Use of hand cream inside gloves in the cleanroom for medical devices

D

DesiQE

We manufacture stent systems - implants (stents - bare metal and drug eluting) and we make catheters as well. The operators in the cleanroom are complaining about the use of gloves making their skin dry and crack up. And the German laws are telling them that if they use gloves for more than 2 hours, they need to apply a skin cream underneath! But that beats the whole point of washing and disinfecting their hands. Also, the risk of the cream being on the gloves while they put them on and that transferring to the product is too high. But since the german law/doctors are saying that, and also not to lose the operators, we need to look into some actions here. Could you suggest some things I could consider here?

Thanks, in advance.
 

J0anne

Joanne
Some ideas:

Staff rotation
Change glove supplies/supplier
Sterile barrier cream underneath gloves
Change handwash supplies/supplier
Change of procedure for putting on gloves so that cream can be applied first and then someone else could put their gloves on them on their behalf
 

Michael_M

Trusted Information Resource
We manufacture stent systems - implants (stents - bare metal and drug eluting) and we make catheters as well. The operators in the cleanroom are complaining about the use of gloves making their skin dry and crack up. And the German laws are telling them that if they use gloves for more than 2 hours, they need to apply a skin cream underneath! But that beats the whole point of washing and disinfecting their hands. Also, the risk of the cream being on the gloves while they put them on and that transferring to the product is too high. But since the german law/doctors are saying that, and also not to lose the operators, we need to look into some actions here. Could you suggest some things I could consider here?

Thanks, in advance.

Is there a way you can contact a local hospital that performs surgery and see what they do to maintain compliance to the law?
 
D

DesiQE

Some ideas:

Staff rotation
Change glove supplies/supplier
Sterile barrier cream underneath gloves
Change handwash supplies/supplier
Change of procedure for putting on gloves so that cream can be applied first and then someone else could put their gloves on them on their behalf

Hi J0anne,

All great ideas. Thanks. But do you know if anyone in the device industry making vascular implants is using such sterile cream? I haven't been able to find anyone that tells me they use this.

Procedure changing is risky. Can't rely on it being followed. :thanks:
 
D

DesiQE

Is there a way you can contact a local hospital that performs surgery and see what they do to maintain compliance to the law?

Michael,

Great idea. :applause: Will contact my sales team to secure that piece of info for me.
 
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