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DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR DISEASE CONTROL AND PREVENTIONNational Center for Emerging and Zoonotic Infectious DiseasesDivision of Healthcare Quality PromotionHealthcare Infection Control Practices Advisory CommitteeMarch 31, 2016Atlanta, GeorgiaRecord of the Proceedings

Table of ContentsMeeting Agenda . 3List of Participants. 4Executive Summary. 6Welcome and Introductions . 7CDC Updates: Division of Healthcare Quality Promotion (DHQP) . 8FDA Device Updates: Flexible Endoscopes and Heater Coolers . 12Update on HICPAC Workgroup and Request for Guidance: Endoscope Reprocessing . 22Devices in Healthcare Settings: Design Considerations for Infection Control . 28Update on Pre-Market Notification Requirements Concerning Gowns Intended for Use in Healthcare . 31Update on HICPAC Workgroup: Antimicrobial Stewardship Principles for Treatment Guidelines: Points toConsider . 34Chlorhexidine Impregnated Dressing Recommendation Update . 37Discussion of Issues and Candidate Recommendations . 41Update on the Draft Guideline for Infection Prevention in Healthcare Personnel . 48Public Comment . 54Liaison / Ex Officio Reports . 54Summary, Work Plan, & Adjourn . 59Certification. 60Attachment #1: Acronyms Used in this Document. 61Attachment #2: Liaison and ex officio Reports . 64DRAFT HICPAC Meeting Minutes, March 31, 2016Page 2

Meeting AgendaHealthcare Infection Control Practices Advisory CommitteeMarch 31, 2016Centers for Disease Control and PreventionTom Harkin Global Communications Center (Building 19, Auditorium 3)1600 Clifton Road NE, Atlanta, GAThursday, March 31, 2016Time9:00TopicWelcome and IntroductionsPurposeInformation9:15CDC Updates: Division of HealthcareQuality Promotion (DHQP)FDA Device Updates: Flexible Endoscopesand Heater CoolersBreakUpdate on HICPAC Workgroup: EndoscopeReprocessingDevice ConsiderationsInformationPresider/PresenterDan Diekema (HICPAC Co-Chair)Deborah Yokoe (HICPAC Co-Chair)Jeff Hageman (HICPAC DFO)Denise Cardo (DHQP,CDC)InformationDiscussionSuzanne Schwartz (FDA)Catherine Wentz a Maragakis (HICPAC)InformationInformationDiscussionTerrell Cunningham (FDA)Jan Patterson (HICPAC)InformationDiscussionErin Stone (DHQP, CDC)Tom Talbot (HICPAC)InformationDiscussionDavid Kuhar (DHQP, CDC)Katy Irwin (DHQP, 005:155:306:00LunchFDA PPE Update: GownsUpdate on HICPAC Workgroup:Antimicrobial Stewardship Principles forTreatment GuidelinesChlorhexidine-Impregnated DressingRecommendation UpdateBreakUpdate on the Draft Guideline for InfectionPrevention in Healthcare PersonnelPublic CommentLiaison/ex officio reportsSummary and Work PlanAdjournDRAFT HICPAC Meeting Minutes, March 31, 2016Michael Bell (DHQP, CDC)Shannon Keckler (DHQP, CDC)Page 3

