Andhra Pradesh MedTech Zone Ltd

ANDHRA PRADESH MEDTECH ZONE LTD

Ultra Modern Medical Equipment Manufacturing and Research hub welcoming Manufacturers & Innovators.

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AMTZ

BEMC SCHEME

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BEMC SCHEME

BEMC - Biomedical Equipment Maintenance Certification Scheme
Introduction

Effective maintenance and proper use of medical equipment are critical aspects in any large or modern hospital to ensure that all patients receive healthcare facilities without compromising on equipment failure. Biomedical equipment maintenance presents a challenge for many countries, especially those with low human and infrastructural technical resources. Almost two-third of all low-income countries do not have a national health technology policy which could ensure the effective use of resources through proper planning, assessment, acquisition and management of medical equipment. So, there is a need to develop a maintenance scheme that can be used globally that addresses how to maintain the medical equipment effectively and efficiently, providing quality, performance and safety aspects to the patients.

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Left to right [Dr Arjun Kalyanpur (CEO and Founder of Teleradiology Solutions), Dr Jitendra Kumar Sharma (MD and Founder CEO, AMTZ), Mr Mrutunjay Jena (Scientist-G and Head of Accreditation and Training Department, AMTZ), Mr. Rajiv Nath (Forum Coordinator, AIMED, Virtually), Dr Girdhar Gyani (Director General, AHPI), Mr Gaurang Dixit (Chairman-Cum-Managing Director, National Small Industries Corporation, Government of India), Dr Archana Sharma (Principal Scientist and Senior Advisor for International Relations, CERN, Geneva]


Biomedical Equipment Maintenance Certification (BEMC) Scheme was launched on the auspicious occasion of Dr. A.P.J. Abdul Kalam’s 91st birth Anniversary on 15th Oct 2022 at the premises of Andhra Pradesh MedTech Zone (AMTZ) Ltd to address the gap in maintenance service of medical equipment.

This voluntary scheme is an initiative of AMTZ Ltd in collaboration with the Association of Indian Medical Device Industry (AiMeD) and Association of Healthcare Providers India (AHPI). AiMeD is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including Consumables, Disposables, Equipment, Instruments, Electronics, Diagnostics and Implants. AHPI represents the majority of healthcare providers in India and advocates with the government, regulatory bodies and other stakeholders on issues, which have a bearing on enabling its member organizations to deliver appropriate healthcare services to the community at large.

This voluntary scheme applies to maintenance process certification including testing and verification of MEDICAL EQUIPMENT and SYSTEM (combination of medical equipment), or parts of such equipment or systems, which need maintenance on a periodic basis. This voluntary scheme can be implemented by the hospital through biomedical maintenance department, biomedical maintenance by the manufacturer and third-party maintenance provider. This voluntary scheme shall not cover implantable medical devices, single-use or disposable medical devices and medical equipment which does not require preventive maintenance as per the manufacturer. This voluntary scheme is developed in compliance with the international standards ISO/IEC 17065, published International Accreditation Forum (IAF) documents and existing best practices available across the Globe.


Purpose

The purpose of the scheme is to determine the efficacy of maintenance of medical equipment’s function after Installation, Servicing, and Repair are done by the organization in accordance with the applicable standards, regulatory and manufacturer’s requirements. However, maintenance service provider (AMC, CMC, Hospitals, Clinics, OEM etc) is responsible for the implementation of the scheme requirements on an ongoing basis.



Click here to view members of Steering Committee, Technical Committee and Certification Committee



Documents
  1. 1 . Technical Criteria document
  2. 2 . Annexures for Technical Criteria document
  3. 3 . Certification Process document
  4. 4 .CB & AB Requirements document
  5. 5 . Provisional approval for CBs document
  6. 6 . Rules for Use of Scheme Mark document

If any comments/feedback on Scheme documents, please provide them through mail ID - karthik.v@amtz.in