How safe are our medical disposables?

April 10, 2021 0 By FM

Medical devices and disposables have been one of the most in-demand segments along with medicines and emergency supplies in the post-COVID-19 healthcare products market across the world. The pandemic has significantly increased the demand for medical disposables and hospital equipment, including gowns, antiseptics, disinfectant products and personal protection kits. Naturally, the industry has been gearing up to satisfy the demand by increasing production, capacity building and strategic acquisitions and mergers. Interestingly, this has also led to several new players — manufacturers as well as traders, entering the market with little to no experience in the field.

The World Health Organisation had appealed to governments and industries to increase the production of personal protective equipment, including hospital gowns, gloves, medical masks, face shields, aprons, respirators, and goggles, by at least 40 to 50% to meet increasing global demand at a time when hospital admissions across the globe started rising significantly. Apart from rising demand, the other incentive for the industry has been the surging prices. For instance, the price of surgical masks increased six-fold and the price of hospital gowns shot up two-fold.

Key players in the market adopted various strategies to strengthen their position and their continued initiatives such as expansion and strategic acquisitions and mergers are now expected to promote market growth. For instance, in April 2019, Smith & Nephew PLC acquired Osiris Therapeutics, Inc. with an aim to accelerate the development of its advanced wound management product portfolio. In May 2019, 3M announced plans to acquire Acelity Inc. with an aim to strengthen wound management solutions. This may expand the customer base of the company. Thus, such initiatives by key players are anticipated to further propel market growth at least over the next financial year or so.

In India, there were only 20 firms manufacturing 62 lakhs of PPE kits per year before the outbreak of COVID-19. But within two-three months of the outbreak, the number of manufacturers increased to 140 with 25.55 crore kits of annual capacity. Similarly, the number of Indian firms manufacturing ventilators went up from 8 to 17, mask manufacturers from 30 to 108, swab manufacturers from zero to five, sanitizer manufacturers from 35 to 49 and RT PCR kit manufacturers from 0 to 8.

REGULATORY CONCERNS

However, the greatest concern of governments and regulators across the globe has been none other than the huge challenge of ensuring the quality and safety of these products reaching the market in massive volumes. Although the onus is on the regulators to eliminate unsafe products, it is ideally the collective responsibility of the industry and regulatory agencies. But, as a matter of fact, the situation in India is seriously awful. The existing medical devices regulation in the country covers just a handful of products and a large majority are not.

Although the law that currently regulates the quality and safety of medical devices has been amended effective from April 1, 2020, making it applicable to all medical devices, the industry is not really happy with the same. Prior to the amendment, only 37 categories of medical devices and disposables were regulated. 

As a consequence of the latest amendment notified in January last year, all hitherto unregulated medical devices will have to be registered by respective importers or manufacturers with Drugs Controller General of India before October 1, 2021. All importers, manufacturers, distributors, wholesalers and retailers of presently unregulated low risk and high risk (Class A, B, C and D) medical devices sold in India will have to compulsorily obtain a license by August 2022 and August 2023 respectively.

The most important part of the amendment is the changed definition of the product category for regulatory purposes. As per the amended law, medical devices will fall under the definition of “drug” and will be regulated under Drugs Control Act and Medical Devices Rules of India. With this, all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially for human beings or animals by any pharmacological or immunological or metabolic means such as diagnosis, prevention, monitoring, treatment or alleviation of any disease, disorder, injury or disability among others are subjected to this regulation. Similarly, any devices or accessories used for clinical investigation, replacement or modification, or support of the anatomy or of a physiological process or even supporting or sustaining life, disinfection of medical devices would also come under its purview.

However, the domestic industry seems disappointed with the new amendment as it argues that medical devices and accessories cannot be defined and regulated as drugs and need a separate set of laws.

One of the large industry lobbies in this area — Association of Indian Medical Device Industry (AiMeD), which prefers a Medical Devices Bill over Drugs Control Act, called the amended law “rigid”.

Rajiv Nath, the Forum Coordinator at AiMeD, an umbrella association of Indian manufacturers of medical devices covering all types of medical devices including consumables, disposables and equipment, had earlier said: “The industry is highly uncomfortable with being regulated under this very rigid and prescriptive Drugs Act as any non-conformity can be treated as a criminal offence by any drug inspector at his discretion and hauled before a court and there is no risk proportionate penalties.”