List of ParticipantsMarch 31, 2016HICPAC MembersDr. Daniel Diekema, Co-ChairDr. Deborah Yokoe, Co-ChairDr. Hilary BabcockMs. Vickie BrownMs. Loretta FauerbachDr. Michael HowellDr. W. Charles HuskinsMs. Lynn JanssenDr. Lisa MaragakisDr. Jan PattersonDr. Tom TalbotEx Officio MembersMs. Elizabeth Claverie-Williams, Food and DrugAdministrationDr. David Henderson, National Institutes ofHealthDr. Melissa Miller, Agency for HealthcareResearch and QualityDr. Gary Roselle, Veteran’s AdministrationDr. Daniel Schwartz, Centers for Medicare andMedicaid ServicesMs. Judy Trawick, Health Resources andService AdministrationLiaison RepresentativesMr. Michael McElroy (America’s EssentialHospitals (AEH))Dr. Elizabeth Wick (American College ofSurgeons (ACS))Ms. Amber Wood (Association of periOperativeRegistered Nursed (AORN))Ms. Michael Anne Preas (Association ofProfessionals of Infection Control andEpidemiology (APIC))Dr. Emily Lutterloh (Association of State andTerritorial Health Officials (ASTHO))Ms. Marion Kainer (Council of State andTerritorial Epidemiologists (CSTE))Dr. Stephen Weber (Infectious Diseases Societyof America (IDSA))Dr. Sarah Matthews (National Association ofCounty and City Health Officials (NACCHO))Ms. Laurie O’Neil (Public Health Agency ofCanada (PHAC))Dr. Craig Coopersmith (Society for Critical CareMedicine (SCCM))Dr. Mark Rupp (Society for HealthcareEpidemiology of America (SHEA))DRAFT HICPAC Meeting Minutes, March 31, 2016Dr. Vineet Chopra (Society of Hospital Medicine(SHM))Dr. Robert Sawyer (Surgical Infection Society(SIS))Ms. Margaret VanAmringe (The JointCommission)FDA RepresentativesMr. Terrell Cunningham, FDA/ CDRHDr. Catherine Gaylord, FDAMs. Julia Marders, FDA/ CDRHMs. Elaine Mayhall, FDA/ CDRHDr. Kapil Panguluri, FDA/ CDRHDr. Suzanne Schwartz, FDA/ CDRMCDC RepresentativesMs. Jessica Adam, CDC/ DHQPMs. Denise Albina, CDC/ DHQPMs. Kathy Allen-Bridson, CDC/ DHQPDr. Matt Arduino, CDC/ DHQPMs. Sonya Arundar, CDC/ DHQPDr. Michael Bell, CDC/ DHQPMs. Ruth Bellflower, CDC/ DHQPMs. Kathy Bruss, CDC/ DHQPMs. Katy Capers, CDC/ DHQPDr. Denise Cardo, CDC/DHQPDr. Matthew Crist, CDC/ DHQPDr. Bryan Christiansen, CDC/ DHQPMs. Nicoline Collins, CDC/ DHQPMs. Katelyn Coutts, CDC/ DHQPMs. Mahnaz Dasti, CDC/ DHQPDr. Chad Dowell, CDC/NIOSHDr. Ryan Fagan, CDC/ DHQPDr. Scott Fridkin, CDC/ DHQPMs. Nancy Gallagher, CDC/DHQPMs. Janet Glowicz, CDC/ DHQPDr. Carolyn Gould, CDC/ DHQPMs. Pam Greene, CDC/ DHQPDr. Nicole Gualandi, CDC/ DHQPMr. Taylor Guffey, CDC/ DHQPMs. Stephanie Gumbis, CDC/ DHQPMr. Jeff Hageman, CDC/ DHQPDr. Lauri Hicks, CDC/ DHQPDr. Kathleen Irwin, CDC/ DHQPMr. Brendan Jackson, CDC/ NCEZID/ DFWED/MDBDr. John Jernigan, CDC/ DHQPDr. Mary Shannon Keckler, CDC/ DHQPDr. David Kuhar, CDC/ DHQPDr. Jason Lake, CDC/ DHQPDr. Brandi Limbago, CDC/ DHQPDr. Meghan Lyman, CDC/ DHQPDr. Cliff MacDonald, CDC/ DHQPPage 4

