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Abstract #160847

Michelle L. Byrne¹, Ameeta Parekh², Colin Pollard³, and Kathleen Uhl². (1) Office of Women's Health & Office of Device Evaluation, Food and Drug Administration, 9200 Corporate Blvd., HFZ-470, Rockville, MD 20850, 202-997-3349, mbyrne9@gmail.com, (2) Office of Women's Health, Food and Drug Adminstration, 5600 Fishers Lane, 16-65, Rockville, MD 20857, (3) Office of Device Evaluation, Food and Drug Administration, 9200 Corporate Blvd., HFZ-470, Rockville, MD 20850

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.

Learning Objectives:

• Recognize that both mechanical and electrical breast pumps are medical devices regulated by FDA; electrical pumps and mechanical pumps mechanical pumps achieving a vacuum pressure greater than 250 mmHg are cleared through the 510(k) Premarket Notification process.
• Be able to evaluate electrical breast pumps based on device features and performance specifications.
• Apply knowledge of pump’s capabilities when deciding upon a suitable breast pump for yourself, your spouse, a family member or a friend.

Keywords: Breastfeeding, Maternal and Child Health

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.