Safety Considerations for Secondhand Breast Pumps

Thanks to the Affordable Care Act that went into effect in August of 2012, most health insurance plans are now required to provide breastfeeding equipment and counseling for pregnant and nursing women.  Learn more about getting a free breast pump.

The re-use of electric breast pumps is a hotly debated topic.  It is up to each individual to decide whether or not to use a secondhand pump.  To help you make an informed decision, we have summarized information about breast pump regulations, breast pump system types and used breast pump safety, as well as provided a chart with detailed information about various breast pump brands and models.

Double Breast Pump
Breast pumps are classified as medical devices and are therefore regulated by the U.S. Food and Drug Administration (FDA).  The FDA website states on their website:

Only breast pumps that are designed for multiple users should be used by more than one person. With the exception of multiple user pumps, the FDA considers breast pumps to be single-user devices. That means that a breast pump should only be used by one woman because there is no way to guarantee the pump can be cleaned and disinfected between uses by different women.

Breast pumps that are reused by different mothers can carry infectious particles, which can make you or your baby sick.

Buying a used breast pump or sharing a breast pump may be a violation of the manufacturer’s warranty and you may not be able to get help from the manufacturer if you have a problem with the pump.

For more information, visit: Are Used Breast Pumps A Good Option?

The article linked at the end of the paragraph above from the FDA website is on the La Leche League website.  It includes information about open vs closed systems and health and hygiene issues.

What is a Hospital-Grade Pump?

The short answer: the term “hospital grade pump” is not  officially defined or regulated.
The FDA website used to say  “Only FDA cleared, hospital-grade pumps should be used by more than one person. With the exception of hospital-grade pumps, the FDA considers breast pumps single-use devices,” with no explanation of how a “hospital grade pump” was defined.  In her 2011 article, Why does the FDA tell consumers that breast pumps can’t be reused?, Tanya Mannes successfully gets to the bottom of the issue by interviewing an FDA representative who stated, “There is no such thing as a hospital-grade breast pump…when we clear them as breast pumps we don’t clear them as hospital-grade pumps. Our OB/GYN branch that reviews breast pumps is generally silent on reuse.”
Although some breast pump manufacturers still use the “hospital-grade” term and old FDA website wording is still quoted on blogs and in online articles, the FDA has since changed their wording by replacing the term “hospital grade pump” with “multiple user pump.”  The FDA explains that the term “hospital-grade” “is not one FDA recognizes, and there is no consistent definition,” in their article Breast Pumps: Don’t Be Misled – Get the Facts.

Closed System vs Open System

Electric breast pumps are made using one of two systems: closed system or open system.  A breast pump with a closed system is built with the pump’s diaphragm or filter placed in a way to ensure that milk never touches the pump motor.  Depending on where the diaphragm or filter is placed, it may also separate the collection system (bottles, bottle connectors, etc.) from the tubing so that milk never accidentally touches the tubing, as well.  Breast pump tubing that becomes moist or moldy may require cleaning or replacement.
A breast pump built with an open system can allow breast milk, which can carry viruses and can also potentially include blood if the person using the breast pump has cracked nipples, to enter the pump motor, which cannot be cleaned and sterilized on a personal or single-user pump.  Airborne bacteria and moisture from condensation can also reach the pump motor leading to unseen mold and bacteria growth.  Although open system breast pumps have more risk of bacteria and mold growth, some mothers find that they provide better suction than closed system pumps.  Wikipedia provides a more detailed explanation of open vs closed system breast pumps.

What About Closed System Single User Pumps?

The FDA guidelines state that “only FDA cleared multiple user pumps should be used by more than one person.”  Their website does not have any mention of open systems or closed systems, although they link to La Leche League International’s article (mentioned above) that addresses the subject of open vs closed.  Although the FDA replaced the term “hospital grade pump” with “multiple user pump,” they still do not offer much information about how the new term is defined.  It is likely that Tannya Mannes’ 2011 findings that “the FDA allows companies to decide whether to market their products as single-user or multi-user devices” is still true.  Following this information, regardless of the breast pump design, it is up the the manufacturer to decide if it is intended for multiple users or single users.
The only companies we have found that manufacture breast pumps designated for multiple users while still being marketed and priced to be bought by individual mothers are Hygeia and Spectra Baby USA** (see our breast pump comparison chart for more information).

How Long Do Breast Pumps Last?

