Helping Hospitals Manage Supply Chain Disruptions

By:  Suzanne Smith, MS, RD, LDN, IBCLC, Consultant, Timeless Medical Systems

Caroline Steele, MS, RD, IBCLC, FAND, Consultant, Timeless Medical Systems

In 2022, a product recall was initiated by one of the largest United States (U.S.) infant formula manufacturers.1 The recall included multiple brands of powdered infant formula products due to bacterial contamination from Cronobacter sakazakii leading to the voluntarily closure one of the country’s largest formula manufacturing facilities. 2  These events coupled with supply chain disruptions related to the COVID-19 pandemic, restrictive trade and tariff policies in the U.S., and relatively few companies manufacturing infant formula, left millions of parents and healthcare providers scrambling to find products and uncertain about their safety.2  Scarcity of all types of infant formula in stores contributed to stockpiling resulting in a high out-of-stock rates for infant formula. Due to inaccessibility, healthcare providers encountered parents using unsafe feeding practices such as diluting formula with water, preparing homemade infant formula, introducing cow milk before one year of age, and using human milk from informal sharing. 3 The nationwide infant formula shortage impacted healthcare facilities as clinicians were forced to base decisions on what products were available rather than the most clinically appropriate product, resulting in some patients needing to be placed on parenteral nutrition.

After the recall was announced, communication challenges compounded the problem. Many institutions did not receive timely notification of the recall, thus infants continued receiving potentially contaminated formula.4  In addition, unless the hospital scans infant formula and fortifiers at the time of preparation and feeding, product lot numbers are not documented. In the absence of scanning infant formula and fortifiers, identifying which patients received recalled lot numbers is virtually impossible. Furthermore, many institutions do not have an in-house inventory tracking system alerting users where specific inventory is stored, thereby increasing the likelihood of not removing every can of recalled formula. Clinicians also struggled to identify and contact families in the community directly impacted by the recall.4 Many clinics and pediatrician offices give samples of infant formula to families; unless these dispensed samples are scanned, clinicians will not know exactly which families received the recalled lot numbers. 4

While the impact of 2022 product recall had been primarily negative, it did lead to updated federal legislation making operational improvements regarding infant and specialty formulas. The U.S. Food and Drug Administration (FDA) created a new office of critical foods and enacted The Food and Drug Omnibus Reform Act of 2022 which has two requirements: 5  

1)  Requires the FDA to be responsible for the oversight, coordination and activities related to critical foods (i.e. infant formula, medical foods and supplements, etc.)

2) Requires hospitals to be able to identify and track recalled items, carry out the instructions of the recall, and maintain records.

Furthermore, the FDA has increased their oversight of formula manufacturers by increasing the number of inspections.5 If a code violation is found within a manufacturing plant, the manufacturer must determine the root cause of contamination, perform cleaning activities, evaluate the sanitation practices and procedures, and provide a detailed corrective action plan to the FDA. 5

Healthcare organizations need an efficient process to identify and remove products based on affected lot number(s). This process should include identifying:

  • Products in stock but not yet fed to patients
  • Products used in preparation but not yet fed to patients
  • Products fed to patients
  • Samples or gift packs provided to inpatients to take home or to outpatients

Enacting policies and procedures for staff notification of recalls further minimizes the potential of inadvertent use or administration. Furthermore, these policies and procedures should address the steps taken to follow up with impacted patients as well as outlining proper documentation and retention of records.

At Timeless Medical Systems, we offer a variety of solutions to improve the safety of your most vulnerable patients and to adhere to the new FDA Omnibus Reform Act. Our Timeless Medical Women & Infant System™ barcoding software can help safeguard your patients through bar code scanning technology of human milk, donor human milk, infant formula, additives, etc.  and provide the needed documentation of those lot/batch numbers. Our scanning software scans all forms of human milk, infant formulas, fortifiers, and feeding additives for inpatients and outpatients ensuring the tracking of lot numbers in the event of a recall.

For more information about the Women and Infants System™ please visit our website at www.timelessmedical.com or email us at sales@timelessmedical.com.

References

  1. Jaffe, S. US infant formula crisis increases scrutiny of the FDA. Lancet 2022, 399, 2177–2178.
  2. US Food and Drug Administration. FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022).Available online: https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022.  Accessed April 4, 2024).
  3. Damian-Medina K, Cernioglo K, Waheed M, et.al. (2024) Cross-sectional analysis of infant diet, outcomes, consumer behavior, and parenteral perspectives to optimize infant feeding in response to the 2022 U.S. infant formula shortage. Nutrients. 16: 748-766.
  4. Mulherin D, Kumpf V, Shingleton K. (2023) Managing nutrition support product shortages: What have we learned. Nutrition in Clinical Practice. 38: 27-45.
  5. U.S. Food and Drug Administration. Immediate National Strategy to Increase the Resiliency of the US Infant Formula Market. https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/immediate-national-strategy-increase-resiliency-us-infant-formula-market. Accessed April 4, 2024.

Learn more about Timeless Medical Systems

The Timeless Medical Systems bar code scanning system offers a variety of reports that can help healthcare organizations evaluate their near-miss data and turn that knowledge into process change. In addition, Timeless Medical Systems also offers preparation room consulting services. Our very experienced and skilled Clinical Team Members have 1st hand experience in creating and implementing centralized preparation rooms and processes in some of the largest most prestigious hospitals throughout North America and are experts in workflows designed to minimize risk of error. If you are interested in learning more about these consulting services, please contact sales@timelessmedical.com.

The material presented in this blog represents the opinion of the author(s) and not necessarily the views of Synova Associates. Synova Associates does not endorse any specific products or organizations but strives to connect its industry partners with leaders interested in product/educational innovation.