Breast Pumps

Overview

Breast pumps are medical devices regulated by the FDA. These devices are often used by breastfeeding women to extract ("express") their breast milk. Breast pumps can also be used to maintain or increase a woman's milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch-on to its mother's breast more easily.

Many women find it convenient, or even necessary, to use a breast pump to express and store their breast milk once they have returned to work, are traveling, or are otherwise separated from their baby. A breast pump can be used as a supplement to breastfeeding and some pumps are designed to mimic the suckling of a nursing baby.

If you have questions about breast pumping or breastfeeding, the best source of information is a qualified health care professional (e.g. doctor, nurse practitioner, lactation consultant, or midwife).

All breast pumps consist of a few basic parts:

  1. Breast Shield: a cone-shaped cup that fits over the nipple and the circular area surrounding the nipple (the areola).
  2. Pump: creates the gentle vacuum that expresses milk. The pump may be attached to the breast-shield or have plastic tubing to connect the pump to the breast-shield.
  3. Milk Container: a detachable container that fits below the breast-shield and collects milk as it is pumped. The container is typically a reusable bottle or disposable bag that can be used to store the milk or be attached to a nipple and used for feeding a baby.

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Types of Breast Pumps

  • Manual pumps
  • Battery-powered pumps
  • Electric pumps

A breast pump is typically held in place by hand or by a nursing bra, a breast pumping bra or a band.

Breast pumps extract milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple, which expresses milk from the breast. Each suction and release combination is called a cycle.

Manual Pumps

Once the breast-shield is placed over the nipple and areola, a handle or lever is squeezed to create suction and express milk from the breast. The breast milk is then collected in an attached container.

Some manual pumps have a small tube which is pumped in and out of a larger tube to create a vacuum that expresses milk and collects it in an attached container.
Another type of manual pump, called a bicycle horn pump, consists of a hollow rubber ball attached to a breast-shield. Some experts discourage the use of bicycle horn pumps because they may be difficult to clean and dry.

Battery-Powered and Electric Pumps

A powered breast pump uses batteries or a cord plugged into an electrical outlet to power a small motorized pump that creates suction to extract milk from the breasts. It may have one or more long tubes connecting the breast-shield to the electric pump. The pump has a control panel with a dial or switch to control the degree of suction.

Some powered breast pumps can be adjusted to create different patterns of suction. Some manufacturers claim the adjustable suction allows the user to find a setting that closely mimics her nursing baby, including features with phases such as let-down. Let-down is the natural reflex which starts the release of milk when the nipple area is stimulated, such as by breastfeeding or breast pumping.

Because these breast pumps rely on a power source, women who use powered breast pumps should be prepared for emergency situations when electricity or extra batteries may not be available. If breastfeeding is not an option, having extra supplies for pumping and a back-up method, such as a manual breast pump, may help a woman maintain her breast pumping schedule during an emergency.

Pumping Types

There are two different pumping types: single and double.

Choosing a Breast Pump

Manual or electric, single or double pump, buy or rent? With the number of options available, choosing the most suitable breast pump for your pumping needs can be tricky.

Keep in mind that the multitude of pump types reflects the many individual needs of lactating women, and what worked well for your mother or a friend may not work well for you. Choosing your ideal breast pump is a decision best made after considering your needs and weighing all of the options.

There are several factors that can help determine your ideal breast pump. If you are having difficulty choosing a pump, a qualified health professional, such as your doctor or a certified lactation consultant can help guide your decision. The following are some points to consider when choosing a pump.

1) How do you plan to use the pump?

    • Are you using a pump in addition to breastfeeding?
    • Do you plan to pump and store several containers of milk?
    • Are you returning to work?
    • Will you be away from your baby for several days?

2) How much time will it take you to pump?

The amount of time it takes to pump varies, but certain types of breast pumps may be easier to use and extract milk faster.

If you plan to pump at work or do not have a lot of time to pump, you may want to consider a battery or electrically powered breast pump. A double pump (which extracts milk from both breasts at the same time) may also decrease the amount of time it takes to pump because both breasts can be emptied simultaneously.

3) Are the pump's instructions easy for you to understand?

If possible, review the instructions included with several different pumps and choose a pump that is easy for you to assemble, use and clean. If you are shopping for a pump in a store, ask a salesperson if the store has display breast pumps so you can practice assembling and taking apart several different pumps before you buy one.

Keep in mind that for health reasons, most stores will not allow you to return a breast pump.

4) Where will you be using a pump?

Manual and battery-powered pumps can be easy to transport and use in small spaces, while an electric pump will require an outlet to power the pump and are larger and heavier and some women may find them more difficult to transport.