SELF REGULATION IS KEY

According to AiMeD, the Association had worked relentlessly to help the country fight the COVID-19 crisis. It also points out that huge efforts were put into increasing the medical device manufacturing capacity by its members and others by reaching out to garment manufacturers, automakers, auto component manufacturers, and electronic component manufacturers as preparedness for possible unprecedented and unpredictable demands.

The association claims that it worked with Quality Council of India (QCI) to expedite the finalization of ICMED Plus Certification as well as with a consultants consortium to provide online training on Quality Management System Certification to new players who had ventured into medical devices manufacturing to build capacity and capabilities to meet QCIs ICMED certification and regulatory compliance so that they could have the confidence to seek global certification of CE and US FDA compliance for enabling global competitiveness.

However, many dedicated and long-time industry players have a different story to tell. They say that only a few firms in India can claim the triple standard of quality certification such as CE, ISO 13485:2016 and GMP apart from an FDA license and it is also a matter of experience to make quality products. The sudden emergence and spread of the COVID-19 pandemic has led to a surge in the demand for PPE kits, including masks, gowns and gloves, but on the quality side, it created a great lacuna.

“When there was a choice, the hospitals normally went for the cheapest and no stipulated standard for quality assurance was maintained. Nobody can be blamed for this sad situation, as it was some sort of an emergency and a question of the lives of thousands of people. But, even before COVID-times, there was no clear-cut direction for maintaining quality standards in the industry,” they say.

According to them, there are mainly two reasons for this poor, but dangerous scenario. The main culprit is the absence of strict enforcement of quality standards, which are not yet imposed strictly in the country. This is either because hospital authorities are careless about such mandates or there is a scarcity of quality products. “One cannot even imagine how the disposable medical products could be manufactured and labelled as ‘sterile’ with such an unhygienic manufacturing ambience,” the long-time players say.

“Disposable medical devices are the riskiest factors affecting your health if you are treated in a hospital which does not give much attention to the quality factor. Most of the patients too do not consider them to be important,” says Kora James, Director, Careon HealthCare Solutions, which manufactures a wide range of medical disposables used in the specialties including orthopaedic, ophthalmic, urology, neurology, cardiology, gynaecology and obstetrics.

Kora James, who stresses the quality and safety of this products as an integral part of his business strategy, says that it is a social and moral commitment of the company and that a disposable medical device requires a careful balance between performance, reliability, material-standard, shelf life and cost.

“So, sometimes the cost of the product can go high. But a dedicated manufacturer’s primary aim should always be to deliver products that can claim utmost safety to the patients at optimum cost,” he added.

At Careon, he says, quality control starts right from the selection of the raw materials and the process of sterilization. All the processes are validated as per European standards. The company collaborates with a medical device manufacturing multinational in Norway, and everything goes as per the quality assurance standards stipulated by FDA, he added.

Chetan Makam, Managing Director of Terumo Penpol, India’s largest blood bag manufacturer and a subsidiary of Terumo Corp, Japan, says; “For us, the real partnership with a multi-national company came in the form of learning about quality management and implementing it.”

“Though founded in 1999, we had to bring about many changes in the manufacturing process, materials used, their physical and chemical qualities over the years, and they could achieve the best in the industry offering the maximum safety and quality to the customers,” Makam says.

“It was indeed through revision of every step that was involved in the manufacturing process. But there was a passion for perfection behind every success that followed. It included the wholehearted cooperation of the employees who always kept themselves more involved in this drive to make those products which were the best in the industry, he added.

MASS AWARENESS NEED OF THE HOUR

Even as surgical disposables have already been categorised under medical device category in India and the country’s drug regulator — Central Drugs Standard Control Organisation — is making all efforts to create awareness within the industry for strict adherence to its rules for maintaining quality standards, many are still found to be flouting the law, especially among the new players who entered the market from unrelated industries of late.

At the same time, there are some efforts from established players such as Careon to conduct awareness programmes and training sessions on aseptic techniques to manufacture surgical disposables to ensure sterility during the procedure as a part of their social initiative.