1. The FDA Ponders Whether to Further Regulate the 5Rs and 1S of Medical Devices by 3rd Parties, In-House and ISOs
Patrick Lynch, CBET, CCE, CHTM, fACCE, CPHIMS
Florida Biomed Society
December 10, 2016

2. What are the 5 Rs and 1S?
Refurbishing
Reconditioning
Rebuilding
Remarketing
Remanufacturing
Servicing

3. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

4. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

5. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

6. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

7. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

8. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

9. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

10. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

11. What is the FDA? What do they do? And how do they do it?
FDA Mission. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

12. What is the FDA? What do they do? And how do they do it?
Pass rules.
Inspect.
Collect Fees.
Impost Fines.
Stop Production.
Stop Sales.
Force Recalls.

13. What is the FDA? What do they do? And how do they do it?
They do all of these things solely through action with the manufacturers of the products to make sure that they are safe for use. The FDA has authority over no one but the manufacturers and sellers of the goods and services that they regulate.

14. What is this all about. Who started it. Who are the stakeholders
What is this all about? Who started it? Who are the stakeholders? What do they disagree about?
According to the March 4 announcement:

15. March 4, 2016 – A call for information
178 responses
Who responded?
What did they say?
Categories, Names, positions, quotes.

16. October 27-28, 2016 – A workshop in Silver Spring, MD
Attendees
Participants
Arguments
Quotes

17. Categories of Attendees
Government
Manufacturers (OEMs) 10
ISOs
Standards Organizations 3
Trade Associations
Hospitals and End Users 11

18. Manufacturers / oemS Bayer GE Healthcare Hitachi America
Johnson & Johnson
MDMA (Medical Device & Mfgr Assn)
Medtronic
Pentax America
Philips
Siemens Healthcare
Varian Medical Systems

19. U.S. Federal Trade Commission
Government
U.S. Federal Trade Commission
Attorney Advisor, Office of Policy Planning

20. Katherine Ambrogi Attorney Advisor, U.S. Federal Trade Commission
Trade Commission Creed –
Competition is at the Core of the American Economy
Job – To Prevent Unfair or Deceptive Acts
Executive Order from Obama – All Federal Agencies are to work to “Increase Competition”

21. ISO / Independent Servicers
Mobile Instrument Repair & Service
Oxford Instruments
Paragon Services
Tri Imaging
TriMedX
Afya Foundation of America
Alpha Source
First Source
Integrated Medical Systems

22. Standards Organizations
AAMI - President
AAMI – Senior VP
Cambridge Polymer Group

23. Hospitals & End USers ACCE Dept. of Veterans Affairs ECRI Institute
Healthcare Technology Consulting
ISS Solutions
Peters VA Medical Center
Mass General Hospital
TriMedX
Zablocki VA Medical Center
VA National Center for Patient Safety

24. Trade Associations AdvaMed IAMERS
MDMA (Medical Device Manufacturers Association)
MITA (Medical Technology & Imaging Alliance)

25. Some Titles of the people who attended . . .

26. The order of things (1 of 5)
Day 1 - Morning
Welcome
History of FDA Involvement in 5 Rs & 1S
Definitions & Overview of Stakeholder Perspectives
Stakeholder Presentations (OEM, ISO, End User)
OEM – MITA, AdvaMed, MDMA
ISO – Mobile Instrument Repair, ISS Solutions, TriMedX
Associations – IAMERS, AAMI
Government – US Federal Trade Commission

27. The order of things (2 of 5)
Day 1- Afternoon
Panel 1 - Benefits and Risks Associated with 5Rs & 1S performed by Third Party and OEM
OEM - Philips, MDMA, Pentax, Siemens
ISO – Tri Imaging, Mobile Inst Repair & Service, TriMedX, Crothall
End User – ECRI Institute, Mass General, VA National Center for Patient Safety
Presentation by Participants

28. The order of things (3 of 5)
Day 2 - Morning
Panel 2 – Characteristics of Good 5R & 1S Entities
OEM – Johnson & Johnson, Bayer, MDMA
ISO – Integrated Medical Systems, Mobile Instrument Service & Repair
End User – ISS Solutions, Peters VA Medical Center, Dept of Veterans Affairs (Gastroenterologist
Panel 3 – Challenges Stakeholders Face in Performing High Quality 5R & 1S Activities
OEM
ISO
End Users

