WHITE PAPERHOTLINE Blood and Fluid Warmer:Sustained Performance and SafetyABSTRACTINTRODUCTIONKeeping surgical patients normothermicis an important objective to preventthe known morbidities associated withunintended perioperative hypothermia.Blood and fluid warmers play asignificant role in preventing unintendedperioperative hypothermia. The HOTLINE blood and fluid warmer offers a safe,reliable, and proven technology to warmand deliver blood and fluids at routine,gravity flow rates to improve patientoutcomes by maintaining normothermia.With its unique triple lumen HOTLINE fluid warming set, the HOTLINE bloodand fluid warmer is the only blood andfluid warming system that eliminatespatient line cool-down and deliversconsistently warmed fluids at the pointof patient connection. Well-establishedmaintenance protocols provide clear andeasy to follow instructions on sustainedquality performance over time. Recentresults from a study that looked at thelong-term antimicrobial effectivenessof 0.3% hydrogen peroxide (H2O2) usedas a bactericidal agent within the fluidreservoir of HOTLINE blood and fluidwarmers show that the solution not onlykills microorganisms but also providesa residual effect after disinfection andcontinues to provide a barrier againstrecontamination.1, 2, 3 These resultsvalidate the disinfection and maintenanceprotocols listed in the HOTLINE Operator’s Manuals, and provideadditional evidence that the HOTLINE blood and fluid warmers are safe and canmaintain a microbial free environmentover time.Keeping surgical patients normothermicis an important objective to preventthe known morbidities associated withunintended perioperative hypothermia,which occurs when the body’s coretemperature falls below 36 C.Unintended perioperative hypothermiahas been called a frequent, preventablecomplication of surgery.4 Among the51 million inpatient5 and 34.7 millionambulatory surgeries6 occurringannually in the United States, it isestimated that 50-90% suffer fromaccidental hypothermia.7Unintended perioperative hypothermiacan be caused by a number of factors,including administration of coldintravenous blood or fluids, exposedsurgical cavities, cold operating theatertemperatures, and administration ofanesthesia. As patient temperaturedeclines, peripheral vessels vasoconstrictto keep warm blood near the core,protecting the vital organs. The inductionof anesthesia causes the smooth musclein veins and arteries to vasodilate andallows the warm blood to flow from thecore out to the cold periphery, and sendscold blood from the periphery back to thecore. This produces a rapid drop in patientcore temperature of 1.0-1.5 C in thefirst hour.4, 8, 9Research has shown that even mildhypothermia can have significanteffects on patient outcomes. Adverseconsequences of unintended perioperativehypothermia include surgical siteinfections, myocardial ischemia,prolongation of drug effects, bleedingdiatheses, and increased morbidity,mortality, and expense.9Based on the adverse outcomes of evenmild perioperative hypothermia, a trendis emerging globally to adopt nationalquality initiatives related to improvingpatient care through temperaturemanagement. In the United States, theDepartment of Health & Human Serviceshas identified reduction of surgical siteinfections and surgical complicationsas a top national priority.10 Specificinitiatives in the US include the SurgicalCare Improvement Project (SCIP), aproject sponsored by the Centers forMedicare and Medicaid Services (CMS) incollaboration with other partners, aimedat improving surgical care by significantlyreducing surgical complications. One ofthe evidence-based elements of SCIP isperioperative temperature management,which is considered a process measuredesigned to improve normothermiafor all patients undergoing surgicalprocedures under general or neuraxialanesthesia lasting 60 minutes or greaterin duration.11 Similar to SCIP, the UKNational Institute for Health and ClinicalExcellence (NICE) has instituted guidanceadvocating for the management ofinadvertent perioperative hypothermia.12
