Besides the fact that we deal with widgets and you deal with people, here's a list of the things that most OR personnel don't fully appreciate about sterile processing. We hope this helps you understand why your instrument sets aren't always ready when you want them to be.

1 What we do is highly regulated.
We must process all devices according to the specific manufacturer's written instructions. This can require many hours of online research, phone calls and faxes. Most often the information is complete, providing specific cleaning instructions (recommended chemicals, cleaning implements, sonication and manual cleaning) and sterilization instructions (pre-vac or gravity cycle, specific temperature and exposure times). However, in some cases, we must call the manufacturer for clarification. When you consider the large number of devices processed in a facility, this requirement can be overwhelming.

2 We must follow instructions.
The time needed to reprocess devices is directly proportional to the manufacturer's instructions. If the manufacturer recommends manual cleaning or that we disassemble the device for sterilization, then that's what we must do. If a special cycle is required (extended sterilization time), then we must sterilize the device at the longer time with no other items in the load. All of these factors impact the total processing time, which can exceed 4.5 hours. Consider how complying with the device manufacturer's instructions could impact the OR schedule.

3 We must wait for items to fully cool.
Did you know that we can't handle sterile items until they're fully cooled, according to the Association for the Advancement of Medical Instrumentation (AAMI)? Depending on the set's weight and density, this can take from 30 minutes to two hours. This is especially difficult in ASCs because most often the sterilizers don't have racks or carts. This means that we must remove items by hand at the end of the cycle. Packs are very vulnerable while still hot because the pores on the packaging materials and filters can remain open until completely cooled.

4 Processing personnel require lots of training.
Due to the nature and sophistication of the work they perform, processing personnel must undergo extensive training with competency verification. AAMI recommends that all processing personnel be certified within two years of employment. The Certification Board for Sterile Processing & Distribution (www.sterileprocessing.org) offers certification programs for ambulatory surgery and flexible endoscope reprocessor personnel. Extensive training ensures the safety of the devices being processed and helps prevent employee injuries, such as burns from steam sterilizers.

5 Rigid containers have their own special requirements.
Many surgery centers are using rigid containers for their sets. These containers don't require wrapping and serve as the transport and sterilization vehicle for instruments. They're reusable and cost effective. However, containers have some constraints. First, they must be washed (not wiped out) after each use per AAMI, regardless of whether they're brought into the procedure room. Second, we must use them according to the container manufacturer's instructions, including:

• the set's maximum weight inside the inner basket;
• chemicals to clean them (most manufacturers recommend a neutral pH detergent to prevent damage to the finish);
• to what height sets can be stacked, if they can be stacked inside the sterilizer;
• biological testing of the containers (AAMI) pre-purchase and annually to verify the facility's ability to sterilize inside the containers; and
• ability to dry sets inside the container.

Rigid containers usually require additional dry time (average is 30 minutes, but follow your container manufacturer's recommendations). Depending on the contents of the set inside the container, dry time may be difficult to achieve in a pre-vacuum steam sterilizer. Drying rigid containers in gravity displacement cycles can be a challenge. Since most tabletop sterilizers are gravity displacement, keep this factor in mind before you buy containers for gravity displacement cycles. The weight of the container and the weight and configuration of the set inside will have a direct impact the ability to adequately dry the set.

Rigid containers have a different dynamic for air removal. In a wrapped set, air can get trapped in the center of the tray or pack (which is why we place the internal chemical indicator or integrator in the center — not the top — of the tray or set). In rigid containers, air can get trapped in the corners of the basket. AAMI recommends that we place the chemical indicator/integrator in opposite corners of the inside basket.

6 We need decontamination "preference cards."
The decontamination area of central sterile should have a special procedure book for all of the items that your staff cleans. Think of this book as the preference cards for decontamination. Included in this book should be all of the cleaning information for the multi part instruments, the rigid scopes and any instrument that includes specific cleaning instructions from the manufacturer. It's not reasonable for central sterile staff to remember all the different instructions without the help of this book. Photos and wall charts (many manufacturers provide them at no cost) also serve as excellent reference material for reprocessing instruments.

7 Sterilization is getting more complex.
Just as the surgical instruments have changed over the last several years, so too have the methods to sterilize them. Ten to 15 years ago, all we had to know was steam or ethylene oxide gas (EO) sterilization. Now we deal with EO, low-temperature gas plasma, peracetic acid and ozone in addition to steam. The newer technologies are lower in temperature, but each of the systems has specific parameters that we must meet. Most have restrictions on packaging materials, lumen size or diameter restrictions and materials compatibility issues. The advent of the extended steam sterilization cycles followed with most of the extended cycles concentrated in the orthopedic service line. These cycles challenge staff to make sure they're processing items on the correct cycle. It's not unusual to have five to six different steam cycles run in the same day.

8 We must measure staff competence.
We must test central sterile personnel for annual competencies on all of the equipment and instruments they handle. Just as it's important for OR staff to understand the surgical procedures they're assisting in, it's just as important for us to fully understand cleaning and sterilization processes.

9 Quality improvement counts, too.
The central sterile staff has to understand quality and process improvement just like all other areas of a surgical facility. They run quality checks on the various cleaning modalities, including checking the function of the sonic and washers, testing the scopes after they've cleaned them and before they're immersed in high-level disinfectant, and checking the water's pH. They also perform quality checks on the trays before sterilization. Are the instruments clean? Were they disassembled (if indicated)? Is the chemical indicator or integrator inside the tray and in the proper location?

10 Our workers are getting older.
How can we attract new blood to a high-stress, low-paying job that exposes workers to infectious agents? Ours isn't a profession touted by high school guidance counselors. Processing managers must be their own advocates and seek motivated workers. An understaffed processing area affects the OR's productivity.

One final thought
Faced with time pressures and demanding surgeons, you want your instrument sets now, not later. We want that for you, too. But as we've discussed, many factors impact how quickly we can turn around your sets. Remember:

• We're under our own time and regulatory constraints. We don't have to deal directly with surgeons as you do — although sometimes they find their way down to us.
• In hospitals, we serve all departments, not just the OR.

So the next time a rankled surgeon squawks or your schedule backs up because you don't have the sets you need, keep this in mind: As the manufacturer of the sterile products used in the OR, it is the responsibility of the sterile processing personnel to ensure the products are safe and effective when used. That's a goal we can all stand behind.