29. The order of things (4 of 5)
Day 2 – Morning (continued)
Panel 3 – Challenges Stakeholders Face in Performing High Quality 5R & 1S Activities
OEM – Medtronic, MDMA, Hitachi
ISO – First Source, Alpha Source, Paragon Services
End Users – Healthcare Technology Consulting, Mass General, Dept of Veterans Affairs (Gastroenterologist)

30. The order of things (5 of 5)
Day 2 – Afternoon
Panel 4 – Current Best Practices and Future Recommendations
Standards – AAMI, Cambridge Polymer Institute
OEM – Varian Medical, GE Healthcare
ISO – Afya Foundation, Oxford Instruments
End Users – Zablocki VA Medical Center, SSM Health, ACCE

31. What might the FDA do? Nothing.
Declare some additional entities as manufacturers and regulate them just as they regulate other manufacturers today.
National ISOs
Local ISOs
Third Parties
In-house employees of end users

32. How does the FDA regulate Manufacturers today?
(My Incomplete information)
Quality systems
Reports
Collection of data
Traceability of parts
Retention of reports, logs - forever
Adherence to Good Manufacturing Practices
Inspections

33. But Servicers have a lot fewer things to do . . .
(Again – my limited knowledge)
Records
Periodic analysis
Periodic reports
Traceability
Labeling

34. Major Arguments by OEMs
It’s NOT about the Money. It’s all about Safety.
ECRI Statistics are wrong – there is gross under-reporting of incidents related to equipment maintenance.
Just because patient injury and death isn’t showing up in the data doesn’t mean that it isn’t occurring.

35. Major Arguments by Everyone Else:
Don’t try to fix a problem that doesn’t exist.
No One has demonstrated that there is any problem.
It is all about money. The manufacturers just want everyone else’s cost to rise so that their’s doesn’t look so high.

36. ECRI Stats

37. An interesting twist at the end of the workshop
Someone asked to the manufacturers, “Would you be in favor of it if the FDA relaxed their oversight of service activities on everybody, including the manufacturers?”
There was a very long quietness, and then a lot of head nodding as the manufacturers were genuinely in favor of the prospect.
It made it clear that they didn’t think that there is a problem, they just want it to be equal.

38. Notable Quotes froM The Workshop
“We are confident that the FDA will not regulate by anecdote.”
“Something may be more afoot than uniform enforcement.”
“Manufacturers cannot have it both ways – claim untrained third parties but refuse to train them.”

39. Panel 0 – General Comments ACCE 1

40. Panel 0 – General Comments ACCE 2

41. Panel 0 – General Comments ACCE 3

42. Panel 0 – General Comments ACCE 4

43. Panel 0 – General Comments MITA 1

44. Panel 0 – General Comments MITA 2

45. Panel 0 – General Comments MITA 3

46. Panel 0 – General Comments MITA 4

47. Panel 0 – General Comments MITA 5

48. Panel 0 – General Comments Poor Quality 1

49. Panel 0 – General Comments Poor Quality 2

50. Panel 0 – General Comments MITA 6

51. Panel 1 – Benefits and Risks

52. Panel 1 – Benefits and Risks

53. Panel 1 – Benefits and Risks

54. Panel 1 – Benefits and Risks

55. Panel 2 – Characteristics of Good Servicers

56. Panel 2 – Characteristics of Good Servicers

57. Panel 3 Challenges for Stakeholders - OEMs

58. Panel 3 Challenges for Stakeholders - OEMs

59. Panel 3 Challenges for Stakeholders - OEMs

60. Panel 3 Challenges for Stakeholders - OEMs

61. Panel 3 Challenges for Stakeholders - OEMs

62. Panel 3 Challenges for Stakeholders – ISO – (Malcolm)

63. Panel 3 Challenges for Stakeholders – End User

64. Panel 4 – Future Recommendations - OEM

65. Panel 4 – Future Recommendations – End Users

66. Panel 4 – Future Recommendations – End Users / ISO

67. What might the FDA do? Nothing
Full Regulation all the way to Hospital BMETS

68. Thanks you for attending
Patrick Lynch
Patrick Lynch Problem Solving & Consulting