FOCUS ON INFECTION PREVENTION Retained Bioburden On Surgical Instruments After Reprocessing: Are We Just Scraping the Surface? James Davis, MSN, RN, CCRN, CIC, HEM, FAPIC INTRODUCTION Senior Infection Prevention Analyst Pennsylvania Patient Safety Authority Imagine a basic tool used for performing a task, such as a chisel. The chisel is a raw powerful tool that one strikes with a hammer, commonly used for removing large chunks of material. A chisel has a handle for stabilization, a striking surface, and a flat, ABSTRACT angled cutting edge. Not complex or compound, the chisel nowadays is usually fabri- The design of medical devices, equip- cated from a single piece of hard metal, is easy to wipe off and sharpen, and maintains ment, and instruments can provide its cutting edge for long periods of use, requiring little maintenance. Now, imagine a ideal spaces for bioburden accumula- tool designed for cutting delicate objects, such as a small pair of scissors. The chisel tion and subsequent development of has one cutting edge that moves in one direction, whereas scissors have two cutting surface biofilms, especially if compound edges that move in opposite directions, requiring the addition of a hinge pin. The hinges, gaps, channels, or lumens are scissors require sharpening of two indexing edges, lubrication of the hinge pin, and a present. Many outcomes related to specific interface with the operator through the two handles. As the precision of work the use of poor-quality instruments are increases, tools seem to become more complex and require more care for proper opera- likely to go unrecognized, especially tion. Care and maintenance of complex tools, in turn, directly affects the quality of if the result of an event is latent in a work when the tool is used. patient’s course. To increase knowledge The same principles can be applied to tools used for operations and procedures con- about the prevalence of reported events ducted on living beings. Tools evolve into instruments and devices as the complexity, related to issues with surgical instru- delicateness, and success of a procedure increase, and their use directly influences a ments, Authority analysts queried the patient’s real or perceived wellbeing. The straight Hibbs chisel, used in orthopedic sur- Pennsylvania Patient Safety Reporting gery to remove large pieces of bone, is made of smooth, high-quality stainless steel; with System (PA-PSRS) database for acute no material gaps, channels, or overlaps, and it is easy to clean, disinfect, and maintain. care events associated with bioburden Compare the Hibbs chisel to the Pratt-Smith hemostatic forceps (Pratt hemostat), with on surgical instruments reported from the Pratt’s T-shaped, tube-like tip with precise, fine, serrated jaws, ratcheting handle, January 1, 2005, through December and smooth hinge action (see Figure 1). Based on its design and intended function 31, 2015. Analysts then compared the (clamping delicate tissue) the Pratt hemostat has more nooks and crannies that are dif- results with Pennsylvania Health Care ficult to adequately reprocess and facilitate the accumulation of bioburden. Thus, the Cost Containment Council (PHC4) design of medical devices, equipment, and instruments may provide ideal spaces for acute-care procedural denominator bioburden accumulation, and subsequent development of biofilm, especially if com- data from the same time frame. The pound hinges, gaps, channels, or lumens are present. results show an increase in the number of reported events over time, both in the number of reports per year and as a Bioburden rate per 1,000 procedures. To combat Bioburden is “the degree of microbial contamination or microbial load; the number the trend of increased bioburden preva- of microorganisms contaminating an object.”1 Colloquial clinical use of the term bio- lence, a quality improvement initiative burden includes both microscopic debris and debris that is visible to the naked eye and in surgical instrument reprocessing may refers to tissue, body fluids, bacteria, or any other biologic material present on, or in, need to occur. The operating room and an instrument or device after use on, or in, a patient. Varying degrees of bioburden will its patients depend on the reprocessing be present on an object after use on a patient; the accumulation of bioburden on used department; operating room