Manufacturers’ instructions for use

Manufacturers’ instructions for use

Extended cycle times

The MDM IFU may recommend sterilization cycle times beyond the standard procedures practiced in health care facilities. These are commonly referred to as extended sterilization cycle times. The need for additional processing times may be the result of the complex design of a device (eg, very long or narrow lumens) the dense configuration of a tray, multiple layers in the tray, the weight of the set, or the design of the containment device itself. To help ensure sterility the MDM-validated recommendations for cycle times must be followed.

Manufacturers of steam sterilizers validate their autoclaves according to specific cycles spelled out in American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI)2 standard (ST) 8, Hospital Steam Sterilizers6 (see Table 1, Table 2). This validation process does not include extended cycles; therefore, when facilities run longer exposure times to comply with MDM IFUs they are essentially performing an off-label use of the sterilizer.7

Manufacturers’ instructions for use

Manufacturers of reusable medical devices and surgical instruments must receive clearance from the Food and Drug Administration before the product can be made available for purchase and use in the United States. Part of the labeling claim process requires that manufacturers produce validated instructions for use (IFU) for reprocessing of the reusable device. The medical device manufacturer’s (MDM) validated IFU for each device must be provided in writing to the health care facility purchasing or borrowing these devices. The instructions should describe, in detail, the validated steps for disassembly, lubrication, cleaning, disinfecting, packaging, and sterilization.1 Written recommendations from MDMs for reprocessing surgical instruments and medical devices should be on file and consistently followed by health care facilities.2,




Last summer, the Food and Drug Administration (FDA), which regulates medical devices, held a little-noticed workshop to address concerns regarding dirty devices. Over two days, manufacturers, hospital representatives, and officials from the CDC and FDA described the challenges of thoroughly cleaning complex but reusable medical devices between procedures. Jahan Azizi, a risk management clinical engineer at the University of Michigan Health System, presented the most ominous data and conclusions to the crowd of around 200 government and industry insiders.

“This is unfortunately after lunch, and I apologize for that if you have a weak stomach,” Azizi said, as he described how his team ran a tiny surgical video camera inside 350 surgery-ready suction tips (a common tool surgeons use to suction blood and fluids). All of the suctions tips, Azizi said, contained blood, bone, tissue, even rust.


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