Resterilization, Reprocessing, and Reuse

Three things may occur once you take a single-use medical device from the clean storage area:
- The device may be brought to the procedure, but the outer package may never be opened.
- It may be brought to the procedure and the package may be opened, but the device may never be used.
- Finally, the device may be used on a patient.

How you handle the device after each event can make a significant difference in both safety and economics. In this column, I'll offer some recommendations.

Not opened, not used

When a device is brought to the OR but remains in its sterile package, it almost always is permissible simply to return it to the clean storage area. Some facilities will "resterilize" these items with either a low temperature gas or steam, depending upon the item and the packaging. This is a waste of time and money and can do more harm than good.

The only exception is if the sterile integrity of the package has somehow been compromised during storage or transit. It is important to carefully inspect any sterile package that has been dispensed before returning it to the storage area.

In some institutions, it has become common practice to resterilize items that have been dispatched to a user area but not opened or used. The theory has been that once it leaves the clean storage area, no one knows what the package has been subjected to, so even though the package has not been opened, the device needs to be resterilized. This practice originated in hospitals, which routinely resterilized their unopened, unused reusable items that had been dispensed and then simply treated their single-use devices the same way.

This practice is an unnecessary expenditure of time and resources. If the package is intact there is no need to resterilize.

It's a good idea to develop written procedures for handling sterile packages. These procedures should include:
1. How and where they are stored.
2. How they are transported to the user area.
3. What happens if a package is not opened or the product is not used.
4. Who is responsible for determining the fate of this package:

a. Can it just be returned to the storage area?

b. Does it need to be wiped off, and if so, how, and with what?

c. Is the package's sterile integrity compromised?

d. Has the product been damaged?

Someone needs to be responsible to see that the procedures are followed. If the package has been compromised but the product is undamaged, unwrap the package and follow these next recommendations for reprocessing.

Opened, but unused
When the staff opens too many single-use items for the case, and some remain on the back table, there are two courses of action available. You can throw them away, or you can reprocess them. That is to say, you can clean, wrap, and sterilize them. Before you exercise the second option, you should do one of two things.

First, try to obtain written recommendations from the manufacturer on how to safely clean, wrap, and resterilize the device, and follow those instructions to the letter. If foreign matter has not splashed on the item, or if it has remained untouched by contaminated gloves, it may not be necessary to subject it to a complete decontamination procedure.

If the maker is not forthcoming with this information-and many single-use device manufacturers will not be-you need to develop a process for handling each type of device and validate that your process works. Your process must result in a product that is safe and effective.

Note that if all you are doing is reprocessing open but unused devices, you will not be subject to new proposed FDA regulations, which I will discuss in a moment. These regulations apply only to devices that have been used on patients or have been in contact with the patient's blood or body fluids through contact with contaminated gloves on scrubbed personnel, and then reused.

If you find yourself dealing with the problem of opened but unused devices frequently, take the following steps:
- Reduce the number of items in your surgical packs so you don't end up with too many of a particular device during a procedure. Have an accessory pack available made up with extras of certain devices, such as extra sutures or drapes, in case they are needed.
- Examine the procedures that habitually result in an assortment of opened but not used devices. Analyze the instrument set-ups for these procedures and work on eliminating the leftover items.
- Target the doctors who insist on having lots of instruments "just in case." Document what is left over after each case, and inform the doctor of the cost of reprocessing or disposing the unused items.
- Look for these sorts of patterns. If the problem is large enough, form a committee charged with the goal of eliminating as many of these reprocessing problems as possible.

Used instruments
The final scenario involves single-use devices that have come into contact with the patient's tissue or body fluids. In this case, you have three options:
- dispose of the device;
-send the device to an FDA-approved third-party reprocessor;
-reprocess the device yourself.

This last option is becoming increasingly complex. Whether you should exercise this option depends in part on the device and in part on your setting.

There are probably very few dangers associated with cleaning, sterilizing and reusing simple single-use devices. Doing the same thing with a complex device, such as any lumened item, is fraught with peril. The FDA has classified devices into separate categories according to the level of reprocessing risk (see www. FDA.gov/CDRH/reuse for up-to-date information on proposed risk categories).

Whether or not reprocessing is a good idea for you also depends on your setting. The FDA recently published a draft regulation regarding the reprocessing of single-use devices. If adopted in its current form, the regulation would make reprocessing these devices prohibitive for most hospitals. Only the ones with very high volumes would be able to justify the expense of compliance.

For now, freestanding surgery centers not affiliated with a hospital will not be required to comply. It's unclear whether freestanding surgery centers that are owned and operated by hospitals would be affected. Those that use the hospital for sterile processing certainly will be.

Whether or not you choose to reprocess, remember that the reason for all the concern is patient safety. If you keep that goal in mind, you will make the right decisions for your facility, your surgeons and your patients.

Dan Mayworm is the former president of Mayworm Associates, Inc. and publisher of The Journal of Healthcare Resource Management and Infection Control & Sterilization Technology. He is the former president of Tower Products, Inc., a manufacturer of packaging materials for the medical device industry. Mr. Mayworm has served as president of the Health Industries Association and as an executive committee member of the Health Industry Manufacturers Association, and has given expert testimony before both the House and Senate subcommittees.

If you have an infection prevention question that you would like Mr. Mayworm to answer in this column, fax it to 610-240-4919, snail mail it to Outpatient Surgery Magazine, 3 Beryl Road, 2nd Floor, Paoli, PA 19301, or e-mail Mr. Mayworm at [email protected].