Blood and fluid warmers playa significant role in preventingunintended perioperative hypothermia.Administration of cold or inadequatelywarmed intravenous fluids contributesto hypothermia, whereas administrationof normothermic fluids may reduceboth the incidence and complications ofhypothermia.13 For optimal performance,blood and fluid warmers need to meetsafety standards similar to those requiredfor other medical equipment as well asundergo regular maintenance to sustainhigh quality performance over time. Inthe past several years, the importance ofsafety and high maintenance standardshas received attention due to concernsabout the potential for these systems toact as reservoirs for microbial pathogens.HOTLINE Blood & Fluid Warmers deliverfluids above normothermic temperatures allthe way to the patientConventional Fluid Warmer30 C30 CHOTLINE Blood and Fluid Warmer40 Cwho may not be able to tolerate a 42 Cinfusion, HOTLINE units with operatingtemperatures of 38 C and 40 C arealso available.The HOTLINE blood and fluid warmerhas demonstrated the most consistentnormothermic blood and fluid deliveryperformance across a range of fluidwarmers (figure 1).14 It achieves thisby utilizing a unique triple lumen fluidwarming set, which maintains a layer of42 C recirculating solution around thesterile fluid pathway, keeping blood andfluids warm all the way to the patient.Figure 1Part I of this article summarizes thewell-established data on the performanceand safety of the HOTLINE blood andfluid warmer that distinguishes it fromother blood and fluid warmer systems.Part II focuses on device maintenance,with particular attention to addressingthe more recent concerns raised overfluid reservoirs as a potential sourceof nosocomial pathogens. Along withdescribing the clearly written and wellestablished protocol for HOTLINE bloodand fluid warmer maintenance, thisarticle provides new data from a studyundertaken to examine the validity of themaintenance protocol. The aim of thisarticle is to provide healthcare providersobjective evidence supporting the safe,effective, and sustained use of theHOTLINE blood and fluid warmer.PART IEssential to the performance of theHOTLINE blood and fluid warmer isthe unique design of the system that iscomprised of a warmer with a pump tocirculate warmth-transferring fluid and adisposable fluid warming set with unique,triple lumen construction. The triplelumen construction allows blood or fluidto travel through the sterile center lumenof the HOTLINE fluid warming set to thepatient as heated circulating fluid flowsthrough the two outer lumens, whichenvelops the center lumen in warmth.PERFORMANCE OF HOTLINE BLOODAND FLUID WARMER: MAINTAININGNORMOTHERMIAAmbient Temperature: 20 CFluid Input Temperature: 20 CFor the past two decades, SmithsMedical Level 1 HOTLINE blood andfluid warmer has played an integralpart in the prevention of perioperativehypothermia in over 30 million surgeries.With its unique technology, the HOTLINE blood and fluid warmer outperformsother conventional blood and fluidwarmer systems in its ability to provideconsistent normothermic performanceacross a range of routine flow rates.14The HOTLINE blood and fluid warmersystem also has a strong establishedsafety record, in addition to a well-definedand clear protocol for maintenance tosustain high quality performance andantimicrobial effectiveness.14, 15The most important factor when choosinga blood and fluid warmer is performance.More specifically, it is imperative that ablood and fluid warmer is able to deliverfluids at normothermic routine flow ratesgiven the majority of routine surgicalprocedures use flow rates 2 L/hr.16The HOTLINE blood and fluid warmeris designed for use with the HOTLINE fluid warming set. The integrated designof the HOTLINE blood and fluid warmerand HOTLINE fluid warming set allowsintravenous blood and fluids to bedelivered to the patient at normothermicgravity flow rates from KVO – 5 L/hr.The HOTLINE blood and fluid warmeremploys a safe, recirculating solutionheating system that is inherently free of“hot spots”. The operating temperaturefor the standard HOTLINE blood andfluid warmer is 42 C. For patientsAs previously described, the HOTLINE warmer maintains the circulating fluidtemperature at 42 C to deliver blood orfluids to the patient at a temperature ableto maintain normothermia. Because theouter and central lumens are separate,circulating fluid never comes in contactwith blood or fluid, and therefore presentsno risk of cross-contamination and is anessential safety feature to the HOTLINE blood and fluid warmer.
