title: Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries.
abstract: 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.
authors: University of Basel, Petersplatz 1, 4003, Basel, Switzerland. myriam.lingg@yahoo.de.|Swiss Tropical and Public Health Institute, Swiss Centre for International Health, University of Basel, Petersplatz 1, 4003, Basel, Switzerland. myriam.lingg@yahoo.de.
authors: Myriam
authors: M
authors: Lingg
authors: University of Basel, Petersplatz 1, 4003, Basel, Switzerland.|Swiss Tropical and Public Health Institute, Swiss Centre for International Health, University of Basel, Petersplatz 1, 4003, Basel, Switzerland.
authors: Kaspar
authors: K
authors: Wyss
authors: Centre for Mexican Studies in the United Kingdom, London, WC2R 2LS, UK.|National Autonomous University of Mexico, Medical faculty, Circuito Interior, Ciudad Universitaria, Av. Universidad 3000, Mexico, CP, 04510, Mexico.
authors: Luis
authors: L
authors: Durán-Arenas
mesh_terms: D003657:Decision Making; D005060:Europe; D005858:Germany; D006801:Humans; D007407:Interviews as Topic; D008800:Mexico; D009983:Orthopedic Equipment; D017063:Outcome Assessment, Health Care; D011682:Purchasing, Hospital / Q000379:methods*; D036301:Qualitative Research; D011787:Quality of Health Care; D012042:Registries; D013557:Switzerland; D013673:Technology Assessment, Biomedical / Q000592:standards*
keywords: Health systems; Medical devices; Medical technology; Orthopaedic; Procurement; Purchasing