National Estimates of Medical Device-Associated Adverse Events from Emergency Departments Brock Hefflin, MD, MPH Cen

1. National Estimates of Medical Device-Associated Adverse Events from Emergency Departments Brock Hefflin, MD, MPH Center for Devices and Radiological Health Food and Drug Administration

2. 2 FDA’s Medical Device Reporting System Mandatory and Voluntary Reporting MDR Analyst Review Passive system that helps provide signals

3. 3 MDR System Limitations Incomplete/inaccurate reports Inability to establish causality Under-/inconsistent reporting Reporting influenced by - Media/alerts - Adverse event severity - Educational initiatives - Advocacy programs - Litigation-related issues

4. 4 National Electronic Injury Surveillance System Sentinel for product-related injuries seen in hospital EDs Collects information from ED records of a national stratified probability sample of hospitals Data can be used to determine statistically-valid national estimates of product-related injuries

5. 5 NEISS Consumer Product Alerts Baby walkers Crib slat width Choking hazard toys Toy boxes Window blind cords Lawn mowers Fireworks Chainsaws

6. 6 NEISS Partners Centers for Disease Control and Prevention National Institute for Child Health and Development Substance Abuse and Mental Health Services Administration Health Resources and Services Administration DOT National Highway Traffic Safety Administration Department of Housing and Urban Development Environmental Protection Agency Coast Guard

7. 7 Medical Device Pilot Study Background FDA-CPSC interagency agreement to establish first-ever national estimates of device-associated adverse events FDA provided to CPSC: - Medical device definition - Examples of medical device variety

8. 8 NEISS Data Collection NEISS Hospital Coordinators Case selection 10,395 NEISS Case Reports collected from July 1999 through June 2000

9. 9 Analysis Case assignment to FDA Medical Specialty group and device group National estimates with 95% CI by: - Medical specialty group - Device group - Injury diagnosis - Demographic characteristics - Patient disposition

10. 10 Results For the Study Year: 454,383 (95% CI, 371,156 – 537,610) emergency department visits in the U.S. due to a medical device-associated adverse event

11. 11 Results Medical Category Estimate (%) 95% CI . Physical Medicine 179,631 (40) 151,826 – 207,436 General Medicine 98,489 (22) 73,853 – 123,127 Ophthalmology 65,188 (14) 44,214 – 86,162 Gastro/Uro 36,858 (8) 22,181 – 51,537 Cardiology 14,159 (3) 6,129 – 22,191 Orthopedics 12,504 (3) 5,929 – 19,079 General/Plastic Surgery 12,043 (3) 8,373 – 15,715 Anesthesiology 10,406 (2) 7,196 – 13,614 Dentistry 10,206 (2) 5,677 – 14,735 OB-GYN 6,923 (2) 2,204 – 11,642 Radiology 5,265 (1) 3,264 – 7,268 Neurology 4,258 (1) 1,728 – 6,787 Otolaryngology 3,513 (1) 1,812 – 5,214

12. 12 Results Injury Estimate (%) 95% CI . Contusion/Abrasion 80,728 (18) 66,592 – 94,864 Puncture 66,568 (15) 44,749 – 88,387 Laceration 52,775 (12) 45,647 – 59,903 Fracture 46,541 (10) 37,290 – 55,792 Strain/Sprain 27,136 (6) 21,835 – 32,437 Foreign Body 18,961 (4) 13,100 – 24,822 Dermatitis/Conjunctivitis 9,879 (2) 5,323 – 14,435 Dislocation 6,643 (1) 3,615 – 9,671 Internal Organ Injury 6,555 (1) 3,929 – 9,180 Hematoma 3,879 (1) 2,576 – 5,182

13. 13 Results Mechanism of Injury Most cases appeared to reflect an incident where an unintentional injury occurred with no explicit device failure Unintentional injury > device failure > use error Often not possible to decisively assign a case to one, and only one, incident type

14. 14 Results Incidents occurred at home most frequently (42%) 22% of incidents were work related Hospital incidents were occupational injuries involving staff, or adverse events involving patients in an outpatient setting

15. 15 Results Hospitalization 13% (58,396) of total estimated cases involved hospitalization Proportion of hospitalizations were highest for incidents involving invasive/implanted devices Highest estimates for hospitalization: - Crutches, canes, walkers (18,751; 13,428 – 24,074) - Wheelchairs, scooters (11,938; 9,300 – 14,576) - Pacemakers, defibrillators (4,912; 1,404 – 8,420) - Prosthetic devices (3,962; 298 – 7,627)

16. 16 Comment Total estimate of 454,383 cases exceeds the 100-200K medical device adverse event reports received annually by FDA Total estimate represents >1% of the 1999 – 2000 average annual number of all injury-related visits to U.S. hospital emergency departments Estimate of 58,396 admissions suggests that serious injuries occurring outside the hospital are underreported Home-use devices increasing in prevalence

17. 17 Study Limitations NEISS does not consistently collect some data elements Universe of potential medical device adverse events was not sampled to produce the estimates (i.e., limited to ED cases) Limited information made the etiology of an injury difficult to ascertain

18. 18 Conclusion Magnitude of our total estimate emphasizes medical device-associated injuries as an under-recognized public health problem More detailed NEISS data will allow for a better understanding of medical device-associated injury etiology and appropriate public health interventions

19. 19 CDRH Ongoing Participation in NEISS Started August 1, 2003 Part of the FDA Patient Safety Strategy to improve surveillance by systematically collecting data on non-hospital adverse medical device events CDRH’s only statistically-based surveillance system

20. 20 Strategies to Improve NEISS for Medical Devices To improve data abstraction: Provided training at NEISS Coordinators meeting Visited three participating EDs to evaluate case ascertainment To improve quality of notes in ED records: Considering instructional posters in ED for ED staff Considering presentations to ED staff to improve their documentation of medical device and adverse event details

21. 21 Current Focus Continue data collection Pay contractor for device coding Continue requesting resources to improve abstraction and notes Publish updates of public health burden