Keep in mind that powered breast pumps require advanced planning for emergency situations when electricity or extra batteries may not be available. If breastfeeding is not an option, extra supplies and or a manual back-up pump may help a woman maintain her breast pumping schedule during an emergency.

5) Do you need a pump that is easy to transport?

If you travel frequently, or plan to pump at work, consider buying a lightweight pump that transports easily in a carrying case that holds the pump and pumping supplies.

If you plan to pump in the same place every time, you may not need to worry about how easy it is to transport.

6) Do the breast-shields fit you?

Make sure that the breast-shield opening is the correct size for you. You should be able comfortably center your nipple inside the breast-shield.

Many pumps are sold with one size of breast-shield. Before buying a pump, check the manufacturer's website to see if you can replace the breast-shields with a different size or texture that is comfortable for you and will work with your pump in case the breast-shields sold with the pump are uncomfortable.

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Buying and Renting a Breast Pump

Breast pumps are often sold at hospitals, baby supply stores and the baby supply sections of toy stores. They are also available at many online retailers. If you buy a breast pump online, make sure you are buying from a reputable source. Also check the store's return policy and customer support statement before you place an order.

Before you buy a pump, check the manufacturer's website or review the instructions on the box. Make sure you can easily assemble and use the breast pump. Keep in mind that if you buy a pump and decide you do not like it, most stores will not allow you to return it for health reasons.

A certified lactation consultant may be able to help you decide which breast pump may be right for you.

Renting a Breast Pump

An alternative to buying a pump is to rent one. Many hospitals, lactation consultants, and specialty medical supply stores rent breast pumps that are safe for multiple users (sometimes referred to as hospital-grade pumps). These pumps are designed to decrease the risk of contamination and each renter is required to buy a new accessories kit that includes breast-shields and tubing.

Please note that the term "hospital-grade pump" is not recognized by the FDA and there is no consistent definition for this term, so individual companies could mean different things when they label their breast pumps as hospital-grade.

If you are considering renting a pump, ask for references from a trusted health professional such as your doctor, your baby's doctor or a certified lactation consultant. Also check with your local Better Business Bureau Disclaimer and the device manufacturer before renting a pump to ensure that the rental company is reputable and the breast pump you will be renting is safe for multiple users.

Used Breast Pumps

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.

Programs to Help Pay for a Breast Pump

During the prenatal care period, contact your private health insurance company to determine what assistance is provided for breastfeeding and breast pumping equipment, including the assistance of a certified lactation consultant or breastfeeding clinic for supportive care.

Some state health departments offer programs to help women purchase or rent a breast pump. For more information on the programs offered by your state, contact your state health department.

Some women may also be eligible to receive assistance with breastfeeding supplies, such as a breast pump, through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program.

Using a Breast Pump

Before using your breast pump for the first time it is a good idea to read through the entire instruction manual. The instruction manual can help you learn the correct way to assemble and use your pump. It should also include the manufacturer's contact information. If the instruction manual is missing from the box, check the outside of the box for a customer service line you can call to request a copy.

General Tips for Using a Breast Pump

Wash and Dry Your Hands

Before using your pump, wash your hands with soap, scrubbing for 10-15 seconds, then rinse with plenty of warm water. After washing, dry your hands thoroughly with a clean paper towel.

You do not need to wash your breasts before you pump unless you have been using a cream, ointment, or other product on your breasts that must be removed first. Check the labels on products you have been using and ask your doctor for advice.

Assemble Your Pump

Consult your pump's instruction manual for the proper way to assemble your pump.

Get Comfortable

Find a clean and comfortable place where you can relax and not be disturbed while pumping. If you have an electric pump, find an area near an outlet so you can plug the pump in. Some mothers find it helpful to hold their baby, or to have a picture of their baby in front of them while they pump.

Position the Breast-Shield(s)

Consult your instruction manual for tips on positioning your nipple in the breast-shield(s). Your nipple should fit comfortably in the center of the opening in the breast-shield(s). Gently adjust the breast-shield(s) until it feels comfortable without pinching, pulling or otherwise irritating your nipple or breast tissue.

Begin Pumping

If your pump is electric or battery-powered, turn the switch to the on position and the lowest suction and/or speed (cycle) setting. If you are using a manual pump, begin pumping. Consult your instruction manual for suggestions on an appropriate pumping speed. Adjust the speed until you find one that is comfortable for you.

What to Expect While Pumping

A qualified health professional, such as a certified lactation consultant, can help determine the best pumping method for you. Keep in mind that the amount of milk produced is different for everyone. A typical pumping session lasts about 10-15 minutes per breast, but you should only pump as long as it is comfortable and productive for you.

