QUESTION: We lately heard that abso...

QUESTION: We lately heard that absorbable hemostatic agents intended to be left in patients have been recalled at the US Food and mix with drugs Administration (FDA). One of our foments thought she read about this however cannot remember where the information appeared. We are a on a level 1 trauma center and often use these agents to help coagulation and help stop internal bleeding during surgery Our surgeon know nothing about this recall. Is there a puzzle 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 produce manufacturers have recalled these fruits The products remain in the marketplace and are available for use. lately 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 upon the device label. (1)

Rare if it were not that devastating adverse events can present itself with use of these proceedss According to FDA reports, paralysis or other neural deficits have occurr when the absorbable agent was placed in succession or near a bony or neural space and left in place. (1) When the material became wet, it expanded in size, creating crushing on the spinal cord or other might tissue. Pain, numbness, and / or paralysis ariseed Even when carefully placed, posterity can pool behind the implanted absorbable agent and form a hematoma that subsequently uses pressure on neural tissue. To obstruct 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 power (ie, hemostasis); and

* removing as frequently of the agent as possible when the desired event has been achieved.

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

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

QUESTION: Our facility freshly was inspected by the state and was cited for using flash sterilization containers when flash sterilizing items either between or during performances Our facility is vend aged as is the sterilizer, which is located at the [i]finale[/i] of a semirestricted corridor. We do not have substerile extents nor do we have a central core area. We have a single corridor in which patients and supplies penetrate and exit the OR, and we have to carry the instruments from the sterilizer within this semirestricted corridor to the place where they will be used. Our routine processing is performed in the central sterile department, on the other hand sometimes we need to flash sterilize certain items in the department. We continue a flash log and can trace our instruments to the patients onward whom they were used, Given our physical configuration, what is the correct system for transporting instruments from the sterilizer to the OR in which they will be used?

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

Unles you are using your containers incorrectly and not according to the manufacturers' recommendations, your practice not solely is correct, it is preferr When the container method is removed from the sterilizer, it immediately should be taken to the point of use and placed forward a draped surface. A draped surface is privationed so that the scrub human frame does not inadvertently contaminate himself or herself when removing the items. The lid or veil of the container should be remov through the circulating nurse, after which the cleanse person should remove the satisfactions of the container and place the sterile items forward the sterile field. The actual container should not be placed forward the sterile field. After the clean person has removed the sterilized items from the container, the circulating suckle should remove the container and prepare it for succeeding use.