Labeling requirements of Alcohol (Isopropanol) Swabs

[Brad Oh]

Hi, All

is there any specific regulation that I could refer regarding Alcohol swab Labeling?

I am wondering if the package labeling need to indicate the volume of alcohol(Isopropanol) and swab's size.

 

[Ronen E]

First a definition is needed:

1. What is the relevant regulatory domain (USA, EC etc.)?
2. What is the intended use of the swab?

 

[Brad Oh]

here is the answer for your question.
1. domain is EC. if there is regulation for US FDA, it is OK. we just want to know there is guideline or regulation for Alcohol swabs labeling (i.e : what information should be included in the labeling)

2. intended use - Topical antiseptic for preparation of the skin prior to puncture or injection.

 

[Ronen E]

here is the answer for your question.
1. domain is EC. if there is regulation for US FDA, it is OK. we just want to know there is guideline or regulation for Alcohol swabs labeling (i.e : what information should be included in the labeling)

2. intended use - Topical antiseptic for preparation of the skin prior to puncture or injection.

Hi,

According to this page, the FDA does not exercise its powers over alcohol swabs any more.

In the EC, there are typically no specific requirements for low risk devices. You should be meeting the applicable Essential Requirements, namely look at ER 13 (MDD annex I).

Cheers,
Ronen.

PS: If you run an image search for "alcohol swab" you will see many items where the individual pouch doesn't state either the alcohol volume or the swab's size; including ones that bear the CE mark; including ones from leading brands (e.g. BD).

 

[AMW02053NOV]

Does anyone have a handle on the new regulation (or borderline status) of alcohol swabs in EU under MDR? We have had a vendor change the status of their alcohol swabs from CE (Class I MDD) to "cosmetic use". This was not acceptable to one of our EU member states. Thanks in advance for any help.

 

[Junn1992]

Swabs are class I under MDR.

 

[Vetty007]

Swabs without impregnation are Class I, but not necessarily if they are soaked with alcohol. Classification strongly depends on the use and could be also Class III due to alcohol being a medicinal component and if its used for skin disinfection, II b could be also an Option for disinfection purposes. Disinfection wipes for use before injection are often only cosmetics and claimed only for skin cleaning, but there are also others with IIb (IIa) available claiming surface disinfection and skin cleaning (disinfection). In a discussion with a NB they told me, that such wipes should be classs III (Which is also in accordance to the borderline Guidance document), even if this was an answer under MDD, it would be also due under MDR.