services equipment is unavoidable. Once bioburden is present on a surface, biofilm formation simply cannot exist without an adequate is not far behind. flow of clean and sterile surgical instru- ments and equipment. Efforts should be Biofilm considered to unify departments and Surface bioburden to any degree facilitates the formation of biofilm. Biofilm is “a processes around the care and main- slime-enclosed community of bacterial colonies that is very difficult to eradicate even tenance of mission-critical items, such with the most powerful antibiotics or sterilizing systems. Biofilms can occur on any as surgical instruments, devices, and body surface, on teeth (as dental plaque), medical equipment, medical tubing, contact equipment. (Pa Pat Saf Advis 2017 Jun; lenses and elsewhere.”2 It is important to note that biofilms can be visible to the naked 14(2): 71-75.) eye in an aquatic or industrial environment, for example when pipes are fouled, but biofilms can also be microscopic and can develop on the surfaces of medical devices and equipment very rapidly (within minutes).3 Vol. 14, No. 2—June 2017 Pennsylvania Patient Safety Advisory Page 71 ©2017 Pennsylvania Patient Safety Authority FOCUS ON INFECTION PREVENTION Figure 1. The Hibbs Chisel verses the Pratt Hemostat PA-PSRS data, in the event that increased volume reporting affected prevalence trends. The PHC4 acute care procedural denominator data report was produced using operating room revenue codes within a claim record to capture and The Hibbs Chisel has no areas that count the number of operating room are difficult to clean and sterilize. revenue codes per claim record thereby arriving at the denominator of inpatient claim records. PA-PSRS event reports include a free-text narrative section for reporters to augment the event report. Analysts also compared reports and narra- tives to discern any recurrent themes. Authority analysts interviewed six indi- vidual operating room clinicians from four hospitals in different regions in Pennsylvania. The interviewees were In contrast, areas on the Pratt Hemostat can be informed that the Authority had received difficult to clean and sterilize, especially if reports of surgical instruments with processed without using a stringer. bioburden and or debris present after MS17350 reprocessing that were for use in operat- ing rooms. Interviewees were asked to describe rationales and possible explana- Healthcare-Associated Infection METHODS tions that they believed contributed to and Endotoxin To help inform healthcare facilities about these events. Interviewees agreed to speak The published literature has examples of the prevalence of inadequate reprocessing with the Authority on a guarantee of com- healthcare-associated infections (HAIs) of surgical instruments, Authority analysts plete anonymity for themselves and their linked to instruments and equipment that queried the Pennsylvania Patient Safety institutions. Interviews were conducted have been processed appropriately but, Reporting System (PA-PSRS) database to via phone and were structured in an open because of their design, have proved to be identify acute-care event reports associated format without specific questions posed difficult to clean and disinfect or steril- with bioburden on surgical instruments by the analyst. ize despite following the manufacturer’s reported from January 1, 2005, through cleaning instructions.4 Furthermore, December 31, 2015. The end of 2015 was RESULTS there is evidence of infection transmis- the last complete data set at the time of sion when cleaning and sterilization the query for all data sets. Analysts then Quantitative Results procedures have not been adhered to, compared the resultant trend identified Figure 2 shows a general increase in the or where quality control has been poor.5 within PA-PSRS data with Pennsylvania number of bioburden related events Several researchers have also noted the Health Care Cost Containment Council reported through PA-PSRS during the risk of endotoxin presence on surgical (PHC4)* acute care procedural denomi- years 2005–2015. Figure 3 shows the rate instruments, which may contribute to nator data within the same time frame of reported events per 1,000 inpatient orthopedic prostheses loosening.6,7 The to account for potential artifact within claim records per year. Figure 3 mimics risk of complications