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Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 19102 A Health Care Provider Perspective CDRH 510(k)

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Presentation on theme: "Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 19102 A Health Care Provider Perspective CDRH 510(k)"— Presentation transcript:

1 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 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 Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Aaron Moskowitz Executive Director Biomedical Research and Education Foundation

2 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Biomedical Research and Education Foundation 501c3 Non-profit Independently Funded Philadelphia, PA Founded in 2003 Research, publication, conferences Listed PSO

3 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Scope Typical Problems of Physicians for patients who already have a device Current Information Sources Suggested Improvements

4 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 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 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Information Gathering Difficulty Finding information about about specific Devices – Determining imaging compatibility – Determining drug interaction – Trouble Shooting problems

6 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Why Images Are Important Radiographic and Photographs Identify non-implants from a catalogue Identifying devices from medical images Identifying normal and abnormal changes in anatomy from images

7 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Current Information Sources Current information sources Ask an expert Literature if you dont 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 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Information Gathering Pick a Device – Implant – Home Use Device Determine The Name Search Expected Sources – Manufacturer Site – FDA Sources – General Internet

9 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Example: CD Horizon Spinal 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

10 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA CD Horizon By Medtronic Manufacturer Website Patient Websites Contains information on Multiple Devices and procedures No Pictures No Implantation warnings found on 510k letter Difficult Navigation

11 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 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 FAQs Images Troubleshooting Internet Retailers FAQs Images Troubleshooting

12 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 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 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Solutions Unique Identifier for Devices used across databases Single site, Collating all information. Requires: Images of Devices Radiographic Images Anatomy Contraindications Resource Lists

14 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Free Service Account not required Designed for consumers Register devices Links to FDAs information Links to other available sites (ie: manufacturers, news)

15 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA Alerts on

16 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA

17 Biomedical Research & Education Foundation 1500 Market Street 12 th Floor – East Tower Philadelphia, PA 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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