In any health institution, the most fundamental thing is the quality health care provision to patients and safe work environment to its workers. Decontamination of medical equipments is proving to be a substantial challenge to health professionals thus makes it difficult to prevention and control of nosocomial infections. This has led hospital, and clinical administrators to come up with effective systems to minimize the risks of infection to healthcare givers as well as patients. Decontamination is the sterilization, cleaning, and disinfection performed on the reusable invasive medical devices for them to be safe for usage by the medical staff and patients.
The materials, sterile barrier, and packaging systems in terminally sterilized medical devices must meet the following conditions: high breathability, UV-light protection, enhanced durability, moisture sensitivity, high-temperature sensitivity, and meeting the conflicting barrier or sterilization requirements (Rogers, 2005). Sterilization must be possible without degradation. It must be able to ensure material stability thereby maintain products’ full shelf life. Physically, they must be strong against impact and abrasion, providing support structurally, and dynamic protection. Performing test at every point of packaging is a requirement that help ensure seal strength and integrity (Rogers, 2005).
According to Rogers (2005), the containers must be able to withstand steam sterilization without any effect on the container or its components. Testing for compliance is by subjecting the container to five use cycles, then putting it under ambient conditions for six months and eventually other five use-cycles. The containers must be able to undergo manufacturer’s stated washing procedures with experiencing any adverse effect. Containers undergo stated number of washing procedures to test this, and then five use cycles followed by storage under ambient condition for six months, after which the container undergo five further use-cycles (Rogers, 2005).
They must from light stable materials under use conditions. Compliance testing is through ISO 4582 requirements. There must be no negative interaction of the components when made from different materials. Compliance testing is through carrying out 4.5.1 and 4.5.2 performance tests. The materials should not generate any electrostatic charge when used as intended. The container design and construction must allow internal and external disinfection with ease (Rogers, 2005).
The paper used in low-temperature sterilization must be permeable to steam, thus assist in their sterilization. High-strength virgin pulp is a requirement coupled with minimal nutrients to microorganisms (Kirwan, 2005). The paper must be effective bacterial barriers; thus impermeable to microorganisms (Kirwan, 2005). Sterilization procedures the paper undergoes must not result in its degradation; thus, it must have sterilization compatibility. The testing methods gauge burst, tensile, and seal strengths. There is also air permeability test. Methods used are leak integrity test, flow integrity test, and pressure decay and mass flow test (Kirwan, 2005).
According to Kirwan (2005), the paper bags have to be sufficiently air permeable or porous to allow steam and air transfer during the autoclave cycle. The papers must be strong enough to provide adequate barrier to contamination. High strength bleached Kraft papers have wet strength and water repellency (Kirwan, 2005). Incases where steam or ethylene oxide sterilization is in use, compliance to air permeability is necessary. The papers must be peelable without generation of loose fibers.
According to Reichert & Young (1997), the wraps must be strong, and the common usage of cloth wrappers is due to their strength. The wrap used must have tortuous path to create a barrier that is hole free. Testing the strength is through Mullen burst test that measures the pressure that can distend and rupture the wraps. There is also grab tensile test, which subject the wrap to unidirectional stress until it breaks then records the strength. The trapezoidal tear test measures force required to propagate a tear in a wrap (Reichert & Young 1997). Abrasion resistance test by tipping the wrap on an arm until it breaks.
According to Woodhead & Wicker (2005), packaging materials and systems for medical devices need sterilization to avoid contamination. The packaging materials need 120-combo shrink system used for shrinking, sealing, and packing products. Magnum medical bagging systems used for packaging medical devices that use tubing coupled with roll bags, and require unique handling (Pankhurst & Coulter, 2009). Some other equipment that need sterilization are automatic baggers, shrink-wrap sealers and heat tunnel, modified atmosphere machines with gas flush, flow wrappers for standard and high-speed application, and airflow systems that fill voids (Woodhead & Wicker,2005).
Fung (2002) informs that adhesive coated nonwoven material must be strong between the base of the fabric and the coating. The material must be water resistant. The material testing is through flexing and abrasion. The colorfastness can also test the strength of the material (Fung, 2002). Adhesive coated paper for low temperature sterilization process requires moisture during lamination in the cross-linking process. Another requirement is the closing of packages incase of tamper–evident closure. The coated paper must be flexible enough so that to interfere with the finished products (Fung, 2002).
According to Rogers (2005), the porous materials must have wet strength properties and permeable to air. The plastic films should consist or two or more layers, when tested after the prescribed sterilization the plastic interplay bond, must not separate, or form cloudy precipitates. The plastic film must free of pinholes (Rogers, 2005). The plastic film when examined under transmitted light such as sunlight or artificial light the film should be free of foreign particles or imperfections that may interfere with compliance to requirements (Ousey, 2005). The plastic film must be sealable to the porous material in all circumstances specified by the manufacturer. The plastic film breaking factor must not be less than 20 N per 15 mm width when put to test Ousey, K. (2005).
According to Kirwan (2005), the paper used must be able to minimize safety hazards to the user and patient. Their sterile barrier system must allow sterilization and be sterilization compatible. The material should be able to provide sterility to that point the device use (Pankhurst & Coulter, 2009). Test methods are physical test testing porosity of the material, standardized test method evaluating the integrity of the paper material, and performance-testing method used to evaluate the paper under specified sterilization processes.
Validation is the process of demonstrating that the processes are capable of fulfilling the specified requirements using documented evidence. Therefore, it provides an assurance that the processes meet their predetermined specifications and attributes (Rogers, 2005). The validation is the comparison of the plan document and finished product conditions. Installation qualification by obtaining and documenting substantial evidence that forming, sealing and assembling processes (Pankhurst & Coulter, 2009). Following operational procedures assures operational qualification. Performance qualification by ascertaining that the seals and forms are consistent to the predetermined criteria thus meets specifications (Rogers, 2005).
References
Fung, W. (2002). Coated and laminated textiles. Cambridge: Woodhead Publishing. P 257.
Kirwan, M. (2005). Paper and paperboard packaging technology. London: Wiley Blackwell publishing. Pp102-103.
Ousey, K. (2005). Pressure Area Care. London: Wiley-Blackwell. Pp 191-195.
Pankhurst, C., & Coulter, W. (2009). Basic Guide to Infection Prevention and Control in Dentistry. London: Wiley-Blackwell. Pp 96-100.
Reichert, M. & Young, J. (1997). Sterilization technology for the health care facility. Maryland: Jones & Bartlett Learning. P59.
Rogers, W. (2005). Sterilization of polymer healthcare products. Shrewsbury: iSmithers Rapra Publishing. Pp 58-74.
Russell, A., Hugo, W., & Ayliff, G. (1999) Principles and practice of disinfection, preservation, and sterilization. London: Wiley-Blackwell publishing. PP 12-20.
Woodhead, K., & Wicker, P. (2005). A textbook of preoperative care. New Jersey: Elsevier Health Sciences. Pp 97-110.