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Steam sterilization is on Joint Commission’s radar


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Steam sterilization is on Joint Commission’s radar

The Joint Commission details what surveyors will focus on regarding sterilization

After reading this article, you will be able to:

  • Explain what a Joint Commission surveyor will look for during the sterilization process
  • Identify the three issues that arose during The Joint Commission’s discussion
  • Describe the importance of correctly completing the entire sterilization process

Editor’s note: The following was adapted from an article originally written by Sarah Kearns for the July 8 HealthLeaders Media Daily News and Analysis.

After working with multiple professional and trade organizations on the common and proper use of sterilization using steam, The Joint Commission has decided to refocus its survey efforts on all critical processes, including sterilization, according to a recent announcement by the agency. The accrediting body will consider sterilization an effective method if a complete process of sterilization is used.

The Joint Commission’s discussion focused on three main points:

  • The terminology used to describe the sterilization process
  • The indication-related issues that involve the selection of the sterilization cycle or method
  • The process-related issues involving the way that a given sterilization method is executed

In addition, Joint Commission surveyors will focus on the critical steps of reprocessing. These steps include the cleaning and decontamination of all visible soil because steam cannot remove these compounds. Any sterilization must meet the parameters by the manufacturer of the sterilizer and the surgical instrument and the maker of any packaging. Also, each sterilized instrument must be carefully protected when being transported to a sterile field.

Joint Commission surveyors are also being asked to perform other activities, which include observing instruments from the time they leave one operating room to when they are returned to the next, observing the cleaning of the instruments, and reviewing the sterilization logs.

Marsha Barnden, MSN, RNC, director of standards and IC at Adventist Health in Roseville, CA, praises The Joint Commission’s updated position on steam sterilization.

“I am delighted with The Joint Commission’s direction related to interpreting and surveying specific infection control standards in the operating room,” says Barnden. “The issue of sterilization is a guaranteed survey topic, and over the past several years, flash sterilization has been particularly problematic for many hospitals.”

The reason for the increased incidence of flash sterilization is often directly related to insufficient instrument trays, most commonly those used for specialty cases such as eye or orthopedic surgeries, Barnden says.

“The mere fact that The Joint Commission has formally recognized the critical steps in the multifaceted sterilization process and are focusing on all three [cleaning/decontamination, sterilization, and packaging/storage with return to the sterile field] is further evidence of the paradigm shift we have been experiencing with Joint Commission surveys. It is all about process and the details therein, drilling down to get the entire picture rather than piecemeal,” says Barnden. “Complicated processes involving multiple steps are processes begging for shortcuts, which can be ill-afforded in the infection control arena.”

However, Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, president and CEO of Seavey Healthcare Consulting, Inc., in Arvada, CO, believes The Joint Commission is on the right track in making sterilization requirements a priority, although some of the specifics are vague.

For example, The Joint Commission says it will observe an entire process, but Seavey questions whether it will truly observe the entire reprocessing procedure. She also points out that although the agency claims to have consulted expert sources, it makes no mention of ANSI/AAMI ST79 or the current Association of periOperative Registered Nurses recommendations, and its requirements for flash sterilization are unclear.

“I’m glad to see The Joint Commission did come out with looking at the entire process; however, I think what they have put out so far is sort of muddying the water because they aren’t being very specific,” Seavey says. “For example, they use the term parametric, but healthcare facilities in the United States do not use that term.”

Shoring up your sterilization processes

Since The Joint Commission will be taking a closer look at your sterilization procedures, it might be time to review your written plan and ensure that your facility has access to the manufacturer’s instructions.

Additionally, the CDC offers sterilization guidelines that were released in October 2008. These guidelines also reference standards from the Association for the Advancement of Medical Instrumentation (AAMI), which were adopted by the American National Standards Institute (ANSI). 3M also offers guidance on sterilization through its Web site, Sterile U. The site requires free registration before visitors can browse through numerous training tools and tutorials.

Keep the following basics in mind to start in the right direction:

Contact your manufacturer. In the past, it has been common practice to simply rely on instructions employees have passed down for years. However, it’s best to have a written manual to reference.

Since every piece of equipment is different, with different parameters and settings, your first step should be contacting the manufacturer for the instructions that come with the machine, if you don’t already have them. These instructions will be your best reference point for any procedural questions or problems with the autoclave.

Make or refine your plan. ANSI/AAMI ST79 states that “policies and procedures provide guidelines of maintaining control and determining methods of improving processes and products.” Creating a specific policy will also eliminate confusion.

Everything from turning the equipment on and off to the actual sterilization process should be recorded, along with how to use your biological indicators (BI), maintenance, troubleshooting, contact numbers, and where the manufacturer’s instructions are kept or maintained. Be sure to maintain a hard copy that is easily accessible for employees.

“To me, OR, IC, and sterile processing are a three-legged stool when it comes to patient safety and hospital-acquired infections, so they all need to be very involved with the procedures that are being written and making sure that they are being followed,” Seavey says.

Initiate hands-on training. Human error is the most frequently occurring problem when it comes to operating a steam sterilizer. At least one employee needs to be up to date on maintenance requirements and standard procedures. Consistency and repetition are crucial in the sterilization process, and both can be implemented during employee training.

During sterilizer training, don’t simply use verbal explanations; show employees what to do and observe them as they run through the process.

Using indicators. BIs and chemical indicators (CI) are the only real assurance that the equipment has been sterilized. AAMI standards recommend using a BI at least weekly, but preferably every day the sterilizer is used.

A rapid readout test is the most efficient because sending out tests can sometimes take up to a week to come back. A BI test is useful in testing an entire load, whereas a CI test will test a single pack to pinpoint a potential problem.

Using flash sterilization. The Joint Commission does not prohibit “flash sterilization,” which originally referred to steam sterilization that did not utilize a full cycle, but surveyors look for indication-related issues such as “high percentage of steam sterilization using less than a full sterilization cycle, as well as exclusive use of this process for certain types of instruments,” according to the accreditor’s statement.

“I think what they are trying to say is you really shouldn’t sterilize anything in less than a full cycle unless the manufacturer actually gives you those recommendations,” Seavey says.

Surveyors will now look to ensure that “steam sterilization of all types, including flashing, must meet parameters (time, temperature, and pressure) specified by both the manufacturer of the sterilizer, the maker of any wrapping or packaging, and the manufacturer of the surgical instrument,” according to the release.

Correct packaging is also important during this process. “Instruments subjected to steam sterilization using methods other than full cycle sterilization may be transported in ‘flash pans’ or other devices specifically designed for the prevention of contamination during and after the steam process,” The Joint Commission said in the release.

“Really, the difference with flash sterilization is it doesn’t have a dry time, but you still can do a flash sterilization in 15 minutes if that’s what the manufacturer recommends for exposure,” Seavey says. “The important thing is that you’ve got to get that air out and you’ve got to expose every surface to the sterilant, and it’s got to be adequately cleaned first.”