The regulation, assessment, and management of orthopaedic medical devices in Mexico : crucial aspects, problems, and steps to improve it

Introduction: In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement or technology assessments. Well-tailored policies for health technologies such as medical devices are essential and contribute to improved quality of health care. The regulation, assessment, and management represent important functions of the Medical Device Life-Cycle (MDLC). Insufficiently developed interactions between these functions impact the quality of health care and health system’s effectiveness. To date studies lack to analyse these functions in a broad way even though they are increasingly of interest to policy makers and health system experts in Mexico. Objective: This Ph.D. research was designed and carried out so get a better understanding on policies and practices of the MDLC areas for orthopaedic medical devices in Mexico. The research encompasses four objectives spanning from (i) defining which areas of procurement are crucial for clinical practice and outcomes of orthopaedic medical devices, (ii) assessing attitudes of stakeholders regarding outcomes of the MDLC areas and analysing knowledge-related factors that influence these areas, (iii) analysing challenges of and discussing possible ways forward in fostering the regulation, assessment, and management of orthopaedic medical devices in Mexico, and (iv) analysing interests, positions, and power of stakeholders to three alternative strategies to improve processes and practices with regard to the regulation, assessment, and management of orthopaedic medical devices in Mexico to assess the political feasibility of these strategies. Methods: We used a mainly qualitative research approach through overall 166 interviews (four sub-studies) and 187 survey participants (one sub-study) as well as a literature review (one sub-study) based on an overall framework that considers the MDLC relevant areas and the different levels by which the delivery of health care is being shaped. First, we determined and analysed themes that were relevant to the different interest groups of the MDLC by using ‘procurement’ as starting point. We used in-depth interviews and interviewed 58 persons representing different stakeholders from four countries to define which areas of procurement are crucial for clinical practice and outcomes of orthopaedic HRMDs. Second, we generated initial conclusions that served to further provide more specific insights on the most relevant themes. To do so we conducted two sub-studies: (i) we conducted a study using semi-structured interviews to assess opinions from 48 stakeholders from Mexico, and (ii) we conducted a survey to assess attitudes of 187 orthopaedic specialists from Mexico. Third, we discussed ideas for possible ways forward in fostering the MDLC. To do so we conducted two sub-studies: (i) we interviewed 42 persons representing different stakeholders from Mexico to analyse challenges of and discuss possible ways forward in fostering the regulation, assessment, and management of orthopaedic medical devices in Mexico, and (ii) we used a literature review to discuss the contribution of survival rate benchmarks as decision-making rule. Fourth, we analysed interests, positions, and power of stakeholders to specific strategies with regard to changes of processes and practices of the MDLC relevant areas. We used a stakeholder analysis method and included 17 persons representing multiple interest groups to analyse interests, positions, and power of stakeholders to three alternative strategies to improve processes and practices with regard to the regulation, assessment, and management of orthopaedic medical devices in Mexico to assess the political feasibility of these strategies. Results: The MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices, and this results in a situation that the quality of services delivered to patients is sub-optimal. First, the management of data and information is a critical aspect of the performance of the MDLC. Our research provided insights into problems related to data and information, and how this might have an influence on outputs and outcomes of the MDLC. The focus on knowledge-related factors (second sub-study) allowed us to better explain the relation of MDLC function such as ‘management’ and clinical procedures for orthopaedic medical devices in Mexico. Second, technovigilance receives relatively high attention by policy makers in Mexico but that stakeholders of the MDLC underestimate its contribution regarding improving MDLC outcomes. Our research showed that the information flow between the micro level (observations from clinical practice) and macro level is relatively weak. Third, in Mexico, HTA adds little value to decision-making and HTA at the level of hospitals has not received a lot of attention yet even though it may provide important benefits to the quality of health care and to the health system’s effectiveness. Fourth, stakeholders of the MDLC function ‘management’ in Mexico underestimate the role played by procurement regarding purchasing of orthopaedic HRMDs. Our research showed that decisions are either based on simple decision criteria or impacted by lowest-price offers. Quality attributes such as clinical long-term performance and intra-operative handling performance is rarely influencing into decision-making. Conclusion: Only some of the findings that our research has produced have been discussed in the literature before. This research is novel in terms of its specific focus on key MDLC functions and on orthopaedic medical devices. Further, it was timely because some of the presented themes are currently undergoing policy discussion in Mexico. The MDLC system in Mexico is not coherently outlined and set-up across the regulatory, the assessment, and the management domains of orthopaedic medical devices. The fragmentation of responsibilities of the MDLC areas, which is underpinned by the health system structure, has recently received more attention from different stakeholders and is subject to the current policy discussion. The suggested changes of current processes and practices of the regulation, assessment, and management can improve outputs and outcomes of these functions and positively influence the quality of health care and health system’s effectiveness. We have the following recommendations to the Mexican policy makers and other stakeholders related to the MDLC: (i) A government agency is needed to broadly oversee, monitor and report on quality-related issues within the health system; (ii) Decision-makers should apply an integrative approach of selecting medical devices to better prevent an economic and health burden due to disconnected processes and practices of the MDLC functions; (iii) Specific policies and organizational practice targeting orthopaedic medical devices are necessary; (iv) Technovigilance needs to be strengthened to improve the understanding of potential health risks associated with sub-standard HRMDs; (v) Data, information, and knowledge need to be managed appropriately across the sub-systems of health care provision; (vi) Technologies should be assessed during the purchasing process by applying strategies such as risk assessment, the adequate involvement of end-users, and basing decisions on multiple criteria including clinical impact in the short-term and long-term; (vii) The methodology applied to technology assessments for evaluating HRMDs needs to be adapted to the gold standard and HTAs at the level of hospitals should be introduced; (viii) Decision-making needs to distinguish between different risk classes of medical devices because decisions on complex medical devices are based on simple decision criteria; and (ix) ‘Procurement’ needs more attention so that actors involved in procurement or impacted by procurement decisions are less confronted by problems

