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The Truth About “Hospital Grade” Breast Pumps

January 2, 2026
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- What the FDA actually says -

Many moms hear “hospital grade” breast pumps as recommended by friends, Reddit threads, or even hospital staff and lactation consultants. Here’s the truth, though. Hospital grade is just a marketing term. The FDA does not define or even recognize the term “hospital grade”. Here is a direct quote from the FDA:

“The FDA does not recognize the term “hospital grade”, so this term doesn’t mean a pump is safe.”

fda.gov

Because the term “hospital grade” doesn’t have a regulatory meaning, any company can technically use it without needing to meet a threshold or standard.


What the FDA does have a definition for is “multi-user”.

Single-user (Personal) vs Multi-User (FDA-Defined)

Here’s what the FDA does define:

  • Single-user (personal use)
  • Multi-user (designed and cleared for use by more than one person)

Is sharing a breast pump safe?

Direct guidance from the FDA is pretty clear:


“Renting or sharing these devices can be dangerous if pumps are not designed for multiple users. Powered breast pumps that are designed for single use should never be rented or shared. Only pumps designed for multiple users should be rented or shared.”


It’s important to note that unless a pump is designated as a multi-user pump, it is considered a personal use pump. That means it should only be used by one person. So, while you may see recommendations in mom groups and Reddit that say you can get plenty of pumps second hand, that is not recommended by medical professionals or the FDA.


In fact, the FDA goes so far as to say it’s dangerous to do so! The FDA warns against renting, sharing, or buying used single-user, or personal pumps. Here are some reasons to avoid buying a second-hand, used breast pump:


  • Hygiene and contamination: Breast pumps can contain milk, bacteria, or viruses within the tubing or internal components, even in a closed system.
  • Warranty: Most pumps only have a 1-year warranty. On top of that, the warranty is only available to the person who purchased the pump. Since moms pump for the first year and warranties often don’t transfer, any secondhand pump you get will not have a warranty. Fun fact: Cimilre pumps actually come with a 2-year warranty to help promote the length of your journey.
  • Past use: You never know what another pump has been through. It’s not like you can look up a “pump fax” and find out who has used it, what accidents there have been, and what third-party parts have been used on it.
person holding collection kit after a pump session

💡  Keep in mind, while you may see people selling or offering second hand breast pumps, the FDA advises against sharing a single user breast pump.

Closed System vs Multi-User Breast Pumps

Virtually all breast pumps are closed system. Meaning contaminants do not enter the pump mechanics, often through use of a backflow protector. Just because a pump is closed system, does not mean a pump is multi-user. Whether a pump is multi-user or intended for single use will be noted on the pump box.

Why we use the term “hospital strength”

Due to confusion between the language hospital grade and multi-user, we consciously made the decision to only use the term “hospital strength”. Why do we even use this term at all? The truth is, the term hospital grade has been used in marketing for years. Moms are used to and actively searching for this term – even if there isn’t a specific definition for what that actually means. It’s important to us to be transparent so moms can make an informed decision. The FDA doesn’t classify a certain mmHg as hospital grade, because they don’t recognize the term “hospital-grade”. All claims listed by a manufacturer are based on performance specs, not definitions by the FDA.


Cimilre breast pumps have an mmHg of 285 when single pumping. More specs for each pump can be seen on each pump product page.

Do I need a pump with the strongest suction?

How one body reacts to pumping could be completely different from how another body (or even breast) reacts. Most experts recommend starting with a lower suction strength or level, then increasing slowly to find what works and feels right for your body. While it may seem counterintuitive, using a suction strength that is too high could actually do more harm then good.


Reasons to avoid using a suction strength that is too high:

  • Reduced milk flow: Using a suction that is too strong can compress breast tissue, constricting milk ducts and preventing breasts from emptying.
  • Discomfort or pain: Very strong suction can make pumping uncomfortable and painful, which can inhibit oxytocin release, the hormone responsible for milk let-down. It also makes for a less enjoyable experience.
  • Tissue or nipple damage: Over time, suction that is too strong can cause issues with sensitive areas like the nipple and areola. If this is sustained for a longer period of time over multiple sessions, it could cause damage.
mom sitting on bed while pumping breast milk with baby next to her

Find what works and feels right

No two journeys, bodies, or boobs are alike. Thankfully, there are pump options that give you the flexibility to change suction strength and even cycle speeds so you can dial in on what works and feels right for your body. 


For instance, the Cimilre S6/S6+ Adjustable Breast Pumps give you 17 strength levels between Massage and Expression Modes with 5 speeds per level to choose from. That’s 85 setting combinations to really fine tune pump sessions. It also has GentleFlow Technology ™ for comfortable and efficient pump sessions. 

The S7 Dual Pro Rechargeable gives you 12 strength levels between Massage and Expression Modes with the ability to change strength on each side to even supply or help with sensitivity. There are also 3 speeds to choose from when in SYNC Mode. Both are covered through insurance! It’s important to choose a primary pump that gives you a variety of levels to choose from so you can find what makes your pump sessions smooth and efficient.


Bottom line, while there may not be a formal definition for “hospital-grade”, there are other factors to consider when choosing a pump that will give you flexibility to adjust and personalize pump sessions based on what your body responds to best.

Bottom line, while there may not be a formal definition for “hospital-grade”, there are other factors to consider when choosing a pump that will give you flexibility to adjust and personalize pump sessions based on what your body responds to best.

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