Information for clinicians

The Milkdrop breast pump cushion is a soft silicone cushion that stretches over the head of Medela, Spectra and Philips Avent breast pumps. 

It is to be used by lactating women to provide a softer interface between the breast and the existing breast pump. It is included in the ARTG (#352892) as a Class I medical device.

Milkdrop breast pump cushion pilot preliminary observations

 

A pilot study was conducted in March 2021, which found: 

  • 92% of women found pumping more comfortable
  • comfort increased (score: 5 /10 to 9 / 10)
  • nipple swelling decreased (score: 6 /10 to 0 /10)
  • nipple swelling decreased (6 /10 to 0.5 / 10), redness decreased (6 /10 to 0.5/10) and damage decreased (4/10 to 0/10) for women identifying as having an uncomfortable pumping experience.
  • 73% of women collected about the same or more milk.

Further benefits will be evaluated through post-market studies, including the effect of the cushion on the perception of pain, comfort and milk production. 

 

 

Detailed information

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.

We provide reusable, sterilisable cushions for use within your clinic or practice, and discount codes for patients ordering on your recommendation. Order a sample.

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. 


Preliminary observations from our pilot indicate that lactating women perceive lower levels of pain, redness and swelling in the nipple, and higher levels of comfort when using the cushion on their existing pump. Most women perceive that they collect the same or more milk when using the cushion on their existing pump. However, 15% of women have difficulty with milk flow due to the 'bulkiness' of the cushion. We are developing a cushion specifically for these women, which will be available in June. Download our pilot preliminary observations report

The cushion is 3-4x softer than existing breast pump cushions and over 10x softer than existing breast pump heads. The Milkdrop cushion measures 10A on the Shore Hardness scale measured with a durometer. Most breast pump heads inserts or cushions measure between 35 and 45A, and most breast pump funnels measure over 100A.

The device is designed to withstand 12-months, assuming maximum use of 8 times per day, at 30 minutes per pumping session. 

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 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.

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