Medical Device Reporting for Needlestick and Other Sharps Injuries
This guidance provides information for user facilities, manufacturers, and importers regarding their obligations for reporting adverse events related to needlesticks and devices intended to prevent needlesticks. It also includes information for healthcare workers to report adverse events through the voluntary MedWatch reporting system.
What You Need to Know? 👇
What are the mandatory MDR reporting requirements for needlestick-related adverse events?
User facilities must report deaths to FDA and manufacturer, serious injuries to manufacturer or FDA. Importers and manufacturers must report deaths, serious injuries, and malfunctions likely to cause death/serious injury if recurring. All use FDA Form 3500A.
When does a needlestick incident require medical intervention reporting under MDR?
Medical intervention includes tetanus shots, gamma globulin shots, or stitches - these trigger mandatory serious injury reports. First aid (bandages, cleaning) and diagnostic blood tests don’t constitute medical intervention and aren’t reportable under MDR.
Do needlestick events caused by user error need to be reported?
Yes, if they result in death or serious injury. User error doesn’t exempt reporting requirements - user facilities, importers, and manufacturers must still report deaths and serious injuries even when user error contributed to the needlestick event.
What constitutes a device malfunction for needlestick-related devices?
A malfunction is failure to meet performance specifications or perform as intended. Importers and manufacturers must report malfunctions likely to cause death/serious injury if recurring. User facilities aren’t required to report malfunctions but are encouraged to.
How can healthcare workers voluntarily report needlestick incidents to FDA?
Healthcare workers can submit voluntary reports using FDA Form 3500 through the MedWatch program at www.fda.gov/medwatch/, by calling 1-800-FDA-1088, or online at www.accessdata.fda.gov/scripts/medwatch/. This supplements mandatory reporting requirements.
What follow-up investigation is required for manufacturers after needlestick events?
Manufacturers must make a “good faith effort” to obtain event information per 21 CFR 803.50. Document all follow-up attempts, reporter responses, and reasons for unobtainable information. Files should support reportability decisions and may be reviewed by FDA.
What You Need to Do 👇
Recommended Actions
- Establish clear procedures for identifying reportable needlestick events
- Implement a system to track and document all needlestick-related incidents
- Create a process for timely reporting to FDA and/or manufacturers as required
- Develop investigation procedures for manufacturers to gather required information
- Train staff on reporting requirements and differentiation between mandatory and voluntary reporting
- Maintain documentation of all follow-up attempts and decision-making rationale
- Set up a system for annual reporting (user facilities) and baseline reporting (manufacturers)
- Create a process to evaluate if malfunctions are likely to cause death/serious injury if they recur
- Establish clear criteria for distinguishing between first aid and medical intervention
- Implement a system to track the two-year presumption period for malfunctions
Key Considerations
Safety
- User facilities must report device-related deaths to FDA and manufacturer
- User facilities must report serious injuries to manufacturer or FDA if manufacturer unknown
- Importers must report deaths and serious injuries to both FDA and manufacturer
- Importers must report malfunctions likely to cause death/serious injury to manufacturer
- Manufacturers must report deaths and serious injuries to FDA
- Manufacturers must report malfunctions likely to cause death/serious injury to FDA
- First aid and diagnostic tests are not considered medical interventions requiring reporting
- Medical/surgical interventions to prevent permanent impairment require reporting
Other considerations
- User facilities must submit annual reports summarizing reported events
- Manufacturers must submit baseline reports for new device models
- Manufacturers must conduct “good faith effort” follow-up investigations
- Blood spillage/splattering only reportable if due to device malfunction
- User error events reportable if resulting in death or serious injury
- Healthcare workers encouraged to report voluntary events through MedWatch
Relevant Guidances đź”—
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Medical Device Reporting Requirements for User Facilities
- Voluntary Malfunction Summary Reporting Program for Medical Devices