Reprocessing of single-use medical devices and their associated problems: an experience from a cancer center in eastern India

To the Editor—Transmission of infectious agents can occur through unclean and unsterile medical devices. Breakdown of sterility of medical devices may lead to the transmission of bacterial and viral pathogens, including those associated with multidrug resistance. Costly medical devices must be reprocessed, and the decontamination process must be conducted under stringent quality control. The central sterile supply department (CSSD) plays an important role in ensuring that these medical devices are sterilized and delivered to various users in the hospital in a quality-assured environment. Here, we discuss the reprocessing of so-called single-use medical devices (SUDs) in a hospital CSSD as well as some advantages and limitations of cleaning, disinfection, and sterilization. ¹

Complex instrument design

Many instruments are available in the medical supply market that cannot be cleaned and sterilized properly due to their complex design; nevertheless, they are declared reusable. Basically, surgical instruments are divided into 2 categories: heat-resistant (metallic) and heat sensitive (nonmetallic, eg, rubber or plastic) where difficulty of reprocessing based on their geometric design (ie, outside shape, lumen, surface, valves and seals), the material used (ie, chemical property, passive layer, corrosion properties and thermal stability), and their construction (eg, ease of disassembly or dead-end areas). ² However, the reprocessing of nonmetallic instruments is more critical than that of metallic instruments because these instruments mainly have specialized uses. The complexities of nonmetallic instruments include their design composition (ie, splits, screws, lumen, and flushing channels), their potential for contamination due to frequent use, and their lack of thermal stability due to plastic or rubber components. ³ Also, these devices are often manufactured with the expectation that they will be discarded after a single use.

Reprocessing difficulties

Body fluids polymerize on instrument surfaces when they are allowed to dry. Thus, instruments must remain wet in area where they are used and must be transferred immediately thereafter to the CSSD. After handover in CSSD, the surgical instruments are disassembled before cleaning. The CSSD should have enough space, with proper cleaning facilities: a manual or mechanical wash system, water jets, suitable cleaning brushes, and a good ventilation system. The instruments should be immersed completely in a neutral enzymatic where proper contact time and concentration should be measured to achieve safe and effective cleaning; electrically powered surgical instruments should not be immersed but should be wiped thoroughly. ⁴ To protect instruments from disinfecting agents that fix soils (ie, aldehydes or per-acetic acid), cleaning should be done prior to disinfection so that fixation of soil can be avoided. Thorough washing then takes place using a manual or mechanical method that requires purified and pressurized water. Sterilization is conducted according to the instrument’s thermal stability and the manufacturer’s recommendations if available. Finally, monitoring and documentation should be proper for legal purposes and for future requirement. ^5,6

Single-use device reuse policy

In every hospital, a committee makes decisions about reprocessing SUDs. Committee members from administration, infection control, central services, surgical services, materials and finance departments should have enough knowledge of reprocessing SUDs to evaluate the related legal, ethical, and economic issues. ² The main reason for reprocessing SUDs is to reduce the charges to the patient, and patient consent may not be required if there is a stringent standard policy for reusing SUDs. ⁷ If full charges were made for every new SUD, people from poor or developing countries would not be able to afford medical services. ^8,9 Additional aspects related to reusing SUDs include device availability, patient safety, equipment availability, and reprocessing time or technique. Any decision to reprocess an SUD product should include a thorough review of the manufacturer’s user’s manual, including any written policies for cleaning, disinfection, and sterilization. ³ Finally, the committee must determine the maximum number of uses for each device as well as the charge to the patient: maximum retail price of the device (MRP) divided by the number of uses.

In our 400-bed cancer center in eastern India, the number reuses is based on our hospital reuse policy and the cost of the product. If the SUD cost is ≤10,000 INR (US$142.85), the charges to the patient will be one-third of the total MRP. Similarly, if an item costs 10,000 INR, the charges will be one-fifth of the total MRP, and if an item costs 30,000 INR (~US$428.57), the charges will be one-tenth of the total MRP. Thus, the patient need not pay more than 2, 000 INR (US$28.57) to 3,000 INR (US$42.85) for a single item. Below 2,000 INR, SUDs are not reused, according to our policy. Software containing date, product name, unique code, frequency of use, and patient’s identification number is used to maintain all the records of reused SUDs and to calculate the number uses along with cost.

In conclusion, the CSSD represents a neglected area of the infection control system in a hospital. Investment in well-equipped CSSD infrastructure is necessary for the smooth functioning of a hospital. Resources should be directed not only toward the development of physical infrastructure and the equipment in the CSSD but also toward the recruitment and retention of technically qualified personnel who are able to operate the system effectively. Every CSSD technician must know the importance of infection control and thoroughly understand their role in the process. Ensuring effective functioning of the CSSD is essential for infection prevention in any hospital. ⁹