2022 Filter Shortage Considerations

General Considerations for Filter Shortage Management
During a shortage of in-line intravenous filters for administration of parenteral nutrition (PN) or lipid injectable emulsions (ILE), consider one or more of the following measures:

  1. Communicate with all key stakeholders (e.g., pharmacy department, nursing department, central supply). Communication is essential to understand the current stock, procurement issues, as well as bedside practice. Establish a process to maintain clear communication across departments.
  2. Use filters only when indicated. Only use filters (all sizes) when they are indicated.
  3. Do not stockpile supply. In the interest of fair allocation to all patients, purchase only as much filter supply as needed.
  4. Consider centralizing acquisition and stocking of filters to one location within the organization (e.g., pharmacy department or central supply). Centralizing stocking allows for a better understanding of the current supply and regulation of use.
  5. Do not extend the use of tubing/filters beyond 24 hours.
  6. Minimize waste.
  7. Remain complaint with guidelines and regulations.1-4
  8. Develop an organizational strategy. Include filters in the healthcare organization’s strategies and procedures for managing medical device shortages and outages. These procedures should include processes to:
    1. Identify and monitor patients who are receiving the filter in short supply, 
    2. Notify providers and care team members when a shortage of filters occurs,
    3. Notify providers and care team members when a shortage of filters has resolved, and
    4. Return to appropriately sized filters as soon as the shortage resolves.
  9. Report shortages and errors.
    1. Report medical device  shortages to the FDA Center for Devices and Radiologic Health (CDRH)  Program at [email protected].
    2. Report any patient adverse events related to shortages of medical devices to MedWatch.
    3. Report any patient adverse events or medication hazard related to administering PN or ILE resulting from a shortage of in-line intravenous filters to ISMP Medication Errors Reporting Program (MERP).

Specific Considerations for Filter Shortage Management

  • Filter PN and ILE per ASPEN recommendations using a 1.2 micron filter.5
    • The only acceptable reason not to filter PN and/or ILE is if absolutely no filter sizes are available. 
      • If no filters exist, avoid medications co-infusion with PN or ILE. Although PN compatibility with co-infused medications is routinely applied in clinical practice, in-line filtration provides a safer approach to accommodate potential conditional differences that may result in microprecipitates. 
  • If the 1.2 micron filter is on shortage or is unavailable, attempt to use the smallest appropriate filter size available for the PN admixture and/or ILE. Place the filter low in the infusion line, below the Y-site. 
    • A 1.2 micron filter is the smallest filter size to be used with 3-in-1 or ILE 
    • A 0.2 micron filter can be used for 2-in-1 (dextrose/amino acids) PN but is not suitable for 3-in-1 (dextrose/amino acids/ILE) or ILE products 
  • If administration tubing sets with 1.2 micron filters are on shortage, obtain add-on 1.2 micron filters 
  • If administration tubing sets with 1.2 micron filters and add-on 1.2 micron filters are unavailable, obtain 5 micron filters, or next available smallest filter size. 

IMPORTANT NOTE: when more than one filter size is used, ensure that filters are appropriately labeled regarding size and advise care team members and patients/caregivers to carefully assess the filter size to ensure that the appropriate filter is in-line with the infusing PN component. Do not filter 3-in-1 or ILE with filters smaller than 1.2 micron in size.

Reference:

  1. Infusion Nurses Society. Infusion therapy standards of practice. J Infus Nurs 2016;2016(1S):S11-S159. 
  2. Ayers P, Adams S, Boullata J, Gervasio J, Holcombe B, Kraft MD, Marshall N, Neal A, Sacks G, Seres DS, Worthington P; American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014 Mar-Apr;38(3):296-333. 
  3. Mirtallo JM, Ayers P, Boullata J, Gura KM, Plogsted S, Anderson CR, Worthington P, Seres DS, Nicolai E, Alsharhan M, Gutsul L, Mason AE. ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations. Nutr Clin Pract. 2020 Oct;35(5):769-782. Epub 2020 May 27. Erratum in: Nutr Clin Pract. 2022 Apr;37(2):482. 
  4. Cober MP, Gura KM, Mirtallo JM, Ayers P, Boullata J, Anderson CR, Plogsted S; ASPEN Parenteral Nutrition Safety Committee. ASPEN lipid injectable emulsion safety recommendations part 2: Neonate and pediatric considerations. Nutr Clin Pract. 2021 Dec;36(6):1106-1125. 
  5. Worthington P, Gura KM, Kraft MD, Nishikawa R, Guenter P, Sacks GS; ASPEN PN Safety Committee. Update on the Use of Filters for Parenteral Nutrition: An ASPEN Position Paper. Nutr Clin Pract. 2021 Feb;36(1):29-39.