Hello Kristina,
The short answer is yes. There is emphasis now on accumulated use that may occur when the device is immediately replaced with another device of the same kind. Discussions revolve around what is meant by immediately, i.e. few seconds to few minutes, but the idea being accumulated use should be considered. It is also important to look at the actual intended use and purpose of the device, how it is used by the patient, is there are strict exposure that is obtained from patient use. Your example is in the correct thinking though some would say 1 minute of use even accumulated might not push into the next duration level; you definitely have the right idea though. What it was looking at is devices like wound care dressings where it is on for 2 - 5 days, but then immediately replaced by another wound care dressing that may be used for months at a time for diabetic ulcer patients, e.g. it would not be prolonged term use, but long term use.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-May-2019 17:53
From: Kristina Cook
Subject: duration of contact
Hi all,
I have a question about duration of contact.
The duration of contact is broken down into limited (<24h), prolonged (24h-30d) and long term (30d+). I'm under the impression that it is the total time that the user is in contact with the device that should be taken into consideration (assuming of course, no residual material remains on the user after use) - is that correct?
For example, if one uses a device for 1 minute per day for 3 months (say a total of roughly 90 minutes), this would fall into the limited contact category as it is less than 24h, even though they are using the device over multiple months.
Any input is appreciated!
Thanks!
- Tina
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Kristina Cook
San Francisco CA
United States
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