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.”
When conducting complimentary sterilization audits at hospital SPDs, Charles Hughes, general manager and educator at SPSmedical Supply Corp.’s Sterilization Products & Services, says he sees 10 significant mistakes:
1. Temperature and humidity not recorded daily or controlled properly for staff comfort and to limit microbial growth. Decontamination should be controlled between 60 degrees F and 65 degrees F (16 degrees C to 18 degrees C), general work areas between 68 degrees F to 73 degrees F (20 degrees C to 23 degrees C) and sterile storage not to exceed 75 degrees F (24 degrees C). Relative humidity should be controlled between 30 percent and 60 percent.
2. Not wearing a face mask to protect against aerosols when manually cleaning soiled items in the decontamination department.
3. Improper loading of mechanical washers, i.e., layered trays, inserts and rigid container filter plates not separated to allow full contact with cleaning/disinfection solution.
4. Lack of individual instrument inspection for cleanliness and function during tray assembly.
5. Paper/plastic peel pouches and/or count sheets placed inside wrapped sets or rigid containers. The plastic side of pouches can inhibit proper sterilization or drying of the set, and the chemicals inside the paper or ink of count sheets may be toxic. Cytotoxicity testing can validate the safety of count sheets.1
6. Incorrect sterilizer parameters selected for processing complex devices and/or heavy instrument sets, i.e., orthopedics. Many healthcare facilities do not maintain each manufacturer’s validated reprocessing instructions to teach staff the proper cycle selection. This is true in the SPD as well as operating rooms where flashing occurs.
7. Sterilized items are not allowed to cool properly before handling/distribution. A minimum of 30 minutes is recommended, with some heavy trays needing one to two hours. Handling processed items before they have cooled can compromise the integrity of the package’s barrier system.
8. Wrapped trays being stacked on top of each other in sterile storage. Rigid containers may be stacked during storage, but the compression of heavy wrapped trays can compromise sterility of both trays.
9. Lack of daily cleaning and disinfection of floors, work stations and frequently touch items, i.e., telephone, door handles; and lack of any cleaning schedule for sterilizers, vents, walls, ceilings as well as storage bins, racks and carts.
10. SPD personnel not 100 percent certified and/or actively involved in local SPD chapters.
“I believe the best way to address each of the aforementioned mistakes is with education of best practices as defined by AAMI and AORN standards,’ Hughes emphasizes. “SPD managers who have facility design and/or environmental control issues should seek help from the infection control department. SPD managers should make certification mandatory and encourage all staff to participate in their profession as an active member in their local SPD chapter. Lastly, vendors should be knowledgeable of best practices and support them in their actions and recommendations provided to sterile processing personnel.”
Lawrence Muscarella, PhD, director of research and development and chief of infection control for Custom Ultrasonics, Inc., emphasizes the importance of drying flexible endoscopes to prevent infection. Society of Gastroenterology Nurses and Associates (SGNA) guidelines recommend drying flexible endoscopes that are wet with rinse water before storage and between patient procedures; whether reprocessing the endoscope manually or using an automated system; and no matter whether the instrument is rinsed after chemical immersion with clean water, tap water, fresh water, rinse water labeled as bacteria-free, or rinse water labeled as sterile. Drying is routinely achieved by flushing the instrument’s lumens with a bolus of 70 percent isopropyl alcohol followed by forced-air drying.
“Patient morbidity and mortality following endoscopy have been directly linked to the clinical use of instruments wet with rinse water,” Muscarella says.” And, demonstrating drying’s effectiveness, both true- and pseudo-outbreaks of bacteria have been abruptly terminated once instrument drying was implemented. As a consequence, the FDA and others recommend that the instruments be thoroughly dried after processing in all liquid-based automated instrument reprocessing systems), to prevent disease transmission.” Muscarella adds, “Drying the instrument after processing also resolves (or “cuts”) the operating room’s proverbial Gordian knot, which — while correctly asserting that water or moisture on the outside packaging of a wrapped surgical instrument set renders the set contaminated and unsafe for patient use — inexplicably claims that instruments wet with filtered tap water after reprocessing (as opposed to flash-autoclaved condensate) are ‘sterile.’”
Muscarella continues, “The implications of this discussion to public health, aseptic technique and healthcare-acquired infections (HAIs) are far-reaching and self-evident. That thousands of patients die each year in the U.S. from HAIs of waterborne (Gram-negative) bacteria including Pseudomonas aeruginosa, underscores the importance of SGNA’s forethought and recommendation to dry the instrument after reprocessing (whether or not the rinse water is ‘sterile’), to compensate for a bacterial filter’s inherent limitations, limited use-life, and proneness to failure; and, to minimize the risk of HAIs.”
Anne Reed, BS, vice president of Mobile Instrument Service and Repair, Inc., says some hospitals still throw out damaged surgical instrumentation, thinking there’s no alternative. Quite frequently, repair can be more economical than replacement. “It’s a change in mindset to seek repair first,” Reed says. “There is a time when an instrument should be replaced and a reputable repair company will always give this advice. However, if the objective is to maximize the life of the facility’s equipment, without compromising patient care or surgeon concerns, then one might consider an enlightened approach to equipment preservation for the ultimate in cost effectiveness.”
The rigid endoscope, one of the most fragile and sophisticated instruments in the operating room, is subject to more frequent damage than most other equipment because of its delicate lens system. “Most damage results from fluid invasions or trauma to the internal optics system,” Reed says. “While complicated by nature, approximately 90 percent of these parts can be replaced at a charge far less than expensive repair/exchange options. To capitalize on the potential efficiency of an original investment in the endoscope, the hospital is economically better served to repair it until it has sustained damage genuinely beyond repair or has become technically obsolete.”
1. March 2009 AORN Journal, page 521.