Dr. Rajal Mody, CDC/ NCEZID/ DFWED/ MDBMs. Shunte Moon, CDC/ DHQPMs. Kerri Moran, CDC/ DHQPMs. Heather Moulton-Meissner, CDC/ DHQPDr. Duc Nguyen, CDC/ DHQPDr. Judith Noble-Wang, CDC/ DHQPMs. Amibola Ogundimu, CDC/ DHQPMs. Amanda Overholt, CDC/ DHQPMs. Danielle Palms, CDC/ DHQPMs. Kaeanne Parris, CDC/ DHQPDr. Priti Patel, CDC/ DHQPDr. Kiran Perkins, CDC/ DHQPDr. Joe Perz, CDC/ DHQPMs. Ruby Phelps, CDC/ DHQPDr. Daniel Pollock, CDC/ DHQPMs. Jan Ratterreee, CDC/ DHQPMs. Meredith Reagan, CDC/ DHQPMs. Cathy Rebmann, CDC/ DHQPDr. Sujan Reddy, CDC/ DHQPMs. Kristin Roberts, CDC/ DHQPMs. Georgeanne Ryan, CDC/ DHQPDr. Melissa Schaefer, CDC/ DHQPDr. Issac See, CDC/ DHQPDr. Lynne Sehulster, CDC/ DHQPMs. Kathy Sieber, CDC/ DHQPDr. Arjun Srinivasan, CDC/ DHQPMs. Erin Stone, CDC/ DHQPDr. Nicola Thompson, CDC/ DHQPMs. Abbigail Tumpey, CDC/ DHQPDr. Snigdha Vallabhaneni, CDC/ NCEZID/DFWED/ MDBMs. Wendy Vance, CDC/ DHQPMs. Ellen Wan, CDC/ DHQPDr. J. Todd Weber, CDC/ DHQPDr. Carrie Whitworth, CDC/ DHQPMs. Sarah Wiley, CDC/ OIDMs. Sarah Yi, CDC/ DHQPDRAFT HICPAC Meeting Minutes, March 31, 2016Members of the PublicDr. Jim Arbogast, GojoMs. Kay Argroves, American Association ofNurse AnesthetistsMr. Nick Austerman, Bard MedicalMr. Steve Brash, HCA Hospitals, Richmond.Ms. Nicole Bryan, CSTEDr. Russ Castioni, 3MMs. Kendra Cox, Cambridge Communications,Training, & AssessmentsMs. Pamela Falk, Northside HospitalMr. Hudson Garrett, PDIMs. Maryellen Guinan, America’s EssentialHospitalsMs. Amna Handley, GA PacificMs. Lori Harmon, Society of Critical CareMedicineMs. Linda Homan, EcolabMs. Eve Humphries, Society of HealthcareEpidemiologists of AmericaDr. Jesse Jacob, Emory UniversityMr. Robert Jones, Goldshield/ Energy andEnvironmentalDr. Jason Kane, Society of Critical CareMedicineMS. Rachel Long, BDDr. Peter Nichol, Medline Industries, Inc.Ms. Renee Odehnal, EthiconMr. Pat Parks, 3MMs. Silvia Quevedo, Association ofProfessionals in Infection ControlMs. Maria Rodriguez, XenexDr. Michelle Stevens, 3MMs. Rachel Stricof, Council of State andTerritorial EpidemiologistsMs. Lisa Tomlinson, APICMs. Kathy Warye, Infection Prevention PartnersPage 5

Executive SummaryThe Division of Healthcare Quality Promotion (DHQP), National Center for Emerging andZoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), USDepartment of Health and Human Services (HHS) convened a meeting of the HealthcareInfection Control Practices Advisory Committee (HICPAC) on March 31, 2016 in Atlanta,Georgia. The Designated Federal Official (DFO) and Chair confirmed the presence of a quorumof HICPAC voting members and ex officio members.The meeting was called to order at 9:07 a.m. on March 31, 2016. Dr. Denise Cardo providedupdates from DHQP, particularly focusing on antimicrobial resistance (AMR). Dr. SuzanneSchwartz and Ms. Catherine Wentz, US Food and Drug Administration (FDA), shared updateson FDA’s ongoing efforts regarding the public health concern of Nontuberculous Mycobacterium(NTM) infections associated with heater-cooler devices and efforts pertaining to duodenoscopereprocessing and instructions. HICPAC member Dr. Lisa Maragakis led a discussion on theprogress of the HICPAC workgroup on Endoscope Reprocessing, which is drafting and revisingan Essential Elements document to provide assistance to institutions that have endoscopereprocessing programs. Drs. Michael Bell and M. Shannon Keckler presented outlines fordocuments to describe device considerations for healthcare facility purchasing departments. Mr.Terrell Cunningham, FDA, briefed HICPAC on the current status of FDA’s review and regulationof surgical/isolation gowns. HICPAC member Dr. Jan Patterson presented the progress of theHICPAC Antibiotic Stewardship Workgroup on antibiotic guidelines. Ms. Erin Stone and Dr. TomTalbot, HICPAC member, presented updated data and an updated draft recommendationregarding Chlorhexidine Gluconate-Impregnated (CGI) Dressings for Intravascular Catheter ExitSites. Drs. David Kuhar and Kathleen Irwin described progress on an update to the 1998Guideline for Infection Control in Healthcare Personnel. There was a public comment period.HICPAC ex officio members and liaison representatives provided written and verbal updates.HICPAC stood in recess at 5:23 p.m. on March 31, 2016. The next HICPAC meeting will be heldon July 14-15, 2016, in Atlanta, Georgia.DRAFT HICPAC Meeting Minutes, March 31, 2016Page 6

