The Times of India recently reported an outbreak of a bacterial infection from a pediatric Intensive Care Unit in Mumbai. The infection had originated from bacteria residing on the rubber stopper of injection vials. The drawing needle probably became contaminated as it passed through the stopper. The contaminated solution had probably entered the patient during intravenous administration.
This outbreak is not an isolated incident; it is likely to be a widespread problem. Indeed, there are several similar reports from India and other parts of the world of contaminated intravenous fluids and injections causing outbreaks with dangerous organisms. Clearly, the use of multidose vials, from which medication is drawn repeatedly, and often administered to several patients, is one the major reasons for such catastrophes. Unfortunately, in India,
unlike in the developed world, multidose injection vials are commonly used. In fact, many antibiotics that are used to kill bacteria, are marketed as multidose vials. Repeated draws are probably frequent among children who need only a small dose; the remaining dose is often preserved for later use.
Another common source of contamination is from the flushing of intravenous catheters with saline. Saline bottles are commonly available as 100 or 500 ml bottles in India. Typically, a small volume of 5–10 ml is used for flushing catheters. The fairly large volume of the solution that remains is used several times in most hospitals, with the risk of contamination and transmission of infection. The only logical way to prevent catastrophic outbreaks is to cut down on the use of multiple-dose vials and fluid bottles, or even ban their use. Clearly, the enormous cost involved in treating serious, at times lethal infections would make any cost saving from the use multidose vials pale into insignificance.
This report raises the question of the reuse of disposable medical devices. A common practice in many Indian hospitals is the reuse of balloon catheters used in patients who undergo coronary angiography. It is fairly well established that these devices are almost impossible to clean satisfactorily. Quite often, blood and tissue debris stick to the inside of these catheters, where they remain invisible and practically irremovable. The consequences can be disastrous if cross-contamination occurs between patients. Cost-effectiveness is the ostensible rationale behind recycling such devices. However, it is often unclear if any such cost-saving is actually passed on to patients. Besides, patients are usually not informed regarding the reuse of equipment and the likelihood of harm that may ensue, however unlikely this may be. Another important consideration is the possibility of mechanical failure of intricate devices during reprocessing. Rupture of a catheter balloon during coronary angiography could turn out to be an unmitigated disaster. There are innumerable devices ranging from syringes and needles to pacemakers that are reused with scant knowledge regarding safety considerations.
In India, there is currently no regulation on the methodology or quality of the sterilization process to be followed when medical devices are reused. Most hospitals run an in-house recycling mechanism. The procedure may be carried out by personnel who may not be adequately skilled or experienced in sterilization and reprocessing. Many health systems across the world require sterilization and reprocessing of reused equipment to adhere to regulatory standards employed by the original manufacturers. Unfortunately, no such system exists in India.
We need to expeditiously frame policies regulating the reuse of disposable devices. What are the devices that may be safely reused? A clearly defined methodology for reprocessing of disposable equipment must be laid down. There must be a robust mechanism to check the reliability of reprocessing and mechanical functioning of devices. Third party reprocessing may be one of the options with strict regulatory control, as followed elsewhere in the world.
It is important to cut down and try to eliminate the use of multidose vials. Finally, in all fairness, the customer deserves to share any cost-saving that accrues from the reuse of devices.
DISCLAIMER : Views expressed above are the author’s own.
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