ICT asked members of the disinfection and sterilization community to share what they believe to be some of the most common mistakes being made in the sterile processing department (SPD) and recommendations for how to improve practice.
Nancy Chobin, RN, AAS, ACSP, CSPDM, a consultant and CS/SPD educator for the Saint Barnabas Health Care System in New Jersey, says that not having or following manufacturer’s written instructions for processing devices is a significant and common misstep. “This information should be acquired and made readily available to staff members,” Chobin says. “One copy should be placed in the decontamination area to reference cleaning protocols, one copy should go in the prep/packaging area for reference how to prepare/sterilize the device. Management must take responsibility for this information so subordinates can safely and effectively process devices and instrument sets.”
“One significant mistake I’ve often seen is the failure to implement a device technical data library to address questions about cleaning and sterilization parameters for reusable medical devices,” says Richard W. Schule, BS, MBA, FCS, FAST, director of clinical education for STERIS Corporation. “Interestingly, the validated cleaning and sterilization parameters for reprocessing a device in a healthcare facility are a required part of the Food and Drug Administration (FDA) 510k submission for reusable medical devices. However, this critical reprocessing information doesn’t always reach the SPD.”
Schule continues, “In most cases, the original equipment manufacturer (OEM) ships reprocessing instructions along with every device. If a clinical department (i.e., the surgical department) is the purchaser of the device, and it is delivered and unpacked in a department other than the SPD, the reprocessing instructions may be discarded with the packaging material before the device reaches the SPD for cleaning and sterilization. ANSI/AAMI ST79:2006 5.2.2 - Newly purchased reusable items and repaired reusable items, states, ‘...After instruments are removed from the external shipping containers, personnel should inspect them to ensure that they meet the required specifications and that instructions for use have been provided and then transport them, together with the instructions, directly to the decontamination area. The manufacturer’s processing instructions should be followed.’”
Schule says that developing, implementing and maintaining a device tech data library would not only support SPD quality processes, but would also go a long way toward reducing the daily frustrations experienced by clinical and technical teams. “For example, SPD personnel often must search for instructions when the OR needs an instrument quickly,” Schule explains. “It’s also not unusual for staff to discover after purchasing a particular device that the OEM has validated alternative sterilization parameters for that device that are not currently used by the healthcare facility. To add to the frustration, if a frequently-used instrument normally reprocessed via a method such as ethylene oxide is dropped, and can’t be quickly reprocessed due to the lengthy EO cycle time, quick access to manufacturer’s instructions might provide a validated alternative method that would save the day.” Schule adds, “I recommend implementing two types of libraries; electronic and an original hard-copy file. Developing an electronic file allows you to easily share information across departments and hospitals. Electronic files can easily be incorporated into most instrument-tracking systems and are a paperless, "green" option. However, it’s also important to have back-up information in the event of a computer crash or other crisis. The SPD should have policies in place outlining contingency plans that include original document files. I often suggest using several four-inch binders or identifying a filing cabinet drawer dedicated to this purpose.”
Lack of this kind of data library can hamper SPD technicians’ compliance with Association for the Advancement of Medical Instrumentation (AAMI) standards, another common mistake Chobin sees. “These standards are national standards and are considered the “minimum” practice level. Yet many facilities have yet to purchase and implement AAMI’s Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities (ST-79). Without these standards, the department may not be complying with best practices for cleaning, assembly, sterilization and quality control monitoring of sterilization cycles. All sterile processing policies and procedures should be based upon and referenced to these standards.”
Chobin emphasizes that she also sees SPDs that do not have a process monitoring system in place to ensure compliance with all policies and procedures. “As a ‘manufacturing’ center, the SPD must ensure that all employees follow the stated policies to enhance consistency in all processes. Examples of some of the types of audits that should be performed include (but are not limited to) tray audits, sterilization record audits, instrument preparation audits, etc.”