It must, therefore, be ensured that the process of sterilization is carried out as per standardized universally acceptable protocols as discussed below.
1. Quality of Infrastructure:
The location, space, lay out, surface finishes, etc. should be as per the standard norms conducive to infection control and high quality sterilization.
Layout should follow functional flow with the receipt (dirty) counter on one end and the sterile issue counter on the other end. Inside the CSSD, there should be no crisscrossing or back tracking and the area should be divided by partitions into dirty, clean and sterile zones (zoning concept).
Similarly, gas and steam sterilization should be separated. The entrance lobby should have a change room with toilet and hand washing facilities. The flooring should be nonskid type.
2. The department should have adequate trained manpower and all the modern equipment essential for high quality sterilization.
3. It should have stable and uninterrupted power supply, running water of desired quality and controlled temperature (15.6-20°C), ventilation (10 air changes per hour), humidity (50-60%) and, illumination (200 Lux) level.
4. Availability of a quality manual including all activities of the department such as receipt of unsterile stores, washing, cleaning, gauze cutting, instrument—washing, cleaning/ drying/packing, preparation of various sets/trays as per the lists, labeling, sterilization, storage, issue and record keeping.
5. A policy about the usage of disposable/reusable items such as gloves and syringes.
6. SOP for the sterilization of different categories of items by different techniques such as steam sterilization (with the fixed time/pressure/temp requirements) and gas or chemical sterilizations.
7. An SOP for internal validation of sterilization process by tests such as use of fusing controls, heat sensitive indicator strips or bacterial survival tests such as Bovie Dick test and external validation by random periodic culture of swabs from the sterilized instruments/trays/stores.
8. SOP for transfer of sterile stores from CSSD back to users including the mode of transfer to ensure maintenance of sterility.
9. Fixing the shelf life of various sterile items after proper microbiological testing in the lab and informing all the users in the hospital about the system.
10. The SOP to decide the acceptability of the sterile packs by the departments. Any pack that has the wrapping damaged/torn/wet/damp or brittle should be considered unsuitable for use and rejected.
11. A system of recall of items from user departments, if and whenever, there sterile status is in doubt.
12. Ensuring availability of adequate number of sets/trays as per the average usage by every department and providing a reasonable reserve (10%) to cater for the Sundays/ holidays and unforeseen fluctuations in demand.
13. A policy for dispatch of used/unsterile stores to CSSD only after cleaning/washing/ disinfection in the wards/departments.
14. A procedure for labeling of the packs so that the labels should have the packing/ sterilization date/expiry date and the signature of the staff involved in packing/ sterilization.
15. Information/education of various departments about the correct way of storage of sterile stores/packs (dry conditions, away from sunlight with good air circulation and temp of 15°C).
16. A program of planned preventive and break down maintenance and regular periodic recalibration of equipment to ensure minimum down time and optimum efficiency of equipment.
17. SOP on infection control in the department including:
a. Restricting the entry beyond dirty zone.
b. Ensuring that the CSSD staff has periodic medical inspection and as a standard drill disallowing entry of any staff suffering from infectious diseases.
c. A system of communication from outside the CSSD with the staff busy inside the sterile zone, to avoid people barging into the CSSD.
d. SOP for cleaning, maintenance and periodic fumigation of the department.
e. SOP for disposal of waste as per the biomedical waste management rules.
f. Periodic swabs for culture from the sterile zone of the department.
For safety of patients, it is imperative that all the above measures are implemented in letter and spirit.
Not only that, there should be a system of monitoring the quality of sterilization so that the deficiencies, if any, can be detected and timely corrective actions taken to maintain high quality of sterilization.