Document, monitor, and limit flash sterilization to stay out of hot water with The Joint Commission

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Flash sterilization should be used only in unplanned or emergency situations, as stipulated by The Joint Commission (formerly JCAHO). But all too often, facilities are using these devices routinely to make up for an inadequate amount of equipment or staff members, putting themselves at risk of a requirement for improvement (RFI) from The Joint Commission and, more importantly, putting patients at risk of a potential infection.

Flash sterilization is a focus of Joint Commission standard IC.4.10, says Peggy Luebbert, MS, MT (ASCP), CIC, CHSP, owner and consultant at Healthcare Interventions, Inc., in Omaha, NE. The infection control (IC) standards are found in the “Infection Prevention and Control” chapter of the Comprehensive Accreditation Manual for Hospitals (CAMH). In 2009, the Joint Commission  will renumber the IC standards and address sterilization requirements under standard IC.02.02.01.

In the current CAMH, IC standards IC.2.10, IC.3.10, and IC.5.10, as well as leadership standards LD.2.20 and EP.2.10, are also relevant to sterilization.

There are five key steps infection control professionals (ICPs) should take to ensure that their facility is in compliance with these standards, including the following, say Luebbert and Ardene Nichols, MSN, an APIC practice guidance council member:

  1. Limit the use of flash sterilization to emergency or nonroutine situations.
  2. Document on which patients the technique is used and why.
  3. Ensure proper decontamination of the instruments. This decontamination should be performed to the same standard as routine decontamination used for normal sterilization processes.
  4. Make certain the flash sterilizers are maintained and functioning properly.
  5. Develop policies and procedures to govern the use of flash sterilization and monitoring facilities for compliance.

Overuse is a common problem

If your facility is using flash sterilization on a regular basis, you’re not alone. Flash sterilization is commonly used at many facilities as a means of quickly turning around needed equipment in everyday circumstances, Luebbert says.

“What it often comes down to is a financial issue. Facilities do not have enough medical equipment, so they have to reuse this equipment during the day,” she says. Typically, when equipment is cleaned, it goes through a longer sterilization process. But clinicians can get more rapid turnaround of needed surgical items by using the flash sterilizer, which is situated outside every operating room.

Another typical use of the flash sterilizer is for staff members to put a surgical instrument that is not cleaned well enough through the flash sterilization process as an added precaution, Nichols says.

However necessary it may seem, this type of routine use of flash sterilization is likely unacceptable, Luebbert says.

Conducting risk analysis

To ensure that your own facility isn’t falling into the trap of overuse, it’s important to perform a risk analysis, determining when, how, and how often your flash sterilizer is being used, Nichols says. For example, your analysis might reveal that your facility performs knee and hip surgeries on Tuesdays, and every Tuesday you run out of equipment for the last few procedures. When this happens, staff members might fall back on flash sterilization. If this is the case in your facility, you need to approach your hospital administration about purchasing more equipment, Luebbert says. Pressure from The Joint Commission to limit the use of flash sterilization might actually work in your favor in this case, helping to convince hospital administrators to spend more money on needed equipment.

Increasing staff member allocation is another potential solution to flash sterilization overuse, Nichols says.

For example, on days when you have a rapid turnover of patient cases, it might help to boost the number of staff members assisting with decontamination, cleaning, and sterilization of equipment.

Documentation is critical

When you use your flash sterilizer, you should carefully document why it was used. Joint Commission surveyors often issue RFIs in conjunction with the flash sterilization standard, and, more often than not, it’s because the facility has inadequate documentation, Nichols says. “It depends on who you get as an inspector, whether they will pursue this issue or not,” she says.

But if your surveyor is interested in this issue, he or she might ask you to show him or her the record of a patient who had a procedure in the operating room. Then the surveyor will ask whether that person had any equipment flashed. Many hospitals have trouble answering that question, Luebbert says, because their records simply aren’t adequate. Often, hospital staff members can tell you whether they flash-sterilized equipment on the day in question, but they can’t tell you what equipment went into the sterilizer and which patient that equipment was later used on, she says.

Sterilizers have master logs, so the Joint Commission surveyor will be able to see that, for example, the sterilizer has been used 50 times in the past month. If your facility can only show documentation for 10 of those cases, you’re going to have trouble explaining the lapse.

Developing a log

Make sure your facility is prepared if surveyors ask for this information. Luebbert suggests that staff members develop a log that can track not only when the flash sterilizer was used, but also which patients it was used on and why its use was necessary. Another way of tracking this information is to indicate use of a flash sterilizer in a patient’s chart, along with the reason that it was used, Nichols says. There are also programs that computerized facilities can integrate into their electronic health record system to track the use of flash sterilization.

Detecting associated infections

If your facility doesn’t track information on flash sterilization properly, it might be difficult, if not impossible, for ICPs to trace an infection, Luebbert says.

Keeping comprehensive records will allow ICPs to search for trends in use of the flash sterilizer. For example, the ICP can look at the log and see that the flash sterilizer was used frequently because staff members kept dropping a piece of equipment. This might warrant an investigation to determine why this particular piece proved difficult to hold, she says.

Monitoring the sterilization process

Another measure that will protect patients and help ensure that your facility is in compliance with the regulations is carefully monitoring your units to make sure they are in top working order and that they are sterilizing equipment properly, Nichols says.

Ensure that sterilizers are maintained. Daily or weekly testing is critical. The units need to be cleaned, the water supply checked, and the whole process documented.

Also make sure each load that goes into the sterilizer is monitored, Nichols says. Staff members don’t always watch the flash sterilization process as closely as they should, and patients might be at risk for an infection if necessary parameters are not met, she says.

Writing policies and procedures

In addition to monitoring the sterilization process, it’s also important to develop a policy to ensure that sterilized equipment remains sterile after it comes out of the machine, Luebbert says. Once the equipment comes out of the unit, it could be recontaminated on its way back to the operating room or the patient. Your policy should spell out how to transport the items. Consider using closed sterilization containers validated for flash sterilization during transportation from the sterilizer unit.