Transcript Document

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: [email protected]
Web Sites: www.ecri.org
www.mdsr.ecri.org
©ECRI 2007
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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
©2007 ECRI
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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.
©2007 ECRI
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“Medical Device Safety Reports”
Free: www.mdsr.ecri.org
©2007 ECRI
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Information Resources and DatabasesMedical Device Accidents
• 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
©2007 ECRI
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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
•
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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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
©2007 ECRI
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Databases on Problem Reports and
Technology Assessments
• Web Sites
– See handout- Health Devices 1998; 27(8):286
– Also FDA sites:
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•
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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
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XX. Electrosurgical Units (Surgical
diathermy)
QUESTIONS?
©2007 ECRI
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