IV Saline Solution Shortage
In light of the current IV saline solution shortage and its effects on AANA members and their patients, the AANA has been in contact with an FDA representative in the 2017 Atlantic Hurricane Incident Management Group. The IV saline shortage has been an ongoing issue since 2014 and has been exacerbated by the impact of Hurricane Maria on Puerto Rico. The FDA continues to work within its authority to increase IV saline solution supply levels in the United States.
The AANA continues to monitor this issue and will post relevant information on this webpage and other AANA communication channels. If your facility is experiencing a shortage, it can be reported to email@example.com to help the FDA gauge the extent of the shortage. Please note, this email address is to provide information to the FDA and may not result in an immediate response or resolution.
The following actions are being taken by the FDA:
- The FDA is working closely with local and federal authorities, and manufacturers of saline and other products, to help address the needs caused by challenges to the basic infrastructure in Puerto Rico. This includes:
- Taking steps to help a subset of critical production facilities gain access to fuel or generators;
- Connecting companies to other parts of the federal and local government to help clear roads or secure transport priority to import critical raw ingredients.
- The FDA is working with federal and local government partners to prioritize a small number of critical facilities based on public health needs, including plants that manufacture IV saline bags, for consideration or prioritization to gain earlier access to the electrical grid.
- The FDA has allowed temporary importation of IV fluids from Baxter facilities in Ireland, Australia, Mexico and Canada and from B. Braun in Germany.
- The FDA continues to expedite review of drug applications that may help relieve shortages. The agency recently approved Fresenius Kabi and Laboratorios Grifols saline products and anticipates that availability of these products will help address the shortage.
- The FDA is encouraging the expansion of production at existing facilities to meet shortfalls.
- FDA update on ongoing efforts to mitigate impact of saline shortages during this flu season, February 1, 2018
- FDA update on ongoing shortages related to IV fluids, January 16, 2018
- Update on recovery efforts in Puerto Rico and continued efforts to mitigate IV saline and amino acid drug shortages, January 4, 2018
- Efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls, November 17, 2017
- FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria, November 14, 2017
- Extended use dates provided by Pfizer to assist with emergency syringe shortages, November 9, 2017
- Securing the future for Puerto Rico: Restoring the island's robust medical product manufacturing sector, November 6, 2017
- Examining HHS’ public health preparedness for and response to the 2017 hurricane season, October 24, 2017
- Medical device manufacturing recovery in Puerto Rico, October 20, 2017
- Baxter manufacturing recovery in Puerto Rico, October 13, 2017
- FDA’s continued assistance following the natural disaster in Puerto Rico, October 06, 2017
- FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico, September 25, 2017
- FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricanes Harvey and Irma, September 22, 2017
Other Shortage Resources
- ASHP: Small-Volume Parenteral Solutions Shortages Suggestions for Management and Conservation
- ASHP: Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems
- AANA: Safe Injection Guidelines for Needle and Syringe Use
- CDC: The One & Only Campaign
- NPR: Hurricane Damage To Manufacturers In Puerto Rico Affects Mainland Hospitals, Too