DEPARTMENT OF HEALTH AND HUMAN SERVICESCENTERS FOR DISEASE CONTROL AND PREVENTIONNational Center for Emerging and Zoonotic DiseasesDivision of Healthcare Quality PromotionHealthcare Infection Control Practices Advisory Committee (HICPAC)March 31, 2016Atlanta, GeorgiaDRAFT Minutes of the MeetingThe Division of Healthcare Quality Promotion (DHQP), National Center for Emerging andZoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), USDepartment of Health and Human Services (HHS) convened a meeting of the HealthcareInfection Control Practices Advisory Committee (HICPAC) on March 31, 2016, at the TomHarkin Global Communications Center at the Centers for Disease Control and Prevention, 1600Clifton Road NE, Atlanta, Georgia.Thursday, March 31, 2016Welcome and IntroductionsJeff HagemanDivision of Healthcare Quality and PromotionNational Center for Emerging and Zoonotic Infectious DiseasesCenters for Disease Control and PreventionDesignated Federal Official, Healthcare Infection Control Practices Advisory CommitteeMr. Jeff Hageman called the meeting to order at 9:07 a.m. He welcomed HICPAC members, exofficio members, and liaison representatives. He noted the following changes to HICPACmembership: Dr. Michael Howell, the former HICPAC liaison representative from the Society of CriticalCare Medicine (SCCM), has rotated onto HICPAC as a member.Ms. Loretta Fauerbach is a new HICPAC member.Dr. Deborah Yokoe is serving as co-chair of HICPAC with Dr. Daniel Diekema.Mr. Hageman conducted a roll call. A quorum was present. HICPAC members disclosedthe following conflicts of interest:o Dr. Diekema has received research funding from bioMérieux.o Dr. Jan Patterson’s spouse conducted research in fungal disease and has servedas a consultant to, or conducted research with, Merck, Astellas Pharma, andToyama Chemical Company.o Dr. W. Charles Huskins has received research support from GOJO Industriesand has served as an advisory board member for Genentech.o Dr. Thomas Talbot’s spouse is a vaccine researcher who has received fundingfrom Sanofi Pasteur, MedImmune, Gilead Sciences, and Novartis.o Dr. Lisa Maragakis receives research funding from Clorox/UltraViolet Devices,Inc. (UVDI) for studies of ultraviolet (UV) light.DRAFT HICPAC Meeting Minutes, March 31, 2016Page 7

