Modular Instruments Pt. 2

Have Modular Instruments Lowered Surgical Infection Rates? Part II In Part I of this blog we looked at how a number of surgical instrument companies introduced ‘modular’ instruments that could be disassembled for internal cleaning during reprocessing. The concept was intended to reduce the risk of a surgical infection (SSI) caused by an instrument that remains contaminated after reprocessing. Some manufacturers’ of modular instruments argue that once they've been disassembled, you can 'visualize' the bioburden inside of the instrument and manually remove it during reprocessing. Regretfully, the human eye is NOT capable of seeing microscopic bacteria and biofilm on the surface of a surgical instrument. Both AAMI and IAHCSMM have long been aware of the limitations and dangers of relying on ‘visual’ inspection to insure the removal of organic debris from instruments during reprocessing. AAMI’s ST 79 on IFUs clearly states “Visual inspection alone may not be sufficient for assessing the efficacy of cleaning processes.” ST 79 goes on to state “The use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.” IAHCSMM points out in its CRCST Self-Study Lesson Plan, Understanding Biofilm, “Even with the use of most visual enhancing tools, microorganisms will still not be seen. To help solve this problem, tests have been developed to help verify that cleaning quality standards have been attained. These tests include protein tests and adenosine triphosphate (ATP) bioluminescence tests, both of which test for residual soils and which might also be suggestive of biofilm formation.” As we have demonstrated in several previous blogs, the only way to ensure clean, sterile, moisture-free surgical instruments on every reprocessing cycle is to only use instruments whose cleaning and sterilization IFUs have been validated using AAMI and FDA testing protocols. The personnel at Joint Commission have also raised concerns about the problems associated with reprocessing modular instruments. Their concerns start in the O.R. where ‘point-of-use’ preparation is often lacking, or simply non-existent. Joint Commission was so concerned that in January of 2011 they revised the guidelines for their inspection teams in the operating rooms. Specifically, the revised guidelines from the Joint Commission read as follows: Point-of-use preparation: “Some typical point-of-use shortcuts that have been observed in operating rooms are: not unlocking instruments; not disassembling instruments; not wiping off gross material and body fluids during procedures; not moistening or pre-treating instruments before transporting them for sterile processing; and not returning instruments to their proper containers.” Based on the Joint Commission's January 2011 inspection guidelines, it is obvious that the failure of O.R. personnel to disassemble and manually prepare modular instruments for transport is a major concern/problem. An even greater concern/problem exists once modular instruments arrive in CS/SPD for decontamination, cleaning and sterilization. The major problem with modular instruments is that most are not labeled as ‘modular’ and as such O.R., CS and SPD personnel don’t disassemble them for reprocessing. In fairness to O.R., CS and SPD personnel, most modular instruments look just like conventional, non-modular instruments. When modular instruments are not disassembled during reprocessing, bioburden quickly accumulates within the instrument. This accumulation of bioburden can increase the risk of a surgical infection caused by the contaminated instrument. Another problem with modular instruments that are re-assembled prior to sterilization is that residual moisture can remain trapped inside of the instrument after the sterilization cycle. This increases the risk of an instrument contaminated with waterborne pathogens being returned to surgery. Instruments whose sterilization IFUs have been validated to return moisture-free instruments after the sterilization cycle are ideal. This significantly reduces the risk of a surgical infection caused by waterborne pathogens and it also reduces the potential for rust to form within the instrument. Next to avoiding an SSI, the most important issue for the surgeon is the tactile feel and response of the instrument coupled with the bite force that can be applied to the jaw. In order to be easily disassembled and re-assembled, modular instruments are not built with the same tight tolerances that conventional instruments are built to. That is why modular designs often don't match the tactile feel, response and bite force of a conventional, non-modular surgical instrument. Despite making us feel more assured, there are no studies showing definitively that modular instruments lower infection rates. Our goal in this blog post is to make sure we are all aware that modular instruments still pose a similar set of risks for inadequate cleaning as do traditional instruments. 1. AAMI’s ST 79 2. IAHCSMM’s CRCST Self-Study Lesson Plan, “Understanding Biofilm”  3. Joint Commission inspection guidelines for “Point-of-use preparation”