Abstract

Collecting information about patient satisfaction with orthopedic and prosthetic medical devices in terms of utility, tolerance, and compliance is essential for verifying and improving the quality of these devices. In addition, such information is useful for improving the patients’ quality of life, and the quality management systems of health care providers. This study assessed patient satisfaction with these devices from a sample of patients with orthopedic, neurologic, and rheumatic diseases at the Specialized Hospital for Orthopedic Prosthetics and at the premises of the Dispenser of Orthopedic and Prosthetic Medical Devices, both in Bratislava in the Slovak Republic. The assessment involved a translated and validated questionnaire about patient satisfaction with orthopedic and prosthetic medical devices to evaluate key factors of weight, fit, appearance, comfort, pain free, free of abrasiveness, ease of application, and durability of each device. The study samples consisted of patients with lower limb problems (42.5%), spine problems (26.9%), and a combination of leg and spine issues (25.9%). Orthopedic disease occurred in 73.6% of these patients, a combination of orthopedic and neurologic disease in 13.5%, and neurologic disease in 7.3%. Orthopedic insoles (36.3%), hip belts (17.6%), and the corset on the spine (5.2%) were the most used devices. Overall, the medical devices rated highly, with a high proportion of patients voting “strongly satisfied” in five of the eight key factors (range 51.8 to 63.2%), followed by a moderately lower proportion for durability (43.5%), comfort (37.3%), and appearance (31.1%). The comfort in wearing the device received the greatest patient dissatisfaction (22.8% of patients), followed by appearance (12.4%), and then fit (7.3%).

Highlights

  • Medical devices are products intended for use in the diagnosis, mitigation, treatment, or prevention of a disease that could affect the structure or function of the human body or of other animals (FDA, 2014)

  • The overall dissatisfaction with OPMD ranged between 0.5% and 7.3%, for all evaluated factors except comfort (22.3%) and appearance (12.4%), which departed from the trend in patient dissatisfaction observed with other factors

  • Another two studies evaluated patient satisfaction relating to health care providers of orthopedic and prosthetic medical devices

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Summary

Introduction

Medical devices are products intended for use in the diagnosis, mitigation, treatment, or prevention of a disease that could affect the structure or function of the human body or of other animals (FDA, 2014). The Orthotics and Prosthetics Users Survey (OPUS) was identified by a systematic literary review as the only tool designed for evaluating patient satisfaction with medical devices. This tool has five separate modules: 1) functional state of the lower limbs; 2) functional status of the upper limbs; 3) client satisfaction with medical devices (CSD); 4) client satisfaction with the services; and 5) health-related quality of life. Module 3, the client satisfaction with medical devices, can be used separately to assess patient satisfaction with the OPMD This questionnaire was originally developed in English (Heinemann, Bode, & O’Reilly, 2003). The resulting modified module for patient satisfaction with OPMD showed a degree of validity and reliability, with eight key factors of weight, fit, appearance, comfort, pain free, free of abrasiveness, easy of application and durability of OPMD to assess

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