January 2014 Vol 99 No 1 • AORN Connections | C1http://dx.doi.org/10.1016/S0001-2092(13)01304-5© AORN, Inc, 2014

A s the increasing complexity of surgical instruments has complicated instrument cleaning processes, health care facilities

face the challenge of reprocessing complex instruments safely and efficiently while meeting the demand for fast turnaround of instruments. “The health care facility is put in a precarious situation because surgery is scheduled, the instruments are needed, there is little time to turn these instruments, and there is pressure to get these instruments there,” said Chuck Hughes, vice president of infection prevention consulting services at Cantel Medical and lead educator for SPSmedical Supply Corp. Reprocessing complex surgical instruments can be an intricate, time-intensive process, and if not done properly, poses significant risks to patients.1 The ECRI Institute considered inadequate reprocessing of endoscopic devices and surgical instruments to be one of the top 10 health technology hazards in 2013.2

Obtaining and following the IFUThe advent and continued growth of minimally

invasive procedures has contributed to the proliferation of complex surgical instruments (e.g., drills, endoscopes), which feature specialized designs that often include narrow lumens and channels that are difficult to clean. Complex surgical instruments require more complex cleaning procedures that may consist of specific times for soaking, ultrasonic washing, and rinsing, along with extended sterilization cycles (i.e., extended exposure time and/or temperature

settings). “We’re definitely seeing more and more complex instruments requiring ultrasonic cleaning,” said Hughes. “This creates an issue because not everyone has an ultrasonic cleaner in their decontamination area.”

One of the most common errors associated with reprocessing complex surgical instruments is not having the manufacturer’s instructions for use (IFU) available and not following the IFU’s recommendations. The manufacturer’s IFU provides detailed information related to critical reprocessing elements such as water temperature, cleaning solution, brush type, and specific cleaning procedures. Many national organizations, including AORN and the

Reprocessing complex surgical instruments requires adherence to manufacturers’ instructionsLeslie KnudsonManaging Editor

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A FLEXIBLE ENDOSCOPE is a complex surgical instrument that requires special, complex reprocessing steps.

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Association for the Advancement of Medical Instrumentation (AAMI) advocate procuring and following manufacturers’ IFUs. AORN recommends that devices should be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment and according to the manufacturer’s validated written IFU.3 In addition, AORN recommends that manufacturers’ IFUs for handling and reprocessing should be obtained and evaluated before purchasing surgical instruments to determine the ability to clean and reprocess the equipment within the health care facility.4

Many health care facilities do not follow recommended practices to secure a written IFU before purchasing, borrowing, or obtaining a new device for trial use. Facilities that obtain the IFU after they have already begun using a device may learn that they are unable to comply with the IFU, which creates a critical patient safety issue if they continue to use the device. “It’s troublesome that so many facilities don’t have the IFUs,” said Hughes. “It’s equally troublesome if they have them and they find out they’re not able to comply with them, yet the instruments are still processed using shortcuts.” Health care facilities who do not have or are not compliant with IFUs may come under scrutiny from national survey organizations. Organizations like The Joint Commission and the Centers for Medicare & Medicaid Services emphasize strict compliance with current standards and pay particular attention to see if instrument reprocessing procedures are completed in accordance with manufacturers’ validated IFUs. As part of the auditing process to verify compliance with reprocessing standards and guidelines, many accrediting agencies use a tray tracer methodology to follow an instrument set from the time it leaves the OR through the reprocessing areas and back to the OR.

Many contributing factors at a health care facility can lead to noncompliance with manufacturers’ validated IFUs and reprocessing protocols, including a lack of resources, time, and accountability. Hughes said that oftentimes he sees facilities spending 15-20 minutes cleaning a complex device when the processing time should be more than an hour. “Most health care facilities have standardized reprocessing procedures and in their mind, they don’t really have time to deviate from that,” said Hughes. “When left unattended

without any accountability, typical reprocessing staff members revert to their memory of how to reprocess a device.” Facilities may also encounter challenges related to manufacturers’ instructions themselves, including a lack of standardization, difficulty interpreting the IFU, and updates not being provided at regular or known intervals.5 In addition, some facilities have reported difficulty securing the IFU. A facility should secure the written IFU directly from the manufacturer, who has a responsibility to update the IFU if they make a change to their device and provide the updated IFU to a facility as soon as a change is made.

Improving reprocessing complianceFollowing reprocessing standards and

recommended practices set forth by national organizations such as AORN and AAMI can help to ensure proper instrument reprocessing. Resources like AORN’s Perioperative Standards and Recommended Practices and the ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities provide detailed information on reprocessing best practices that facilities can incorporate into their policies and procedures.

Training and educating sterile processing personnel is another critical part of ensuring adherence to national reprocessing standards and recommendations. National certification opportunities exist that provide formal training for personnel to become certified in specific areas of sterile processing, such as sterile processing management or processing flexible endoscopes. Though professional certification is not mandatory for all sterile processing personnel, it is considered best practice for all health care personnel working in a reprocessing area to become certified within two years of employment. In addition, cross-training opportunities can help to improve teamwork and communication between OR staff members and sterile processing personnel for safe instrument care and handling.

Hughes also stresses the importance of the role of suppliers and vendors in reprocessing. “They should be knowledgeable of best practices,” said Hughes. “They have to lead by example and they should always lead with their validated written IFU.” When securing IFUs from the manufacturer, health care personnel should speak directly to someone in a quality assurance or regulatory affairs department. “We’re all working hard but

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I think we can work smarter in how we secure these,” said Hughes. “It’s not a bad thing for a health care facility to have a working relationship with that department within their suppliers, so that they understand if and when a change or update is made to that IFU.”

ConclusionReprocessing complex surgical instruments

is a critical, sensitive process with significant implications for patient safety. Health care facilities must obtain the manufacturer’s validated IFU before purchasing, borrowing, or trialing a surgical device and must provide sterile processing personnel with the necessary resources, equipment, education, and time to be able to be compliant with manufacturers’ IFUs. “In the 2,500 plus facilities that I’ve been in, they’re all following best practices some of the time but I haven’t seen anyone following best practices all of the time, which is what the surveyors are looking for, and frankly, that’s what our patients are looking for,” said Hughes.

References1. Important information for infection

preventionists regarding media attention

on an outbreak involving reusable surgical instruments. Association for Professionals in Infection Control and Epidemiology. http://www.apic.org/Resource_/TinyMceFileManager/Position_Statements/Dirty_Surgical_Instruments_TalkingPoints.pdf. Accessed December 9, 2013.

2. Top 10 health technology hazards for 2013. Health Devices. 2012;41(11):342-365. https://www.ecri.org/Documents/Secure/Health_Devices_Top_10_Hazards_2013.pdf. Accessed December 9, 2013.

3. Recommended practices for sterilization. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013: 513-540.

4. Recommended practices for cleaning and care of surgical instruments and powered equipment. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013: 485-504.

5. Challenges with reprocessing reusable instrumentation. Johns Hopkins Medicine. http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM268690.pdf. Accessed December 9, 2013.

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