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					       The Big Picture




                                                       A Roundtable Discussion
                                                       Alarm Safety: A
                                                       Collaborative Effort
                                                       Mary K. Logan, Moderator



       Roundtable Participants
                                                       When an 89-year-old man died in his bed at          prompted us as an organization to try to wrap
                               Mary K. Logan,
                                                       Massachusetts General Hospital and the alarms       our hands around the whole issue of alarm
                               JD, CAE is
                               president of
                                                       that should have sounded didn’t, the incident set   fatigue. We just completed a study funded by
                               AAMI. Email:            off a different kind of alarm throughout the        one of our alarm manufacturing vendors on the
                               mlogan@aami.            hospital, in Boston, and in state regulatory        issue of alarm fatigue.2 We were aiming to
                               org                     agencies. The tragic situation also provided a      partner with this vendor to increase the
                                                       learning experience for Mass General and the        specificity and positive predictive value of the
                                                       larger medical community.1 In that spirit, AAMI     information the monitors give us.
                        Angela Andrew-                 recently gathered a group of experts to discuss a
                        Webb, RN is                    number of alarm safety questions. What kinds of     Steve Wilcox But I see two other problems with
                        private duty                   alarms are necessary, and how many alarms are too   alarm systems. Besides the false alarms, the
                        nursing case                                                                       second problem is the lack of integration
                                                       many? How can technology help solve this
                        management
                                                       problem rather than compound it?                    between devices. All these independently
                        supervisor with
                        Christiana Care                                                                    developed alarm systems don’t talk to each
                        Health System.                 Mary Logan What are some common problems            other or integrate in any way. So even if the
       Email: aandrew-webb@christianac-                seen with alarm systems for medical devices?        false alarm problem was eliminated, there
       are.org                                                                                             would still be this cacophony because of that
                                                       Linda Talley I’m responsible for looking at how     lack of integration. The third problem is that
                         Cleveland
                                                       nurses interact with technology. The literature     the signals themselves are poorly designed so
                         Cartwright, RN is
                         program director              tells us, and our own experience at Children’s      they’re not natural sounds. They’re difficult to
                         of private duty               National Medical Center indicates, that we’re       learn and identify, and they go out of their way
                         nursing with                  dealing with anywhere from an 85% to 99%            to be annoying. I think it’s an artifact of the way
                         Christiana Care               false positive rate on alarms. We are inundated     they’re designed.
                         Health System.
                                                       with information and alarms, most of which are
                         Email: ccart-
       wright@christianacare.org
                                                       meaningless to us.                                  Tobey Clark IEC standards for alarm systems3,4
                                                          Nurses become desensitized to the huge           aim to prescribe a way to standardize alarms
                          J. Tobey Clark               number of alarms they’re confronted with in         in terms of priority and parameters so people
                          is director of               their daily work and, as a result, critical or      can learn and understand alarm signals, and
                          instrumentation
                                                       clinically significant events can be missed. We     better recognize the higher versus lower prior-
                          and technical
                          services with                had a serious patient event many years ago that     ity alarms. The American College of Clinical
                          the University of            related to the timeliness of our response to a      Engineering’s Healthcare Technology Founda-
                          Vermont Techni-              monitor. In our post-event review, we learned       tion published a white paper about clinical
                          cal Services                 that it wasn’t an equipment failure. Rather, it     alarms and one of their recommendations was
       Program. Email: tobey.clark@its.
                                                       was a human factors failure. That really            for clinical alarm standards.5
       uvm.edu


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                                                                                                                                                      The Big Picture