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

We 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.; We 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.; Our 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).; Procurement 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

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

Background: 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. Methods: This qualitative study included 42 stakeholders involved directly or indirectly in the regulation, assessment, or management for orthopaedic medical devices in Mexico. Results: 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. Conclusions: 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

Thesis "The regulation, assessment, and management of orthopaedic medical devices in Mexico: Crucial aspects, problems, and steps to improve it."

The regulation, assessment, and management of orthopaedic medical devices in Mexico: Crucial aspects, problems, and steps to improve it

ESTRATEGIAS PARA MEJORAR EL CICLO DE VIDA DE DISPOSITIVOS MÉDICOS EN MÉXICO

Supplementary fil

Strategies to improve the medical device life cycle in Mexico

Objective. To analyze the role of stakeholders to three alternative strategies to improve processes and practices regarding the regulation, assessment, and management oforthopaedic medical devices in Mexico. Materials and methods. The study was based on document analysis and 17 structured interviews with multiple key actors within the Mexican health system to inform a stakeholder analysis aiming at assessing the political feasibility of these strategies. Results. Central level government agencies, those with a relation to quality of care, were identified as most relevant stakeholders to influence the adaption and application of the strategies. Major barriers identified are financial and human resources, and organisational culture towards reform. Conclusion. Discussed strategies are political feasible. However, solving identified barriers is crucial to achieve changes directed to improve outputs and outcomes of medical device life cycle and positively influence the quality of health care and the health system’s performance

Attitudes of orthopedic specialists toward effects of medical device purchasing

The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes.; We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico.; We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments.; To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement

Additional file 1: of The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare?

Interview Guide. (DOCX 117 kb

Economic evaluation of a novel genetic screening test for risk of venous thromboembolism compared with standard of care in women considering combined hormonal contraception in Switzerland

AIM The aim of this study was to assess the cost effectiveness of the Pill Protect (PP) genetic screening test for venous thromboembolism (VTE) risk compared with standard of care (SoC), for women considering combined hormonal contraceptives (CHCs) in Switzerland. METHODS A two-part microsimulation model was developed to estimate VTE events, costs and quality-adjusted life years (QALYs) associated with the PP and SoC strategies. In the first portion of the model, a cohort of 1 million Swiss first-time seekers of a CHC were simulated. It was determined whether each women would receive a CHC or non-CHC by using prescribing patterns elicited from a modified Delphi study. These results formed the basis of the SoC strategy. For the PP strategy, a PP test was included and the results considered in addition to SoC practice. Each woman then entered a Markov model that captured morbidity and mortality over a lifetime. The risk of having a VTE was derived from the risk algorithm that underpins the PP test. The remaining model inputs relating to population characteristics, costs, health resource use, mortality and utilities were derived from published studies or national sources. The model was validated and calibrated to align with population-based studies. Extensive uncertainty analyses were conducted. RESULTS From a Swiss health system perspective, the PP strategy in comparison with the SoC strategy generated an additional CHF 231, and gained 0.003 QALYs per woman, leading to an incremental cost-effectiveness ratio of CHF 76 610 per QALY gained. Assuming a threshold of CHF 100 000 per QALY gained, the PP strategy is likely to be cost effective. Our results were generally robust to variations in the parameter values. CONCLUSIONS The PP test may be cost effective in Switzerland for screening women seeking CHCs for their risk of VTE based on the current evidence

Economic evaluation of a novel genetic screening test for risk of venous thromboembolism compared with standard of care in women considering combined hormonal contraception in Switzerland

The aim of this study was to assess the cost effectiveness of the Pill Protect (PP) genetic screening test for venous thromboembolism (VTE) risk compared with standard of care (SoC), for women considering combined hormonal contraceptives (CHCs) in Switzerland.; A two-part microsimulation model was developed to estimate VTE events, costs and quality-adjusted life years (QALYs) associated with the PP and SoC strategies. In the first portion of the model, a cohort of 1 million Swiss first-time seekers of a CHC were simulated. It was determined whether each women would receive a CHC or non-CHC by using prescribing patterns elicited from a modified Delphi study. These results formed the basis of the SoC strategy. For the PP strategy, a PP test was included and the results considered in addition to SoC practice. Each woman then entered a Markov model that captured morbidity and mortality over a lifetime. The risk of having a VTE was derived from the risk algorithm that underpins the PP test. The remaining model inputs relating to population characteristics, costs, health resource use, mortality and utilities were derived from published studies or national sources. The model was validated and calibrated to align with population-based studies. Extensive uncertainty analyses were conducted.; From a Swiss health system perspective, the PP strategy in comparison with the SoC strategy generated an additional CHF 231, and gained 0.003 QALYs per woman, leading to an incremental cost-effectiveness ratio of CHF 76 610 per QALY gained. Assuming a threshold of CHF 100 000 per QALY gained, the PP strategy is likely to be cost effective. Our results were generally robust to variations in the parameter values.; The PP test may be cost effective in Switzerland for screening women seeking CHCs for their risk of VTE based on the current evidence