Absorbable hemostatic agents; transporting sterile instruments; alcohol-based hand rubs; microwave warming of fluids

AORN Journal,  July, 2004  by Dorothy Fogg

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QUESTION: We recently heard that absorbable hemostatic agents intended to be left in patients have been recalled by the US Food and Drug Administration (FDA). One of our nurses thought she read about this but cannot remember where the information appeared. We are a level 1 trauma center and frequently use these agents to promote coagulation and help stop internal bleeding during surgery. Our surgeons know nothing about this recall. Is there a problem with these agents? Why were they recalled? What does AORN know about this? Where can we find information for our surgeons?

ANSWER: Neither the FDA nor the product manufacturers have recalled these products. The products remain in the marketplace and are available for use. Recently, the FDA did issue a public health notice from the Center for Devices and Radiological Health (CDRH) reminding practitioners that the agents should be used with attention to the specific advice and warnings contained on the device label. (1)

Rare but devastating adverse events can occur with use of these products. According to FDA reports, paralysis or other neural deficits have occurred when the absorbable agent was placed on or near a bony or neural space and left in place. (1) When the material became wet, it expanded in size, creating pressure on the spinal cord or other nerve tissue. Pain, numbness, and / or paralysis resulted. Even when carefully placed, blood can pool behind the implanted absorbable agent and form a hematoma that subsequently exerts pressure on neural tissue. To prevent these rare occurrences, the FDA suggests

* reviewing device or agent labeling, especially contraindications, warnings, and precautions;

* using the minimum amount of agent necessary to achieve the desired effect (ie, hemostasis); and

* removing as much of the agent as possible when the desired effect has been achieved.

Adhering to the above recommendations will reduce the likelihood of nerve and other soft tissue damage when the wetted agent swells or breaks apart and migrates to other locations in the area.

A letter from David Feigal, Jr, MD, director of CDRH, was issued to surgeons and can be found on the CDRH web site at http://wwwfda.gov/cdrh/safety.html. Visit this web site, copy the letter, and make it available to your surgeons. The Office of Surveillance and Biometrics at the FDA is available to respond to questions on this topic. Contact the office by e-mail at phann @cdrhfda.gov or by mail at 1350 Picard Drive, Rockville, MD 20850.

QUESTION: Our facility recently was inspected by the state and was cited for using flash sterilization containers when flash sterilizing items either between or during procedures. Our facility is vend old, as is the sterilizer, which is located at the end of a semirestricted corridor. We do not have substerile rooms, nor do we have a central core area. We have a single corridor in which patients and supplies enter and exit the OR, and we have to carry the instruments from the sterilizer through this semirestricted corridor to the room where they will be used. Our routine processing is performed in the central sterile department, but sometimes we need to flash sterilize certain items in the department. We keep a flash log and can trace our instruments to the patients on whom they were used, Given our physical configuration, what is the correct method for transporting instruments from the sterilizer to the OR in which they will be used?

ANSWER: If you are using a closed container system designed specifically for the flash cycle and for transporting sterile items, you are using a correct method. By definition, flash sterilized items are intended for immediate use (2) and are not likely to be subjected to a drying cycle, especially given the age of your sterilizer, although, some newer models have special cycles with abbreviated drying times. Instruments that are flash sterilized will be wet when the flash cycle is completed. Hot, wet, sterile items should not be transported openly through semirestricted corridors to the point of use. Using a closed container system allows transport and delivery without compromising sterility of the items inside.

Unless you are using your containers incorrectly and not according to the manufacturers' recommendations, your practice not only is correct, it is preferred. When the container system is removed from the sterilizer, it immediately should be taken to the point of use and placed on a draped surface. A draped surface is needed so that the scrub person does not inadvertently contaminate himself or herself when removing the items. The lid or cover of the container should be removed by the circulating nurse, after which the scrub person should remove the contents of the container and place the sterile items on the sterile field. The actual container should not be placed on the sterile field. After the scrub person has removed the sterilized items from the container, the circulating nurse should remove the container and prepare it for subsequent use.