Contamination Problem

Microscopic foreign body contamination, in the form of particulate or fibers, can adhere to stents, balloons, wires, gloves and other medical instruments during cleaning, handling and wiping of equipment with cotton based products such as gauze, telfa pads, surgical towels and lap sponges.

This contamination, inadvertently transferred to the patient by the medical device or instrument, can cause foreign body reactions, such as granulomas, necrosis, arteritis or embolization resulting in arterial occlusion, infarct, stroke, phlebitis, kidney failure, seizures, misdiagnosed carcinomas and death.

Additionally, disposable gauze sponges used intra-operatively in body cavities during surgery can leave behind cellulose-based contaminates. Cellulose is not digested by tissue macrophages; therefore, a cascade of inflammatory reactions occurs forming foreign body granulomas and significantly contribute to post-operative complications such as adhesions or infections.

Many medical devices, particularly implants and intravascular devices are manufactured to strict requirements concerning cleanliness, particulate and fiber content, however, once the sterile medical devices are opened for a procedure, they become exposed to a number of foreign bodies and contaminating elements, primarily cotton based products previously described.

Essentially, the cleanliness, particulate and fiber requirements the device was manufactured to no longer benefits the patient when the device is subjected to the elements in the operating room or the interventional lab.  Therefore, it is imperative, that the operator and support staff keep the sterile medical devices and instruments as clean as possible prior to every insertion into a patient’s body.

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