Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Biomechanical analysis of a novel Y-plate designed for the treatment of extraarticular distal humerus fractures

Adult distal humerus fractures are infrequent, yet they account for one-third of all humerus fractures. For the treatment of comminuted and osteoporotic fractures, locking plates are claimed to be biomechanically superior to alternative internal fixing techniques. Treatment remains difficult despite recent advancements and the use of locking plates due to frequent comminution, low bone quality, and limited healing ability in osteoporotic bone. An optimal design of the newly constructed plate and the control model were selected. The biomechanical characteristics of non-osteoporotic and osteoporotic synthetic bone were compared on six models. The biomechanical properties of the new plate were tested and compared on 54 osteoporotic synthetic humerus models. The control models were reconstructive and parallel LCPs. The tests were carried out under static and dynamic axial, lateral and bending loads. Fracture displacements were measured by optical measuring system Aramis. The test model is significantly stiffer for lateral load (p = 0.0007) and for bending load at the moment of model failure (p = 0.0002), while for axial load the LCP model showed greater stiffness (p = 0.0017). During lateral dynamic loading, all three LCP models broke and there was a significant difference compared to the test model (p = 0.0125). The LCP model is dynamically significantly more durable under axial load, while the largest displacements were recorded with the test model (p = 0.029). The displacements induced by all three loads are within the limits that fulfil the parameters of appropriate biomechanical stability. A novel locking plate for extra-articular distal humerus fractures may provide an alternative to the traditional two-plate.     

Review of Variables Associated With Positive Surgical Margins Using Scout Reflector Localizations for Breast Conservation Therapy

ObjectiveTo evaluate factors contributing to positive surgical margins associated with reflector guidance for patients undergoing breast conserving therapy for malignancy.Materials and MethodsA retrospective IRB-approved review of our institutional database was performed for malignant breast lesions preoperatively localized from January 1, 2018 to December 31, 2020. The following data was recorded using electronic medical records: lesion type and grade, lesion location, reflector and wire placement modality, use of intraoperative ultrasound, margin status, patient age, family history, BMI, and final pathology. Statistical analysis was performed with univariate summary statistics and logistic regression. P < .05 was significant.ResultsA total of 606 image-guided pre-surgical localizations were performed for lumpectomies of breast malignancies. A total of 352 of 606 (58%) wire localizations and 254 of 606 (42%) SCOUT reflector localizations were performed. Sixty out of 352 (17%) of wire-localized patients had positive surgical margins, whereas forty-eight out of 254 (19%) of reflector-localized patients had positive surgical margins. (OR = 1.12, P value: .59). For reflector guided cases, the use of intraoperative ultrasound (IOUS) was associated with decreased positive margin status (OR = 0 .28, 95% CI = [0.14, 0.58]) while in situ disease was associated with increased positive margin status (OR = 1.99, 95% CI = [1.05, 3.75]). No association between modality used for localization (mammography vs. ultrasound) and positive margin status was observed (OR = 0.63, 95% CI = [0.33, 1.19]). No association between positive margins and age, family history, tumor location and BMI was observed.ConclusionFor reflector guided surgeries, the use of IOUS was associated with decreased positive margins, by contrast the presence of ductal carcinoma in situ was associated with increased positive margins. There was no statistically significant difference in surgical outcomes for reflector-guided localization compared to wire localizations of the breast.