Advancing Patient Safety in the Medical Device Industry, Health News, ET HealthWorld
Medical devices range from simple wooden tongue depressors or small suture implants to large implants and complex or life-saving equipment, such as pacemakers or medical imaging equipment. Drug tragedies, medical experiments, and clinical trials for war crimes created the importance of drugs; therefore, to control the quality of drugs, the United States passed the Drug Importance Act of 1848, following which many laws and guidelines were made for the improvement of the quality of drugs and therefore the safety of its users. In 1949, the Council of the International Organization of Medical Sciences (CIOMS) set out to improve public health through health research and policy guidance – including ethics, the development of medical products and the security ; however, there were some issues with quality and medical device guidelines.
Medical devices are essential parts of patient care, but faulty or unsafe devices can have serious consequences resulting in medical device-related adverse events (MDAE). The life cycle of medical devices requires the integrated participation of regulator, manufacturer, seller and end users. The safe and effective use of medical devices requires collaborative inputs, i.e. development, delivery, management, instrumentation and related technology, which in turn affect patient outcomes and safety. Currently, we are in the era of medical device evolution where the adoption of new technologies and innovation in new era medical devices has caused a visible shift in the adoption of safety parameters and higher monitoring, resulting in better quality, performance and safety of medical equipment.
Innovation in medical devices must go hand in hand with user and patient safety with the risk-benefit profile in favor of the intended user. Manufacturers of medical devices and in vitro diagnostics must follow specific requirements to maintain product quality during design and development, manufacturing, packaging, labeling, testing, installation and maintenance. An internationally harmonized regulatory framework agreed by the respective regulatory authorities with timely identification, integration and communication of potential adverse events will contribute to patient safety. ISO 13485:2016 specifies a quality management system requirement in which an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
The Ministry of Health and Family Welfare (MoHFW), Govt. of India (GoI) has taken stringent steps to reduce AEFIs by endorsing the Materiovigilance Program of India (MvPI), which was launched on 6 July 2015 at IPC, Ghaziabad. In addition to patient safety, the materiovigilance program contributes to reducing the probability of recurrence of harmful incidents by improving the quality of medical devices. The Indian Pharmacopoeia Commission (IPC) functions as a National Coordinating Center (NCC) for MvPI. In order to provide necessary information to all stakeholders in the country regarding regulatory requirements, quality management systems and standards, MvPI has published the Guidance Document for Medical Devices. IPC regularly organizes skill development programs across India with the aim of improving the quality standards of medical devices. These programs educate healthcare professionals on causality assessment and quality review, signal detection, evaluation and understanding of individual case reports for patient safety.
Another important step towards the regulation of medical devices in India has been to regulate all medical devices. Until recently, only a few implantable devices were regulated in India, with a wide variety of medical devices unregulated, resulting in questionable quality and safety of these products. It is safe to commend the Indian government for undertaking this daunting task of regulating all medical devices. This will automatically ensure improved quality and safety standards of Indian-made medical devices and facilitate India’s development mantra ‘Make in India’ and ‘Make for the World’.
Technological advancements in medical devices benefit patient treatment, but when medical devices are connected to computers, hospital networks and mobile devices, they become more vulnerable to security breaches. Therefore, healthcare institutions should implement proper security measures by creating strong passwords and cybersecurity facilities. Since cyber security requires more cost and can be a challenge for rural hospitals, training staff and securing funds from the government will solve the problem to a large extent.
Since medical devices are also subject to wear and tear, they require regular calibration to ensure they are operating at peak performance. No medical device is entirely without risk. Therefore, post-marketing surveillance (PMS) plays a crucial role in eliminating the use of those medical devices, which do not meet minimum quality, safety and performance requirements. In addition to the PMS, it is essential to involve and encourage district hospitals, medical schools and company hospitals in the country to report EMDs in order to ensure the safety of patients and users.
The future of the medical device industry is bright in India. By maintaining the required international quality guidelines, healthcare professionals will be able to provide better patient care, which will ultimately result in a healthier nation.
Dr Ashok Moharana, Chief Medical Officer at Healthium Medtech Ltd.
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