9 APRIL 2025store surgical instruments and other medical devices. The IFU is included in the premarket 510k submittal for all medical devices for approval by the U.S. Food and Drug Administration. The reprocessing of an instrument set begins with the surgical technician during and after the surgical procedure. The surgical technician is responsible for pre-cleaning the instrument set at the point of use prior to the instrument being transported to the sterile processing department for decontamination. The pre-cleaning is important because it's aiding the SPD staff in the cleaning process. SPD technicians routinely feel pressure in their daily work. Due to the following unwarranted contributing factors: · Staffing shortages · Manufacturer's IFU compliance · Lack of surgical staff communication · Lack of communication from SPD leadership · Lack of education and training · Lack of surgical instrumentation inventory · Vendor instrumentation management gaps · Vendor trays arrive at SPD without the manufacturer's IFU. · Lack of inventory sheet · Late arrival outside of the agreed-upon delivery window It is imperative for surgical staff, surgical leaders, and vendors to understand and appreciate the time it takes for the surgical process team to reprocess the instruments following the manufacturer's instructions for use (IFU). This is how we can ensure a patient-safe product that is ready for use. Failing to implement the use of the manufacturer's IFU creates a significant risk to patient safety. To alleviate the pressure on the SPD technicians, SPD leadership needs to implement a plan of action to include the following: ·Implement a monthly education program for the department. This in-service training should be consistent and not just when new instrumentation or equipment is introduced in the department. · Constantly review the manufacturer's IFU to ensure that the SPD staff complies. · Encourage the SPD staff to stay current on sterile processing issues. · Educate the surgical staff on the time that is needed to reprocess an instrument set. Their lack of understanding of the time needed to perform each decontamination step contributes to unnecessary stress on the SPD staff. · Create a career ladder for the SPD technicians that will provide opportunities for growth in the profession. Staff recruitment and retention is very difficult since the pandemic. Surgical technology is advancing every day and the instrumentation that comes along with the technology is complex. Complex surgical instrumentation often yields a device that has more moving parts and is difficult to clean. This is not making an SPD technician job any easier, but education, training, and time can ease the process. If SPD is given the allotted time to perform their job, then their output will yield quality excellence across the organization. IT IS IMPERATIVE FOR SURGICAL STAFF, SURGICAL LEADERS, AND VENDORS TO UNDERSTAND AND APPRECIATE THE TIME IT TAKES FOR THE SURGICAL PROCESS TEAM TO REPROCESS THE INSTRUMENTS FOLLOWING THE MANUFACTURER'S IFU
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