Biocompatability Testing - Electric Breast Pumps , Silicone Component

Chani

Registered
My company wants to start selling electric breast pumps. We are a virtual manufacturer. I have advised that we need the supplier to send us their Biocompatability tests for the silicone attachment which will come into contact with the skin. The company plans on marketing this item as a medical device. The managing director is not convinced that we need Biocompatability testing and has pointed out that 'breast pumps are sold as appliances and I doubt there is biocompatibility testing on them" . Additionally, silicone is a widely used and accepted substance in the medical device industry. My argument is that we need testing to be done on the final product , to which he asked How can the moulding process change the chemical composition of silicone?" . Any advice on this matter would be appreciated, please link your sources for me to show as objective evidence for wither side of the argument. Thank you!
 

yodon

Leader
Super Moderator
Additives (colorants, etc.) and process agents can impact biocompatibility. (Not saying that's applicable in your case, but it's possible.)

I realize this is in the EU bucket, but FDA published a guidance in 2020 regarding biocompatibility and seemed to offer some leeway regarding testing but I've found that it's a difficult, if not impossible argument, to not test.
 

Philip B

Quite Involved in Discussions
If your product is a medical device, you need to carry out a biological evaluation. Get yourself a copy of ISO 10993-1 (if you haven't already) and start to map out the evaluation. You need to look at the materials of construction of the device, any additives or process agents, any further processing carried out eg sterilisation and the nature of use (transient, medium term or long term). You need to consider all possible biological end points and construct a rationale as to whether testing is necessary or not. Collate all of your findings in a biological evaluation report - this will be the basis for your rationale for having done / not done testing.

In my experience, take Managing Directors who say ' it's not necessary' with a large bucket of salt...
 

Orca1

Involved In Discussions
My company wants to start selling electric breast pumps. We are a virtual manufacturer. I have advised that we need the supplier to send us their Biocompatability tests for the silicone attachment which will come into contact with the skin. The company plans on marketing this item as a medical device. The managing director is not convinced that we need Biocompatability testing and has pointed out that 'breast pumps are sold as appliances and I doubt there is biocompatibility testing on them" . Additionally, silicone is a widely used and accepted substance in the medical device industry. My argument is that we need testing to be done on the final product , to which he asked How can the moulding process change the chemical composition of silicone?" . Any advice on this matter would be appreciated, please link your sources for me to show as objective evidence for wither side of the argument. Thank you!

Biocompatibility testing is required for medical devices that come into contact with the patient's body. Electric breast pumps, when marketed as medical devices, must comply with these regulations. The silicone attachment, which comes into contact with the skin, should undergo biocompatibility testing to ensure safety and compliance.

Relevant regulations and guidelines include:

MDR, ANNEX II (b)(1): Requires the identification of all materials in direct or indirect contact with the patient or user, including biocompatibility of the device.
MDR, ANNEX I, CHAPTER II, 10.3: Devices must be designed and manufactured to be safely used with materials and substances they come into contact with during their intended use.

(For US FDA, if that applies to you) -
21 CFR 890.3110(b)(6): Appropriate analysis and non-clinical testing must validate that the skin-contacting components of the device are biocompatible.
21 CFR 878.3510(b)(2): The patient-contacting components of the device must be demonstrated to be biocompatible.

These regulations and guidelines emphasize the importance of biocompatibility testing for medical devices, including electric breast pumps with silicone attachments. The managing director's claim that breast pumps are sold as appliances does not exempt them from biocompatibility testing if they are marketed as medical devices. Silicone, although widely used and accepted in the medical device industry, still needs to undergo biocompatibility testing to ensure safety and compliance.
 
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