The aim of this study was to assess whether the reprocessing facilities in rural hospitals in India were suitable for handling minimally invasive equipment. After evaluating the reprocessing methods found in these rural hospitals, we found that reprocessing procedures, recommended by either WHO, CDC or dictated in ISO standards, have not spread to rural hospitals. India is an ISO member(22), yet these standards are not enforced throughout the country. In the peripheral centres, strong preconceptions exist in sterile reprocessing, because new knowledge, such as scientific literature and manufacturer’s instructions, does not reach the nurses. For instance, instruments were commonly disinfected using bleach solutions, which has long been known to corrode surgical instruments(13).
Laparoscopic equipment is expensive due to the complexity of the components, therefore hospitals generally own one laparoscopic instrument set. This means that the instruments have to be reprocessed in between surgeries. This severely limited the time nurses have to clean the instruments and leads to inspection and validation not being actively performed.
The nurses had 30–45 minutes in between cases to prepare the operating room for the next patient, and clean and sterilise the instruments. The lack of inspection after cleaning resulted in many of the instrument surfaces to still contain visual contamination. In addition, damages to components, such as the electrical insulation, might be overlooked as a result of limited inspection tools. Burns caused by insulation failure is one of the most common and severe complications during laparoscopy(23). The lack of replacement instruments are also a cause of converting the surgery from laparoscopic to an open procedure, as indicated by one of the nurses. This increases the risk of infection.
Staff in the hospitals try to reduce operative costs by maximising the lifespan of all pieces of equipment. Therefore, gentler reprocessing procedures, like high level disinfection are preferred over more effective methods such as steam sterilisation. Many of the limitations of high level disinfection were not known to hospital staff.
The concentration of glutaraldehyde has to be periodically verified by using indicator strips, even within the manufacturers’ recommended expiry time of 14 days(20). The disinfectant can lose effect due to dilution caused by the introduction of wet instruments or because of high levels of bioburden(24). However, none of the hospitals were familiar with this method of testing the glutaraldehyde. Glutaraldehyde can also inhibit proper cleaning as it binds the proteins on instruments that are not sufficiently cleaned. This causes a build-up of bioburden, giving microbes a higher chance of surviving the disinfection or sterilisation process(19, 25).
The other main form of disinfection was using formaldehyde gas. This sterilant is unreliable as it is difficult to maintain the exact conditions needed for sterilisation such as the correct room humidity(26). In the hospitals, it was impossible to maintain these conditions because of the lack of monitoring and the wide variety of containers used for formaldehyde disinfection.
Staff also seemed unaware about the risks they face when handling soiled instruments and chemicals. For instance, the use of PPE was thought to be too cumbersome, which puts staff at risk of cross contamination. Additionally, no precautions were taken to minimise contact with disinfectant chemicals. Formaldehyde and ethylene oxide are known to be carcinogenic, and glutaraldehyde has been reported to cause asthma and allergic reactions(27, 28).
Ensuring sterile laparoscopic equipment
Laparoscopic equipment contains long narrow tubes and is considered a porous load. Hence, to successfully autoclave these long tubes, an autoclave is needed that performs vacuum air removal before injecting steam for sterilisation, according to standard EN 285(29). Neither of the autoclaves measured during this study was suitable for sterilising laparoscopic instruments due to a lack of deep, pulsed, vacuum cycles.
Without active air removal by steam-pulsing in deep vacuum, air remains trapped in the middle of the tube and sterilisation cannot be guaranteed. Active air removal is not only required to sterilise surgical equipment. In India, surgical gowns are reused by laundering and sterilising them in textile packs. Active air removal by means of steam-pulsing (above-atmospheric or in combination with a vacuum) is required for the steam to penetrate to the centre of a bundle of gowns, to ensure sterilisation(30, 31).
Both autoclaves measured during this study, showed a lack of adequate air removal or underpowered steam generation. Mainly because the lack of an adequate vacuum, these autoclaves are not suitable for the sterilisation of laparoscopic equipment. Textile packs require least above-atmospheric steam pulsing; performance can be yet improve with steam pulsing in combination with vacuum. There are currently many methods to validate autoclave cycles, however, most of these tests are unsuitable for rural LMIC hospitals. The existing methods are currently financially out of reach, or the tests are not critical for the manual autoclaves that are used in these hospitals. This raises the need for adequate low-cost process challenge devices for batch sterilisation monitoring in rural hospitals.
Because of the Covid-19 pandemic, we were only able to visit four hospitals. This limited number does not portray the diverse landscape of sterile reprocessing in Indian healthcare. However, because of the conformity of the methods practiced in these four hospitals, we can assume that this level of reprocessing is to be expected in many Indian public hospitals.
Today, pre and post-operative broad spectrum antibiotics are used to reduce the risk of post-surgical wound infection. However the combination of intensive use and poor confirmation to protocols, as provided in the Instructions For Use (IFU), can lead to a high incidence of multidrug resistant bacteria such as MRSA(32), which influences surgical safety on a national level. Training programmes in sterile reprocessing for rural healthcare workers have to be compiled that take into account the wide range of responsibilities they carry. However, this will only become a priority when policy is installed at the local hospital levels up to the upper levels of government.
Naturally, the financial limitations have a severe impact on the reprocessing methods. With more financial means, hospitals can afford more of the necessary machinery, tools, and chemicals which are optimised for cleaning delicate instruments like laparoscopic instruments. However, because of the limited size of many of these hospitals, installing the internationally recommended processes and equipment will never be financially viable. Many international standards are written to ensure the highest levels in reprocessing safety for hospitals dealing with a large patient turnover. A minimum viable safety standard is needed so that it is clear up to what level processes have to be improved.
In support of this, redesign of both surgical equipment and reprocessing tools is needed such that the reliability of the reprocessing is less dependent on local knowledge and practices. Surgical instruments should be robust, repairable and easy to inspect so that the lifespan is maximised and procedures become more economical because of an increased availability of instruments(33, 34). Reprocessing equipment is needed that can operate with a small batch of surgical instruments and that takes resource consumption, like water, into account.