and frequency of the trend identified in Figure 2 and dem- these types of events is difficult to deter- * The Pennsylvania Health Care Cost Contain- onstrates a general increase in bioburden mine; peer-reviewed literature addressing ment Council (PHC4) is an independent state prevalence per year, accounting for the the topic is lacking. Many adverse out- agency responsible for addressing the problem number of patients. Figure 4 displays the of escalating health costs, ensuring the quality rate of bioburden reports per 1,000 inpa- comes related to the use of poor quality of health care, and increasing access to health instruments are likely to go unrecognized, care for all citizens. While PHC4 has provided tient claim records by event type per year. especially if the result of an event is latent data for this study, PHC4 specifically disclaims Figure 4 further validates the initial trend in a patient’s course. responsibility for any analyses, interpretations, of an increased bioburden prevalence over or conclusions. time isolated within PA-PSRS data. Page 72 Pennsylvania Patient Safety Advisory Vol. 14, No. 2—June 2017 ©2017 Pennsylvania Patient Safety Authority Figure 2. Number of Bioburden Reports by Event Type Qualitative Examples NUMBER OF REPORTS The following narratives from events reported through PA-PSRS are examples 300 of the adverse impact ineffective cleaning Event type J. Other/Miscellaneous and sterilization procedures can have in a F. Complication of Procedure/Treatment/Test 20 clinical setting:* 250 E. Error related to Procedure/Treatment/Test 18 13 Loaner instruments ran through C. Equipment/Supplies/Devices 20 16 washer decontaminator then wrapped 21 and run through sterilizer. While 200 81 setting up, staff noticed dried blood 71 on the set. 13 89 150 17 11 While pushing bone graft into the 12 3 6 12 instrument, a large piece of dried 11 tissue from a previous case came out 65 5 7 onto the field, contaminating the 100 2 7 79 62 40 5 patient’s bone graft and set-up. 151 8 6 4 49 Debris from a prior procedure 59 137 106 50 36 dislodged from the endoscope and 82 44 76 floated into the ventricle, unable to 56 65 42 35 32 retrieve. Ventricle flushed and patient 15 placed on antibiotics. 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Laminectomy with local bone YEAR MS17351 graft. Staff noted that a sterilized Note: Data submitted to the Pennsylvania Patient Safety Authority, 2005–2015. instrument pan containing spinal instruments was found to be contami- nated with old bone and tissue from a Figure 3. Rate of Bioburden per 1,000 Inpatient Claim Records previous case. The case was delayed. RATE PER 1,000 INPATIENT CLAIM RECORDS Fragments of bone cement were observed in the patient’s knee, and 0.488 0.5 the surgeon had not used cement. The 0.434 0.443 scrub nurse noticed the instrument impactor in the set had cement from 0.4 a previous case on it. Wound class was changed from 1 to 2. 0.306 0.3 Interview Results 0.262 0.249 0.241 The following problematic, common themes emerged during interviews with 0.2 0.167 0.179 six individuals involved in surgical instru- 0.140 ment reprocessing and use: 0.122 —— Reprocessing staffing patterns not 0.1 aligned with increases in surgical case loads 0.0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 * The details of the PA-PSRS event narratives in this article have been modified to preserve YEAR MS17352 confidentiality. Note: Data submitted to the Pennsylvania Patient Safety Authority, 2005–2015. Vol. 14, No. 2—June 2017 Pennsylvania Patient Safety Advisory Page 73 ©2017 Pennsylvania Patient Safety Authority FOCUS ON INFECTION PREVENTION Figure 4. Rate of Bioburden per 1,000 Inpatient Claim Records, by Event Type applicable, are operating room revenue codes. The report was RATE PER 1,000 INPATIENT CLAIM RECORDS produced using operating room revenue codes within a claim 0.5 Event type .037 record to capture and count J. Other/Miscellaneous the number of operating room .024 F. Complication of Procedure/Treatment/Test .032 .038 revenue codes per claim record. 0.4 E. Error related to Procedure/Treatment/Test One inpatient claim record may C. Equipment/Supplies/Devices .029 .039 have one or more operating room revenue code associated with one .127 .149 or more procedures performed 0.3 .023 on the same day. For example, .020 .167 a hospitalized patient who had .029 .021 6-procedures during the same day .005 .021 .010 .019 may have two operating room 0.2 .116 revenue codes reported/counted .009 .012 .003 .009 .012 .134 .106 .069 (one for general operating room .246 .014 .278 service and another for minor .010 .007 .084 operating room surgery).” 