          Wilcox Of course these standards have made                          Jim Welch A study published in Anesthesiology6
          things a little more rational. But they haven’t                     focused on a general care setting, Dartmouth
          addressed the problems of integration or                            Hitchcock Medical Center, where my company
          false alarms.                                                       worked directly with the end users. Rather than
                                                                              study how many alarms were occurring, we
          Talley Our experience, and our discussions                          asked, “How many alarms are tolerable from
          over a three-year period with a vendor we were                      a human factors standpoint to avoid alarm
          working with, indicates that device manufactur-                     fatigue?” The nurses told us two to four alarms
          ers are challenged as well by a consumer base                       per patient per day.
          that has asked them, over the past 10 years,                           I would encourage the community to agree to
          to throw it all at us. We ask them to give us                       a common set of metrics and terminologies.
          everything they can with these “magic                               Everybody knows what alarm fatigue is, but it
          machines” and we’ll deal at the front line with                     needs to be defined. They took a different
          how we are going to discriminate between                            approach at Dartmouth by actually separating
          the massive amounts of noise we’re                                  the alarm annunciation, or the sound of the
          confronted with.                                                    alarm, because alarm fatigue is mostly an audio
             So I think they are very anxious to partner                      rather than a visual phenomena. They set
          with us to figure out how to strike that balance.                   alarms to a lower threshold for surveillance,          Roundtable Participants
          The machines we put in the hands of clinicians                      that is, letting you know when a patient needs
          present serious challenges. The level of                                                                                   Dr. John Hedley-Whyte, MD is
                                                                              to be rescued versus letting you know when a
                                                                                                                                     the David S. Sheridan Professor of
          decision support is increasingly sophisticated                      patient crosses the threshold. That is a very          Anaesthesia and Respiratory
          and complex for any one clinician to manage.                        different approach to the traditional conditional      Therapy at Harvard University.
          In many of our intensive care units (ICUs), we                      settings found in ICU settings. By adding a            Email: john_hedley-whyte@hms.
          have additional personnel doing the decision                        delay to it, they were able to achieve four alarms     harvard.edu
          support, trying to counteract the massive                           per patient per day. And because of that, they
                                                                                                                                                          Linda Talley,
          amounts of noise the technology produces.                           were able to actually improve patient safety                                MS, RN is vice
             In our study we recorded tens of thousands                       methods as measured by escalation of care to                                president of
          of alarms in a 30-day period, which translated                      the ICU and rapid response activations.                                     nursing for
          to approximately 900 per day. In one of our                            On the technical side, monitoring companies                              Critical Care,
          critical care units, a total of 39,000 alarms were                                                                                              Heart Institute
                                                                              have followed this paradigm of alarms being
                                                                                                                                                          and Nursing
          recorded in a 30-day period which equaled 1300                      activated by the crossing of a threshold. Those                             Systems at
          alarms per day, or one alarm sounding every 66                      thresholds often have not been defined using                                Children’s
          seconds. In another critical care unit, we                          an evidence-based, rationalized approach to            National Medical Center.
          observed approximately 600 alarms per patient                       alert a nurse or clinician to go to the bedside.       Email: ltalley@cnmc.org
          per day.                                                               In a study out of Johns Hopkins,7 they found
                                                                                                                                                         Jim Welch is
             In direct response to the sentinel event we                      that by lowering an Sp02 alarm from 90% to                                 vice president
          had here at Children’s National several years                       88%, they were able to reduce the occurrence of                            of patient
          ago, we decided every patient in every unit was                     alarms by more than 50%. A methodology to                                  safety at
          going to be on a monitor. So we became even                         rationalize what’s an appropriate alarm is                                 Masimo, Inc.
          more acutely aware then of the dilemma of                                                                                                      and vice presi-
                                                                              needed. The whole topic of alarm fatigue
                                                                                                                                                         dent of ACCE.
          having very little science to drive how we                          really begs the question of why are we doing                               Email: jwelch@
          monitor alarm limits.                                               alarms? What’s the primary purpose of them,                                masimo.com
             We felt bound, from an ethical perspective, to                   and how do we create decision systems or
          do no harm and monitor patients to the fullest                      filters so that nurses can focus on clinically                             Stephen B.
          degree possible. But we find ourselves now in                                                                                                  Wilcox is a
                                                                              actionable alarms?
                                                                                                                                                         principal with
          this conundrum where we encounter an
                                                                                                                                                         Design Science,
          abundance of information that is of very little                     Logan What are the biggest obstacles to solving                            a human
          value. So we have duplicative measures on all of                    challenges related to alarms?                                              factors
          our units in terms of humans with an eye on                                                                                                    consultancy.
          patients, as well as trying to filter through what                                                                                             Email:
                                                                              Wilcox One is a strong bias toward false
                                                                                                                                     sbw@dscience.com
          the alarms are telling us.                                          positives instead of false negatives. If an
                                                                              alarm signal fails to annunciate when there is