Your breast milk may not flow immediately after you start pumping, so try to be patient. When it does flow, your milk should be collected in the container attached to your pump. If milk is leaking out of your pump, stop pumping and make sure you have assembled the pump correctly before trying again. If your pump continues to leak, call the manufacturer's customer service line for help.

When you have finished pumping, gently insert a finger between your breast and the breast-shield to break the vacuum seal. Remove the bottle or bag of collected milk from the rest of the pump, and label it with the date and time of pumping before storing it in the refrigerator or freezer.

Cleaning a Breast Pump

Cleaning Breast Pump Parts

All breast pump parts that come in contact with breast milk, such as bottles, valves and breast shields, should be cleaned after each use. It is not possible to completely sterilize breast pump parts at home, even if you boil them. However, sterilization is not necessary to keep these parts safe and sanitary. You can do that by thoroughly washing away germs and bacteria with liquid dishwashing soap and warm water.

Some breast pumps parts can be put in the top rack of a dishwasher. Consult your instruction manual to make sure pieces are dishwasher safe before you put them in the dishwasher.

It is not necessary to clean breast pump tubing unless it comes in contact with breast milk. If you wash your tubing, make sure you hang it to air dry before attaching it to your breast pump. If small water drops (condensation) appear in the tubing after you have pumped, turn the pump on for a few minutes until the tubing is dry.

Microwave sterilizers are available for breast pump parts, but these sterilizers do not meet the FDA definition of sterilization. However, they will sanitize the parts, which is sufficient for processing between uses for a single user.

Cleaning the Electrical Unit for a Powered Breast Pump

Electrical units, which hold the motor and batteries, should be wiped down with a clean paper towel or soft cloth after each use.

The electrical unit should never be put into water or other liquids for cleaning. It should also never be cleaned using a microwave sterilizer.

Some breast pump manufacturers make wipes just for cleaning breast pumps, which can make cleaning more convenient when you are away from home. Even if these wipes are used, breast pump parts that come into contact with breast milk should still be cleaned using liquid dishwashing soap and warm water before pumping.

Basic Cleaning Method

  • Consult the instruction manual to determine which parts should be washed and the best method for removing parts that must be cleaned.
  • Rinse each piece that comes into contact with breast milk in cool water as soon as possible after pumping.
  • Wash each piece separately using liquid dishwashing soap and plenty of warm water.
  • Rinse each piece thoroughly with hot water for 10-15 seconds.
  • Place the pieces neatly on a clean paper towel or in a clean drying rack and allow them to air dry.
  • Avoid using cloth towels to dry your pump parts because they can carry germs and bacteria that are harmful to your breast milk and your baby.
  • Once the pump parts are dry, assemble the pump before you store it or use it.
  • Try not to touch the inside of any parts that will come in contact with your breast milk.

Injury and Infection

The first few times you pump may feel uncomfortable but pumping should not be painful, result in sore nipples, or cause bleeding. Pain, sore nipples, and nipple irritation or bleeding may be signs of an injury.

Signs of infection can include soreness, yellowish discharge, a fever, and/or flu-like symptoms, such as feeling run down or very achy. Check with your health care provider if your symptoms do not improve within 24 to 48 hours.

If you are injured or experience persistent pain or bleeding when using your breast pump, contact your doctor, lactation consultant or other health care professional for advice.

If you are having trouble using your pump, a qualified health care professional may be able to help you.

If your pump is not working, contact the manufacturer. Check the box your breast pump came in or call directory assistance for the manufacturer's contact information.

Reporting Problems to the FDA

Reporting of injuries and other adverse events can help the FDA identify and better understand potential risks associated with medical devices, like breast pumps. If you suspect a problem with a breast pump, we encourage you to file a voluntary report with the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Things you might not think to report, that should be reported:

  • Pump problems (breaking, not working right)
  • Infections that might be related to the pump
  • Presence of mold or mold-like substances in a pump

Additional Information

  • What to Know When Buying or Using a Breast Pump
    https://www.fda.gov/consumers/consumer-updates/what-know-when-buying-or-using-breast-pump
  • Womenshealth.gov Breastfeeding Website
    http://www.womenshealth.gov/breastfeeding/index.cfm?page=231
  • Women, Infants, and Children (WIC) State Contacts
    https://www.fns.usda.gov/wic
  • Search for all FDA cleared breast pumps through [email protected]
    https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?st=breast%20pumps
  • MedWatch: The FDA Safety Information and Adverse Event Reporting Program
    https://www.fda.gov/medwatch-fda-safety-information-and-adverse-event-reporting-program
  • Food Safety for Moms-To-Be
    https://www.fda.gov/food/people-risk-foodborne-illness/food-safety-moms-be
References
FDA. Breast Pumps.

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices

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