oMs. Lynn Janssen’s spouse works for a biotech company developing vaccinesand immunologics.CDC Updates: Division of Healthcare Quality Promotion (DHQP)Denise Cardo, MDDirector, Division of Healthcare Quality PromotionNational Center for Emerging and Zoonotic Infectious DiseasesCenters for Disease Control and PreventionDr. Denise Cardo welcomed HICPAC and provided updates on CDC’s plans regardingantimicrobial resistance (AMR) and the funds allocated for CDC in the fiscal year (FY) 2016budget related to antibiotic resistance (AR). The budget initiative is an example of how evidencecan lead to policy, and then to a budget initiative with opportunities to expand programs that arealready being implemented.Vital Signs is a monthly publication with CDC’s Morbidity and Mortality Weekly Report (MMWR).Each of CDC’s “Winnable Battles” is featured in an issue of Vital Signs in a specific month.Healthcare-associated infections (HAIs), which include AMR, were featured in March. DHQPuses the Vital Signs mechanism to make a case for infection prevention and for the importanceof engaging a range of different groups in making a difference in the problem of HAIs. The first Vital Signs on HAIs focused on successes in preventing central lineassociated bloodstream infection (CLABSI) and on the lives that were saved. Theissue also called for more action to continue to work on prevention.The next issue highlighted Clostridium difficile (C. diff) infections and their relationnot only to infection control but also to antibiotic use.The topic of the third Vital Signs was emergence of carbapenem-resistantEnterobacteriaceae (CRE), an issue that was well-known to experts but may nothave been perceived by the broader healthcare community or public as an emergingthreat.After presenting a series of HAI-related problems, the next Vital Signs presented asolution: promoting stewardship programs. This publication represented the first timethat CDC clearly recommended antibiotic stewardship programs for all hospitals.DHQP worked closely with the American Hospital Association (AHA) and otherpartners to ensure that the publication was not isolated, but served to add CDC’svoice to other partners’ voices to facilitate implementation of stewardship programs.The next Vital Signs related to a coordinated approach to prevention, particularly theimportance of working not only within but also across healthcare facilities to preventthe transmission of multidrug-resistant organisms (MDROs) and C. diff.The most recent Vital Signs focused on integrating information from previous Vital Signs issues.The solutions proposed in the prior issues focused on programs and administrative strategies.This issue focused on resistant bacteria as a cause of HAIs. The publication described progressrelated to HAIs, but also noted that a large percentage of infections in healthcare are caused byresistant pathogens. The solutions require improvements in both horizontal strategies that areimportant for preventing a range of HAIs as well as vertical strategies aimed at preventingtransmission of specific AR pathogens. This Vital Signs was aimed at informing the broadhealthcare community beyond just infection control experts, , the general public, andpolicymakers.DRAFT HICPAC Meeting Minutes, March 31, 2016Page 8

Because the overall burden of AR needed to be defined, DHQP used available data to createthe “AR Threat Report.” The report clarifies that the numbers are not precise and are a lowestimate of the number of infections. The report was critical to highlight the magnitude of the ARproblem for different groups, such as policymakers, and to engage them to be part of thesolution. The solution involves not only the creation of new antibiotics. In addition, the reportpresented a framework for preventing infections, preventing the spread of infections, trackinginfections, improving antibiotic use, and developing new drugs and new diagnostics.DHQP works closely with federal partners and partner professional groups. The President’sAdvisory Committee on Antimicrobial Resistance, which included public health and healthcareexperts as well as other participants, created the National Action Plan for Combating AntibioticResistant Bacteria (CARB). The plan has five specific goals: Slow the emergence of resistant bacteria and prevent the spread of resistantinfectionsStrengthen national one-health surveillance efforts to combat resistanceAdvance development and use of rapid and innovative diagnostic tests foridentification and characterization of resistant bacteriaAccelerate research to develop new antibiotics and alternative therapeutics andvaccinesImprove international collaboration and capacities for disease prevention andsurveillance and antibiotic research and developmentCARB also has specific goals for reducing and preventing infections in the next five years.Monitoring progress toward these goals is important and helps to provide insight if certain goalsare not being met. CDC’s role in CARB is to: Detect and respond to resistant pathogensPrevent the spread of resistant infectionsEncourage innovation for new strategiesCDC developed the AR Solutions Initiative and requested 264 million to address the agency’sgoals related to AR. CDC’s appropriation in FY ’16 was 160 million which represents asignificant increase over previous years. The FY ’17 budget includes an additional 40 millionfor CDC to expand its programs further. It is important to note that the funding is not for newprograms but instead will be used to expand existing programs that are making a difference.CDC’s overall approach incorporates urgent threats such as CRE, C. diff, and Neisseriagonorrhoeae, as well as strategies for serious infections such as Methicillin-resistantStaphylococcus aureus (MRSA) and other MDROs.Regarding “detect and respond,” CDC’s approach includes laboratory as well as public healthactivities, and the response includes identification as well as containment of infections.“Prevent” focuses on a coordinated approach, and “innovate” includes new diagnostics and newways to prevent HAIs.The budget will support expansion of funding to state and local health departments. TheRecovery Act allowed for the creation of HAI programs in state Health Departments, and theywill continue to be funded through the Prevention Fund of the Patient Protection and AffordableCare Act (ACA). The support can be expanded to address AR. States will be eligible to receiveDRAFT HICPAC Meeting Minutes, March 31, 2016Page 9