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                                                                                                                                                The Big Picture


          a legitimate situation, the liability is obvious. On the other hand,             ond audio delay on it, essentially a filter, we found that we could
          when the alarm signal annunciates when there’s not actually a                    eliminate more than 80% of the alarms. So now we’ve got the
          problem, there is a logical liability because it’s undermining the               alarms people care about, the ones where levels fall and stay
          value of the alarm. However, I’ve never heard of anybody being                   below a threshold for a sustained amount of time, that would
          sued for a false positive. So to avoid even the thought of a false               cause a clinician to rationally say, “I’m worried about
          negative, we’re just inundated with                                              that patient.”
          false positives.
                                                                                           In part, machines are going off because they
          Welch There is a lack of research in this area. I’ve scoured the                 are too sensitive. With the probes we use in the
          literature for publications on alarm recurrences, origins, and                   home setting, if the client moves a bit too much
          causes, and I’m only aware of a few published studies: the ones                  or even if their extremities are cold, we see a lot
          I’ve already mentioned and another in the Journal of Emergency
          Medicine (JEM)8
                                                                                           of false alarms.
             The JEM piece studied the occurrence of alarms and what                       Angela Andrew-Webb I can offer a home healthcare perspective
          were clinically actionable events. It was predominantly focused                  on the alarm fatigue issue. In part, machines are going off
          on electrocardiogram (ECG) alarms, which is, I think, the                        because they are too sensitive. With the probes we use in the
          primary cause of most alarms, along with impedance respiration                   home setting, if the client moves a bit too much or even if their
          rate. In the emergency room, they found that less than 2% of all                 extremities are cold, we see a lot of false alarms. If ventilators are
          alarms require a physician to do something at bedside to reverse                 not set up properly, we can have water in the lines, which will
          the condition.                                                                   give us false alarms also.
             So what we don’t answer in the literature is, what’s being                      The payer source is our major obstacle to solving these
          monitored? What’s the alarm mean? And what’s the profile of                      problems. For instance, with ventilators, some of the home
          that alarm? We conducted a study in 10 hospitals looking at Sp02                 medical equipment (HME) companies are only compensated to
          alarm occurrences using our technology. We found that if you                     give us two vent circuits a month. That means the circuits are
          set your Sp02 alarm at 90%, you will have a lot of true alarms. But              only changed every two weeks. They need to be changed every
          those true alarms do not require a clinical intervention. By                     week to function properly.
          lowering the alarm level from 90% to 88% and putting a 15-sec-




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                     Save the Date                        Fourth Annual Lucian Leape Institute Forum & Gala                          For details, visit
                     September 22, 2011                   Guest Speaker: Atul Gawande, MD, MPH                                         www.npsf.org
                     Boston                               Best-selling Author. Surgeon, Brigham & Women’s Hospital

