Open AccessHandling of Medical Devices: Reforms and Regulations
Author(s) -
M. Charmila,
M. P. Venkatesh,
G. Ramya Shree
Publication year - 2021
Publication title -
journal of pharmaceutical research international
Language(s) - English
Resource type - Journals
ISSN - 2456-9119
DOI - 10.9734/jpri/2021/v33i60a34520
Subject(s) - work (physics) , medical device , set (abstract data type) , risk analysis (engineering) , business , medical care , welfare , medicine , engineering , computer science , nursing , political science , law , mechanical engineering , biomedical engineering , programming language
With the evolving technology and changing regulations, the medical device sector is set to grow quickly soon. Even though they are an integral part of patient care they present several unique problems which are not sufficiently addressed by the device manufacturer or the medical community in general. Medical device is widely used by professionals in a clinical setup, by patients, family members at home. As step towards better understanding the rules, regulations, and the required reforms for the safe use of medical devices various measures taken by different regulatory authorities to ensure the minimization of use error are discussed. Human factor engineering and ergonomics are considered while designing a medical device. It is evident that all the stakeholders involved contribute to the safety of the medical device keeping in mind the welfare of the patient but is that enough and what can be done is discussed in this review work.