“Conventional linen is one of the biggest culprits in hospital acquired as well as surgical site infections”December 11, 2021
The ‘green colour’ linen is synonymous with hospitals, as it has been in use for centuries in hospitals world over, especially the conventional healthcare settings. But how many, even in the medical community, are really conscious about the responsibility for and the critical role of this piece of medical accessory in ensuring patient safety? Evidence from most hospitals in India indicates that not many are aware of the standards, and even if they are, not many bother with them. Again, going by real world experience, there exists another paradox. Though the actual cost of the repeated use of the linen is higher than the cost of single-use disposables (recommended in modern-day care), it is still being used in a large majority of hospitals and clinics in India — because it is the convention. Therefore, transformation hesitance is more of a mindset issue rather than ignorance or economics. Most in the industry also oppose quality regulations in the country. In a market where hundreds of textile weavers and cloth merchants turned medical mask and accessory manufacturers overnight during the Covid pandemic, the market situation serves the unscrupulous minds who only eye the profits. However, there are a handful of local companies, besides the large organised players, who stick to quality products in this predominently price conscious market due to internal SOPs or pure commitment. For James George, Founder and Managing Director at Kochi-based Careon Healthcare Solutions, it is more of a personal commitment.
In a freewheeling interview with Editor CH Unnikrishnan, George says that the primary reason behind the rise of unscrupulous players in the medical disposables market is lack of awareness among the users and the patients. Edited excerpts:
Medical disposables and accessories used in hospitals do play a vital role in preventing hospital acquired and surgical site infection, two of the most serious medical challenges. But, why is the medical disposable market in the country crowded with unsafe products?
Most of the medical accessories such as surgical drapes and packs, general care products, including medical apparels, surgical gowns, surgical sheets etc., which keep the patients and healthcare workers safe and infection free, were not under the ambit of any strict quality regulations in the country. Most of the general quality certifications were either voluntary or merely part of some guidelines. So, there was no mechanism to control or penalise the offenders who are not in compliance with the supposed-to-be patient safety parameters. Even after the government introduced rules to make the registration of medical devices, disposables and accessories mandatory under the provisions of Drugs and Cosmetics Act, not all products were included in it. Now, even with the recent amendments to medical devices rules introduced last year to bring more products under the registration rules with quality norms equivalent to drug products, there is strong resistance from the industry. Therefore, this scenario has been exploited by the manufacturers, and the user industry, which is often under cost pressure, found it convenient to cut costs on these items knowingly or unknowingly.
Has this scenario, like the absence of regulations and lack of awareness, created challenges for quality manufactures?
It is a big challenge for the quality manufacturers as there are much cheaper products available in the market. The medical services industry, though mostly aware of the patient safety aspects,would be tempted to buy cheaper products as they are already under financial pressure due to high cost overheads in this sector, unless they are extremely committed to providing quality care. Lack of awareness is another big issue in India, especially in backward states, where both manufacturers and even healthcare workers are not really aware of quality requirements and patient safety aspects. Many in the medical and healthcare profession are not fully exposed to the scientific updates happening in the industry. For instance, the healthcare industry witnessed a huge revolution in recent times especially with the pandemic led revaluation of almost all conditions pertaining to the industry. One of such key transformations is the use of single-use medical apparels. In addition to the surge in demand for personal protection kits among healthcare workers, the use of single-use medical apparels has also been increasing worldwide for the fear of hospital acquired infections. But strangely, more than 70 percent of the hospitals in India still rely on traditional reusable linen for surgical gowns, drapes and other requirements with a misconception of disposables being expensive. Often, the cumulative costs of washing, disinfection, sterilisation, labour, electricity, water, machinery etc are ignored. In addition, the use of linens also increases the probability of infections during these intensive surgical procedures.
How do you overcome these challenges?
Unlike the evolved markets, the Indian healthcare market is highly price conscious, though the consumers do not often realise the bigger cost impact of a compromised quality in this segment. At the same time, lack of awareness is another lacunae which fails the very purpose of quality manufacturing. For us, it is a personal commitment to ensure that the products used in hospitals are as safe for the patient as for the care providers. So, we see this in the perspective of the user and the patient, who could be your family member or relative. That way, in a scenario where there is no mandatory law to discipline the industry to stick to quality norms and on the other hand the user isn’t in complete awareness of the impacts of an unsafe product, the only solution is to create and spread awareness. We conduct training programmes for hospital staff and we also invite them to our plant to show them how these products are designed and manufactured to conform to the medical safety standards, the type and grade of fabrics or material used and how the manufacturing lines are arranged and what safety and quality layers the products are passed through etc. We also train them to compare the quality and safety aspects of different products available in the market. However, we don’t see such a requirement in an evolved market, where the medical accessory procurement system in most hospitals is driven by the internationally accepted quality and safety norms, which are part of the SOPs implemented.
How helpful are the hospital accreditation processes such as NABH and others in the context of using standard medical accessories in hospitals?
Hospital accreditations are helpful in the way that at least some have developed SOPs and are trying to train nurses with broadly designed infection control practices. However, in most cases, the experience hasn’t been very robust when it comes to ensuring the procurement of standard quality products, may be due to cost conscious approaches, though they don’t realise that a compromise on this comparatively smaller component of the overall expenditure could cost the institution as well as the patient substantial damage.
What is the level of quality compliance that your manufacturing lines are adapted to currently?
The products of Careon have been authorised with various international certifications, including US FDA registration, CE, ISO13485, GMP and BIS. A SEDEX member with SMETA audit compliance for ensuring prime quality and social responsibility, Careon’s production is done in class 8 clean rooms. We also have our most advanced surgical gown unit with ultrasonic sealing technology for high protection and safety.
We also ensure that our products leave the facility only after a robust quality control check using most modern testing equipment and the raw materials — imported and indigenous — are tested to ensure the required standards as well.
In addition, a team of quality control people monitor the production, while the automatic sterilization plants are validated as per European standards.
What is the roadmap for Careon?
We are now focusing on creating a national footprint along with an aggressive strategy to expand the export market presence. Looking at the increasing demand, we are now planning a significant expansion of the manufacturing infrastructure — a new plant of 40,000 sq. ft. for storage, dispatch and sterilization is already under development. The company would now expand substantially in the national and export markets, including the neighbouring countries, Middle East, Europe and the US, tapping the regulated markets and leveraging our internationally accepted quality standards.