Breast Milk Collection: Hygienic Insight

It's been a decade since my first. My first experience with collecting my breast milk, that is. I remember it like it was yesterday. It was my first day back to work at the hospital since maternity leave. My co-workers had offered me all the instruction and information that they thought I would need. "Plug in the pump, connect your kit, and turn on the switch", they told me. Kit in hand and filled with first time fear, I went behind closed doors to express myself. More like "relieve" myself.

I flopped in a chair and faced my reliever; an archaic machine nicknamed Old Silver. Not only did it look old, it looked scary. Apparently, this was the first suction pump designed for emptying milk from a mother's breasts. I could only hope that it would empty and relieve mine! I did what I was told. Plug it in, connect the kit, and turn it on. Within minutes of use, I realized that the breast pump itself doesn't collect milk like I thought. The kit that you connect to the pump's suction port actually does. Wow, what a revelation! Five years of "nursing" school and not one instructor taught me the mechanics of a powered breast pump.

As I continued to meet behind closed doors with my breast pump, I learned many things. I learned that other patients and employees used this pump. After all, it was hospital equipment. It was a multiple user medical device. It was the type of breast pump intended for use by several users. I learned that each mother must use her own kit for milk collection. A collection kit is an assembly of one or two breast flanges, container, tubing and connector. That means your kit can be single or double. Your kit is your connection to the pump. You can apply the pump's suction to one or both of your breasts. I learned that by using your own collection kit, it protects you against cross-contamination. It separates you from other users that have access to the pump's suction. Most importantly, I learned that you must keep breast milk and its moisture from flowing back through your tubing into the pump itself. But why and how?

Each of us — parent, health care provider, salesperson, and lactation consultant — could benefit from more insight regarding the collection of a human milk resource, Clearly, I needed to talk to some experts in the health care field. I pumped them with questions. And they expressed some valuable answers, not to mention some "food for thought"! Whether you've mastered milk collection or you're a first timer with collection concern, see if the following "Questions & Answers" can be of health to you.

To start with, I spoke with Anthony E. Rodgers, Associate Director for Radiological Health Devices at the Food and Drug Administration (FDA). I really wanted to know more about breast pumps, specifically their over-the-counter availability to health care consumers.

Question: Is there any regulation of the makers or manufacturers of breast pumps?

Answer: The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. A breast pump is a medical device. These medical devices are classified into Class I, II, and III. A powered breast pump, like a hospital grade breast pump, is a Class II device, he explained. This device classification has regulatory control requirements. A manufacturer must have a quality control system in place for Class II devices to record any malfunction, injury, or the unlikely death that may occur with its use. The Medical Device Reporting (MDR) program requires that incidents in which a device may have caused or contributed to a serious injury or death must be reported to the FDA. In addition, certain malfunctions must also be reported. This MDR regulation is a mechanism for the FDA and manufacturers to identify and monitor events involving any medical device, such as powered breast pumps.

Question: How is cross-contamination prevented when a medical device breast pump is shared?

Answer: Since the 80's and 90's, the kit was found to be the most important component in preventing cross-contamination with breast pump devices that are shared. Rodgers emphasized that each mother must use her own kit with a shared pump device. Breast pumps intended for shared uses include hospital pumps and those available over-the-counter to rent. The manufacturer should clearly label their device to indicate that a personal kit for mothers is required with the use of this type of breast pump. He further explained that labeling refers to all labels and other written, printed or graphic matter on the device as well as descriptive and informational literature that accompanies the device.

Question: Should the health care consumer be aware that the FDA has cleared the protective claim for the HygieniKit by Ameda?

Answer: "Absolutely" Rodgers commented. "It should be labeled on the packaging by the manufacturer", he stated.

I now questioned whether any standards existed for the use of this type of medical device. With memories of my hospital days preparing for a visit from JCAHO, I queried The Joint Commission on Accreditation of Healthcare Organizations.

The Joint Commission evaluates and accredits more than 17,000 health care organizations and programs in the United States. JCAHO accreditation is recognized nationwide as a symbol of quality that reflects an organization's commitment to meeting certain performance standards. JCAHO's evaluation and accreditation services are "provided for hospitals, health care networks, and home care organizationsÉincluding those that provide durable medical equipment services". Standards that address quality and safety of care include infection control É and performance improvement.

Question: Are there any written standards for the use of breast pumps in hospitals, health care networks, or home care organizations?

Answer: Lucille Skuteris stated that the JCAHO had only "broad infection control standards" when it comes to breast pumps and their use. She also stated that "individual organizations are responsible for drafting their own policies and procedures". She recommended that I contact APIC, the Association for Professionals in Infection Control and Epidemiology, for more guidance and commentary.

Following her recommendation, my next contact was Loretta L. Fauerbach, Leader of Practice Guidance Team for the Association for Professionals in Infection Control and Epidemiology (APIC). She is also Director of Infection Control at Shands Hospital, University of Florida, in Gainesville, Florida.

