Sumersingh Rajput Dhirajsingh, Galib R, Kalaiselvan V, Ziaur Rahman Syed, Manoj Nesari Tanuja
Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of India, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, Janakpuri, New Delhi, India.
All India Institute of Ayurveda, New Delhi, India.
J Ayurveda Integr Med. 2022 Jul-Sep;13(3):100593. doi: 10.1016/j.jaim.2022.100593. Epub 2022 Jul 15.
Materiovigilance is regulatory system to study and follow incidents that might result from using medical devices. To trail the occurrence of untoward effects associated with medical devices as well as to document and prevent their recurrence; the Indian Pharmacopeia Commission initiated Materiovigilance program in India (MvPI) in 2015. Classical texts of Ayurveda include substantial description of devices intended for various therapeutic purposes such as Panchakarm (penta-bio purification procedures), Surgeries and for management of gynecological conditions etc. The implemented program of Materiovigilance does not include Ayurveda devices and thus there is need for documentation, systematic classification of Ayurveda devices and development of Ayurveda Materiovigilance (AMv). In this review, relevant information from classical texts of Ayurveda, latest published information related to Materiovigilance and information of medical devices from classical texts of Ayurveda has been scrutinized along with systematic correlation and applied interpretation of the collected data. It is observed that Materiovigilance has been well documented in Ayurveda in context of twenty six surgical and diagnostic devices; eleven mostly utilized pharmaceutical instruments five Panchakarma instruments and five home devices. For regulation of quality of Ayurveda medical devices, their manufacturing, standard utilization, reporting and prevention of medical device associated errors; it is the need of hour to create and implement regulation in the form of AMv. The Ayurveda literature highlights that the ancient seers of Ayurveda were well aware regarding Materiovigilance in their own way. However in view of modern era and mainstreaming of Ayurveda heritage, critical revision, updating, systematically categorization of Ayurveda devices, development and implementation of AMv regulation is the need of hour.
医疗器械警戒是一种监管系统,用于研究和跟踪使用医疗器械可能导致的事件。为了追踪与医疗器械相关的不良事件的发生情况,并记录和预防其再次发生;印度药典委员会于2015年在印度启动了医疗器械警戒计划(MvPI)。阿育吠陀的经典文献对用于各种治疗目的的器械有大量描述,如五疗法(五种生物净化程序)、手术以及妇科疾病的管理等。已实施的医疗器械警戒计划不包括阿育吠陀器械,因此需要对阿育吠陀器械进行记录、系统分类以及开发阿育吠陀医疗器械警戒(AMv)。在本综述中,对阿育吠陀经典文献中的相关信息、与医疗器械警戒最新发布的信息以及阿育吠陀经典文献中的医疗器械信息进行了审查,并对收集的数据进行了系统关联和应用解读。据观察,在阿育吠陀中,关于26种手术和诊断器械、11种最常用的制药器械、5种五疗法器械和5种家用器械的医疗器械警戒已有充分记录。为了规范阿育吠陀医疗器械的质量、其制造、标准使用、报告以及预防与医疗器械相关的错误;当务之急是以AMv的形式制定和实施相关规定。阿育吠陀文献强调,阿育吠陀的古代先知们以自己的方式对医疗器械警戒有充分的认识。然而,鉴于现代时代以及阿育吠陀遗产的主流化,对阿育吠陀器械进行批判性修订、更新、系统分类、开发和实施AMv规定是当务之急。