On July 8, ARSA Managing Director & General Counsel Marshall S. Filler underwent successful heart surgery. He is recovering at home and is on track to continue his passion as the association’s resident golf expert; as he explained to members in the June 2021 hotline newsletter, the operation is an opportunity to transition more completely into retirement while still maintaining connection to ARSA’s work.
The surgery included installation of a “bovine replacement” for Filler’s aortic valve. During his recuperation, Executive Director Sarah MacLeod has been keeping well wishers updated and has begun a healthy debate about how the maintenance community should define his procedure.
ARSA’s members and some other colleagues have already begun to weigh in. See their analysis of maintenance vs. alteration (and good wishes) in the de-identified responses below and add your own by completing the survey at the bottom of this page:
|I’d classify this as maintenance. It is also a minor change in type design.
Get well soon!
|Major alteration means an alteration not listed in the aircraft, aircraft engine, or propeller specifications—
(1) That might appreciably affect weight, balance, structural strength, performance, powerplant operation, flight characteristics, or other qualities affecting airworthiness; or (2) That is not done according to accepted practices or cannot be done by elementary operations.
Major repair means a repair:
(1) That, if improperly done, might appreciably affect weight, balance, structural strength, performance, powerplant operation, flight characteristics, or other qualities affecting airworthiness; or (2) That is not done according to accepted practices or cannot be done by elementary operations. Meets the definition of Maintenance.
Get better soon and hit one for me Marshall!!
|Depends on if the repair is covered under the person’s SRM… Or is there an STC? Or Alaska Field Approval documentation???|
|It is an alteration, due to the fact that in most cases humans were not born nor certified with cow tissue installed. The insertion of such tissue would be classified as an alteration. However, this alteration was performed during a maintenance function. So both might be appropriate. Get well soon Marshall!|
|Marshall, get well Soon! The new valve will add yards to your Driver Stroke!|
|Good luck during your recoup, Marshall. Your operation constitutes an alteration to your original type certificate as you were not built with any cow tissue installed.|
|The replacement is from different materials, not doing something to maintain the heart. Replacing a problematic component with a different design.|
|First, I hope Marshall is getting better and can return to the Golf Course soon.
As for the Survey – Nice try ARSA. This is obviously a trick question designed so Sarah can yell at me for doing it wrong (again).
The Answer is: I can’t tell you because the OEM for Marshall’s heart will not distribute or publish the Instructions for Continued Respiration (ICR). The Food & Drug Administration (FDA) regulations on this are clear (21 CFR Part 21.50b). If only the Human Repair Stations (colloquially called Hospitals) had a trade association that could force the FDA to follow and enforce its own rules then maybe they coud get the OEM (Marshall’s mom) to “hand over the damn manual” (citation—Sarah MacLeod) so I can answer this question.
Get well Soon!
|Marshall: Best wishes for a speedy recovery & return to the golf course.
Sarah: Shout out to you as well – keep Marshall’s maintenance records up to date!!
|Hi Marshall, I truly hope you are feeling better and that you’ll soon find your way back onto the links. It seems like the Nats are getting a bit better as Soto’s hitting has improved, and I hope that you’re getting to watch the games whilst recuperating. Please rest and we’ll all look forward to hearing great news about your recovery!|
|100 percent alteration.
Marshall glad you are still with us, who knows what Sarah would have planted by now on the private Green of yours.
|C check revealed surprisingly that Marshall had a heart so a Boeing ODA team came to approves an MCAS to control his heart.|
|Major alteration since the valve was not part of the original TC. Hopefully he has an STC or DER approved data :).|
|That would be an alteration since it changed the material and Marshall is now moooooing.|
|Feel better soon! … Oh, and don’t hesitate to use this as a reason to ask your buddies for 2 a side on the links!|
|Let’s ask Marshall if it felt major or minor! I really hope you are doing much better, we have a lot of golf clubs to swing. Take good care.|
|The bovine valve was not a part of the original “Type Design” for Marshall. Due to the fact this was a new part introduced to this type design, an appropriate FAA Form 337 Shall be completed and a copy placed in Marshall S. Fillers records.|
|Hello Marshall best wishes for a speedy recovery. I would ask Sarah to check on the parts PMA status. All kidding aside glad to hear your well.|
|It’s a repair using approved parts (but may require a 337). Get well soon Marshall!|
|I didn’t add or remove functionality, therefore it is not an alteration. If it had been a swine valve, it may have improved his ability to wrestle pigs and therefore would potentially been an alteration. Tell Marshal to take care!|
|It’s an alteration that will hopefully restore the victim, er patient, to be at least equal to his original or properly altered condition (with regard to lawyerly function, cardiac strength, resistance to unnecessary FAA directives, and other qualities affecting public safety).|
|This could be considered maintenance or alteration, depending on what the approved technical data stated. If the approved data allowed for alternate material in the repair of a heart, then it could be maintenance. And you are not going to re-identify the heart are you? Then that would be an alteration. Get well soon Marshall.|
What do you think?
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