ESTABLISHED SAFETY: HOTLINEBLOOD AND FLUID WARMER Safety standards for medical equipmentare rigorous and essential for theprotection of clinicians and patients. TheHOTLINE blood and fluid warmer hasgone through extensive testing to meetclinical expectations for performanceas well as being a safe tool withinthe perioperative environment. TheHOTLINE blood and fluid warmer meetsall electrical safety and biocompatibilitystandards, complying with IEC 606011:2005. Furthermore the HOTLINE bloodand fluid warmer has been tested by TÜVSÜD America Inc., a nationally recognizedtechnical laboratory, to meetrequirements for product safety.BUILT-IN SAFETY FEATURESAlarmsDesigned with both audio and visualalarms, the HOTLINE blood and fluidwarmer actively alerts the user if thefollowing scenarios occur: reservoirtemperature exceeds 43.1 C, reservoirvolume is below the minimum level, orHOTLINE fluid warming set is missing orimproperly installed. These alarm modesare indicated via the following mediums: The green Operating LED on the displaypanel turns off The red Check Disposables LED on thedisplay panel illuminates The audible alarm sounds and repeatsapproximately every two seconds The recirculating solution stopscirculatingAir ProtectionSmiths Medical offers the L-10 HOTLINE gas vent, which is intended to ventoutgassed micro bubbles from HOTLINE L-series fluid warming sets. The L-10HOTLINE gas vent is connected directlyto the distal end of the HOTLINE L-series fluid warming sets via standardLuer fitting.MANUFACTURINGHOTLINE fluid warming sets areindividually packaged single-usedisposables that contain a sterilefluid path and are 100% tested onthe manufacturing floor – both theintravenous lumen and recirculatingsolution lumens. The closed loopHOTLINE fluid warming sets arepressure tested to 300 mm/Hg to confirman uncompromised fluid pathway.Figure 2Thermal Hemolysis Prevention Limit51.55150.5Temperature ( C)Unlike the HOTLINE blood and fluidwarmer, conventional fluid warmingsystems suffer from cool-down betweenthe warmer and the patient connection,particularly at lower routine flow rates.In these systems, active warming ceasesafter blood or fluid has passed throughthe conventional warmer heater, whichallows fluid to cool in the intravenous linebefore being delivered to the patient.50heart-lung bypass machines,mechanical ventilators, and patientmonitors are a few examples of hospitalproducts that require regular (monthly,semi-annual, annual) preventativemaintenance to improve equipmentlife and avoid unplanned maintenanceexpenses. Preventative maintenanceis required for all serviceable medicaldevices for sustainable 2530354045Time (Minutes)INDUSTRY GUIDELINESHOTLINE blood and fluid warmers aredesigned to stay well below the limitfor heat-caused hemolysis – that is, thealteration, dissolution, or destructionof red blood cells. Per the standard,blood would have to be exposed to atemperature of 46 C for 60 minutes toalter the properties of the cells. Fluid inthe HOTLINE fluid warming set is neverexposed to dangerous temperatureswhile the HOTLINE blood and fluidwarmer is operating. Figure 2, takenfrom the Standard Specification forBlood/Intravenous Fluid/Irrigation FluidWarmers (ASTM Standard F2172-02)supports this claim.17Further evidence that the HOTLINE blood and fluid warming system is aclinically safe tool for the perioperativeenvironment can be gleaned from areview Smiths Medical undertook ofsafety complaints between 1 January2009 and 31 March 2013. A comparisonof the total number of complaints inthe last four years versus the salesof disposables (representing thepotential number of uses) over thesame time period resulted in a yieldrate of 0.01%, demonstrating minimaldissatisfaction.14 This provides furtherevidence that the HOTLINE blood andfluid warming system is a clinically safetool for the perioperative environment.Furthermore, this supports the notionthat the vast majority of HOTLINE bloodand fluid warming system users followrecommended maintenance protocolsenabling long-term device performanceand functionality.PART IIMAINTENANCE: HOTLINE BLOODAND FLUID WARMERIn general, equipment maintenancein healthcare settings is a necessaryand critical step to sustained productperformance and effective patienttreatment. Anesthesia