As surgical procedures advance, the design of surgical instrumentation that central sterile processing staff and nurses are asked to reprocess also becomes more complex.
Many instructions for use (IFU) that were once short and easy to understand are now rigorous, time intensive, and difficult to measure. This increase in complexity in IFUs, tied with other environmental challenges such as staffing shortages, changing guidelines, and lack of control over the operating room’s pre-cleaning quality, makes staying compliant with IFUs more difficult than ever.
Certain surgical instrumentation is more challenging to reprocess than others. Here are five types of surgical instruments that may require additional planning and consideration by staff to ensure IFUs are being met.
1. Robotic instrumentation
Robotic devices continue to be a difficulty for sterile processing staff because robotic instrumentation cannot be disassembled. The instrument’s design includes many intricate nooks and crannies.
A 2016 Infection Control & Hospital Epidemiology study conducted on cleaning robotic instruments concluded that it is virtually impossible to fully remove contamination from their arms.
“These instruments are wonderful tools that allow surgeons to operate with care; but completely decontaminating them has been a challenge for hospitals,” said Yuhei Saito, RN, PHN, MS, lead author of the study and assistant professor at the University of Tokyo Hospital.1
Sterile processing departments may also face another challenge: Robotic arms that are too long for many of their existing sink basins. Pre-existing stations become outdated more quickly as instruments become larger, longer, and heavier, and difficult to scale up as the OR evolves.
Ask the following questions about your own processes if you are reprocessing robotic devices, or plan to implement a robotic system:
- Do my sink basins fit robotic arms for proper soaking?
- Can I sacrifice a sink basin for a full, 30-minute soaking period, per IFU requirements?
- Am I really flushing robotic channels for their full IFU every time, and can I ensure I meet pressure requirements?
- Do I have the automated cleaning systems in place to meet robotic IFUs?
2. Flexible endoscopes
Flexible endoscopes are notoriously difficult to reprocess due to their complex designs. Some of these design elements might include:
- Long, dark, and often narrow channels, which favor bioburden and biofilm development, especially if channels are left wet and/or improperly cleaned
- Rough or pitted surfaces
- Heat and chemical sensitive construction
- Right angle bends, and complex ports
Reprocessing departments responsible for cleaning flexible endoscopes may consider supplementing their existing standards of practice by requiring certification to staff cleaning flexible endoscopes, enhancing training, or re-writing procedures for worst case scenarios. All of these areas can help draw extra attention to a scope’s complex design, which may prevent errors.
3. Ocular and ophthalmic instruments
Any ocular surgery where the anterior segment is exposed is at risk of a potential Toxic Anterior Segment Syndrome (TASS) infection. These procedures not only include cataract cases, but also eye trauma and macular degeneration procedures. Facilities reprocessing instrumentation which supports these cases should pay special attention to ANSI/AAMI ST79:2017 “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” guidance.
Ocular instruments might be best processed in dedicated areas of the department solely for eye instrumentation. Eye instrumentation IFUs may, for example, restrict the use of enzymatic detergents. When residual enzymatic gets in a patient’s eye during a procedure, it can lead to blindness or other severe, negative outcomes. You may also find your ocular IFU now includes single-use brushes only, or specific water quality requirements.
4. Flexible reamers
In a 2018 study by the Healthcare Infection Society, “Soil and/or biofilms were evident on complex-design [flexible reamers] following 20 cycles of contamination and reprocessing, even using the reference standard method of cleaning… although the depth gauges could be disassembled, biological residues and biofilm accumulated in its lumen.” 2 Flexible, exterior channels are prime locations for bioburden and biofilm development and require special attention during cleaning.
This study points to a key issue: Even under best practices and total compliance to IFUs, complex designs may sometimes prevent even the most well-trained reprocessing staff from completely decontaminating instrumentation. Instrument design may be purposeful in the operation room, but it can be a roadblock for those reprocessing said instrumentation.
Departments should consider if the manual cleaning methods they’ve implemented are meeting or exceeding IFU requirements consistently, even in worst-case scenarios.
5. Loaner instrumentation
Loaner instrumentation poses a unique challenge for reprocessing departments. Many staff members may be asked to clean instrumentation for the first time without adequate training and preparation. A lack of communication from vendors on IFUs and proper cleaning protocols could further complicate the cleaning process. Even if the instrumentation is not complex in its design, these outside factors make reprocessing loaner instrumentation more difficult for even seasoned staff.
Having a robust loaner instrumentation program, including strict IFU reporting by vendors, a thorough decontamination process for instruments arriving at your facility for the first time, and giving teams proper time to clean pre- and post-procedure can help reduce manual cleaning errors. 3
For any department that is reprocessing any of these complex instrument designs, proper training and processes become foundational to ensuring your patients’ wellbeing and safety.
For more information about enhancing your manual cleaning procedures for robotic, endoscope, ocular, orthopedic, or loaner instrumentation, watch our free, 1 CE educational program, A Royal Flush: Your Winning Hand for Pre-Cleaning Protocol.
- Yuhei Saito, Hiroshi Yasuhara, Satoshi Murakoshi, Takami Komatsu, Kazuhiko Fukatsu, Yushi Uetera. Challenging Residual Contamination of Instruments for Robotic Surgery in Japan. Infection Control & Hospital Epidemiology, 2016; 1 DOI: 10.1017/ice.2016.249
- Lopes LKO, Costa DM, Tipple AFV, Watanabe E, Castillo RB, Hu H, Deva AK, Vickery K. Complex design of surgical instruments as barrier for cleaning effectiveness, favouring biofilm formation. J Hosp Infect. 2019 Sep;103(1):e53-e60. doi: 10.1016/j.jhin.2018.11.001. Epub 2018 Nov 10. PMID: 30423413.
- Sadler, D. (2016, November 15). Cover story: The challenges associated with loaner instrumentation. OR Today. https://ortoday.com/cover-story-the-challenges-associated-with-loaner-instrumentation/.