Infusion Pumps - Total Product Life Cycle Recommendations for Safety and Performance
This guidance covers class II infusion pumps classified under 21 CFR 880.5725, including devices used in healthcare facilities to pump fluids into patients in a controlled manner. It also includes prescription infusion pumps intended for lay users in home settings. The guidance aims to improve infusion pump quality and reduce recalls and adverse events through recommendations for the total product lifecycle.
What You Need to Know? 👇
What documentation level is required for infusion pump software in FDA submissions?
Based on the 2023 FDA guidance “Content of Premarket Submissions for Device Software Functions,” infusion pumps should generally address Enhanced Documentation Level requirements due to their risk profile, replacing the previous Major Level of Concern classification.
What are the four main system hazards FDA identifies for infusion pumps?
FDA identifies four key system hazards: Infusion Delivery Error (wrong time/dose/volume/patient/site), Incorrect Therapy (wrong substance selected), Biological/Chemical Contamination (unintended contact with substances), and Traumatic Injury (burns, cuts, air embolisms, electric shock).
When does FDA conduct pre-clearance inspections for infusion pump manufacturers?
FDA may conduct pre-clearance inspections when devices present new technological characteristics, facilities haven’t been inspected within two years, previous inspections showed violations, or 510(k) submissions address device failures or malfunction reports.
What is a safety assurance case and why is it required for infusion pumps?
A safety assurance case is a structured argument supported by scientific evidence demonstrating that an infusion pump adequately addresses hazards within its intended use environment. It consists of claims, arguments linking evidence to claims, and evidence demonstrating argument validity.
What biocompatibility testing is recommended for infusion pump components?
FDA recommends evaluating biocompatibility of materials contacting patients/users, conducting leachables and extractables studies using representative solvents, performing particulate evaluation per USP <788>, and comprehensive risk assessment of device-related residuals based on exposure routes.
What are the key MDR reporting requirements for infusion pump manufacturers?
Manufacturers must report events where devices may have caused death/serious injury or malfunctioned with likelihood of causing harm if recurring, submit reports within required timeframes, maintain written procedures for event identification, and conduct thorough investigations of each reportable event.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive safety assurance case addressing all hazards and controls
- Conduct thorough verification and validation testing including:
- Performance testing
- Human factors validation
- Software validation
- EMC testing
- Environmental testing
- Prepare complete labeling including:
- Directions for use
- Cleaning/disinfection instructions
- Alarm descriptions
- Special instructions for home use if applicable
- Submit documentation for:
- Safety assurance case
- Test reports
- Labeling
- Risk analysis
- Software documentation
- Implement quality system controls and post-market surveillance
- Prepare for potential pre-clearance inspection
- Establish MDR reporting procedures
- Consider early interaction with FDA through pre-submission process
Key Considerations
Clinical testing
- Clinical investigation required if simulated use studies alone are insufficient
- Must be conducted under approved IDE
- Must comply with IDE requirements, IRB requirements, and informed consent requirements
Non-clinical testing
- Performance testing to verify/validate pump design
- Testing should be conducted with complete infusion pump system
- Must include detailed documentation of verification and validation activities
- Flow accuracy specifications must be appropriate for intended use
- Reliability analysis at component and system level required
Human Factors
- Human factors validation study report required
- Must evaluate user interface components
- Must assess potential use errors and hazards
- Must consider different user populations (healthcare professionals vs lay users)
- Must validate instructions for use with representative users
Software
- Enhanced Documentation Level required for infusion pumps
- Static analysis of all software required
- Must address information security (CIAA framework)
- Must validate dosing algorithms if present
- Must address network capabilities and risks if applicable
Cybersecurity
- Must address confidentiality, integrity, availability and accountability
- Must describe network security if applicable
- Must address wireless technology security if applicable
- Must provide security controls and risk mitigation strategies
Labelling
- Must include complete directions for use
- Must specify intended use environment
- Must include cleaning/disinfection instructions
- Must include alarm descriptions and troubleshooting
- Special considerations for home use labeling
Biocompatibility
- Must evaluate biocompatibility of patient-contacting materials
- Chemical and particulate characterization required
- Sterilization validation if applicable
- Shelf life data if applicable
Safety
- Safety assurance case required
- Must address all identified hazards and controls
- Must include alarm systems meeting IEC 60601-1-8
- Must validate safety control mechanisms
Other considerations
- Environmental testing per applicable standards
- EMC testing per IEC 60601-1-2
- Mechanical safety per IEC 60601-1
- Pre-clearance inspection may be required
- Post-market surveillance and MDR reporting required
Relevant Guidances đź”—
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Considerations and Recommendations for Interoperable Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms đź“‚
- IEC 60601-1: Medical electrical equipment - Part I: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Electromagnetic disturbances
- IEC 60601-1-8: Medical electrical equipment - Alarm systems
- ISO 14971: Medical devices - Application of risk management to medical devices
- AAMI ANSI HE75: Design of Medical Devices
- IEC 62366: Medical devices - Application of usability engineering to medical devices