gas machines,Blood and fluid warmers also requireregular preventive maintenance. To meetthis requirement, the HOTLINE bloodand fluid warmer includes a clear anddetailed maintenance protocol in itsOperator’s Manual that provides guidanceon how to sustain product performance.15The protocol recommends disinfecting thereservoir and changing the recirculatingsolution every 30 days or every 12 monthsbased on the recirculating solutionused for the HOTLINE warmer. Table1 summarizes the disinfection andmaintenance protocols stated in theHOTLINE Operator’s Manual.Table 1. Maintenance of HOTLINE Blood and Fluid .3% HydrogenPeroxideSolutionMix 140 ml of3% hydrogenperoxide with1,260 ml ofdistilled waterReplacesolution anddisinfectreservoir every12 monthsDistilled WaterUse distilledwaterReplacesolution anddisinfectreservoir every30 days35% IsopropylAlcoholSolutionMix 700 ml of70% isopropylalcohol with700 ml ofdistilled waterReplacesolution anddisinfectreservoir every30 daysAdherence to this protocol hasdemonstrated the sustained qualityperformance of the HOTLINE blood andfluid warmer.1, 2, 3 Over the past severalyears, however, concerns have beenraised regarding the potential for bloodand fluid warming systems to act asreservoirs for nosocomial pathogens.Water-based systems in particular havebeen targeted. However, the evidenceused to support the argument that waterbased systems may act as reservoirsfor pathogens comes largely from anarticle by Rutala and Weber that lookedat this potential problem in water bathssuch as sinks, ice and ice machines, anddialysis water.18 The article did not look atrecirculating baths for heating purposesnor did it examine the HOTLINE bloodand fluid warmer or any other blood andfluid warmers in particular. Of the waterbased devices evaluated within the contextof the article, most were not accompaniedby manufacturer maintenance protocolsleading the authors to suggest that
“it would be prudent to develop policiesfor the routine cleaning, disinfection, andchanging of water in water baths usedto thaw or warm blood products.” Thissuggestion is in line with what has alreadybeen established by the maintenanceprotocol in place for the HOTLINE blood and fluid warmer system asdescribed previously.What this concern over pathogens doeshighlight is the critical importance ofimplementing maintenance protocols thatare developed and followed for sustainedsystem performance. Although waterbased systems may seem at higher risk ofacting as a reservoir for these pathogens,evidence shows that even dry heat fluidwarmers and their disposable sets arenot inherently free of gram-positive orgram-negative bacterium and have beenlinked to Staphylococcus epidermidis,Serratia marcescens, and Staphylococcuswarneri.19 Of critical importance forany type of system is not its warmingtechnology (e.g., water bath, dry heat) butthat the system is accompanied by a clear,specific protocol for routine cleaningand disinfection to sustain ongoing highquality and safe performance.The HOTLINE blood and fluid warmermeet this standard requirement. TheOperator’s Manual provides a detailedmaintenance section for ongoing qualityand safe performance. In light of theongoing debate and concern over thepotential for nosocomial pathogens,the HOTLINE blood and fluid warmer.Distilled water and 35% Isopropyl alcoholare also well-established circulatingsolutions based on over two decades ofuse but are not detailed in this article.VALIDATION OF MAINTENANCEPROTOCOL: ANTIMICROBIALEFFECTIVENESS STUDYSmiths Medical conducted a yearlong study to determine the long-termantimicrobial effectiveness of 0.3% H2O2solution used as a bactericidal agent withinthe fluid reservoir of HOTLINE bloodand fluid warmers.2, 3 Hydrogen peroxideis well known for its high oxidative andbiocidal efficiency. In addition, unlike otherchemical substances, hydrogen peroxidedoes not produce toxic residues or gasses.REGULATORY REQUIREMENTSThe study satisfies regulatoryrecommended requirements by the Foodand Drug Administration (FDA) to developantimicrobial maintenance instructionsthat are clear and easy to follow, aswell as to test the methods under worstcase scenarios to demonstrate that theinstructions, if properly followed, willprovide safe, sustained, contaminationfree, long-term