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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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:

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

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

Categories of Attendees Government 1 Manufacturers (OEMs) 10 ISOs 9 Standards Organizations 3 Trade Associations 4 Hospitals and End Users 11

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

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

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”

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

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

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

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

Some Titles of the people who attended . . .

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

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

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

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)

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

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

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

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

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.

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.

ECRI Stats

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.

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.”

Panel 0 – General Comments ACCE 1

Panel 0 – General Comments ACCE 2

Panel 0 – General Comments ACCE 3

Panel 0 – General Comments ACCE 4

Panel 0 – General Comments MITA 1

Panel 0 – General Comments MITA 2

Panel 0 – General Comments MITA 3

Panel 0 – General Comments MITA 4

Panel 0 – General Comments MITA 5

Panel 0 – General Comments Poor Quality 1

Panel 0 – General Comments Poor Quality 2

Panel 0 – General Comments MITA 6

Panel 1 – Benefits and Risks

Panel 1 – Benefits and Risks

Panel 1 – Benefits and Risks

Panel 1 – Benefits and Risks

Panel 2 – Characteristics of Good Servicers

Panel 2 – Characteristics of Good Servicers

Panel 3 Challenges for Stakeholders - OEMs

Panel 3 Challenges for Stakeholders - OEMs

Panel 3 Challenges for Stakeholders - OEMs

Panel 3 Challenges for Stakeholders - OEMs

Panel 3 Challenges for Stakeholders - OEMs

Panel 3 Challenges for Stakeholders – ISO – (Malcolm)

Panel 3 Challenges for Stakeholders – End User

Panel 4 – Future Recommendations - OEM

Panel 4 – Future Recommendations – End Users

Panel 4 – Future Recommendations – End Users / ISO

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

Thanks you for attending Patrick Lynch Patrick Lynch Problem Solving & Consulting Patrick@plynch.us 704-941-0116 www.pklynch.com