Question: Is contamination of breast milk during expression and collection possible within a hospital setting? What about the home or work environment?

Answer: "Of course, in any setting, whether that's hospital, home, or at work". She explained that practicing the basics of hygiene with the collection of human milk could minimize the possibility of contamination. First, and foremost, use clean equipment, collection kit, and containers for your milk. Secondly, always wash your hands prior to collection. After washing, be careful what you touch and handle. Third, clean your breasts with your daily practice of self-hygiene. Keep in mind that a washcloth can harbor organisms and should be laundered routinely. She adds that the manufacturer's directions should be read and followed for the pump and its specified collection kit.

Question: Could a Multiple User Device such as a hospital breast pump device be a potential source of contamination when collecting breast milk? If so, how?

Answer: Yes, a Multiple User Device such as a breast pump used in a hospital or clinic environment can be a possible source of contamination. Anytime that more than one person handles or uses such a device, the potential for contamination exists. She cites that the kit is of utmost importance because its design should prevent the backflow of milk into the pump during use. The kit itself must be for single patient use only. If milk flows back into a pump, it could provide a medium for organisms to multiply. No question, this becomes a potential contamination source.

She further explained that hygienic measures for care of the pump should include wiping the controls or on/off switch with an appropriate cleanser or disinfectant. This should be done on a routine basis, especially if there are multiple users such as a breast pump used in hospital. Preventative maintenance should also be performed with the mechanical/electrical operation of the device. She concluded that each user should be taught basic hygienic measures as well as the proper use of the breast pump itself.

My next questions concerned human milk, itself. Of its many unique components, the live cells actually provide protection against organisms that cause illness and disease. So I questioned why the prevention of contamination was so important when protection already exists in human milk?

With expert commentary on breast pump regulation, infection control, and hygiene, my focus turned to an essential for breast pump use: your kit. The experts all commented that cross-contamination is prevented with the use of one's own kit. And hand washing is an essential hygienic measure in reducing the possibility of self-contamination. But what about a collection kit with hygienic features?

I posed this question and a few more to an accomplished expert in the field of human lactation, Mary Rose Tully, MPH, IBCLC. She is Director of Lactation Services at the University of North Carolina Women's & Children's Hospitals in Chapel Hill, North Carolina. She has extensive experience with milk donors and human milk bank operations.

Question: Shouldn't a kit designed with a barrier that prevents milk backflow be used with a Multiple User Device breast pump? Could a mother reduce or prevent possible contamination of her breast milk with the use of such a kit?

Answer: A barrier between the individual user and the machine is always going to be optimal with any medical Multiple User Device. This leaves "less room for human error" Tully remarks. She explains that if individual users cannot contaminate the device with their milk during use, the user is not dependent on someone else to clean the breast pump and assure its safe use.

Question: Should health care consumers be aware that the FDA has cleared the claim that the HygieniKit barrier protects breast milk from bacteria and viruses? How important is this FDA clearance to you and your clients who use breast pumps?

Answer: "As a hospital-based lactation program director this is important to me because the pumps are not always cleaned between users". She says that someone who is clinically trained to recognize and deal with contamination is often not the person cleaning these pumps. It would only take one circumstance of contamination to cause a problem; either to the breast pump or to another user. When collecting milk at home and at work, it's important that a mother not have to worry about milk flowing back into her pump and burning out the motor. If the kit prevents this, is easy to use and disassemble for cleaning, that's definitely worth knowing she concludes.

Last, but certainly not least, I looked for some expressed insight from a working, breastfeeding mother. Leslie M. Arthur, RN is a Clinical Nurse Researcher at Eli Lilly Incorporated in Indianapolis, Indiana, who pumps and collects her milk while at work.

Question: Which product(s) did you choose for your milk collection and why?

Answer: "Based on my clinical knowledge of infection control and hygiene, I chose to use the Egnell Elite breast pump and its collection kit. The HygieniKit meant that I could safely use a shared breast pump. That was my biggest worry. I had a hard time figuring out how and which pump to share. Its kit components prevent the milk from flowing back into your pump. And I wouldn't have to worry about catching something from the pump. Its no-need-to-wash tubing is a definite plus. I explained it to my co-workers. I discussed it with a nurse practitioner. This kit gave me confidence and was easy to use. That's how and why I made my choice".

Among the experts and user, the consensus is that you don't mix milk with your machine. Period. It appears that the combination of hygiene and kit is breast for your milk collection. So why don't you grab your HygieniKit, plug in your pump, flip the switch on, and express yourself!

Anne P. Mark, BSN, RN, IBCLC is the author of The Complete Idiot's Guide¨ to Breastfeeding. She is an international board-certified lactation consultant with a private practice. Her business, Mommies & Poppies Inc, offers product sales and services to mothers, fathers, and breastfeeding babies.

© 2003 Anne P. Mark. All rights reserved. Contact author for permission to reprint.