[Based on an interview given to CNS Editor Shobha Shukla by Dr Sudhir Krishna, consultant pediatric surgeon at Fortis Hospital, New Delhi and Chairman of the working group on scientific evaluation of sterilization practices in India, constituted by the Office of Principal Scientific Adviser to Govt of India. To listen to audio podcast, click here]
Infection and communicable diseases form a large part of the health care burden in India, despite the ongoing progress made to combat and control life threatening diseases. Amongst these, the most difficult to treat infections are those that the patients pick up while in a hospital. Read more
Despite major developments, surgical treatments are still associated with considerable complications arising out of hospital-acquired (nosocomial) infections, which remain a major killer in most hospitals --whether it be a 5 star hospital or a small town government hospital and/or private clinic. These infections can enter the body of the patient through surgical instruments, linen/cotton/gauze, unsterile commercially available disposables and human factor, due to improper sterilization situations in operation theatres, hospital wards and clinics.
Many research papers have documented increased hospital stay, morbidity, and increased cost of treatment as a result of these infections. Lack of antiseptic measures and poor instrument sterilization practices stand out as sore thumbs in the back drop of surgical advancements.
Lack of awareness about the ways in which infection can enter the body and lack of awareness of sterilization protocols, are the major road blocks in our journey towards making health care ‘infection free’ in our country. It is believed that the current infection rate in many Indian hospitals can be as high as 70%-80%
There is a crying need for 100% sterilized and infection proof medical devices in India. Gauze and cotton as is available and used, is a source of life threatening infections. Autoclaving, as done in our country, has no effective controls or checks which can ensure that the end product is totally infection free and safe. These products are accepted “sterile on assumption”.
Autoclaving is the process where saturated steam is used under pressure to kill micro organisms. It is one an efficient and economical means of sterilization used in health care facilities for sterilization of surgical instruments, medical devices, gauze, cotton and linen. But it has now become suspect due to extremely poor quality control of the steam and sterilization strips used. Also the items for steam sterilization have to be packaged properly in permeable material for loading into sterilizers. Traditionally, wrapping material for surgical trays, instruments, table tops, dressing sets is green linen. But generally this of very poor quality and gets contaminated with blood and pus stains due to poor washing and drying techniques. Again, all autoclaved products, wrapped in cloth have a shelf life of 48-72 hours only. Unfortunately, this fact is not known to most medics and para-medics. These packs are often stored on racks for weeks together.
So, the next best alternative is steel drums, trays and boxes. But sufficient steam cannot penetrate these containers, even through the inlet vents (which are often not opened). So the end products are actually unsterile.
Gauze and cotton are an integral part of all hospitals, clinics and nursing homes. They constitute the very basis of surgical and medical care. Yet they are the worst perpetrators of infections. They are manufactured under deplorable conditions with scant regard for their bio chemical impurities. In the hospitals they are cut to size/requirement under extremely unhygienic conditions and then overstuffed in steel drums for autoclaving. Moreover, unused gauze and cotton is not discarded but is recycled and reused, causing infection. They breed very potent heat resistant organisms. Ideally speaking, they should be packed in disposable pouches made of sterisheets, sealed and gamma irradiated.
There are no regulatory laws in India for sterilization and packaging of medical devices. These include a huge variety of consumables like implants, knee/hip joints, plates, screws, valves, mesh, shunts, tubes, catheters, urinary bags, etc. The list is endless. These medical devices are freely available in the market and claimed either ETO sterilized or gamma radiated. Unfortunately there are no regulatory laws to check the veracity of the stamp put on them by the manufacturer. Products are often falsely labelled as gamma sterilized, without actually being so.
ETO is a toxic gas which is not only hazardous for health, but also depletes the ozone layer. It is a cheap and most commonly used method of sterilization of commercially available medical devices in India, although they are being phased out worldwide. In most cases, ETO leaves a heavy residue on the sterilized products causing general and allergic reactions. It can be a potential threat to human life, as most of the ETO installations do not follow stringent regulations.
Dr Sudhir Krishna advises that proper autoclaving having high quality soft water steam is good for sterilizing linen and heat/moisture tolerant instruments. But for heat and moisture sensitive instruments, the low temperature Hydrogen Peroxide Gas Plasma Sterilization is highly recommended. It can be effectively used to sterile metallic and no metallic devices, and can make ‘infection free surgery a reality’. This would go a long way in fighting the war against infection and in reducing the harmful dependence on antibiotics.
Another very efficient (perhaps the best) method is sterilization by gamma radiations. It ensures completely safe bulk sterilization, as it is a cold process, which is fully controlled and automated.
According to Dr Sudhir Krishna “safe sterilization is the single most important factor responsible for safe surgery and is one area which cannot be ignored by doctors and health care administrators. The right to safe and infection free surgery should be the right of every Indian patient and strict punitive action should be taken against health care providers and hospitals that ignore this basic requirement. It is high time that the medical personnel were educated at all levels about sterilization methods. First rate sterilization systems in hospitals and at the manufacturers’ level will ensure better survival rates for patients dying because of infections contacted inside hospitals. At the level of the patient, one needs to become aware that it is not only a good doctor, but also a caring medical system which assures the sterility of products used.”
The time is ripe to take positive action and to launch a nationwide awareness campaign to demand simple solutions to the complicated problems of life threatening and cost escalating hospital infections. Investment in best practices in sterilization will definitely yield rich dividends, by way of saving human lives.
(The author is the Editor of Citizen News Service(CNS), Director of CNS Diabetes Media Initiative, has worked earlier with State Planning Institute, UP, and teaches Physics at India's prestigious Loreto Convent. Email: firstname.lastname@example.org, website: www.citizen-news.org)
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