1. ©ECRI 2007 1 IV.Information Resources & Databases: Medical Device Problem Reports TRAINING SEMINAR ON MEDICAL DEVICE ACCIDENT INVESTIGATION for Kingdom of Saudi Arabia Saudi Food & Drug Authority Riyadh 11-14 February, 2007 Presenter: Mark E. Bruley Vice President, Accident and Forensic Investigation ECRI 5200 Butler Pike, Plymouth Meeting, PA, 19642 USA Tel: +1 610-825-6000, ext. 5223 E-mail: mbruley@ecri.org Web Sites: www.ecri.org www.mdsr.ecri.org

2. ©2007 ECRI 2 Information Resources & Databases: Medical Device Problem Reports Hospital –Clinical Engineering Department –Facilities Engineering –Materials Management ECRI Databases FDA MedWatch Program –MAUDE Database –MDR Database National Library of Medicine

3. ©2007 ECRI 3 Databases on Problem Reports and Technology Assessments ECRI –Health Device Alerts (HDA) 1977 - present 950,000 records Published recalls and reports (international) FDA Databases: MDR, MAUDE –Healthcare Standards Directory 37,000 citations –International Health Technology Assessment Database 40,000 documents –Medical Device Safety Reports: Numerous published device cases. Free on-line: www.mdsr.ecri.org.

4. ©2007 ECRI 4 “ Medical Device Safety Reports ” Free: www.mdsr.ecri.org

5. ©2007 ECRI 5 FDA/CDRH –MAUDE (Mfr And User Device Experience), ‘ 96 to present www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM –MDR/ PRP, 1982-1996 www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM National Guideline Clearinghouse: www.guideline.gov National Library of Medicine: www.ncbi.nlm.nih.gov/PubMed ECRI ’ s Medical Device Safety Reports Web site (free): –www.mdsr.ecri.org –Includes taxonomy of device failures and mechanisms of injury ECRI (subscription or fee) www.ecri.org –Health Device Alerts (HDA) –Healthcare Standards Directory –International Health Technology Assessment Database Information Resources and Databases- Medical Device Accidents

6. ©2007 ECRI 6 Standards, Regulations, Guidelines & Publications for Accident Investigation ECRI –Medical Devices-Int’l Perspectives on Health & Safety. Bruley, ME. Ch. 13. Accident Investigation. –Insp & PM Inspection System Procedures (for most critical devices) – Healthcare Standards Directory US Food and Drug Administration (FDA) –Human Factors Engineering Group http://www.fda.gov/cdrh/HumanFactors.html American Society for Testing and Materials (ASTM) –Standards for Forensic Sciences

7. ©2007 ECRI 7 Databases on Problem Reports and Technology Assessments ECRI –Health Device Alerts (HDA) CD-ROM, Dialog 1977 -present 700,000 records Published reports (international) FDA Databases: MDR MAUDE –New ECRI/CHUBB!! “Medical Device Safety Reports” www.mdsr.ecri.org

8. ©2007 ECRI 8 Databases on Problem Reports and Technology Assessments ECRI (cont.) –Health Devices Sourcebase 20,000 companies 150,000 products –Healthcare Standards Directory 37,000 citations –International Health Technology Assessment Database 40,000 documents –TARGET

9. ©2007 ECRI 9 Databases on Problem Reports and Technology Assessments FDA/CDRH –MDR, PRP 1982-1996 –http://www.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfm –MAUDE- >300,000 records 1996 to present –http://www.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

10. ©2007 ECRI 10 Databases on Problem Reports and Technology Assessments. FDA –MedWatch System (www.fda.gov/medwatch) 1991- present Voluntary and Mandatory Reporting –Manufacturer And User Device Experience Database (“MAUDE”) 1996 to present: >300,000 records to present www.fda.gov/cdrh http://www.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

11. ©2007 ECRI 11 Databases on Problem Reports and Technology Assessments FDA –Medical Device Reporting (MDR) http://www.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfm 1982-1996 Vendors Hospitals –Problem Reporting Program (PRP) 1978-1996 Users, Hospitals, Public

12. ©2007 ECRI 12 Databases on Problem Reports and Technology Assessments - European Union –Medical Device Directives –“Competent Authority” in each country –Stricter Limits on release of problem information to public –Vendor Reporting Mandatory

13. ©2007 ECRI 13 Databases on Problem Reports and Technology Assessments Medical Device Nomenclature –Universal Medical Device Nomenclature System (UMDNS) –UMDNS developed and maintained by ECRI –Key to database development and searching –Common device terms / Unique numeric code –Adopted by National Library of Medicine –Adopted by EU as interim system –Translated into more than 6 languages

14. ©2007 ECRI 14 Databases on Problem Reports and Technology Assessments Web Sites –See handout- Health Devices 1998; 27(8):286 –Also FDA sites: www.fda.gov/medwatch www.fda.gov/cdrh/mdr.html www.fda.gov/cdrh/mdrforms.html www.fda.gov/cdrh/manual.mdrman.html www.fda.gov/cdrh/manual.mdrman.pdf

15. ©2007 ECRI 15 QUESTIONS? XX. Electrosurgical Units (Surgical diathermy)