Blood Lancets - Single Patient Use Only Labeling Requirements
This guidance applies to all blood lancet devices (21 CFR 878.4800) and provides labeling recommendations for single patient use only. It addresses concerns about the risk of transmission of hepatitis and other bloodborne pathogens when blood lancets are used on multiple patients.
What You Need to Know? 👇
What are the FDA’s key labeling requirements for blood lancet devices?
FDA recommends all blood lancet devices be labeled “single patient use only” with clear instructions that they should never be shared between patients, even when lancet blades are changed, due to bloodborne pathogen transmission risks.
Why does FDA prohibit multi-patient use of blood lancets even with blade changes?
Blood contamination can remain on reusable lancet device bases despite blade changes. Improper design, device malfunction, or user error may leave blood from one patient that could contaminate new blades and transmit hepatitis B and other bloodborne pathogens.
What specific labeling is required for multiple-use blood lancet devices?
Multiple-use devices must state “single patient use only” and include warnings against healthcare provider use. They must provide manufacturer-validated cleaning/disinfection instructions for the reusable base and safe disposal instructions for single-use blades.
Are there different requirements for single-use versus multiple-use blood lancets?
Yes. Single-use devices should be labeled “single use only” with disposal instructions. Multiple-use devices need “single patient use only” labeling plus validated cleaning instructions for reusable components and disposal guidance for replaceable blades.
What healthcare settings are affected by these blood lancet labeling requirements?
All healthcare provision sites including hospitals, long-term care facilities, assisted living facilities, clinics, health fairs, shelters, detention facilities, senior centers, schools, and camps where fingerstick procedures are performed.
When did FDA issue these blood lancet labeling recommendations and why?
FDA issued this guidance in November 2010 following CDC reports of increasing hepatitis B outbreaks from multi-patient blood lancet use. The guidance addresses serious infection control deficiencies identified in various healthcare settings.
What You Need to Do 👇
Recommended Actions
- Review and update all device labeling to include “single patient use only” statements
- Develop and validate cleaning/disinfection instructions for multiple use devices
- Create clear disposal instructions for both single use lancets and replaceable blades
- Update Instructions for Use to explicitly prohibit multiple patient use in healthcare settings
- For reusable devices, validate and document cleaning/disinfection procedures
- Implement prominent warnings about the risks of sharing devices between patients
- Consider transitioning to single-use disposable lancets for healthcare settings
- Ensure all accompanying documentation consistently reflects single patient use requirement
Key Considerations
Labeling
- All blood lancet devices must be labeled for “single patient use only”
- Statement limiting use to a single patient should appear on device labeling
- For multiple use-capable devices:
- Reusable base portion must carry “single patient use only” labeling
- Include instructions that devices should not be used for assisted blood draws by healthcare providers
- Include validated cleaning and disinfection instructions for the reusable base
- Include safe disposal instructions for single use lancet blades
- For single use devices:
- Must be clearly labeled as “single use only”
- Include instructions that these are preferred for healthcare provider use
- Include safe disposal instructions
- Include instructions for sharps safety/self-disabling features if present
Safety
- Devices should never be shared between patients, even among family members
- Single use disposable lancets are preferred for healthcare settings to minimize bloodborne pathogen transmission risk
Other considerations
- Cleaning and disinfection instructions must be validated by the manufacturer
- Special attention to use in healthcare settings including hospitals, long-term care facilities, assisted living facilities, and non-residential care settings
Relevant Guidances 🔗
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Labeling Requirements and Recommendations for Medical Devices
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms 📂
- 21 CFR 878.4800: Manual surgical instruments for general use