Manual on radiation sterilization of medical and biological materials




















Keywords: gamma radiation, sterilization, medical devices, tissue grafts, micronized amniotic membrane injections, food, detrimental effects. Introduction Medical materials, tissue allografts and food samples must be sterilized prior to their use 1.

Molecular mechanisms involved in gamma rays-induced cell damage Morphological and functional changes, observed in irradiated products, are happening due to the adsorption of energy released during gamma radiation 7. Resistance of microorganisms to gamma radiation Resistance of microorganisms to gamma radiation is mainly dependent on the microorganisms' capability to repair single strand breaks due to the activity of their DNA repair enzymes Consumption of irradiated food: what have we learnt from animal models?

Structural changes seen in polymer medical devices sterilized by gamma rays During sterilization, structural characteristics of polymer medical devices are considerably modified by gamma radiation 50 - Conclusions The standard sterilization method for many medical devices and food samples over the past 40 years involves gamma radiation.

References 1. Infect Dis Clin North Am. Shintani H. Biocontrol Sci. Radiation and ethylene oxide terminal sterilization experiences with drug eluting stent products.

Alvarado CJ. Sterilization vs. Nurs Clin North Am. Radiation sterilization of tissue allografts: A review. World J Radiol. Converting to gamma-radiation sterilization: an overview for medical device manufacturers. Med Device Technol. Farkas J. Irradiation as a method for decontaminating food. A review. Int J Food Microbiol. Indian J Hematol Blood Transfus. Rendic S, Guengerich FP. Summary of information on the effects of ionizing and non-ionizing radiation on cytochrome P and other drug metabolizing enzymes and transporters.

Curr Drug Metab. Nitric Oxide. Sage E, Shikazono N. Radiation-induced clustered DNA lesions: Repair and mutagenesis. Free Radic Biol Med.

DNA postreplication repair and mutagenesis in Saccharomyces cerevisiae. Mutat Res. Unraveling the mechanisms of extreme radioresistance in prokaryotes: Lessons from nature. Mutat Res Rev Mutat Res. Halls N. The microbiology of irradiation sterilization. Effective use of optimized, high-dose 50 kGy gamma irradiation for pathogen inactivation of human bone allografts. Tritsch GL. Food irradiation. Genome sequence of the radioresistant bacterium Deinococcus radiodurans R1. The mechanical properties of the lyophylized and irradiated bone grafts.

Acta Orthop Belg. Sterilization of allograft bone: effects of gamma irradiation on allograft biology and biomechanics. Cell Tissue Bank. Effects of ionizing radiation on the mechanical properties of human bone. J Orthop Res. Biomechanical effects of gamma irradiation on fresh frozen allografts in vivo. The effect of gamma radiation sterilization on the fatigue crack propagation resistance of human cortical bone.

Bone Joint Sur. Complications os irradiated allografts in orthopaedic tumor surgery. J Clin Orthopaedic Relat Res. Massive allografts sterilised by irradiation. Effect of sterilization on bone morphogenetic protein. Removal of the surface layers of human cortical bone allografts restores in vitro osteoclast function reduced by processing and frozen storage. Use of structural allografts in spinal osteomyelitis: a review of 47 cases. J Neurosurg.

High-dose electron beam sterilization of soft-tissue grafts maintains significantly improved biomechanical properties compared to standard gamma treatment.

Arthroscopic anatomic double-bundle ACL reconstruction using irradiated versus non-irradiated hamstring tendon allograft. Knee Surg Sports Traumatol Arthrosc. The feasibility of gamma radiation sterilization for decellularized tracheal grafts. Comparison of structural changes in skin and amnion tissue grafts for transplantation induced by gamma and electron beam irradiation for sterilization.

The growth, reproduction, longevity, and histopathology of rats fed gamma-irradiated carrots. Toxicol Appl Pharmacol. Biochemical effects of irradiated sucrose solutions in the rat. Radiat Res. Influence of age, sex, strain of rat and fat soluble vitamins on hemorrhagic syndromes in rats fed irradiated beef.

Fed Proc. Vitamin K deficiency in rats induced by the feeding of irradiated beef. J Nutr. Growth, reproduction, survival and histopathology of rats fed beef irradiated with electrons. Food Res. Appearance of direct-acting mutagenicity of various foodstuffs produced in Japan and Southeast Asia on nitrite treatment. Shaw MW, Hayes E. Effects of irradiated sucrose on the chromosomes of human lymphocytes in vitro. Cytotoxic and radiomimetic activity of irradiated culture medium on human leukocytes.

Current Science. A chemical indicator on a package verifies exposure to a sterilization process. An indicator should be clearly visible on the outside of every on-site sterilized package. This helps differentiate sterilized from unsterilized items.