use and reuse. Althoughno national or international regulatoryrequirements exist specific to theapplication of antimicrobial maintenancein a medical device fluid reservoirenvironment, the FDA released on May 2,2011 a comprehensive draft guidance fora similar application entitled Processing/Reprocessing Medical Devices in HealthCare Settings: Validation Methods andLabeling which states that adequatereprocessing and handling of reusablemedical devices is vital to protectingpatient safety.20 When final, this documentwill supersede the previous FDA documentreleased in 1996 Labeling ReusableMedical Devices for Reprocessing in HealthCare Facilities: FDA Reviewer Guidance.21ANTIMICROBIAL EFFECTIVENESS STUDYhowever, Smiths undertook an in-depthmicrobiological study to validate themaintenance protocols set forth inthe HOTLINE blood and fluid warmerOperator’s Manual. The scope of themicrobiology study includes data specificto 0.3% hydrogen peroxide (H2O2) as itrepresents a worst case scenario froma planned maintenance perspective(annual v. 30 days). Furthermore, thesuggested annual maintenance for0.3% H2O2 is the most recent protocoladded to the HOTLINE Operator’sManual maintenance instructions and,as such, yields the most current data tosupport the sustained effective use ofThe purpose of this study was toevaluate the long-term antimicrobialeffectiveness of 0.3% H2O2 used asa bactericidal agent within the fluidreservoir of HOTLINE blood and fluidwarmers. A protocol to test this solutionwas developed at Ethide Laboratoriesin Coventry, RI. Ethide Laboratories isa well-established, ISO 13485 certifiedlaboratory that has provided customizedmicrobiology services to the medicaldevice industry for over 50 years. A testingprotocol was derived from targetedinvestigation in which the researchersstudied possible contamination risks.The final protocol provided a study seriesto test H2O2 antimicrobial effectivenessagainst contamination challenges ofthree specific bacteria: Eschericia coli,Pseudomonas aeruginosa, and Bacillussubtilis. The three bacteria were chosenfor their ability to thrive in low-nutrientwater-borne environments. E. coli and P.aeruginosa are common environmentalbacteria with tolerance of a wide varietyof physical conditions, including pH andtemperature. B. subtilis, a common sporeformer, is especially resistant to adverseenvironmental factors.MethodsTo evaluate the antimicrobial effectivenessof 0.3% H2O2 over an extended period oftime, the study followed the maintenanceprotocols established in the HOTLINE Operator’s Manuals on when and howto disinfect the reservoir and changethe recirculating solution. This includesthe instructions on “topping off” thereservoir with the same solution asnecessary. To simulate extended, normaluse, HOTLINE blood and fluid warmerswere filled with 1400mL of 0.3% H2O2 andallowed to run 8 hours per day, 5 days perweek, for up to 12 months. Once daily,the fluid warming set was replaced oneach unit with the fluid reservoir “toppedoff” with the same 0.3% H2O2 solutionwhen the solution level approached the“minimum” operating level.At predetermined time periods (0, 30, and60 days followed by 3, 6, 9, and 11 months)the 0.3% H2O2 fluid reservoirs werechallenged by introducing high colonyforming unit ( 1 x 104 CFU) populationsof each Bacillus subtilis, Eschericia coli,and Pseudomonas aeruginosa. Immediatelyafter CFUs were introduced, followedby hourly, then daily, and finally weeklyintervals for up to one month, the 0.3%H2O2 fluid reservoir solutions weresampled and the sample solutions weretested for viable populations of thetest organisms.Actual test methods used in thestudy followed the 2002 best practiceguidance of US. Pharmacopeia 25, 2002Antimicrobial Effectiveness Testing.22ResultsResults of the disinfection rate of 0.3%H2O2 are available in the figures shownhere. Results are shown for disinfectioncapability immediately (0 months) and 12months after inoculation. The test unitswere initially filled with 0.3% H2O2 andrefilled (“topped off”) per Smiths Medicalrecommended instructions for a periodup to 12 months with additional 0.3%H2O2 solution. The figures clearly indicatethe 0.3% H2O2 solution provides fast andsustaining antimicrobial activity for theHOTLINE blood and fluid warmer.