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       The Big Picture


                                                       Welch If we look at this from a systems              John Hedley-Whyte These problems have been
                                                       perspective, think about links in a chain. If you    around for a long time. Many of the topics we’re
                                                       don’t have the correct or optimized sensor, then     addressing here were also addressed in a 1992
                                                       you don’t have a high-performance sensor, and        publication I edited.10 The bottom line is that
                                                       you’re going to generate false data. False data      everyone is to blame for problems with
                                                       leads to false alarms. If you’re trying to use the   alarm systems.
                                                       same cable over and over and it’s at the end of        The use of technology to allow intelligent
                                                       its life and its signal is becoming intermittent,    escalation of alarms up the management chain
                                                       you’ll get false alarms.                             and alarm retrievability is essential. We need to
                                                          So from a provider medical community, how         tap into the literature from other disciplines on
                                                       do you optimize every link in that signal chain?     this topic, such as aeronautics.
                                                       Because the more you measure, the more                 The liability issue is a big one here. When
                                                       alarms you’re going to have. Once you have           you talk to vendors, purchasers, trustees, and so
                                                       optimized the sensor, its placement, the skin        forth, they all come back behind the defense of
                                                       prep, and you’ve got a good signal, now you can      the incredibly high cost of litigation.
                                                       ask, what is a rational approach towards where I
                                                       set the alarms? For example, the heart rate          Welch One more obstacle is FDA clearance for
                                                       area—is it okay to set it at 140 versus 120?         any kind of rationalized improvement in
                                                       If you do that, you will get fewer alarms. The       alarms. Any company that moves forward with
                                                       question is, at what point is the alarm threshold    an intelligent or smart alarm solution will have
                                                       set beyond a reasonable level, such that you’re      to run the FDA gauntlet of getting clearance.
                                                       causing harm? That evidence does not exist           The question to the industry is, is that worth
                                                       right now. And it’s not a one-size-fits-             the effort? There’s almost a resistance in the
                                                       all solution.                                        area of alarms because it raises the specter of a
                                                                                                            prolonged clearance cycle for any new platform
                                                       Wilcox The aircraft cockpit used to be like our      that’s developed.
                                     situation in the ICU or the operating room
                                     (OR) today. Separate vendors made different                            Talley The partnership between the clinician,
                                     devices that had alarms, and when multiple                             vendor, and FDA needs to be strengthened so
                                     things started happening simultaneously, pilots                        we can get the national attention we need to
                                     were overwhelmed. But they had the advantage                           discuss how more is not necessarily better in
                                     of a general contractor who could create a                             the realm of alarms. That would lead us into a
                                     unified, integrated system that represents an                          dialogue about interoperability and intelligence,
                                     alarm philosophy that is consistent.9                                  and how we can use that to move ahead. There
                                                               We’re not in that                            is a mistaken notion that the information glut
       The liability issue is a big one here. When situation because there’s                                puts us at an advantage; instead, we find
       you talk to vendors, purchasers, trustees, no comparable general                                     ourselves at a disadvantage.
                                                            contractor who can
       and so forth, they all come back behind
                                                            rationalize everything like                     Hedley-Whyte Another barrier to examine is
       the defense of the incredibly high cost              in the aircraft industry.                       the Health Insurance Portability and
       of litigation.                                       And there’s no incentive                        Accountability Act (HIPAA) regulations about
                                                            for individual manufac-                         confidentiality of medical records. People are
                                     turers. So the only way that could happen is for                       finally realizing that, if your survival depends
                                     hospitals and medical facilities to demand it.                         on transmission of what your critical care state
                                     There have been third-party attempts to come                           is, then HIPAA is a bad thing. David Pogue
                                     up with a unified system that you plug all your                        wrote in Scientific American recently11 that the
                                     devices into. To my knowledge, none of them                            general population of the United States needs
                                     have gotten off the ground yet, but ultimately                         to be told that some regulations about confiden-
                                     that’s going to be one of the solutions.                               tiality or medical care need revising, and
                                                                                                            Congress needs to revisit the whole issue.




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                                                                                                                                     The Big Picture


                                                                              vendor to another in a lot of parameters, it is
          Logan What steps can and should healthcare                          very difficult for healthcare organizations to
          facilities be taking to address the problems?                       make those decisions. Some organizations like
                                                                              ECRI are beginning to test various technologies
          Hedley-Whyte Solving this issue will require                        relative to false or nuisance alarms.
          involvement from top hospital executives.
          These hospital executives are generally not                         Hedley-Whyte When I am asked to visit other
          aware of the problems we’re discussing today.                       medical institutions, I have found it rare that
          The need for intelligent, integrated alarm                          hospitals have appropriate alarm policies. To
          systems generally comes as a surprise to them.                      initiate rational alarm policy often takes a
                                                                              committee or a very powerful central adminis-
          Clark Individual hospital units typically follow                    tration. The development of rationalized
          specific policies for alarm parameters, which                       policies and procedures should be based on
          is appropriate. But at the institutional level,                     local evidence and published literature.
          there isn’t a clear awareness of the problem.                          Also, the move of so much medicine and
          Unfortunately, the reporting of alarm events in                     surgery toward home care does require urgent
          The New York Times or Boston Globe that are                         rethinking of the alarm systems that should be
          read by a trustee or hospital executive is a                        deployed. Nobody on a ventilator, hemodialysis
          common impetus to develop an alarms                                 machine, or infusion pump at home should be
          improvement program.                                                left without a distributed alarm system. It is
                                                                              nonsense to think that a single alarm is
          Wilcox Facilities can use the likelihood of false                   sufficient. You need a system distributed to
          alarms as one of the top criteria for acquiring                     other rooms where other people are.
          devices. Right now, that criterion is pretty low
          on the list, if it’s even considered at all when                    Cartwright From a home healthcare
          comparing devices. However, with the lack of                        perspective, it’s part of our assessment to verify
          good metrics or research that compares one




