Quality Certification of Medical Devices in Venezuela: Process Developed by Simón Bolívar University, Caracas-Venezuela

Abstract

Background and Objective: The development of medical technology and advances in biomedical engineering are in constant growth. Every year new medical devices are found in the market that seeks to satisfy the demand and requirements of medical services in health institutions. Consequently, health systems of the countries generate methodologies to regulate and accredit medical devices that really satisfy the needs of medical services with safety, effectiveness, efficiency, and quality. A third party must guarantee the safety and effectiveness of medical technology and issue a quality certification before its available to use in medical establishments. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Health) that grants quality certification to medical devices is the Health Technology Management Unit (UGTS in Spanish), attached to the Research and Development Foundation (FUNINDES) of the Simón Bolívar University (USB). The objective of this work is to show the protocol for UGTS certification to comply with ISO 9001 standards and guarantee the quality of the processes of the medical devices certifying unit.

Material and Methods: The process is based on the ISO 9001 standard. Five activities were determined: (i) Prepare the teach-ing, technical and administrative staff as ISO auditors. (ii) Carry out an external audit, to make proposals for improvement; (iii) Plan changes in our quality management system and processes and qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company; (iv) Submit our capabilities and to the Ministry of Health, and (v) Execute the protocol to certify medical devices.Medical devices certification includes the analysis not only of the devices itself but the manufacturer, distributor, and post-market services. All these stages and stakeholders are evaluated in the certification process per the guide-lines established by the ISO 9001 standard.

Results: The UGTS has developed a protocol that guarantees the safety and effectiveness of new medical devices before its use in the Venezuelan health care system. The protocol is based on the national and international regulations; it has been evaluated by Johnson & Johnson Medical S.C.S. and the UGTS it has been approved as a supplier for the analysis of medical devices by the company in complying with ISO 9001 Standard. Under this new protocol, 550 medical devices have been certified.

Conclusions: Advance on technology allows the breakthrough in medical device development. It is important to acknowledge the need to incorporate less invasive, more accurate and effective devices, in which physicians often rely on to treat a patient, but also developers must be compelled to meet the bioethical principles. The UGTS protocol to certify medical devices is had been recognized and the unit is authorized by the Ministry of Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.