Breast pumps have lifespans and intended uses that vary by model and manufacturer.  Whether you are planning to use a secondhand breast pump or a new breast pump, take into consideration how often you plan to pump (exclusively–pumping for every feeding, while at work, or for an occasional night out) and for how many months/years.  For secondhand breast pumps, the amount of use from previous owner(s) should also be factored.  Some breast pump manufacturers offer charts comparing the intended uses and lifespans of their various models.  This information can also be found in some product manuals, which are often available on manufacturers’ websites.

Our Final Thoughts

  • It appears that the FDA does not have clear regulations defining single-user and multiple-user electric breast pumps and it is up to breast pump manufacturers to decide whether to market their products as single-user or multiple-user.  This means that two different pumps with identical designs could be labeled in two different ways, one as single user and the other as multiple-user, depending on the marketing decision(s) of the manufacturer(s).
  • Open system pumps can allow breast milk and moisture into the breast pump motor, which can lead to the growth of bacteria and mold inside the pump.  This brings into question the safe lifespan, even for a single user, of single-user open system pumps, which are built so that they cannot be taken apart and sterilized.
  • Closed system breast pumps do not allow milk to touch pump motor, but they do involve parts that touch or have the potential to touch breast milk (flanges, valves, tubing–depending on where the diaphragm or filter is located, etc.).  These parts can usually be bought separately and are often sold as accessory kits.
  • Closed systems are not 100% foolproof.  Depending on the design of the breast pump, user error like improper assembly or using broken/torn parts can potentially allow breast milk to get past the protective diaphragm or filter and into the tubing or pump motor.

 

The table below includes information about a variety of double electric breast pumps.  It includes the EnJoye pump by Hygeia and Spectra Baby USA’s** pumps; the only pumps we have found that are designated for multiple users while still being marketed and priced to be bought by individual mothers.  If you are trying to find information for a pump not included, the manual (usually available on the manufacturer’s website) will most often state if the breast pump is an open or closed system, if it is intended for multiple users, and if the warranty will be voided if the pump is transferred or sold to another user.

Double Electric Breast Pump Comparison Chart

ManufacturerModelsOpen
vs
Closed
System		Single User
or
Multiple User		Warranty voided
if more than
one user?		Other Information
AmedaPurely Yours®
Purely Yours Ultra™
Lactaline™ 		Closed
System
Single UserYes, voided
AmedaAmeda Elite™
Ameda Platinum™		Closed
System		Multiple UserNot voidedPumps cost upwards of $900. Usually purchased by hospitals & service providers to rent to customers.
Each user uses their own set of accessories.
AventComfort DoubleClosed
System		Single UserYes, voided
The First YearsBreastflow® Memory PumpOpen
System		Single UserYes, voided
The First YearsBreastflow® miPumpOpen
System		Single UserYes, voided
HygeiaEnJoye™ Closed
System		Multiple UserNot voidedEach user uses their own set of accessories. Pump is priced for and marketed to individual mothers.
HygeiaEnDeareClosed
System		Multiple UserNot voidedPumps cost upwards of $900. Usually purchased by hospitals & service providers to rent to customers.
Each user uses their own set of accessories.
LansinohAffinity®
&
Affinity® Pro™		Closed
System		Single UserYes, voided
MedelaPump In Style®Open
System		Single UserYes, voided
MedelaFreestyle®Likely
Closed
System*		Yes, voided
MedelaSymphony®
Closed
System		Multiple UserNot voidedPumps cost upwards of $1,000. Usually purchased by hospitals & service providers to rent to customers.
Each user uses their own set of accessories.
PlaytexSystem PetiteClosed
System		Single UserYes, voided
Spectra Baby USAS1
S2		Closed
System		Soon to be Multiple User**Not voidedEach user uses their own set of accessories. Pump is priced for and marketed to individual mothers.
Spectra Baby USADew 350Closed
System		Single User**Not voidedEach user uses their own set of accessories. Pump is priced for and marketed to individual mothers.

*The Medela Freestyle double electric breast pump appears to be designed as a closed system, with a diaphragm between the milk collection system (bottles, breast shields, etc.) and tubing.  We contacted Medela in 11/2013 to verify the system type and they stated that they do not designate their breast pumps as open or closed systems.

**We contacted Spectra in 11/2013 and learned that Spectra’s S1, S2 and Dew 350 breast pumps are classified as single user pumps, but Spectra stated that they are in the process of changing the status of the S1 and S2 to multiple user.  Regardless of the user classification (multiple user or single user), Spectra states that all of their electric breast pumps are safe to use with multiple users, as long as each user has their own accessory kit (breast shield, tubing, etc.).  Spectra’s breast pump warranties are not voided if the pumps are used by more than one user.