OPERATING ROOM
and transport complications if devices and equipment are needed in these areas.
• Facilities that have outsourced their O and SPD teams to the intensive care unit (IC), emergency department (ED), and acute care floors may have complications with communication among staff and an additional need for retraining and staffing as caseloads increase.
• Many sterile processing departments have had the new role of reprocessing N95 masks, which increases the workload of the department and may change the way the department flow is structured.” Ramos agrees that staff must manage resources wisely to keep pace with the uptick in patient cases.
“Many hospitals around the country are returning to pre-COVID case volumes, and many are ramping up anesthesia, PC and operating room personnel,” he indicated. “An incremental case volume should, at minimum, be correlated to staffing patterns in SPD. Additionally, as you take on cases, do you know what your actual inventory is I have seen differences of up to 5 sets between the tracking system and what actu- ally exists.”
Follow the standard rules How does SPD meet the needs of instru- ment reprocessing during the continuing COID- crisis Fisher recommends using the same sup- plies and protocols.
“Throughout the pandemic, OR and SPD
staff were questioning whether they needed to change their practices and work instruc- tions around cleaning and sterilization,” Fisher said. “The good news is, the virus classification of COID- is affected by the OR and SPD general cleaning and reprocess- ing instructions. The chemical agents used in the cleaning, disinfecting, and sterilization of surgical devices is effective in neutralizing and killing the COVID-19 virus.” With all equipment, it is vital to adhere
to the instructions for use (IF) and stan- dards in place, emphasizes Lynn Burbank, DNP, RN, CRNP, Global Senior Manager for Infection Prevention, Olympus Corporation of the Americas. “New products have emerged with microbio- logical efficacy claims that may be significant, but have limited evidence sup- porting long-term use,”Burbank noted. “Emergency se uthorization (E) has allowed access to goods and services that previously went through extensive research to come to market. lthough E has been necessary, this change in access or utilization
Lynn Burbank
has created a multitude of questions that will impact the future of patient care.” She added, “The most effective practice change has been to stay with what is known. The use of evidence-based practice (EBP) is still the gold standard in patient safety. When utilizing new equipment or products, implement a risk management assessment, audits, and surveys of the effect, i.e. ask, ‘is it fulfilling the claims made by the vendor’”
Get IFU-educated
How can SPD departments and teams stay informed and confident in their work Ramos suggests caring for surgical instru- ments starts early on, “before generating a purchase order by answering: • Do I have the equipment needed to process this instrument
• Do we have the recommended chemicals for the cleaning process
• Are my staff and the end user trained on this product
“Once the instrument is in your facility,
it’s essential to process it according to the manufacturer’s instructions for use (IF). It’s also important to continually update the set contents to make sure it reflects your current practice and to ensure you do not have unnecessary instrument inven- tory and redundant instrumentation in the sets that could potentially damage needed instruments.”
The Association for the Advancement for Medical Instrumentation (AAMI) recently released new guidance to medical device manufacturers about making their IFs more understandable for processing. “Medical device manufacturers, regula- tors, and healthcare technology manage- ment experts recently joined forces to solve a long-standing issue for medical device processing: confusing instructions for use (IFs). These essential instructions explain how to properly clean, disinfect, sterilize and make the device ready for use on the next patient. This updated technical informa- tion report, TIR12:2020, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, ‘standardizes manufacturer IFs for the processing of clinically used medical devices and helps manufacturers understand how well the end users comprehend a device’s instructions and labeling.’”2
AAMI also referenced, “the 2017 update of the standard ANSI/AAMI/ISO 17664, Pro- cessing of health care products—Informa- tion to be provided by the medical device manufacturer for the processing of medical devices, which details what information must be provided to healthcare facilities (including instructions for pretreatment,
22 April 2021 • HEALTHCARE PURCHASING NEWS •
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cleaning, disinfection, drying, inspection, maintenance and functionality testing, and packaging). It also describes the validation testing that needs to be conducted to ensure each of these processes is suitable for the device…TIR12 now ensures that manufac- turers not only know what information they need to provide, but also how to provide it.”2 Additionally, the Association of periOper- ative Registered Nurses (AORN) announced the publishing of “the 2021 Guidelines for Peri- operative Practice with six revised guidelines” and that the “Instrument Care and Cleaning Practice updates in this guideline emphasize the importance of an interdisciplinary team when selecting equipment and instruments as well as establishing and implementing policies and procedures.”3 In regard to training, Northfield edical
developed online videos for staff, shares Matthews. “Northfield edical has created a number of video in-services that are now available on-demand, complete with continuing education certificates that are issued after the viewer completes a quiz with a passing grade,” he highlighted. “This shift to on- demand education has a number of benefits, particularly that it can always fit into the schedule of the facility. While this shift in educational delivery was likely to happen eventually, COVID-19 forced the shift much more quickly.”
Managing instruments What are the processes for cleaning and pre- cleaning instruments amos first points to the Centers for Dis- ease Control and Prevention (CDC), which “defines cleaning as the removal of foreign material (e.g., soil and organic material) from objects and is normally accomplished using water with detergents or enzymatic products.’”4 Fisher continued, “Effective instrument care begins in the OR bedside with immedi- ate cleaning after use. This starts the break- down of the bioburden. Often, there are extended periods of time between use and decontamination. The longer the time, the more difficult it can be to eliminate biobur- den, especially for instruments with channels or cannulas. The IF provides the step-by- step instructions on how to effectively clean the instrument or device.”
Ramos adds, “Keep surgical instruments moist at the end of the procedure and trans- port them to the decontamination area as soon as possible. Additionally, understanding and keeping the purified water system in place is essential for meeting minimum standards and preserving the instruments’ value by avoid- ing pitting, corrosion, and staining. Pitted instruments can hold microorganisms past
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