Description
This guidance is intended to alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups. The Food and Drug Administration (FDA) has received reports during the past 4 years from hospitals and nursing homes involving 7 deaths and 15 injuries to patients who were thought to be receiving medical grade oxygen, but were receiving a different gas (e.g., nitrogen) that had been mistakenly connected to the oxygen supply system. This guidance makes recommendations that will help hospitals, nursing homes, and other health care facilities avoid the tragedies that result from medical gas mix-ups.
Scope & Applicability
Product Classes
2products subject to DSCSA tracing requirements
Medical gases are prescription drugs
Stakeholders
6all medical gas manufacturers who receive reports of death or serious injury
a knowledgeable person should ensure that the correct vessel has been connected properly
different supplier or contract manufacturer
Guidance is intended to alert other health care facilities to the hazards of medical gas mix-ups.
Guidance is intended to alert nursing homes to the hazards of medical gas mix-ups.
Guidance is intended to alert hospitals to the hazards of medical gas mix-ups.
Identified Hazards
Hazards
2Safety risks alerted via warnings/caution statements
The Agency has identified practices that may contribute to continuing medical gas mix-ups resulting in injury and death.
Related CFR Sections (2)
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →
Related Warning Letters (10)
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Compounding Pharmacy/Adulterated Drug Products
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- 2025-05-13
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- 2025-03-25
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- 2025-03-04
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- 2024-10-22
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- 2023-08-08
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US Specialty Formulations, LLC
- 2022-01-18
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Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- 2021-10-26
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Empower Clinic Services, LLC dba Empower Pharmacy
- 2021-08-31
Compounding Pharmacy/Adulterated Drug Products
AnazaoHealth Corporation
- 2021-08-03
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See Also (8)
- Accelerated Approval – Expedited Program for Serious Conditions (Status: Draft)
- CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory Action (Status: Final)
- Review of FDA's Implementation of the Drug Export Amendments of 1986 (Status: Final)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- E2BM Data Elements for Transmission Of Individual Case Safety Reports (Status: Final)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (Status: Final)