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ISSUE ONE—2011  

Common Mistakes in Instrument & Device Reprocessing

In order to prevent infections in patients due to inadequately processed medical devices and surgical instruments, sterilization and disinfection guidelines and standards must be meticulously followed. However, time constraints, limited staffing, insufficient training, and increasingly complex medical devices, among other factors, can lead to infection control process lapses. As part of a commitment to best practices in instrument sterilization and disinfection, Frontiers in Infection Prevention is launching a new series of articles that will examine common mistakes in instrument processing and offer practical solutions.

Mistake #1: Packaging a Wet Instrument for Sterilization
While some central processing and operating room staff members think that moisture left on instruments to be sterilized is acceptable, the reality is that moisture on a device may interfere with the ability of any sterilization process to successfully sterilize it. This principle applies to many sterilization modalities, including steam, ethylene oxide (EtO), hydrogen peroxide gas plasma, and other hydrogen peroxide and ozone-based systems.1

According to Candy LeBlanc, senior manager of global training, guidelines such as those from the Association for the Advancement of Medical Instrumentation (AAMI ST-37) state that instruments must be properly pre-cleaned, cleaned, and dry before being processed/packaged for sterilization.2 This requirement also is supported by the instructions for use (IFUs) of many instrument and device manufacturers, LeBlanc said.

There are a variety of issues associated with processing wet instruments. For example, LeBlanc said water left on instruments to be processed with contact sterilants such as steam, hydrogen peroxide, and ozone must be removed because the moisture may prevent the sterilant from making contact with that area of the instrument and sterilizing it. With EtO systems, moisture left on instruments may lead to the formation of ethylene glycol (antifreeze)—a chemical byproduct of water and EtO that is not removed from instruments during the aeration phase and can harm patients.3

In addition, moisture left on instruments can result in cancelled cycles. For example, instruments processed in STERRAD® Systems, low-temperature hydrogen peroxide gas plasma sterilization systems from ASP, must be dry in order for the system to draw a vacuum as part of its process. According to LeBlanc, STERRAD® Systems help verify that devices are dry by automatically canceling any load in which moisture is detected, thereby allowing staff members to thoroughly dry the instruments before reprocessing. “STERRAD® Systems help ensure that processing standards are maintained by detecting moisture in the load,” she said.

Mistake #2: Inadequate Cleaning
The goal of cleaning instruments prior to sterilization or high-level disinfection is the removal of bioburden.1 The Centers for Disease Control and Prevention Guidelines for Disinfection and Sterilization in Healthcare Facilities state that, “thorough cleaning is essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.”1

Technologies such as STERRAD® Systems can help instrument processing staff identify whether bioburden is left on instruments by cancelling a cycle if any moisture is detected. As an example, LeBlanc cited a visit she made to a hospital that uses STERRAD® Systems in its Central Processing Department. A load of instruments canceled several times. “The central service staff members thought they had thoroughly cleaned and dried the instruments, but when they took them out and unwrapped them, they discovered blood underneath the mat—the instruments weren’t properly cleaned,” she said.

“The central service manager said that if the instruments had been processed, it would have been ‘sterile blood,’ but there is no such thing as sterile bioburden,” LeBlanc added. “That is a common misperception—some people think that if bioburden such as blood or tissue goes through the sterilization process, it becomes sterile. In reality, the device is not sterile because the sterilant can’t make contact with the instrument.”

As a result, it is critical to recognize the importance of effective and thorough cleaning before high-level disinfection and sterilization of instruments and medical devices in order to prevent transmission of bloodborne pathogens. Following the appropriate guidelines and instructions for use at all times is imperative.

Mistake #3: Placing One Package System Inside Another
Processes for packaging instruments also need to be carefully followed in order to help ensure successful sterilization. According to LeBlanc, another common mistake in reprocessing practices is placing one type of instrument packaging system in another. For example, users should not seal instruments into a peel pouch such as ASP Tyvek® Pouches with STERRAD® Chemical Indicator (CI), put the package into an APTIMAX® Instrument Tray System, and then wrap the tray prior to reprocessing. She also said users should not package small instruments in a peel pouch and then put the pouch in a separate package with other instruments. This is important because incorrect packaging could interfere with the sterilization process.

Example of Tyvek® peel pouch incorrectly placed in a tray.

Additional Information
“Our goal at ASP is to help educate people about best practices in instrument processing,” LeBlanc said. “We realize that people occasionally may forget about best practices or they may not have been correctly trained. We work hard to get the information out and remind them. In the end, we want to help everyone recognize the importance of correctly applying reprocessing methods in order to ensure the safety and integrity of patient care equipment.”

A team of skilled clinical education consultants from ASP is available to answer questions about instrument processing, as well as ASP’s comprehensive infection prevention solutions. For more information, call (888) 783-7723 or visit A wealth of information also can be found on ASP’s Facebook page, so be sure to visit often.

In addition, the company offers innovative tools such as the STERRAD® Sterility Guide, an online database designed to help users quickly and easily determine which instruments can be sterilized in STERRAD® Systems. A guide to preparing devices for sterilization in the STERRAD® NX® System, which received the seal of approval from the AORN, can be downloaded by clicking here.

