191217_MD-labelling_Symbols-guidance_REVISED_FINAL
It is a reusable product, meaning that it can be used multiple times, but for only one patient, An example is some kinds of radiation therapy. The patient has a mask fitted to the individual patient. For each therapy dose, the patient uses the same mask. When the course of therapy terminates, the mask is subject to disposal.
In contrast there are devices that are single use and single patient. Dispose of the device after its single use.
This yields four combinations. (I had a colleague who asserted the world is described by 2×2 matrices.)
In one dimension we have single-patient or multiple-patient. In the other dimension we have single-use or multiple-use.
The four combinations are:
Single-patient & single-use: This has a symbol
Single-patient & multiple-use: This has a symbol
Multiple-patient & single use: I don't think this happens in practice
Multiple-patient & multiple-use: This is the default for medical devices, so it doesn't have a symbol
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 19-May-2020 15:16
From: Lee Leichter
Subject: Reusability
Al,
You are correct, but just to be sure it is clear, the single patient, multiple use product is a disposable, not reusable product that is used for a single patient (e.g. disposable multi-dose insulin injection pen).
I am not aware of any symbol for a true "reusable" device.
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Lee Leichter RAC
President
Fort Myers FL
United States
Original Message:
Sent: 18-May-2020 12:07
From: Al Van Houdt
Subject: Reusability
I'm not aware of a symbol with a "1" crossed out, but there is a symbol with a "2" crossed out for Do Not Reuse.
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Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
Original Message:
Sent: 15-May-2020 06:17
From: Richard Vincins
Subject: Reusability
Shikha,
For single-use devices, yes - there is the symbol with the ONE crossed out which is from the standard indicating single-use only. For reusable devices, I would say there is not a specific requirement in the EU MDR either in Annex I or specifically Annex I, Section 23 for stating whether a device is reusable or not. There are alot of wording around reusable, with alot of interpretation on how these devices should be handled from a regulatory perspective. With that said, there is a requirement if the device is reusable the UDI number needs to be on the device itself when separated from the packaging (this is quite common for other agency requirements for UDI). Also from personal experience, if the device "reuse" is only for a number of times you could include this on the label with the number crossed out. I worked with a device that should/could not be used more than 20 times, so we did put this in the labeling. Guaranteed this is hard to control how many times a person uses a device though there is still reuse of single-use devices too. The comment I would make is there is much more scrutiny and review of lifetime of a device including usable life, serviceable life, and how the device reuse is done by the user under the EU MDR. I can already seen where in the Instructions for Use, there needs to be information provided to the user about the lifetime of the device, how they know it can be used, what to look for during reuse, etc.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 14-May-2020 11:10
From: Shikha Malik
Subject: Reusability
Hello,
Do we have a requirement to specify if a device is reusable or not on the labeling per EU MDR?
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Shikha
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