Regulations for the Prescription of Footwear as Medical Device

Abstract

ABSTRACT. Orthopedic footwear is part of the category of medical devices used in the conservative treatment of foot and lower limbs pathomechanics. For the custom-made medical device the manufacturer has to perform the design based on the prescription of a duly qualified medical practitioner that sets the specific design characteristics of the device. Quality management standards in the field of medical devices govern the entire process (or parts thereof) from design and development to delivery and provide technical support for their implementation. In this respect, the prescription is constituted as an input, respectively an essential requirement of the design process and must be complete and unambiguous. This paper aims to analyse aspects of medical prescription as an essential requirement of the design and manufacturing process of custom-made orthopedic footwear. KEY WORDS: orthopedic footwear, medical device, prescription, quality management REGLEMENTAREA ACTIVITĂŢILOR LEGATE DE PRESCRIPŢIA ÎNCĂLŢĂMINTEI CA DISPOZITIV MEDICALREZUMAT. Încălţămintea ortopedică intră în categoria dispozitivelor medicale utilizate în tratamentul conservator al patologiilor de natură mecanică ale piciorului şi membrelor inferioare. În cazul dispozitivului medical fabricat la comandă, producătorul trebuie să realizeze proiectarea pe baza prescripţiei practicianului medical calificat în mod corespunzător prin care acesta stabileşte caracteristicile specifice de proiectare ale dispozitivului. Standardele de management al calităţii în domeniul dispozitivelor medicale definesc condiţiile de calitate care guvernează întregul proces (sau părţi ale acestuia) pornind de la proiectare şi dezvoltare până la livrare şi acordarea suportului tehnic pentru implementarea acestora. În acest sens, prescripţia medicală se constituie ca o intrare ("input"), respectiv o cerinţă esenţială a procesului de proiectare şi trebuie să fie completă şi lipsită de ambiguitate. Prezenta lucrare îşi propune să analizeze aspecte ale prescripţiei medicale ca o cerinţă esenţială a procesului de proiectare şi realizare a încălţămintei ortopedice fabricate la comandă. CUVINTE CHEIE: încălţăminte ortopedică, dispozitiv medical, prescripţie, managementul calităţii DES ACTIVITÉS RÉGLEMENTAIRES POUR LA PRESCRIPTION DES CHAUSSURES COMME DISPOSITIF MÉDICALRÉSUMÉ. Les chaussures orthopédiques entrent dans la catégorie des dispositifs médicaux utilisés dans le traitement conservateur des pathologies de nature mécanique du pied et des membres inférieurs. Dans le cas du dispositif médical fait sur mesure, le fabricant doit effectuer la conception à partir de la prescription d'un médecin dûment qualifié qui définit les caractéristiques de conception spécifiques du dispositif. Les normes pour la gestion de la qualité dans le domaine des dispositifs médicaux définissent les exigences de qualité qui régissent l'ensemble du processus (ou ses parties) à partir de la conception et du développement et jusqu'à la livraison y compris fournir un soutien technique pour la mise en oeuvre d...

L'importance de la concordance linguistique dans les soins médicaux : le cas des patients francophones au Ghana

“…• Le recueil des informations renvoie à la partie de la consultation au cours de laquelle le patient fournit des informations sur ce dont il souffre tout en répondant aux questions du personnel de santé. inclut les produits pharmaceutiques que le patient doit acquérir, ainsi que les obligations et les dispositions à prendre (Petcu et Rosculet, 2017). • La terminaison de l'entretien renvoie à la fin du processus de prise en charge.…”

Practical aspects of implementation of quality management system requirements for the medical footwear design

“…Thus, for the process of designing medical footwear, prescription is constituted as an input. The prescription concept implies that the prescription form includes specific design features in accordance with the definition of medical custom-made devices but in reality this does not happen in current practice [5][6][7].…”

Prescription variables for the medical footwear

“…Moreover, in Romania the only book describing in detail the footwear characteris" cs in each chapter related to a foot pathology dates from 1964 [16]. The prescrip" on defi ni" on and its implica" on especially in the countries where specifi c professions such as podiatry or pedorthics are not developed was extensively treated in a previous ar" cle [17]. As in the podiatric literature the foot ortho" cs are seen as "in-shoe" medical devices, numerous papers dealing with their prescrip" on variables [18][19][20], the purpose of this paper was to focus on the specifi c prescrip$ on variables of the medical footwear, part of the medical prescrip$ on, without considering those of the "in-shoe" medical devices.…”

“…As in the podiatric literature the foot ortho" cs are seen as "in-shoe" medical devices, numerous papers dealing with their prescrip" on variables [18][19][20], the purpose of this paper was to focus on the specifi c prescrip$ on variables of the medical footwear, part of the medical prescrip$ on, without considering those of the "in-shoe" medical devices. These prescrip$ on variables could be part of the "technical prescrip$ on" elaborated by the physician or by ortho$ st/pedorthist according to their exper$ se highlighted by literature [11,13,17].…”