funding for more expertise in analyzing data and in responding to resistance issues at the stateand local levels. State laboratories in all 50 states will be eligible to receive funding to improvecapacity to detect CRE. Further, up to 25 states will receive additional funds to focus onprevention strategies with a coordinated approach. Data from the Prevention Epicenters showthat if healthcare systems and facilities do not work together, then it is difficult to prevent HAIs.This work will take place with a network of facilities and expert groups and will be evaluated forits impact.The laboratory network will also be expanded. Up to seven regional laboratories in the PulseNetregions will be funded to build capacity to address resistant pathogens. The work varies bypathogen and includes identifying mechanisms of resistance, as well as responding to outbreakevents, implementing containment strategies, and screening patients. This support cannot beprovided by hospitals or health departments; therefore, the regional laboratories will be fundedto provide those services. The laboratories will work closely with academic centers and clinicallaboratories on specific projects that respond to trends and problems.The HAI Emerging Infections Program (EIP) also will expand to include more pathogens,including more multidrug resistant (MDR) gram-negatives. Additional settings will be included.For instance, work on MRSA work will expand to include community as well as healthcaresettings. Plans for the future will incorporate assessments of extended spectrum betalactamases (ESBLs) and urinary tract infections (UTIs) in the community and their potentialimpact on healthcare. Pilots will be conducted in these areas before adding the work to theentire EIP. Annual prevalence surveys will continue not only in acute care, but also in long-termcare. The HAI EIP will also work on sepsis. The EIP can add to understanding of risk factorsand prevention strategies.Innovation is critical for HAI prevention. Academic partners are vital to innovation. ThePrevention Epicenters and other mechanisms provide opportunities to fund academic groupsand healthcare systems to improve antibiotic use. Social networking tools will help implementcoordinated approaches to stop the spread of AR. Other initiatives include improving sepsisrecognition and early detection, particularly in partnership with SCCM and other partners.Electronic health records (EHRs) are potentially important tools to define appropriate use, andthe healthcare environment can also play a critical role in the transmission and prevention ofinfections. The human microbiome is another innovative area for exploration.The isolates housed at CDC can help industry and academic partners to develop newdiagnostic tools, treatment tools, and vaccines. With the US Food and Drug Administration(FDA), the AR Isolate Bank has been developed. The US Department of Defense (DoD) alsohas a large collection of isolates, but the FDA-CDC bank is targeted for unique resistance thatindustry and academic partners can use. The bank has approximately 260 isolates.Regarding implementing antibiotic stewardship programs and practices, new diagnostic toolsare an important means for better detection of infections, improving use of antibiotics, andadding to knowledge regarding sepsis. CDC considers the entire spectrum of care to protectpatients from infections, including HAIs, sepsis, and viral infections. Several healthcare systemsreceive CDC funding to implement strategies to improve use and improve outcomes. Thesystems are encouraged to use the antibiotic use (AU) module of the National HealthcareSafety Network (NHSN). In outpatient settings, stewardship work incorporates using the dataand working with partners to implement concrete interventions. Stewardship efforts are justbeginning in long-term care, but CDC is already working with partners to determine how best toDRAFT HICPAC Meeting Minutes, March 31, 2016Page 10

