All new and exchanged devices shipped to an investigator are sterile and ready for implantation. Prior to returning device to DSI for analysis or exchange, the devices must be cleaned and decontaminated. The following procedures are recommended to ensure all devices being returned to DSI have been properly cleaned and decontaminated.
Removal of Tissue and Debris
Enzymatic detergents are available from most hospital supply companies, and they are generally labeled for use on fabrics or surgical equipment/instruments. The purpose of the detergent is to remove blood, serum proteins, and tissue debris from the surface of the device. DSI-tested and approved products are Tergazyme® (Alconox, Inc.) and Haemo-Sol® N.S. (Haemo-Sol, Inc.).
Terg-A-Zyme is an enzyme-active powdered detergent made by Alconox, Inc. To make a 1% solution, mix 10 grams of powder with 1 Liter of water. Allow the device to soak for a minimum of 4 hours and a maximum of 72 hours in the solution. Rinse thoroughly, preferably with running water. Fisher Scientific is a vendor that supplies Tergazyme (www.fishersci.com) but please refer to the Alconox website for other domestic and international vendors (www.alconox.com).
Haemo-Sol N.S. is a non-sudsing, proteolytic powdered detergent made by Haemo-Sol, Inc. To make 1 Liter of the solution, mix 5 grams of powder with 1 Liter of water. Allow device to soak for a minimum of 4 hours and a maximum of 72 hours in the solution. Rinse thoroughly, preferably with running water. Fisher Scientific is a vendor that supplies Haemo-Sol N.S., but please refer to the Haemo-Sol website for other domestic and international vendors (www.haemo-sol.com). It is important to note that there are multiple types of Haemo-Sol available, but DSI only recommends using the N.S. (non-sudsing) type.
All devices being return to DSI for analysis or exchange will need to be cleaned and decontaminated. Shipments that have not been cleaned and decontaminated will be charged a handling fee per item. These products are subject to transportation regulations as published by the US DOT or ICAO, or your carrier. If the products are fully decontaminated, they may be exempt from part or all of the requirements (including packaging, marking, labeling and documentation). The recommended decontamination procedures involve the use of a chemical sterilant or high level disinfectant.
Available from most hospital supply companies, chemical sterilants are considered cold sterilants and should be used for the sterilization of heat sensitive medical equipment such as DSI devices. When used properly, chemical sterilants will destroy all viable forms of microbial life. The only DSI-tested and approved chemical sterilant currently available is Spor-Klenz®.
Spor-Klenz is a chemical sterilant composed of the same mixture (peracetic acid, hydrogen peroxide, and acetic acid) as Actril, but produced by Steris (https://shop.steris.com/en/us). Spor-Klenz is available in the U.S. and internationally.
To sterilize using Spor-Klenz: Use in a well-ventilated area. Pour an adequate amount (enough to cover the device completely) into a sterile container. Place the device into the sterile container and tightly cap both the bottle with the remaining solution and the sterile container. Allow the device to soak in Spor-Klenz for a minimum of 5.5 hours at approximately 25°C. The sterilant will remain a clear liquid. After sterilizing the device in Spor-Klenz, thoroughly rinse the device with tap water. The device does not need to remain sterile for return to DSI
Cidex Activated Dialdehyde Solution
Cidex is a Glutaraldehyde based chemical disinfectant. To make Cidex, pour the entire contents from the activator vial into the sterilizing and disinfecting solution. The solution will change to a green color after being mixed. Cidex has a shelf life of 14 days once the two containers are mixed together. After this time, the solution can no longer be used either as a sterilant or as a disinfectant. Cidex is available in both the U.S. and internationally.
To disinfect using Cidex: Use in a well ventilated area. Pour an adequate amount (enough to cover the transmitter) into a container. Place the transmitter into the container and tightly cap both the bottle with the remaining solution and the container. Allow the device to soak in Cidex for a minimum of 10 hours at approximately 25°C. After soaking the device in Cidex, thoroughly rinse with tap water.
Some examples of chemicals that will cause damage to DSI devices include, but are not limited to: alcohols, phenols, iodophors, and hypochlorite.
Please note that any items not listed in this article have not been tested and therefore DSI cannot guarantee that the device will not be damaged by its use.
Customers are liable for device repair if products other than the specified detergents and sterilants/disinfectants are used.