A comparison of electrical breast pumps cleared by FDA in the past ten years

Breast pumps are Class II medical devices regulated by FDA that aid mothers with busy schedules or who are unable to naturally breastfeed with collecting breast milk. According to the Department of Health and Human Services' Office on Women's Health website, breastfeeding can be beneficial to both mother and baby. Breastfeeding burns calories and strengthens a baby's immune system. To help women choose an appropriate pump, design features and performance capabilities of FDA-cleared breast pumps were researched. CDRH's website was referenced for a comprehensive list of FDA-cleared pumps. Manufacturers were contacted for publicly available information including product labeling, device features, marketing of device, and performance specifications. As of February 9, 2007, FDA cleared 81 breast pumps: 24 mechanical, 57 electrical. Information on electrical pumps cleared in the last ten years was collected; research is ongoing. Of these pumps, 59% have user-controlled cycle rates (sucking speed) and vacuum pressures (sucking strength), while 41% have pre-programmed cycle rates. Maximum vacuum pressures range from 110 to 250 mmHg, while maximum cycle rates range from 30 to 130 cycles/min. Thirty-eight percent of these pumps massage the breast, encouraging milk let-down; 65% can either plug into an outlet or use batteries. Labeling of all but one pump includes instructions for storing breast milk. This research will help women better understand the correlation between breast pump design features and natural breastfeeding. Productive pumping results when the breast pump closely mimics the baby's sucking pattern. Educating consumers about currently available pumps will aid in their selection process.