The Limerick team are incredibly proud to provide hospital grade support and equipment to new moms and their babies, and we're likewise very proud to be able to say that we do so in pieces of content like this, and elsewhere on our website. What does hospital grade mean? Well, in the eyes of our breastfeeding experts, 'hospital grade' means that staff in a hospital (and in our particular case, the NICU) would use a piece of equipment there, on site, on their own patients. With that being the case, a big part of achieving our goal of providing 'hospital grade' quality was becoming FDA qualified.
'FDA-qualified’ is a term that you've all heard before-we're sure of it- but what does this language actually mean? How does something become FDA qualified? What's involved in clearing this first critical hurdle on the journey to 'hospital grade' quality? Read on, and we'll tell you!
Who is the FDA?
The Food and Drug Administration's mission is "to protect public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply; and cosmetics."
As a result of this mission, the FDA is the body charged with evaluating all of the new drugs proposed for use on or by human beings, and new drugs proposed for use on animals in the United States. That much may be clear just from the organization's name, however, their mission also covers regulation of all medical devices and durable medical equipment (DME) sold or used in the United States.
FDA classifications for medical equipment
According to the FDA, breast pumps fall into one of three classes - Class 1, Class 2, or Class 3. The class assigned depends on how much risk the device poses to users and patients.
Class 1 devices pose the least amount of risk. They don't interact with internal organs, cardiovascular system or the central nervous system, aren't designed to support life and present no unreasonable risk of injury. In other words: these devices don't interact with vital body functions in any way.
Class 3 is at the other end of the scale. These include devices which are designed to support life and/or implanted into the body and/or present a significant risk of illness or injury. For example: pacemakers and hip replacements are both class 3 devices because they support life (by regulating heartbeat), but also pose some significant risks when implanted into humans.
Class 2 encompasses devices that sit somewhere between these two extremes. Items that are likely to fall into prolonged use, or which do come into contact with the vital organs and other key systems of the human body. Most breast pumps (both hand pumps and those powered by electricity) best meet these criteria, and are thus assigned to FDA class 2.
Submitting DME for FDA qualification
In order to gain FDA approval, one must first apply for it.
The application and approval process for the low-to-moderate risk devices in class 1 and 2 (which as we've mentioned above includes breast pumps) is as follows:
A 'PMN' (Pre Market Notification) must be provided. The manufacturer must notify the FDA at least 90 days before their devices go on sale to allow for testing to take place.
Once this notification has been received, the FDA will review it and determine whether or not testing should take place. If it is decided that testing should proceed then a formal investigation will begin with an appointed panel of experts who will examine all aspects of the device in question including its design, manufacture, performance, safety and effectiveness. This process can take several months or even years depending on how complex the device is and how many other similar products are already on the market, but the PMN must prove that the device is:
- Substantially equivalent to a similar, legally-marketed device
What does FDA qualification testing involve?
The FDA's testing process sees most devices first undergo lab (and where applicable, animal) testing. This lets the FDA assess safety at a basic level. From here devices are then tested on humans. At this stage the FDA will test products in order to make sure that they don't contain any contaminants or dangerous materials.
If there are no problems with the initial review, then they move on to testing the actual product itself, at which point the equipment being tested will be subject to analysis looking for all kinds of things like bacteria growth rate, flow rates and pressure levels, and ensuring that all of these data points fall within safe ranges.
All of this testing is done at an independent lab, and this two-pronged approach to testing ensures that the equipment being tested is safe for use specifically with humans, and that the devices do what they are supposed to do for / with humans. Once those results come back positive for both safety and efficacy, FDA clearance can be granted.
What does this mean for Limerick users in the real world?
In brief, it means that breastfeeding women can use their Limerick pump knowing that all of the individual parts that went into it – from the medical grade silicone breast cups that come into contact with your breast to the BPA free bottles that collect your breast milk and DEHP free tubing used for the air to flow through have all been tested and qualified by the FDA.
The FDA has two classifications for electric breast pumps. The classifications include single user pumps, these pumps do not have a barrier to protect the milk from flowing into the motor of the pump and there is no way to guarantee the pump can be cleaned and disinfected between uses by different women. Single user breast pumps that are reused by different mothers run the risk of spreading infectious material to mother and baby.
The other classification is multiple user breast pumps. This means there is a barrier of sorts that protects the milk from getting into the motor of the pump making it safe for more than one mom to use the same breast pump. Pumps used in a hospital setting have to be FDA approved as a multiple user breast pump.
All of Limerick’s electric breast pumps are FDA qualified as multiple users because of the extra level of safety we provide. Limerick’s ComforTouch kit comes with a 1 micron filter that prevents milk or fluid from back-flowing into the motor of your breast pump along with filtering out bacteria and viruses so the air exhausted back into the room is filtered air.
A mom will need to have her own personal kit to use with the limerick breast pumps. The ComforTouch kit should not be shared but the breast pump may be used by more than one mom. Because of the one-micron filter Limerick’s pumps were qualified as a multiuser pump. Mom’s using Limerick’s breast pump can rest assured we have your safety and comfort covered giving you peace of mind.