A mushrooming medical devices market makes it vital to manage healthcare complexities
Healthcare systems across the globe strive to maintain quality of service. With the availability of a wide range of medical devices — from simple needles to high-tech implants — it has become pertinent to ensure they can be safely and effectively used.
While some medical devices are invasive in nature, others explore anatomy of the human body. These devices help treat the disease, or in some cases, remain inside the body, like a prosthetic hip or an artery stent. To manage the complexities in the procedure involved, standards are essential.
In India, Standards are formulated by special technical committees of the Bureau of Indian Standards (BIS). The committee structure is designed to bring together all subjects catering to a field. This is done to ensure that standards are developed while maintaining a balance of interests among stakeholders —manufacturers, users, technologists and regulators — after taking into account all viewpoints through a process of consultation.
BIS is a national standards body working under the administrative control of Ministry of Consumer Affairs, Food and Public Distribution, Government of India. The erstwhile Indian Standards Institution (now BIS) was established in 1947 with the objective of harmonious development of standardisation activity in India. Formulation of Indian Standards (IS) is one of the core activities of BIS.
Technical committees working under Medical Equipment and Hospital Planning Department (MHD) of BIS for the formulation of National Standards include the surgical equipment, implants and accessories, equipment for the disabled, veterinary surgical equipment, electromedical and forensic sciences equipment, medical laboratory instruments, health informatics etc.
Today, the X-ray equipment has become integral to hospitals and medical centres. It is, therefore, essential to have performance specifications for the equipment. IS 7620 (part-1) specifies the general and safety requirements for all types of diagnostic X-ray equipment. Part-II of this standard specifies performance requirements of diagnostic medical X-ray equipment.
Similarly, IS 3235 specifies the design, performance and corresponding test methods for reusable syringes having capacity of 100 ml. For surgical rubber glove, another item in the list of common used products, IS 4148 specifies the manufacturing process requirements, physical properties, and method of testing.
Standards for external pacemakers require attention to information to help select and apply them. IS13450 (part-2): Sec-31 applies to basic safety and essential performance of external pacemakers powered by an internal electrical power source. It is through these aspects of standardisation that the central role of clinical experience should be acknowledged.
With easy availability of face masks and respirators these days, one may find it difficult to choose from a myriad of options. This is where Indian Standards can help.
For example, while IS 9473 prescribes requirements and tests for filtering half masks intended to provide partial cover, IS 14166 prescribes requirements for full face masks for respiratory protection.
Standards act as a building block for regulatory processes to ensure safety, quality and performance of medical technologies.
Standards that can be implemented by industries, regulators and stakeholders around the world are not only essential in disseminating medical technologies, but also reducing technical barriers to trade. Their role in improving efficiency of production and facilitating international trade are recognised in the World Trade Organization’s Agreement on Technical Barriers to Trade (WTO TBT).
Healthcare is one of the fastest growing industries. With an increase in life expectancy, there is a need to address growing complexities. There is also a need to deliver an affordable and efficient healthcare system. BIS is striving to provide the much-needed standards to our healthcare system.
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