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       The Big Picture


                                                       that an alarm can be heard in every area of a      because there’s no profit in it. On the acute-care
                                                       home. Desensitization to alarm sounds is also a    and the long-term care side, however, industry
                                                       problem in the home environment. Because           definitely can do more because that’s where
                                                       there is not a clinical person there with the      monitors are today. How we solve these
                                                       patient all the time, family members come up       problems is really the call to arms.
                                                       with their own interpretation as to what alarms       At a children’s hospital, we analyzed what
                                                       mean because of what has happened in the past.     measurements are most often alarming. We
                                                       Often, family members will actually turn off       found that respiration rate was the root cause of
                                                       alarms because they’ve heard so many               most of the alarms that were driving nurses,
                                                       false ones.                                        patients, and families crazy. So that gives us an
                                                                                                          attack point from a technology standpoint. What
                                                       Welch In fact, if you go through device            can we do about improving that particular
                                   incidents reports, you’ll find that home apnea                         parameter? How do we integrate all of the
                                   monitors are one of the most egregious exam-                           parameters? For instance, why not couple
                                   ples of too many false or nuisance alarms, and                         respiration rate with oxygenation in patients?
                                                                       an inability to                    There are some rational ways of approaching
       In 2002, the Joint Commission issued an alert on                relay the true                     this. The question for industry is, will that
       alarm safety. . . We’re almost 10 years past their              alarms that                        provide a competitive advantage of one company
                                                                       somebody                           versus the other?
       recommendation and we’ve made little to no real
                                                                       would do
       advance in solving this alarm safety problem.                   something                          Logan AAMI has just established a new standards
                                   about. Remote annunciation of alarms is                                committee on alarms, because of the importance
                                   essential because caregivers, especially ones                          of the issues that need to be addressed from a
                                   outside ICU settings, are not at the bedside                           standards perspective. What do you think is need-
                                   when these events occur.                                               ed on the regulatory, accreditation, or standards
                                     However, if you don’t solve the problems of                          fronts to deal with this issue?
                                   nuisance alarms or alarm fatigue, moving those
                                   alarms to an already-busy clinician, home                              Hedley-Whyte The international standards-
                                   healthcare provider, or family member is just                          setting process in this area is not smooth at all.
                                   going to annoy them, and they’re going to turn                         We’ve had international standards for about 40
                                   off alarms. So first solve the alarm fatigue                           years on alarm systems. There’s currently a
                                   problem, and then start thinking about how to                          disagreement between two standards bodies on
                                   get alarms to the right person to rescue                               how to approach these systems, which needs to
                                   that patient.                                                          be resolved.

                                                       Logan What should industry be doing to address     Logan The new AAMI standards committee is
                                                       these problems?                                    waiting to get started until they hear the needs
                                                                                                          and priorities from all perspectives at the alarms
                                                       Hedley-Whyte There are many barriers to what       summit that AAMI is co-hosting this October
                                                       industry can do to solve these problems in the     4-5 with ECRI Institute and ACCE. The commit-
                                                       home environment. In Massachusetts, we’ve          tee is also waiting on a revision of an updated
                                                       had political infighting to get sophisticated,     IEC foundational standard (60601-1-8), upon
                                                       distributed alarm systems deployed in the          which our new work will build. If we can solve
                                                       home. You have to battle insurance companies       many of the challenges with alarms from what
                                                       for reimbursement to wire another room, set up     we learn at this year’s summit, then hopefully
                                                       a local area network, and so forth.                this preferable non-regulatory route for
                                                                                                          improvements throughout the system will
                                                       Welch Until there’s reimbursement for compa-       eliminate the need for any additional
                                                       nies developing these body-worn sensors for        regulatory action.
                                                       home healthcare, you are not going to get
                                                       venture capitalists or their companies to invest