move forward with programs as well as concrete strategies to improve antibiotic use in thosesettings. CDC is funding healthcare systems, health departments, academic groups, andprofessional and public health organizations in these areas.The concept of antibiotic stewardship also incorporates sepsis. The two issues have beenperceived as contrary, but they should be messaged together. CDC is considering not only howto improve antibiotic use but also how to better detect infections and create strategies forreassessing antibiotic use. Education is important for patients, especially in the outpatientsettings. It is also important for clinicians and a range of different groups to improve use.CDC is building upon opportunities to work with different groups on the early detection andmanagement of sepsis. Some professional organizations and groups have been working toimprove antibiotic use and others have been working on early detection of sepsis. The work ofthese two groups may not have been optimally integrated in the past. There are opportunities towork on these issues holistically and to help patients. CDC is launching an educationalcampaign that unifies the messages of sepsis and appropriate antibiotic use: “Think sepsis”Collect laboratory culturesEncourage clinicians to “act fast”Encourage clinicians to reassess the need for a specific antibiotic, or for anyantibiotic, 48-72 hours laterPrevent future infections: if infections are prevented, there will be no sepsisBased on the gaps identified by partners, the campaign considers the entire cycle. CDC andDHQP are conducting more activities related to sepsis, including the following: Better understand the epidemiology of the patient and the risk factors that can leadto better prevention, sometimes primary preventionTrack sepsis infections for prevention activities to determine the impact of successfulinterventionsPromote prevention, early recognition, and use of effective and appropriateantibioticsWork with various groups to conduct and refine campaigns, building on opportunitiesto help partners work together with facilities to implement infection prevention andstewardship activitiesDiscussion PointsThere may be state-to-state and region-to-region variation in existing capacity. As CDC movesresources out, individual states’ ability to utilize the funding most effectively or to increasecapacity may need to be assessed. For instance, the Targeted Assessment for Prevention(TAP) reports from NHSN focus on the most quickly and easily achievable goals that requirelimited effort and resources for preventing infections in hospitals. Nationally, it may be importantto focus on geographic areas that are in most need of additional resources.Dr. Cardo agreed that capacity varies by state. A group in DHQP is assessing state programsnot only in terms of whether they prevent infections but also regarding the infrastructure that isneeded to do the work. The health departments should work with academic centers in order notDRAFT HICPAC Meeting Minutes, March 31, 2016Page 11

to duplicate efforts and to leverage synergies. States can apply for direct assistance in makingthese connections and building capacity in prevention, detection, and response.The overall program has aggressive targets. HICPAC asked about metrics. Some MDROs ininstitutions are real infections, while some results are related to testing behaviors and the typeand sensitivity of diagnostics that laboratories use. The problem can be addressed withprevention and education of clinicians regarding appropriate testing.Dr. Cardo said that the metrics for the budget initiative should be aggressive. Payment metricsare different. DHQP is setting goals for the national initiative to help assess where progress isbeing made and why targets are not being met. The evaluation will help to assess whetherabsence of progress around C. diff., for example, reflects deficiencies around antimicrobialstewardship or increasing community transmission. Specific metrics for states may bedeveloped at a later time.FDA Device Updates: Flexible Endoscopes and Heater CoolersSuzanne Schwartz, MD, MBACatherine Wentz, MSCenter for Devices and Radiological HealthUS Food and Drug AdministrationDr. Suzanne Schwartz and Ms. Catherine Wentz updated HICPAC on FDA’s ongoing effortsregarding the public health concern of Nontuberculous Mycobacterium (NTM) infectionsassociated with heater-cooler devices. An FDA advisory committee meeting on this topic will beconvened on June 2-3, 2016. They also updated HICPAC on FDA’s work regarding flexibleendoscopes. FDA welcomes HICPAC’s input and advice regarding its multi-prongedapproaches to these problems.Dr. Schwartz explained that in May and June of 2015, based on early signals observed inEurope, CDC and its European counterpart reached out to FDA regarding a potentialassociation between heater-cooler devices and NTM infections in patients who had undergonecardiac surgery. Reports to FDA regarding heater-cooler devices are classified into two areas:1) patient infections, and 2) device contamination.FDA receives user facility reports, voluntary reports, and manufacturer-submitted reports. Whena safety notice is issued by FDA or its regulatory partners outside of the US, it is typical forr

Dr. Ryan Fagan, CDC/ DHQP . Dr. Scott Fridkin, CDC/ DHQP . Ms. Nancy Gallagher, CDC/DHQP . Ms. Janet Glowicz, CDC/ DHQP . Dr. Carolyn Gould, CDC/ DHQP . . Terrell Cunningham, FDA, briefed HICPAC on the current status of FDA’s review and regulation of surgical/isolation gowns. HICPAC member

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