Custom packs; alcohol rubs; delivering medications; flash pans; sterilization indicators; "speak up" program - Clinical Issues

AORN Journal, May, 2002 by Dorothy Fogg

Question: As a result of the recent US Food and Drug Administration (FDA) regulations for hospitals and third-party reprocessors of single-use devices (SUDs), we have stopped reprocessing SUDs. We use the devices only once and then dispose of them. We considered contracting with a third-party reprocessor for their services but found it was not cost-effective for us to do so. Now a question regarding our custom packs has arisen. We assemble custom packs for some specialty surgeons and for certain specialty procedures at our facility. Some items in the packs are labeled for single-use only and do not have resterilization instructions. The items may be removed from their original packaging and placed in the custom pack or placed in the custom pack in the original packaging. After assembly, the entire pack is sterilized, usually by steam but occasionally by ethylene oxide. Without instructions for sterilizing the single-use items in the custom pack, how do we know they actually are sterile when we open the pack? How do we know the items remaining in the original packages are sterile? Are there other sterilization issues we should be concerned about? Does this practice of producing our own custom packs classify us a manufacturer according to the FDA? If a product fails, will the original equipment manufacturer (OEM) stand behind the original warranty?

Answer: Sterility of items in your kit can be determined by randomly culturing the items to determine a pattern of sterilization. This can be done for both wrapped and unwrapped items contained in the kit. Determining sterility of the items is the easy part of the equation. If you are assembling and sterilizing custom kits in your facility, the FDA considers the facility to be a kit manufacturer and subject to all regulatory requirements applicable to other manufacturers.

The FDA has provided a guidance document for manufacturers of custom kits. (1) According to the FDA, there are five broad areas that, at a minimum, must be addressed when creating and sterilizing custom kits. The answers to the following questions must be based on documented studies performed by the kit manufacturer.

Sterilization process.

* What are the effects of the sterilization process used?

* Does the sterilization process cause degradation of component materials in the kit to shorten the life of any product in the kit?

* Does the sterilization process affect the form and/or function of any component part of the kit (eg, irradiation can cause certain polymers to lose strength)?

* Does the sterilization process affect the package integrity of any packaged items in the custom kit?

* Is the selected sterilization process appropriate for all items in the kit?

Sterilization residuals.

* Is the sterilization process compatible with any previous sterilization process to which the item(s) have been subjected (eg, ethylene oxide, irradiation)? The OEM should be able to provide information about sterilization process compatibilities.

Labeling.

* Does the label provide instructions for storage conditions (eg, safe storage time and temperature)?

* Does the label provide an expiration date supported by component part stability data from the kit manufacturer's testing?

* Does the label reflect the expiration date for the component part having the shortest life span?

Premarket notification.

* Does the custom kit require submission of a 510(K) or premarket-approval application (PMA) to the FDA? If the sterilization process substantially alters the safety and/or effectiveness of any component part of the kit, a PMA and/or 510(K) may be required.

General controls.

* Is your facility in compliance with the FDA's general controls for manufacturing, labeling, postmarket reporting of adverse events, correction and removals, and quality systems regulations as noted in Title 21 of the Code of Federal Regulations? Some items in your kit may never have been sterilized, but many of the items in the kit have been sterilized by the OEM. Placing items that have been sterilized by the OEM in the kit equates to reprocessing, regardless of whether the items are intended for single-use or multiple use and whether you have reprocessing instructions from the OEM. If any of the items are intended by the OEM for single use, it is unlikely you have been given reprocessing instructions by that manufacturer. Without specific instructions for reprocessing these items, you are accountable and liable for the sterility, integrity, and functionality of the products. Instructions for sterilization provided by the OEM also would be necessary to sterilize multiuse items that have not been sterilized previously. When an item is placed in a custom kit for processing, it is likely that the OEM will retain liability for that item if it is intended to be reprocessed and if the kit manufacturer follows the OEM's specific instructions for reprocessing. If the OEM intended for an item in the kit to be an SUD and processing or reprocessing instructions are not supplied by the OEM, it is unlikely that the OEM will retain liability for that item. When assembling and sterilizing custom kits, your facility must meet the same general FDA regulations as any kit manufacturer. Using FDA regulations as a guide, AORN has developed a summary guidance statement to be followed if SUDs are to be reprocessed and reused. (2) The FDA regulatory requirements for facilities who engage in any type of reprocessing of SUDs include