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Prenatal Monitors


Why Doesn’t NextStep Carry Prenatal Monitors?
What You Need To Know About Prenatal Monitors

- Prenatal monitors that utilize Doppler (ultrasound) are illegal when sold or rented without a doctor’s prescription and can be potentially harmful if used excessively.

- Passive prenatal monitors while safe, are unfortunately ineffective. They are consistently unable to pick up fetal heartbeats or meet consumer’s expectations.



Learn more below...




Ultrasound Doppler Fetal Monitors
Prenatal monitors (also called fetal monitors and Doppler monitors) that actively radiate ultrasonic frequencies into the body are regulated by the FDA as Class II medical devices. These devices most commonly use frequencies of 2 or 3 MHz. Doppler monitors are very easy to use and are effective at allowing you to hear a fetal heart beat.

Your doctor will use a Doppler monitor to check for a fetal heartbeat during an office visit. There are also a wide range of consumer Doppler monitors available that provide great performance at affordable prices. However, Doppler monitors are classified by the FDA as Class II medical devices regardless of the level of power they use. This means according to the FDA they can only legally be sold or rented under the prescription of a physician and used under your physician’s guidance.



What’s The Concern?
FDA physicist Robert Phillips, Ph.D., with the Center for Devices and Radiological Health (CDRH) says “when ultrasound enters the body, it heats the tissues slightly. In some cases, it can also produce small pockets of gas in body fluids or tissues.” Phillips says the long-term effects of tissue heating and of the formation of partial vacuums in a liquid by high-intensity sound waves (cavitation) are not known. Using ultrasound equipment only through a prescription ensures that pregnant women will receive professional care that contributes to their health and to the health of their babies, and that ultrasound will be used when medically indicated (Source: FDA (PDF)).

There will always be that expecting mother who uses a Doppler monitor every night for extended periods of time. It is situations like these that the FDA is looking to avoid by controlling these monitors with a Class II prescription only classification.



What About Those Advertising As "FDA Approved"?
Some companies promote their fetal Dopplers as "FDA Approved." This is true, but they fail to add they are not approved by the FDA for "over the counter" use. These Class II medical devices are approved for prescription only. If a company disputes this ask them to provide what is called the 510K Summary for their product. This public document is the approval paperwork with the FDA that will specify if the device is approved for over the counter use or prescription only.



Self-Diagnosis
Another less talked about issue is the false sense of security that a mother may get from using a prenatal monitor at home. There are cases where a mother simply did not feel right about her unborn baby’s condition or level of movement. She was able to hear a heartbeat using a home prenatal monitor and as a result delayed contacting her doctor. Whenever you have a concern you should always contact your doctor. A prenatal monitor should never be relied upon in lieu of seeking medical attention.



Ultrasound Imaging & 3D Imaging
The same ultrasonic radiation can also be used to generate a visible image at your doctor’s office or at companies offering prenatal videos (including 3D). Again, while safe for short periods under your doctor’s supervision, there may be adverse effects if exposed for extended periods of time. Having your doctor use ultrasound for short periods is perfectly safe. However, using a Doppler monitor nightly at home or going for repeated visits to a prenatal 3D company is not recommended by the FDA.



Not Everyone Follows The Rules
You can still find a large number of merchants selling prenatal Doppler monitors. We even came across a well-known national drug store chain selling them on-line. Just because you can purchase an item on-line doesn’t mean it is safe or legal to do so. It is a liability for the manufacturer, merchant and consumer. Fetal Dopplers are specifically Prohibited on Amazon because selling them without a prescription is illegal. However even Amazon is failing to enforce the law and its own rule.



The NextStepBabyMonitors Commitment
NextStepBabyMonitors is committed first and foremost to our customer’s safety as well as abiding by the law. As a result we do not sell any Doppler prenatal monitors or any systems that radiate ultrasonic frequencies into the body.



Passive Prenatal Monitors
As an alternative we have taken a close look at passive prenatal monitors. These devices include fetal stethoscopes and basic monitors that simply listen and try to amplify the sounds. Being passive means no ultrasonic energy is directed into the mother’s body which means there is no health risk no matter how long these monitors are used. Unfortunately passive monitoring simply does not work very well.

Without active ultrasound, passive devices are unable to pick up fetal heartbeats with any consistency and are simply unable to meet the expectations demanded by today’s consumers. As a result NextStepBabyMonitors does not carry any passive prenatal monitors.



The Bottom Line
Doppler fetal monitors and active ultrasound imaging are great tools when used by your doctor or in cases where your doctor has advised you should monitor while at home under their prescription. Ultrasound and 3D imaging by commercial vendors should be minimized or avoided altogether according to the FDA. And purchasing and using a Doppler fetal monitor (Class II medical device) without a prescription is illegal and if used for long durations may have the potential for effects that have not yet been fully studied.





Referenced FDA Regulations & Classifications
Regulation Number: 21 CFR 884.2740
Regulation Name: Perinatal monitoring system and accessories
Regulation Number: 21 CFR 884.2960
Regulation Name: Obstetric Ultrasonic Transducer
Regulatory Class: II
Prescription Use: Part 21 CFR 801 Subpart D
FDA Consumer Bulletin: Click Here (PDF)



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