Distributing Replacement Parts for Class II Medical Devices

#1
Hi All!
Was curious if you could help lead me in the correct direction. Hypothetically speaking, I manufacture a Class II Medical Device and would like to know what it would take to ship replacement parts for this device, directly to the consumer. The replacement part would be a whole new device. Currently, the health care provider must write an RX for the device and then we must ship it to them and then they can give it to the patient. In this hypothetical world, we are talking about a device worn on the outside of the body which has a battery and the whole device itself needs to be swapped out every 6 weeks (the battery is not removable). Would appreciate it if you could let me know your level of expertise or background when answering. Thanks!
 
Last edited:

Al Rosen

Staff member
Super Moderator
#4
RX is for the whole device. Think of a replacement pod. I tried to clarify my question above. The battery is not really important to my question. Thanks for asking a clarifying Q.
I missed that. If it was just the battery, it wouldn't be an issue.
I guess hypothetically it's the same as refilling your Xanax prescription.
 

Al Rosen

Staff member
Super Moderator
#5
I think if it doesn't require special skills, there is a low risk of harm and your IFU has instructions for changing the pod, you could present an argument for supplying the replacement directly.
 
#6
I think if it doesn't require special skills, there is a low risk of harm and your IFU has instructions for changing the pod, you could present an argument for supplying the replacement directly.
yes, exactly. But the question is...to whom do I present that argument.
 
#8
I've got no answers, but perhaps clarifying the question would help forward discussion. Correct me if I'm wrong, but the situation is as follows:
  • Rx-only device
  • Health practitioner issues Rx to patient, and orders the device on behalf of patient
  • Patient takes the device home. After a period of time, requires a replacement.
  • In this situation, you'd like to ship directly to the patient, without involving the health practitioner that made the initial prescription.
If this is the case, one consideration might be: how do you know a person requesting a replacement has a legitimate Rx? Your initial "customer" would have been the health practitioner and, presumably, they would not disclose individual patient information to you.

Is this correct? Like I say, I don't have any concrete answers, just hoping to frame the situation in a clear way so that others might want to weigh in...
 

Al Rosen

Staff member
Super Moderator
#9
I've got no answers, but perhaps clarifying the question would help forward discussion. Correct me if I'm wrong, but the situation is as follows:
  • Rx-only device
  • Health practitioner issues Rx to patient, and orders the device on behalf of patient
  • Patient takes the device home. After a period of time, requires a replacement.
  • In this situation, you'd like to ship directly to the patient, without involving the health practitioner that made the initial prescription.
If this is the case, one consideration might be: how do you know a person requesting a replacement has a legitimate Rx? Your initial "customer" would have been the health practitioner and, presumably, they would not disclose individual patient information to you.

Is this correct? Like I say, I don't have any concrete answers, just hoping to frame the situation in a clear way so that others might want to weigh in...
Not a replacement, but needs to replace the battery.
 
#10
Not a replacement, but needs to replace the battery.
Oh... Sorry. If this is the case, then I agree...there should be no problem. The battery is not a medical device.

But to me, it was not clear. From the original post:
...the whole device itself needs to be swapped out every 6 weeks (the battery is not removable)...
How could you issue replacement batteries, if the batteries aren't removable?

In anycase, the scenario I laid out is still of interest (to me, at least - maybe others..).
Assuming you could get patient info from the health practitioner, and then use this to confirm the identity of a person requesting a replacement, is it ok to fulfil this request without having to go through the health practitioner/Rx process again?
 


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