CHALLENGE RESULTS –ESCHERICIA COLICHALLENGE RESULTS –PSEUDOMONAS AERUGINOSACHALLENGE RESULTS –BACILLUS SUBTILIS Consistent evidence of disinfectionactivity beginning within minutes (figure3 – Bacteria Kill Rate Immediately PostInitial Fill of 1400ml 0.3% H2O2). Consistent evidence of disinfectionactivity beginning within seconds tominutes (figure 5 – Bacteria Kill RateImmediately Post Initial Fill of 1400ml0.3% H2O2). Consistent evidence of sporedisinfection activity beginning within4 hours (figure 7 – Bacteria Kill RateImmediately Post Initial Fill of 1400ml0.3% H2O2). Consistent 100% disinfection capabilityagainst P. aeruginosa within 4 hoursof challenge inoculation (figure 5 –Bacteria Kill Rate Immediately PostInitial Fill of 1400ml 0.3% H2O2). Consistent 100% disinfection capabilityagainst B. subtilis within 24 hoursof challenge inoculation (figure 7 –Bacteria Kill Rate Immediately PostInitial Fill of 1400ml 0.3% H2O2). Consistent repeatability of 100%disinfection capability for up to 12months of sustained use (figure 6 –Bacteria Kill Rate 12 months PostInitial Fill of 1400ml 0.3% H2O2). Consistent repeatability of 100%disinfection capability for up to 12months of sustained use (figure 8 –Bacteria Kill Rate 12 months PostInitial Fill of 1400ml 0.3% H2O2). Consistent 100% disinfection capabilityagainst E. coli within 4 hours ofchallenge inoculation (figure 3 –Bacteria Kill Rate Immediately PostInitial Fill of 1400ml 0.3% H2O2). Consistent repeatability of 100%disinfection capability for up to 12months of sustained use (figure 4 –Bacteria Kill Rate 12 months Post InitialFill of 1400ml 0.3% H2O2).Figure 3Figure ure 4Time Post InoculationUnlabeled Values DaysTest Unit #2 Test Unit #3Control Test Unit #1Figure 0.1O minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -1Time Post InoculationUnlabeled Values DaysControl Test Unit #1 Test Unit #2 Test Unit #3CONCLUSION – MAINTENANCEPROTOCOLS VALIDATEDThe study shows that with properattention to solution care andmaintenance, microbial contaminationmay be prevented in the HOTLINE blood and fluid warmer system. As such,the study validates the maintenanceprotocols established in the HOTLINE Operator’s Manuals. These protocolsB. subtilis CFU10001Kill Rate: Bacillus subtilisInoculation: 11 Full Months Post Initial Fill of 1400 mlControl Unit and Test Units refilled equally10000010001001010.1O minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -P. aeruginosa CFU100Time Post InoculationUnlabeled Values DaysTest Unit #2 Test Unit #3Control Test Unit #1Figure 8100001000Kill Rate: Pseudomonas aeruginosaInoculation: 11 Full Months Post Initial Fill of 1400 mlControl Unit and Test Units refilled equallyKill Rate: Eschericia coliInoculation: 11 Full Months Post Initial Fill of 1400 mlControl Unit and Test Units refilled equally10000O minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 -Time Post InoculationUnlabeled Values DaysTest Unit #2 Test Unit #3Control Test Unit #10.1Time Post InoculationUnlabeled Values DaysControl Test Unit #1 Test Unit #2 Test Unit #3provide instructions for use of the correct0.3% hydrogen peroxide (H2O2) solution,the correct initial fill volume, and therecommended refilling or ‘topping off’procedure when indicated by operationallevels (see Table 1). As confirmedby the data presented above, whenmaintained properly, the 0.3% hydrogenperoxide (H2O2) solution not only killsmicroorganisms, but provides a residualO minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -0.1O minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 -E. coli CFU10001O minute 1 minute 4 hours 12345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 -0.1100000B. subtilis CFU100000P. aeruginosa CFUE. coli CFU10000000100Kill Rate: Bacillus subtilisInoculation: Immediately Post Initial Fill of 1400 mlKill Rate: Pseudomonas aeruginosaInoculation: Immediately Post Initial Fill of 1400 mlKill Rate: Eschericia coliInoculation: Immediately Post Initial Fill of 1400 ml10000001000Figure 7Time Post InoculationUnlabeled Values DaysControl Test Unit #1 Test Unit #2 Test Unit #3effect after disinfection and continues toprovide a barrier against recontamination.The disinfection and maintenanceprotocols listed in the HOTLINE Operator’s Manuals, therefore, may beused confidently to maintain a microbialfree environment in HOTLINE blood andfluid warmers.