0.1 .061 .101 .199 .147 The analysts note the limitations of the .075 .132 PHC4 data collection method by using .055 .095 .111 .072 .060 .026 claim records and revenue codes. Thus, 0.0 the bioburden rates per surgical procedure 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 shown in Figure 4 might be lower than YEAR MS17353 typical instrument bioburden prevalence per procedure in a clinical setting. Note: Data submitted to the Pennsylvania Patient Safety Authority, 2005–2015. The Authority acknowledges that the —— Unrealistic expectations related to —— Poor workflow design in the repro- interview data is of a limited nature and reprocessing production pressure cessing department likely does not represent all conditions (demands for quicker turnaround of across Pennsylvania. —— Inconsistent auditing of process mea- instruments) sures and quality indicators —— Subpar levels of surgical instru- DISCUSSION When considering the quantitative and ment stock qualitative data, the explanations provided High-quality reprocessing of surgical —— Re-processors’ unfamiliarity with by the interviewees seem to deserve inves- instruments and equipment is a mission manufacturer’s instructions for use tigation for quality improvement because critical task. Although the interview evi- and care of instruments the prevalence of events shows an upward dence is limited, it must be considered —— Operating room staff not con- trend over time. All interviewees stated that all interviewees noted some amount sistently wiping, precleaning, or that their individual hospitals were aware of separation and discordance between soaking instruments prior to sending of and actively addressing the issue of the operating room and reprocessing for reprocessing surgical-instrument reprocessing quality. departments. The operating room and its patients depend on the reprocessing —— Used surgical instrument trays sitting LIMITATIONS department; operating room services for prolonged periods of time before cannot exist without an adequate flow of being sent for reprocessing Limitations of PHC4 data on the pro- quality surgical instruments and equip- —— The operating room and repro- cedural denominator data report as per ment. Efforts can be considered to unify cessing departments treated as PHC4:8 departments and processes around the separate teams—a lack of cohesive- “PHC4 data captures procedures care and maintenance of mission criti- ness between departments that are performed per patient cal items, such as surgical instruments, —— Lack of standardized training and claim record. Also included devices, and equipment. education on the claim record, when Page 74 Pennsylvania Patient Safety Advisory Vol. 14, No. 2—June 2017 ©2017 Pennsylvania Patient Safety Authority As demonstrated by the examples of the the literature of infection transmission equipment into the work place. The Hibbs chisel and Pratt hemostat, surgical occurring after a device was processed tool is available with an accompanying equipment comes in all shapes and sizes, according to the manufacturer’s instruc- Pennsylvania Patient Safety Advisory article with varying levels of complexity. Based tions, essentially due to device design at http://patientsafety.pa.gov/pst/Pages/ on the design and complexity level, some that made adequate reprocessing dif- PSAPatientSafetyTopicList.aspx. instruments may be inherently easier to ficult.4 When purchasing equipment and The data presented in this article scrapes clean and subsequently disinfect or sterilize instruments, the design and the entire the surface on a multitude of factors appropriately. Reprocessing and operat- use, reprocessing, and reuse cycle should that affect the critical task of reprocess- ing room staff need to have access to each be considered. An optimal approach ing surgical instruments and equipment. instrument’s instructions for use that would bring all users of an instrument Quantitative, qualitative, and expert include particular methods for cleaning, to the table during the evaluation for interview data have been compiled to care, disinfection, sterilization, and