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          Talley In 2002, the Joint Commission issued                               more we can look at it from an evidence-based
          an alert on alarm safety. That was helpful; it                            perspective, the more we can maintain the
          established a call to action and gave us lever-                           momentum we’ve begun here.
          age to say we are all accountable. We’re almost
          10 years past their recommendation and we’ve                              Welch This is an enormously important issue
          made little to no real advance in solving this                            in healthcare because we’re already seeing that,
          alarm safety problem. The Joint Commission                                due to so many nuisance alarms occurring,
          has since established a standard aimed at ap-                             hospitals are looking at not monitoring
          propriate alarm settings and audible alarms.                              patients. Removing the technology because
          It’s a start; however, it does not effectively get us                     there are problems with it is a step backward.
          to where we need to be. Clinicians are still en-                          Therefore, at a stakeholder meeting, it’s going
          countering alarm fatigue in the hospital setting.                         to be extremely important to have the right
                                                                                    participants representing the political, financial,
          Logan What next steps are needed to solve                                 insurance, and vendor spectrums. Everybody
          these problems?                                                           recognizes that this is a worthy problem to
                                                                                    solve. Getting agreement and collaboration on
          Talley We must continue to seek research                                  a way forward is the only way this is going
          opportunities. Healthcare providers must                                  to be solved.
          represent the patient and the family interests.
          As we said earlier, vendors are looking at the                            Andrew-Webb With home healthcare, we need
          bottom line. The providers are the ones who are                           to work more with vendors to make sure they’re
          most closely aligned with patient/family                                  aware of issues we are having with alarms so
          interests. And it is incumbent on us to keep the                          we can present that to insurance companies
          topic alive through research endeavors. The                               and try to resolve these issues together. n




          References
          1. AAMI. “Alarm Fatigue: An Issue Across the                        5. American College of Clinical Engineering          9. Jacobsen A et al. Crew Station Design and
             Country,” in Infusing Patients Safely: Prior-                       Healthcare Technology Foundation. Impact             Integration, in Human Factors in Aviation,
             ity Issues from the AAMI/FDA Infusion                               of Clinical Alarms on Patient Safety. 2006.          Edition 2, edited by Eduardo Salas and Dan
             Device Summit. Arlington, VA; 2010:35.                              Available at http://thehtf.org/White%Paper.         Maurino, 2010.
                                                                                 pdf.
          2. Talley LB, principal investigator.                                                                                    10. Hedley-Whyte J, ed. Operating Room and
                                                                              6. Taenzer AH et al. Impact of Pulse Oximetry
             “Understanding Factors Associated with                                                                                    Intensive Care Alarms and Information
                                                                                 Surveillance on Rescue Events and Intensive
             Monitor Alarm Generation in Critically Ill                                                                                Transfer. ASTM Special Technical Publica-
                                                                                Care Unit Transfers. Anesthesiology 2010;              tion (STP) 1152. American Society of Testing
             Children.” IRB-approved study at Children’s
                                                                                112:282-7.
             National Medical Center, externally funded                                                                                and Materials, 1992.
              by Philips Healthcare. January 2008.
                                                                              7. Graham KC et al. Monitor Alarm Fatigue:
                                                                                                                                   11. Pogue D. Don’t worry about who’s
                                                                                 Standardizing Use of Physiological Monitors
          3. IEC 60601-1-8:2006. Medical electrical                                                                                    watching. Scientific American
                                                                                and Decreasing Nuisance Alarms. American
             equipment - Part 1-8: General requirements for                                                                            2011;304(1):32.
                                                                                Journal of Critical Care 2010; 19(1):28-38.
             basic safety and essential performance - Collat-
             eral standard: General requirements, tests and
             guidance for alarm systems in medical electrical                 8. Atzema C et al. ALARMED: Adverse events
             equipment and medical electrical systems.                           in low-risk patients with chest pain receiving
                                                                                 continuous electrocardiographic monitoring

          4. IEC 60601-2-49:2011. Medical electrical equip-                     in the emergency department: A pilot study.
             ment - Part 2-49: Particular requirements for                      American Journal of Emergency Medicine
             the basic safety and essential performance of                      (2006); 24:62-67.
             multifunction patient monitoring equipment.


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