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A Health Care Provider Perspective

A Health Care Provider Perspective . Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 19102.

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A Health Care Provider Perspective

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  1. A Health Care Provider Perspective Biomedical Research & Education Foundation 1500 Market Street 12th Floor – East Tower Philadelphia, PA 19102 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 Aaron Moskowitz Executive Director Biomedical Research and Education Foundation

  2. Biomedical Research and Education Foundation • 501c3 Non-profit Independently Funded • Philadelphia, PA • Founded in 2003 • Research, publication, conferences • Listed PSO • www.medicaldeviceregistry.org

  3. Scope • Typical Problems of Physicians for patients who already have a device • Current Information Sources • www.medicaldeviceregistry.org • Suggested Improvements

  4. 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

  5. Information Gathering Difficulty • Finding information about about specific Devices • Determining imaging compatibility • Determining drug interaction • Trouble Shooting problems

  6. 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

  7. 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

  8. Information Gathering • Pick a Device • Implant • Home Use Device • Determine The Name • Search Expected Sources • Manufacturer Site • FDA Sources • General Internet

  9. Example: CD HorizonSpinal Fixation Device FDA Approval 510k 70Approval Numbers from 12/05/1996 by SofamorDanek USA, Inc to 1/26/2011 by Medtronic SofamorDanek, Inc. FDA MAUDE 29 REPORTS FDA Medsun 2 results

  10. “CD Horizon” By Medtronic Manufacturer Website No Pictures No Implantation warnings found on 510k letter Difficult Navigation Patient Websites www.LessInvasiveSpine.com Contains information on Multiple Devices and procedures

  11. Example: ACCU-CHEK Aviva Blood Glucose Meter FDA Approval 510k 52 devices ACCU-CHEK Aviva Blood Glucose Meter FDA MAUDE >500 REPORTS 5 results, 2 likely relevant FDA Medsun FAQs Images Troubleshooting Manufacturer Website FAQs Images Troubleshooting Internet Retailers

  12. 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

  13. Solutions • Unique Identifier for Devices used across databases • Single site, Collating all information. • Requires: Images of Devices Radiographic Images Anatomy Contraindications Resource Lists

  14. 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)

  15. Alerts onwww.medicaldeviceregistry.org

  16. www.MedicalDeviceRegistry.org

  17. Final Suggestions • Unique identifiers • Images • Images of devices • Images Anatomy • Labeling and user manuals • Contraindications for imaging • Legacy devices, Version tracking • List online resources

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