Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries

Abstract

BackgroundWe know little about how procurement of a high-risk medical device (HRMD) affects clinical practice and outcomes. In health systems in high-income countries, and specifically those that maintain a national arthroplasty registry, procurement decisions are frequently guided by long-term clinical results, with the goal of ensuring at least standard quality of HRMDs. But in countries like Mexico, decision-making is often dominated by lowest acquisition price. We set out to study the impact of procurement for orthopaedic HRMDs on clinical procedures and outcomes.MethodsWe based our qualitative study on 59 in-depth interviews with stakeholders from Mexico, Switzerland, Germany, and UK: orthopaedic specialists, government officials, other experts, and social security system managers or administrators. We took a healthcare delivery approach to capturing and comparing factors that affected the regulations of HRMDs and procurement processes, and to understanding connections between procurement and clinical practice.ResultsOur findings demonstrate for procurement processes that the three European countries compared to Mexico don’t have similar concerns with regards to their procurement processes. Deficiencies of procurement regulations and practices identified from representatives in Mexico were almost absent in European countries. We identified three areas of deficiency: 1) HRMD regulations based on insufficiently robust clinical evidence (mainly noted by European countries); 2) Follow-up on Health Technology Assessments is inadequate (noted by Mexico) and methodology not always good enough (noted by European countries); and, 3) Lowest-acquisition price often guides procurement decisions and thus may not align with needs of clinical procedures (noted by Mexico and some European countries).ConclusionsProcurement processes for orthopaedic HRMDs may have an impact on clinical procedures and outcomes. A favourable approach is one where orthopaedic specialists are parties to the procurement process, and post-market surveillance data informs decision-making. Actors in the procurement process can improve their impact on clinical procedures and outcomes by developing specific strategies that better align the needs of both, procurement and clinical procedures.

Strategies to improve the medical device life cycle in Mexico

“…At the same time the participation of the public and professional associations in decision-making remains limited. [13][14][15] These findings coincide largely with the literature that portrays public policy-making in Mexico as a governmental-centred process, largely impermeable to civil society participants, but increasingly influenced by the private sector.…”

“…[13][14][15][16] The findings highlighted that the overall MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices (OMDs), resulting in suboptimal quality of services delivered to patients. This finding resonates with concerns raised by other authors regarding the regulation, assessment, and management of health services in Mexico at different levels of health care delivery.…”

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

“…material, mechanical characteristics, dimensions) and lowest-price offers [3][4][5]. Many interviewees thought that the applied procurement regulations and practices in use have not advanced over the past years.…”

“…This can be achieved when necessary interactions between these areas are established because of their interdependence. To date, there are indications of questions regarding different attributes of the MDLC for orthopaedic high-risk medical devices (HRMDs) in Mexico and their influence on clinical practice and thus on the delivered quality of health care [3][4][5][6][7]. HRMDs are implanted in the human body (such as a knee joint implant) and are therefore recommended subject to the highest level of pre-market and postmarket regulation [8].…”

A Scoping Review of the Health Technology Procurement Decision Process in Indonesia

“…In Indonesia, it has been identified that the procurement of advanced technology requires a high degree of financial investment, and the need to develop capabilities is often not existing at the clinician or institutional level (Clifford, Blaya, Hall-Cliffor, & Fraser, 2008). Procurement processes in nursing and healthcare, in general, include purchasing inclusive of contracting and operational delivery (Lingg, Wyss, & Duran-Arenas, 2016). There is a limited budget to invest in procuring and implementing advanced technology, so the decisions of what to procure are critical.…”