Table 1 Extraction of interview guide questions
Group 1 | |
Q1 | On which organizational levels did Mexico achieve the required quality assurance of already established programs? Please explain how. |
Q2 | Which organizational level manifests the biggest barrier to translate efforts of quality assurance into results? |
Q3 | Please describe your opinion on quality assurance and clinical efficacy as contributing elements for the provision of medical devices?. |
Q4 | Please describe how clinical data from the clinical practice level is transferred back to the institutional level and how to the national level? |
Q5 | Please describe the general consciousness of Mexican stakeholders for the contribution of clinical evidence to their practice. |
Q6 | On which organizational levels or specific areas do you observe weaknesses with regards to the consciousness? |
Q7 | Other countries say that it is a challenge to assure clinical effectiveness of a medical device without the support of clinical evidence? Only product safety is not sufficient for high-risk medical devices. Based on which attempts or programs Mexico tries to manage this situation. |
Q8 | Please describe what this means for the clinical practice and outcome of the patient? |
Q9 | What actions are needed to improve this situation? |
Group 2 | |
Q1 | What should be the relation of the orthopaedic surgeon and the procurement of medical devices? |
Q2 | Please describe your role and knowledge in terms of the procurement of medical devices? |
Q3 | Please describe what this means for yourself as surgeon who takes over the responsibility for the clinical outcome of the patient? |
Q4 | In Mexico it is common practice to procure the majority of medical devices through tenders and to award based on the best price (respecting its listing in cuadro basico). What is your experience on that? |
Q5 | Please describe how you perceive the outcome of the procurement in terms of your clinical practice, the quality of supplier service, and the intrinsic quality of the product? |
Q6 | How is clinical evidence and clinical data considered? |
Q7 | Please describe how long you can stick to the same implant system in your public institution. Please distinct between trauma and reconstruction devices? |
Q8 | Please describe what this means for the clinical practice and outcome of the patient? |
Q9 | What actions are needed to improve this situation? |
Q10 | How do you currently obtain sustainable information on clinical safety of a medical device? |