Information for clinicians

Description

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. 

Benefits

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. 

Download our report. 

Milkdrop breast pump cushion pilot preliminary observations

Report summary:

  1. 92% of women found pumping more comfortable

  2. comfort increased (score: 5 /10 to 9 / 10 where 10=very comfortable).
  3. nipple swelling decreased (score: 6 /10 to 0 /10 where 10=severe and 0=none)
  4. 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.
  5. 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.

Instructions

See general instructions page and instruction video.

Cleaning 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

Design Life

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.

Manufacturer 

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.

 

Frequently Asked Questions

What are the intended benefits of the cushion?
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

Are you available outside Australia? 

We have not yet registered with medical device regulators outside Australia, but plan to soon.
What do you mean by ‘soft’?
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.

Can I have a sample for my clinic or practice?

We provide reusable, sterilisable cushions for use within your clinic or practice, and discount codes for patients ordering on your recommendation. Please contact us at hello@milkdroppumps.com. We’d love to hear from you.

Do you provide education or demonstrations?

Of course! If you would like us to provide a demonstration or education session, please contact us at hello@milkdroppumps.com. In the meantime, please see our instructions here.


Where can I find more information about the product?
For help with existing cushions, see troubleshooting FAQs.
For updates, see our instagram @milkdrop_pumps


Didn't answer your question? See our full FAQs.

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