential and contribute to improved quality of healthcare. The regulation, assessment, and management represent important functions of medical devices. Insufficiently developed interactions between these functions impact the quality of delivered healthcare. To date studies lack to analyse these functions in a broad way. The aim of this study is to analyse the regulation, assessment, and management of orthopaedic medical devices in Mexico and how they shape healthcare. This qualitative study included 42 stakeholders involved directly or indirectly in the regulation, assessment, or management for orthopaedic medical devices in Mexico. The fragmentation of responsibilities for medical device functions may be a central aspect of our findings concerning challenges reported by interviewees. Strengthening technovigilance based on improved reporting across health care institutions emerged as pathway to improve medical device regulation. With regard to improving the medical device assessment, a comprehensive update of the standard list represents a relevant opportunity. Integrating advanced quality attributes into procurement processes regarding decision-making, purchasing strategy, and procurement agent is needed to fostering the management. This study provides a broad analysis of medical device functions within a health system and highlights in this specific context how improvements might be achieved. It addresses a broad range of interest groups represented by policy makers, health service providers, managers and administrators of healthcare facilities, and doctors with an interest in health technologies. In this paper we highlight important themes that influence outputs and outcomes of the regulation, assessment, and management and discuss strategies in fostering these areas. To date, the regulation, assessment, and management of medical devices are rarely analysed in a broad way, even though these functions importantly contribute to the successful implementation of health technology policies. The quality of delivered healthcare is influenced by the performance between and within these functions. In Mexico, little discussion has been raised on challenges of the regulation, assessment, and management of medical devices. Changes to current processes and practices can improve outputs and outcomes of these functions and positively influence the quality of delivered healthcare. Stakeholder involvement and commitment is essential to this.