This page provides additional information for health professionals, carers and partners about the manufacturing and medical regulation compliance of the Milkdrop silicone breast pump cushion.
The Milkdrop breast pump cushion is a soft silicone standalone insert that fits a variety of existing breast pumps. It is to be used by lactating women to provide a softer interface between the breast and the existing breast pump.
The cushion is designed to make pumping more comfortable for women experiencing pain, damage or discomfort from using breast pumps by providing a softer interface* between the breast and the pump. Further benefits will be evaluated through post-market studies, including the effect of the cushion on the perception of pain, comfort and milk production.
*The Milkdrop cushion measures 10A on the Shore Hardness scale. Most breast pump heads inserts or cushions measure between 35 and 45A, and most breast pump funnels measure over 100A.
See general instructions.
The cushion is designed for re-use. Clean by washing in warm soapy water, then air dry on a clean towel. The cushion can withstand the dishwasher and steam sanitisers. The silicone has been tested to withstand steam, ethylene oxide and gamma radiation sterilisation methods as specified by the silicone manufacturer (Wacker Chemie) without materially affecting the mechanical properties of the device:
Steam - DIN EN ISO 17665 – ageing test specified in DIN EN 868-8, 134°C for 5 minutes
Ethylene oxide (ETO) - DIN EN ISO 11135: 1h, 54°C, 600mg/L ETO
Gamma radiation - DIN EN ISO 11137-2, 2007
The device design life is 6-months, assuming maximum use of 8 times per day, at 60 minutes per pumping session.
Safety and quality control
The device is manufactured in Melbourne in a facility certified to ISO13485 (Medical Devices), ISO14871 (Application of Risk Management to Medical Devices) and ISO9001 (Quality Management). The device is made from USP Class VI silicone certified to ISO 10993 and manufactured in clean environment to ISO 14644. The silicone meets the food regulation requirements of FDA CFR Section 177.26000 and BIR Recommendation XV Silicone. Routine toxicology testing is undertaken on packaging. The device is included in the ARTG (#352892) as a Class I non-sterile, non-measuring device under GMDN code 35337: Shield, nipple, reusable.
The device is manufactured and sponsored by Milkdrop Pumps Pty Ltd (2/23 Foster Street Surry Hills NSW 2010 Australia). Milkdrop Pumps is majority owned by Alexandra Sinickas and Dr Andrew Mason.