Do you need to report needlesticks to the FDA?
According to the Food and Drug Administration, user facilities must submit a medical device adverse event report to the agency and the manufacturer if a device causes or contributes to a patient death or serious injury. Manufacturers and importers must file an adverse event report if they become aware that one of their devices caused or contributed to a serious injury or death, or if a device malfunction occurred that “would be likely” to cause or contribute to a serious injury or death.
In its alert on blunt suture needles, the FDA said, “Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with suture needles (sharp and blunt), we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.”
Here is the previous FDA guidance on reporting of needlesticks:
“A needlestick-related event is reportable as a death, serious injury or malfunction as detailed below:
1. A death report should be submitted by a user facility, importer and manufacturer if the device may have caused or contributed to the death of the individual.
2. A serious injury report should be submitted by a user facility, importer and manufacturer if the device resulted in an injury to an individual and the injury was life-threatening, resulted in permanent impairment of a body function or permanent damage to a body structure, or necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
3. A device malfunction report should be submitted by an importer and manufacturer if the device failed to perform as intended and would be likely to cause or contribute to a death or serious injury if the needlestick event recurred.
If a person who is exposed to infectious materials via a needlestick that resulted from a device failure is subsequently treated medically or surgically to prevent permanent impairment, then the event becomes reportable by the user facility, importer, and manufacturer as a serious injury report.
We do not consider first aid to constitute medical intervention, and this type of intervention will not require an MDR report. Examples of first aid are the application of a bandage or simple cleaning of the site of a needlestick. In addition, we do not consider an in-vitro diagnostic test for blood-borne diseases to constitute medical intervention. However, administration of a tetanus shot, a gamma globulin shot or stitches is considered medical intervention. This type of intervention triggers the submission of a mandatory serious injury adverse event report by a device user facility, importer, or manufacturer.”
What is a medical device malfunction?
“A malfunction is the failure of a device to meet its performance specifications or to perform as intended. If you are an importer or manufacturer of a device, you must report a malfunction when it is likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for a period of two years, or valid data shows that the likelihood of another death or serious injury because of the malfunction is remote.
A malfunction that is or can be corrected during routine service or device maintenance should be reported if the malfunction is likely to cause or contribute to a death or serious injury if it were to recur.
You do not need to report a malfunction if it is not likely to result in a death or serious injury.
If you are a user facility, you are not required to report any device malfunctions. However, we encourage you to report device malfunctions to the device manufacturer and/or to the FDA through the voluntary MedWatch program.”
Do I have to report a needlestick-related event that involves blood spillage or splattering?
“You do not need to report a device-related blood spillage or splattering event unless the incident is the result of a device malfunction. If you are a manufacturer or an importer, you should report any spillage or splattering malfunction event if a recurrence is likely to cause or contribute to a death or serious injury.
Do I have to report a needlestick-related event due solely to user error?
“It depends on the severity of the event. Events involving a death or a serious injury where user error may have caused or contributed to a needlestick-related event are reportable by a user facility, importer, and manufacturer.”
How and what to report:
In the FDA blunt suture needle alert, the agency asks for the following information on adverse events associated with suture needles:
Manufacturer’s name
Device name (needle brand name)
Type of needle (blunt or sharp)
Type of suture
Date device was manufactured
Distributor’s name
Details of adverse event and medical and/or surgical interventions (if required)
Date the event occurred
Location of the event
Nature of the injury and associated health outcome
Status of the device
Can the FDA contact the reporter for further follow-up?
Source
Food and Drug Administration, Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers, November 12, 2002 (www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071588.htm) and FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel, May 30, 2012 (www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305757.htm).
According to the Food and Drug Administration, user facilities must submit a medical device adverse event report to the agency and the manufacturer if a device causes or contributes to a patient death or serious injury. Manufacturers and importers must file an adverse event report if they become aware that one of their devices caused or contributed to a serious injury or death, or if a device malfunction occurred that would be likely to cause or contribute to a serious injury or death.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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