PATIENT SATISFACTION WITH ORTHOPEDIC AND PROSTHETIC MEDICAL DEVICES

Ivona Malovecká; Daniela Mináriková; Viliam Foltán

doi:10.12955/cbup.v3.632

Ivona Malovecká Faculty of Pharmacy, Department of Organization and Management in Pharmacy, Comenius University in Bratislava
Daniela Mináriková Faculty of Pharmacy, Department of Organization and Management in Pharmacy, Comenius University in Bratislava
Viliam Foltán Faculty of Pharmacy, Department of Organization and Management in Pharmacy, Comenius University in Bratislava

DOI: https://doi.org/10.12955/cbup.v3.632

Keywords: Orthopedics, prosthetic, medical device, patient satisfaction, quality, patient quality of life, quality management, health care provider

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%).

References

Berke, G. M, Fergason, J., Milani, J.R., Hattingh, J., McDowell, M., Nguyen, V., & Reiber, G. E. (2010). Comparison of satisfaction with current prosthetic care in veterans and service members from Vietnam and OIF/OEF conflicts with major traumatic limb loss. Journal of Rehabilitation Research & Development, 47, 361–372.

Bosmans, J., Geertzen, J., & Dijkstra, P. U. (2009). Consumer satisfaction with the services of prosthetics and orthotics facilities. Prosthetics and Orthotics International, 33, 69–77.

Bravini, E., Franchignoni, F., Ferriero, G., Giordano, A., Bakhsh, H., Sartorio, F., & Vercelli, S. (2014). Validation of the Italian version of the Client Satisfaction with Device module of the Orthotics and Prosthetics Users’ Survey. Disability and Health Journal, 7, 442-447.

FDA. (2014). Is the product a medical device? Retrieved from: http://www.fda.gov/MedicalDevices/DeviceRegulationand

Guidance/Overview/ClassifyYourDevice/ucm051512.htm.

Geertzen, J. H. B., Gankema, H. G. J., Groothoff, J. W., & Dijkstra, P. U. (2002). Consumer satisfaction in prosthetics and orthotics facilities. Prosthetics and Orthotics International, 26, 64-71.

Heinemann, A. W., Bode, R. K., & O’Reilly, C. (2003). Development and measurement properties of the Orthotics and Prosthetics Users’ Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthetics and Orthotics International, 27, 191-206.

Karmarkar, A. M., Collins, D. M., Wichman, T., Franklin, A., Fitzgerald, S. G., Dicianno, B. E., Pasquina, P. F., & Cooper, R. A. (2009). Prosthesis and wheelchair use in veterans with lower-limb amputation. Journal of Rehabilitation Research & Development, 46, 567-576.

Jarl, G. M., & Hermansson, L. M. N. (2009). Translation and linguistic validation of the Swedish version of Orthotics and Prosthetics Users’ Survey. Prosthetics and Orthotics International, 33, 329-338.

Jarl, G. M., Heinemann, A W, & Hermansson, L. M. N. (2012). Validity evidence for a modified version of the Orthotics and Prosthetics Users’ Survey. Disability and Rehabilitation Assistive Technology, 7, 469-478.

Jarl, G. M., Holmefur, M., & Hermansson, L. M. N. (2014). Test-retest reliability of the Swedish version of the Orthotics and Prosthetics Users’ Survey. Prosthetics and Orthotics International, 38, 21-26.

Magnusson, L, Ahlström, G, Ramstrand, N, & Fransson, E. (2013). Malawian prosthetic and orthotic users mobility and satisfaction with their lower limb assistive device. Journal of Rehabilitation Medicine, 45, 385-391.

Pezzin, L. E., Dillingham, T. R., & MacKenzie, E. J., Ephraim P., Rossbach P. (2004). Use and satisfaction with prosthetic limb devices and related services. Archives of Physical Medicine and Rehabilitation, 85, 723-9.

Sastri, V. R. (2014). 2 - Regulations for Medical Devices and Application to Plastics Suppliers: History and Overview. In V. R. Sastri (Ed.), Plastics in Medical Devices (Second Edition) (pp. 9-18). Oxford: William Andrew Publishing.