Look for more common instrument processing mistakes and solutions in upcoming issues of Frontiers in Infection Prevention. Have a mistake you’d like to share with colleagues? E-mail the information to

1. Rutala W, Weber D. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Washington, D.C.: Centers for Disease Control and Prevention;2008.
ANSI/AAMI ST79:2010 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation;2010.
3. Tighe S. Instrumentation for the Operating Room: a Photographic Manual. St Louis, MI: Mosby; 2003.

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Improving Infection Control Practices in Ambulatory Surgery Centers

Adhering to infection control standards and guidelines is important in any clinical setting. This includes busy ambulatory surgery centers (ASCs), which performed more than 6 million procedures in 2007.1 A study published in the June 2010 issue of JAMA, however, found that lapses in infection control practices in ASCs were common.2 The study, led by Melissa Schaefer, M.D., of the Centers for Disease Control and Prevention (CDC), assessed compliance with basic infection control practices, as well as with other Medicare health and safety standards.

Between June and October 2008, 68 ASCs were assessed in Maryland, North Carolina, and Oklahoma. Surveyors focused on compliance with infection control practices in five areas: environmental cleaning, equipment reprocessing, hand hygiene, handling of blood and glucose monitoring equipment, and injection safety and medication handling.

During the five-month study, surveyors found that:2

  • 67.6 percent (46 of 68) of the ASCs had at least one lapse in infection control
  • 17.6 percent (12 of 68) of the facilities had lapses in three or more of the five infection control categories
  • 28.4 percent (19 of 67) failed to adhere to recommended practices regarding reprocessing of surgical equipment
  • 57.4 percent (39 of 68) were ultimately cited for deficiencies in infection control

Inadequate infection control practices in any healthcare setting put patients at risk, and prior outbreak investigations have linked lapses in infection control to transmission of healthcare-associated infections (HAIs).2 As a result, this study is a timely reminder of the importance of meticulously following reprocessing guidelines to protect patient safety. However, this can be a challenge due to pressures to provide quick turnaround of instruments, the increasing complexity of medical devices, and other factors.

The study authors outlined steps that ASCs should take to improve infection control practices, such as adherence to updated ASC health and safety standards from the Centers for Medicare and Medicaid Services (CMS).2 These include requirements that ASCs maintain infection control programs based on nationally recognized infection control guidelines, directed by a designated healthcare professional trained in infection control.2

Experts also stress the importance of having and following manufacturers’ written instructions for processing devices.3 Facilities should develop and maintain a library of device instructions for use, and make the information readily available to staff members responsible for instrument reprocessing. Having IFUs in both electronic and print formats facilitates access.

Technology also can play a role in improving instrument processing practices in ASCs, including systems that automate the reprocessing of flexible endoscopes, with the goal of increasing accuracy, consistency, and efficiency. For example, the EVOTECH® Endoscope Cleaner and Reprocessor (ECR) from ASP is the first commercially available system that both cleans* and high-level disinfects endoscopes. Manual cleaning has been found to be prone to errors and inconsistency.4 Studies have shown that the EVOTECH® ECR helps improve compliance with reprocessing guidelines,5 and that it provides an automated approach superior to the manual cleaning required when using traditional AERs.4 (See “Study Shows ASP EVOTECH® ECR is the Superior Cleaning Choice for Flexible Endoscopes” in this issue of Frontiers)

Technology also can play a role improving instrument processing practices in ASCs, including systems that automate the reprocessing of flexible endoscopes, with the goal of increasing accuracy, consistency, and efficiency.

For critical devices and instruments that require sterilization, ASP’s STERRAD® NX® System provides speed and flexibility in a compact size that is ideal for space-challenged ASCs. It offers fast cycle times, including a 28-minute cycle for most surgical instruments, and an advanced 38-minute cycle for single-channel flexible endoscopes. Its gentle, low-temperature, moisture-free environment allows ASCs to potentially decrease damage and lower repair costs on delicate instruments. Terminally sterilized devices maintain sterility so they can be used immediately or stored for later use, helping to keep surgical schedules on track.

Ambulatory surgery centers play an important role in healthcare today, providing high-quality, patient-centered, affordable care. As with other healthcare settings, improving infection control practices at ASCs is both a priority and a challenge. The recently published JAMA study highlights the need to work diligently toward improved performance, leveraging resources such as reprocessing guidelines and manufacturer instructions for use, as well as technology advances that help improve consistency and efficiency in instrument processing.

Click here to read the JAMA study.

1. Study finds infection control lapses at ASCs. Infection Control Today: Virgo Publishing, LLC; July 2010:12.
2. Schaefer M, Jhung M, Dahl M, et al. Infection control assessment of ambulatory surgical centers. JAMA. June 2010;303:2273–2279.
3. Common SPD mistakes and how to solve them. Infection Control Today. 2009. Accessed June 20, 2011.
4. Alfa M, DeGagne P, Olson N, Fatima I. EVOTECH® Endoscope Cleaner and Reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy. BMC Infectious Diseases. 2010;10:1–14.
5. Ofstead C, Wetzler H, Snyder A, Horton R. Endoscope reprocessing methods: A prospective study on the impact of human factors and automation. Gastroenterol Nurs. 2010;33:304–311.

* Does not eliminate bedside precleaning. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR when selecting cycles that contain a wash stage.

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© Ethicon, Inc. 2011


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