Though breast pumps are used quite commonly, it is suggested to consult a doctor regarding a prescription for a breast pump rental or purchase. Though most insurance companies will reimburse either partially or fully for rental costs or for the purchase of a retail hospital grade breast pump, it depends upon the coverage provided by the insurance company for medical equipment.
There are a few important things to consider while using a rented hospital grade pump. First, other patients and employees have used the pump, since it belongs to a hospital. Hence, it is a multiple user medical device. The mothers must use a personal kit that has to be connected to the pump for the collection of the milk. These kits contain one or two breast flanges, container, tubing and connector. Using a personal kit offers protection as it prevents cross-contamination. Another way to prevent contamination is to prevent the breast milk and its moisture from flowing back through the tubing into the pump itself.
All the firms that manufacture, repackage, re-label, and/or import medical devices are regulated by the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). All these medical devices are classified into Class I, II and III. Since breast pumps are considered Class II devices, they have to follow the quality control system that is the requirement of all Class II devices. They have to undergo a quality control check for any malfunctions, injury, or likely death that might occur by the product’s usage.
To avoid cross-contamination, all the pumps must carry a label on top indicating that a personal kit ought to be used by the mothers with that particular type of breast pump. As also, a descriptive literature providing all the requisite information regarding cross-contamination must be provided along with the medical device.
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