More importantly, it helps monitor physical conditions within the sterilizer to alert personnel if the process has been inadequate. An indicator may be placed inside a package in a position most likely to be difficult for the sterilant to penetrate. A chemical indicator can detect sterilizer malfunction or human error in packaging or loading the sterilizer. If a chemical reaction on the indicator does not show expected results, the item should not be used.

Several types of chemical indicators are available:. Positive assurance that sterilization conditions have been achieved can be obtained only through a biologic control test. The biologic indicator detects nonsterilizing conditions in the sterilizer. A biologic indicator is a preparation of living spores resistant to the sterilizing agent. These may be supplied in a self-contained system, in dry spore strips or discs in envelopes, or sealed vials or ampoules of spores to be sterilized and a control that is not sterilized.

Some incorporate a chemical indicator also. A biologic indicator must conform with USP testing standards. A control test must be performed at least weekly in each sterilizer. Many hospitals monitor on a daily basis; others test each cycle. Very load of implantable devices must be monitored and the implant should not be used until negative test results are known. Biological indicators also are used as a challenge test before introducing new products or packaging materials, after major repairs on the sterilizer, or after a sterilization failure.

All test results are filled as a permanent record for each sterilizer. Functions Sterile Processing Departments are typically divided into four major areas to accomplish the functions of decontamination, assembly and sterile processing, sterile storage, and distribution.

The Decontamination Process Introduction Decontamination is the physical or chemical process that renders an inanimate object that may be contaminated with harmful microbial life safe for further handling.

Steps in the Decontamination Process Transport - Used supplies and equipment should be collected and taken to the Decontamination Area in the Sterile Processing Department in a way that avoids contamination of personnel or any area of the hospital.

Equipment should be covered and supplies should be moved in covered carts, closed totes or containers, or closed plastic bags. Attire - Personnel working in the decontamination area should wear protective clothing, which includes a scrub uniform covered by a moisture-resistant barrier, shoe covers, rubber or plastic gloves, and a hair covering. During manual cleaning processes, when splashing can occur, safety goggles and a face mask should be worn.

Sorting - sorting begins at the point of use. Handling of contaminated items should be minimized unless the user of the device is already wearing full personal protective attire, such as following care in the operating room. In areas where workers are wearing no or minimal protective attire, sorting should consist only of removing disposable sharps and discarding other single-use items. Soaking - this is necessary only if you have lumens or other complex designs that are filled with debris or if the devices are very bloody and cannot be rinsed or wiped at the point of use.

Washing Detergent - should be compatible with the materials in the device and suited for the type of soil. Consult the recommendations from the device manufacturer. The cycle consists of several washes and rinses, followed by a steam sterilization cycle appropriate for the types of items contained in the load. Ultrasonic - the ultrasonic washer is used to remove fine soil from surgical instruments after manual cleaning and before sterilization.

The equipment works by converting high-frequency sound waves into mechanical vibrations that free soil from the surface of instruments. The high-frequency energy causes microscopic bubbles to form on the surface of the instruments and as the bubbles implode, minute vacuum areas are created, drawing out the tiniest particles of debris from the crevices of the instruments.

This process is called cavitation. Tunnel washers - they resemble a mini car-wash. The chief advantage of these units is that most of them allow totally hands-off processing. Instruments in perforated or mesh-bottom trays can come directly from the operating room or other department and be placed into the tunnel washer without any further handling or arranging.

Inside, the instruments are subjected to cycles of pre-rinse, washing, ultrasonic, rinse, and drying. Cart washers - carts and other transportation vehicles and containers must be cleaned routinely to remove dust and spillage.

Carts are placed in the washer in a tilted position to enable water to drain out and prevent restriction of any moving parts within the washer. Items removed from this type of washer are very hot and must be allowed to cool before they are handled.

Carts must be thoroughly dried before they have contact with clean or sterile supplies. Inspection - after cleaning, all instruments should undergo inspection before being packaged for reuse or storage. Box locks, serrations, and crevices should be critically inspected for cleanliness. Instruments with cutting edges such as scissors, rongeurs, chisels, curettes, etc.

There should be no dull spots, chips, or dents. Hinged instruments such as clamps and forceps should be checked for stiffness and alignment of jaws and teeth. Tips should be properly aligned, jaws should meet perfectly, and joints should move easily. Ratchets should close easily and hold firmly. Any instruments with pins or screws should be inspected to make sure they are intact. Plated instruments should be checked to make sure there are no chips, worn spots, or sharp edges.

Worn spots can rust during autoclaving. Chipped plating can harbor soil and damage tissue and rubber gloves. If any problems are noticed during the inspection process, these instruments should be either cleaned again, or sent for repair depending on the problem observed. Assembly 1. Assembly 2. The Sterilization Process Introduction Bacterial spores are the most resistant of all living organisms because of their capacity to withstand external destructive agents.

Methods Reliable sterilization depends on contact of the sterilizing agent with all surfaces of the item to be sterilized. Steam Heat destroys microorganisms, but this process is hastened by the addition of moisture.

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