SUMMARYThe HOTLINE blood and fluid warmeroffers a safe, reliable and proventechnology to warm and deliverblood and fluid at gravity flow ratesto improve patient outcomes andmaintain normothermia. With itsunique triple lumen HOTLINE fluidwarming set, the HOTLINE blood andfluid warmer is the only blood andfluid warmer system that eliminatespatient line cool-down and delivers consistently warmed fluids at the pointof patient connection. Well establishedmaintenance protocols provide clearand easy to follow instructions onsustained quality performance overtime. Recent results from a study thatlooked at the long-term antimicrobialeffectiveness of 0.3% hydrogen peroxideused as a bactericidal agent within thefluid reservoir of HOTLINE blood andfluid warmers show that the solutionnot only kills microorganisms butalso provides a residual effect afterdisinfection and continues to provide abarrier against recontamination. Theseresults validate the disinfection andmaintenance protocols listed in theHOTLINE Operator’s Manuals, andprovide additional evidence that theHOTLINE blood and fluid warmers aresafe and can maintain a microbial freeenvironment over time.References:1. Determination of Long-Term Antimicrobial Effectiveness of Various Solutions Used in the HOTLINE Blood and Fluid Warmer Bath.Protocol #TR-02-0217. November 2002.2. Determination of Long-Term Antimicrobial Effectiveness of Solutions Used in the Level-1 HOTLINE Blood and Fluid Warmer (HL-90).Six Month Protocol #TR-03-0206. June 2003.3. 0.3% Hydrogen Peroxide Solution 12 Month Report For Use in the HOTLINE Heater Bath. Protocol # TR-04-0001. December 2003.4. Kurz A. Thermal care in the perioperative period. Best Practice & Research Clinical Anaesthesiology. Vol. 22, No. 1; pp. 39-62, 2008.5. Center for Disease Control and Prevention. FastStats. Inpatient Surgery (Data are for the U.S.). Accessed May 10, 2013.Available at http://www.cdc.gov/nchs/fastats/insurg.htm.6. Center for Disease Control and Prevention. U.S. Outpatient Surgeries on the Rise. Accessed May 10, 2013.Available at .7. Young V, Watson M. Prevention of Perioperative Hypothermia in Plastic Surgery. Aesthetic Surgery Journal 2006; 551-571.8. Matsukawa T, Sessler DI, Sessler AM, et al. Heat Flow and Distribution During Induction of General Anesthesia.Anesthesiology 1995; 82: 662–673.9. Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended Perioperative Hypothermia. The Ochner Journal. 2011; 11:259-270.10. Institute for Healthcare Improvement. 2013. Surgical Site Infection. Available at 11. Michel AE. Surgical Care Improvement Project (SCIP). Mosby’s Nursing Consult 2012.Available at s/full-text?article id 239117.12. National Collaborating Centre for Nursing and Supportive Care (NCCNSC). The Management of Inadvertent Perioperative Hypothermia in Adults.National Institute for Health and Clinical Excellence (NICE). 2008. Available at pdf.13. Smith C, Wagner K. Principles of Fluid and Blood Warming in Trauma. International TraumaCare 2008; 18: 71 – 79.14. Smiths Medical. Data on File.15. Smiths Medical Level 1 HOTLINE Blood and Fluid Warmer Operating Manual. Part Number: 4534005-GB. 2011.Available at .html16. Medical Market Research, October 2003.17. ASTM International. ASTM F2172-02 Standard Specification for Blood/I
The HOTLINE blood and fluid warmer system also has a strong established safety record, in addition to a well-defined and clear protocol for maintenance to sustain high quality performance and antimicrobial effectiveness.14, 15 Part I of this article summarizes the well-established data on the performance and safety of the HOTLINE blood and