Slide 1 by IEtTF70j

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									AHRQ’s 2006 Annual Patient Safety & Health Information Technology Conference
    Frequency of Adverse Medical Device Events:
       Impact on Patient Safety and Role of HIT

          Literature on the Frequency of
          Adverse Medical Device Events
                     in Hospital Settings



                 Roselie A. Bright, Sc.D.
                 Center for Devices and Radiological Health
                                                        1
Outline


      • FDA adverse event reports
      • Epidemiologic data (in this and
        following talks)
      • (Implications covered in my later
        talk)




                                            2
FDA adverse event reports

                                                 Deaths
                                 Serious Injury (Only if mfr unknown)
                                            - 10 work days

User Facilities                                                D, SI
                                             Importer
   Death (D) &
Serious Injury (SI)                          D, SI & M
                                                              30
                                                           calendar
                                                                          FDA
 - 10 work days                              - 30 calendar   days
                       Other Sources
                                             days
                           D, & SI
                      Product Problems/
                                                       Remedial Action w/
                      Malfunctions (M)                unreasonable risk harm
                                                        or FDA requested -
                                                           5 work days

                                                                   Death, Serious Injury
                                                                     & Malfunction
                                                                                    3
                                                                    30 calendar days
                      Manufacturer
FDA adverse event reports
  Numbers of reports by year and program
  210,000                                       Voluntary
  180,000
  150,000                                       User facility
  120,000
   90,000                                       Distributor or
   60,000                                       importer
   30,000                                       Manufacturer
       0                                        summary
            1997


                    1999


                           2001


                                  2003


                                         2005
                                                Manufacturer
                                                individual
                   2005 data may not be complete.               4
FDA adverse event reports
      Unique Recognition and
    Reporting Aspects for Devices
  • Human factors issues inherent in virtually
    every event.
  • Complex multi-device situations are
    common.
  • For diagnostic devices, hard to recognize
    false positives and false negatives.
  • Information in reports is often limited.
  • Lack of standard device nomenclature.
  • Lack of records for most device use.         5
Epidemiologic data
                                                AE /1000 patient days
                                                Device Drug
 Overall hospital type           Paper          related related   Any
 Adult tertiary hospital   Samore et al ‘04       15
 All US hospitals          Bright and Shen       3.7
 Hospital general          Chaudry et al ‘03               3      9.3
 medicine service
 Urban tertiary hospital   Bates et al ’93                10
 French hospitals          Hanesse et al ’94              2.3
 Hospital                  Bates et al ‘95                12
 41 Italian geriatrics and Carbonin et al ‘91             4.8
 internal medicine
 clinical centers                                                  6
Epidemiologic data

              “Surveillance of
     medical device-related hazards and
              adverse events in
          hospitalized patients.”
                Samore et al.
             JAMA 2004; 291:325-334.



                                          7
Epidemiologic data

                Bright and Shen.

 Use of a Free, Publicly-Accessible Data Source
 to Estimate Hospitalizations Related to Adverse
         Medical Device Events (AMDE).




                                               8
Epidemiologic data
                                                AE /1000 patient days
                                                Device Drug
 Overall hospital type           Paper          related related   Any
 Adult tertiary hospital   Samore et al ‘04       15
 All US hospitals          Bright and Shen       3.7
 Hospital general          Chaudry et al ‘03               3      9.3
 medicine service
 Urban tertiary hospital   Bates et al ’93                10
 French hospitals          Hanesse et al ’94              2.3
 Hospital                  Bates et al ‘95                12
 41 Italian geriatrics and Carbonin et al ‘91             4.8
 internal medicine
 clinical centers                                                  9
Epidemiologic data
                                         AE/1000 patient days
                                         Device Drug
  Type of ICU          Paper             related related Any
  Adult shock/ trauma Samore et al        240
  and adult medical/
  surgical ICU
  Neonatal ICU        Frey et al ’00      >16      20     67
  Pediatric ICU       Stambouly et al     >19      3      27
                      ’96
  Medical ICU         Bates et al ’95              19
  Surgical ICU        Bates et al ‘95              11
  Medical ICU and     Rothschild et al             38     81
  Coronary Care Unit ’05
                                                           10
Epidemiologic data -- Stambouly

  Stambouly JJ et al. Complications of care in a
  pediatric intensive care unit: a prospective study.
  Intensive Care Med 1996; 22:1098-1104.

  PICU in a pediatric tertiary care referral center
  on Long Island. Age 0 to 18 years old.

  Authors recorded data daily and solicited
  reports from rest of staff.
  18 month study.

  1035 patients. 4266 pt days.
                                                        11
Epidemiologic data -- Stambouly
        Complication    # (115 total)

        Ventilator-related    60
        Infections            24
        Invasive devices      22
        Drug-related          14
        Procedure-related     13
         (medical-surgical)

      82 AMDE  19 AMDE/ 1000 pt days

        14 ADE  3 ADE/ 1000 pt days
                                        12
Epidemiologic data -- Frey
 Frey B et al. Comprehensive critical incident monitoring in a
   neonatal-pediatric intensive care unit: experience with the
   system approach. Intensive Care Med 2000; 26:69-74.

 Pediatric and neonatal ICU. Non-univ, teaching
   children’s hosp in Switzerland. 12 month study.

 Briefed staff on systems approach and use of incident
   report form. Every 2 months, rpts analyzed and
   positive changes implemented.

 467 patients. 3140 patient days.
 • 48% used mechanical ventilation.
 • 45% used central venous catheter.
 • 30% used intra-arterial catheter.
                                                             13
Epidemiologic data -- Frey
      Critical incident category      # (211 total)
      Management/environment                 62
      • 1 infusion pump & 1 bed/restraint AMDE
      Drugs                                  62
      Procedures                             37
      • 5 umbilical artery catheter AMDE
      Respiration                            29
      • 29 AMDE
      Equipment dysfunction                  15
      Nosocomial infections                  6

        51 AMDE  16 AMDE/1000 pt days
          62 ADE  20 ADE/1000 pt days
                                                      14
Epidemiologic data
                                         AE/1000 patient days
                                         Device Drug
  Type of ICU          Paper             related related Any
  Adult shock/ trauma Samore et al        240
  and adult medical/
  surgical ICU
  Neonatal ICU        Frey et al ’00      >16      20     67
  Pediatric ICU       Stambouly et al     >19      3      27
                      ’96
  Medical ICU         Bates et al ’95              19
  Surgical ICU        Bates et al ‘95              11
  Medical ICU and     Rothschild et al             38     81
  Coronary Care Unit ’05
                                                           15
16

								
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