Laser Focused: How misleading OEM practices make me support third-party FDA registration

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Scott Carson

Laser Focused: How misleading OEM practices make me support third-party FDA registration

An editorial by Scott Carson and David Engelhardt

When will the energy based (lasers, IPLs, RFs, etc.) device manufacturer's leadership give their sales teams the proper education and coaching to avoid instilling problematic habits and misinformation into their trusting reps?

This statement, sent to a doctor from a regional sales representative at one of the top five laser OEMs last week, highlights the problem:

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"[Our company] does not service any system that is being sold by a third party vendor without a recertification fee ($35,000). There is no way for us to know exactly what has been done to the system after being sold to the dealer, stripped for parts, unauthorized tweaking or repairs, etc. What are you going to do when the system needs to be serviced? I don't care if he gives you a 10-year warranty instead of a 90-day warranty, in the event that something needs to be serviced, [our company] won't be doing to the repair work without a recertification fee. If ANYTHING happens to a patient with a device that isn't under FDA guidelines (and any repair from anyone other than the manufacturer is a direct violation), you are in serious legal trouble."

Here is another statement, this one addressed to a doctor from a sales manager at another leading OEM:

"God forbid a burn or some sort of negative response occurs and there's a lawsuit, questions asked are going to be: where did you buy it, when was it last inspected by the manufacturer, when were you trained by the manufacturer and if you do not have good answers for those questions you will not be in a good place."

On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed House Resolution 2118 seeking to require registration of independent servicers of medical devices.

Currently, the FDA does not require registration by a third-party reseller or service provider.

I am in favor of the regulation of independent servicers of medical devices, as this could force the energy based device manufacturer's leadership to provide parts and service manuals to independent servicers of medical devices. This would create an open market, lowering the cost required to provide these services and put patient safety first.

The extortionately high recertification fees (of $35,000 or more, as noted above) are nothing more than a highly effective barrier to restrict the sale of used devices. What doctors don't realize is that this fee directly impacts reps' abilities to sell a device and reduces its value by more than $35,000.
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Wayne Moore

LASER Focused Editorial

May 25, 2017 10:33

"...as this could force the energy based device manufacturer's leadership to provide parts and service manuals to independent servicers of medical devices." As a regulatory professional I am unclear how FDA registration of a 3rd party service provider would somehow automatically "force" manufacturers to do anything. The two issues are wholly unconnected. I too am in favor of 3rd Party servicers registering with the Agency.

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Scott Carson

re: LASER Focused Editorial

May 30, 2017 10:17

Wayne, fair correction. I chose the incorrect word. I should have suggested the regulatory policy may lead to changes that might include -- so sorry for the error.

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