biomedical research & education foundation 1500 market street 12 th floor – east tower...
TRANSCRIPT
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
A Health Care Provider Perspective
CDRH 510(k) Implementation: Discussion of an On-line Repository of Medical Device Labeling, and of Making Device Photographs Available in a Public Database without Disclosing
Proprietary Information
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Aaron MoskowitzExecutive Director
Biomedical Research and Education Foundation
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Biomedical Research and Education Foundation
• 501c3 Non-profit Independently Funded
• Philadelphia, PA• Founded in 2003• Research, publication, conferences• Listed PSO• www.medicaldeviceregistry.org
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Scope
• Typical Problems of Physicians for patients who already have a device
• Current Information Sources• www.medicaldeviceregistry.org• Suggested Improvements
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Problems
• Number One Problem We Hear: What device does my patient have?– Imaging procedures– Prescribing drugs– News about recalls– Where to direct a patient for more
information
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Information Gathering Difficulty
• Finding information about about specific Devices – Determining imaging compatibility– Determining drug interaction– Trouble Shooting problems
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Why Images Are ImportantRadiographic and Photographs
• Identify non-implants from a catalogue
• Identifying devices from medical images
• Identifying normal and abnormal changes in anatomy from images
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Current Information Sources
• Current information sources• Ask an expert• Literature “if you don’t want a primary care
physician to see it, publish it”• Web at large: google• Direct information sources• Then there is:• Personal Healthcare Record• Available resources to a practitioner
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Information Gathering
• Pick a Device– Implant– Home Use Device
• Determine The Name• Search Expected Sources
– Manufacturer Site– FDA Sources– General Internet
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Example: CD HorizonSpinal Fixation Device
FDA Medsun
FDA MAUDE
FDA Approval 510k
2 results
70 Approval Numbers from 12/05/1996 by Sofamor Danek USA, Inc to 1/26/2011 by Medtronic Sofamor Danek, Inc.
29 REPORTS
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
“CD Horizon” By Medtronic
Manufacturer Website
Patient Websites
www.LessInvasiveSpine.comContains information on Multiple Devices and procedures
No PicturesNo Implantation warnings found on 510k letterDifficult Navigation
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Example: ACCU-CHEK Aviva Blood Glucose Meter
FDA Medsun
FDA MAUDE
FDA Approval 510k
5 results, 2 likely relevant
52 devices ACCU-CHEK Aviva Blood Glucose Meter
>500 REPORTS
Manufacturer Website
FAQsImagesTroubleshooting
Internet Retailers FAQsImagesTroubleshooting
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Review of FDA access
• Currently the access databases are not connected.
• Absent fields make linking difficult• Device Name, Manufacturer are
insufficient to verify a device• There are no images or manuals
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Solutions
• Unique Identifier for Devices used across databases
• Single site, Collating all information.
• Requires:Images of DevicesRadiographic Images AnatomyContraindicationsResource Lists
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
www.medicaldeviceregistry.org
• Free Service• Account not required• Designed for consumers• Register devices• Links to FDA’s information• Links to other available sites (ie:
manufacturers, news)
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Alerts onwww.medicaldeviceregistry.org
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
www.MedicalDeviceRegistry.org
Biomedical Research & Education Foundation1500 Market Street 12th Floor – East TowerPhiladelphia, PA 19102
Final Suggestions
• Unique identifiers• Images
– Images of devices– Images Anatomy
• Labeling and user manuals• Contraindications for imaging• Legacy devices, Version tracking• List online resources