mainte- purchase, to gather input on the features provide insight into the complexity of nance. As noted in the results, there have and design of the device. If reprocess- a process that affects patient outcomes, been many reports of debris lodged on and ing staff point out that the design of a patient satisfaction, staff satisfaction, inside instruments, especially those with device is problematic from a cleaning workflow, finance, and other variables. gaps, lumens, and channels. Once debris perspective, it may warrant evaluating The data and concepts presented herein dries inside or on an instrument surface, equipment of a different design that can are intended to give facilities a starting the instrument becomes increasingly dif- perform the same task. If there are no point for self-assessment of the reprocess- ficult to clean; thus when cleaning starts other alternatives, instructions about how ing continuum, inclusive of all users and at the point of use (in the operating room), to process the device need to be explored. departments that interact with surgical removing debris at the point of reprocess- For example, ultrasonic washers may be instruments and equipment, to find ing becomes more effective.9 needed, or a facility may need to purchase quality-improvement opportunities. Equipment design plays a vital role in more washers, adding time and cost to determining how easily an effective, the process for a given piece of instru- ACKNOWLEDGMENTS high-quality reprocessing method can mentation. The Authority has a sample Edward Finley, BS, data analyst, Pennsylvania be accomplished. There are examples in tool available, providing equipment-pur- Patient Safety Authority, and PHC4 analytic staff chasing guidance in terms of integrating contributed to data acquisition for this article. NOTES 1. Bioburden. [internet]. Farlex Partner 4. Centers for Disease Control and 7. Landgraeber S, von Knoch M, Löer F, Medical Dictionary; 2012 [accessed Prevention (CDC). Notes from the Brankamp J, Tsokos M, Grabellus F, 2017 Jan 09]. [1 p]. Available: http:// Field: New Delhi metallo-ß-lactamase- Schmid KW, Totsch M. Association medical-dictionary.thefreedictionary.com/ producing Escherichia coli associated with between apoptotis and CD4(+)/CD8(+) bioburden. endoscopic retrograde cholangiopancrea- T-lymphocyte ratio in aseptic loosening 2. The American Heritage® Medical Dic- tography - Illinois, 2013. MMWR Morb. after total hip replacement. Int J Biol Sci. tionary [internet]. Houghton Mifflin Mortal. Wkly. Rep.. 2014 Jan 03;62(51- 2009;5(2):182-91. PMID: 19214244 Company; 2007, 2004. [accessed 2017 52):1051. PMID: 24381080 8. Nelson JZ. (Supervisor, Special Requests, Jan 10]. Biofilm. [1 p]. Available: http:// 5. Dancer SJ, Stewart M, Coulombe C, Pennsylvania Health Care Cost Contain- medical-dictionary.thefreedictionary.com/ Gregori A, Virdi M. Surgical site infec- ment Council (PHC4), Harrisburg, PA). biofilm. tions linked to contaminated surgical Personal communication. 2016 Oct 7. 4 p. 3. Koseki H, Yonekura A, Shida T, Yoda instruments. J Hosp Infect. 2012 9. Standards of practice for the decon- I, Horiuchi H, Morinaga Y, Yanagihara Aug;81(4):231-8. Also available: http:// tamination of surgical instruments. K, Sakoda H, Osaki M, Tomita M. Early dx.doi.org/10.1016/j.jhin.2012.04.023. Littleton (CO): Association of Surgical staphylococcal biofilm formation on solid PMID: 22704634 Technologists (AST); 2009. 27 p. Also orthopaedic implant materials: in vitro 6. Goveia VR, Mendoza IY, Guimarães available: http://www.ast.org/uploaded- study. PLoS ONE. 2014;9(10):e107588. GL, Ercole FF, Couto BR, Leite EM, Files/Main_Site/Content/About_Us/ Also available: http://dx.doi.org/10.1371/ Stoianoff MA, Ferreira JA. Endotoxins Standard_Decontamination_%20Surgi- journal.pone.0107588. PMID: 25299658 in surgical instruments of hip arthro- cal_Instruments_.pdf. plasty. Rev Esc Enferm USP. 2016 May-Jun;50(3):405-10. Also available: http://dx.doi.org/10.1590/S0080- 623420160000400005. PMID: 27556710 Vol. 14, No. 2—June 2017 Pennsylvania Patient Safety Advisory Page 75 ©2017 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 14, No. 2—June 2017. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2017 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://patientsafety.pa.gov. 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