Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to promote awareness of labeling to enhance device safety and prevent patient harm.
What is the problem?
FDA received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer; thus exposing it to radiant heat from the warmer.
How are these devices used?
The Giraffe Spot PT Lite™ Phototherapy System, made by GE Healthcare, provides light for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, in term and premature infants in a hospital setting, administered by trained, professional staff.
The light intensity delivered to the patient varies depending on the distance of the lens head from the infant. Intensity of the light can be changed by manually adjusting this distance. The flexible light pipe allows the lens to be positioned as desired; the light pipe bends to a new position and then holds the lens in place. The flexible light pipe transmits the light from the lamp to the lens, where it can be directed at the infant.
What can I do to prevent patient injuries?
- When using the Giraffe Spot PT Lite™ Phototherapy System with a radiant warmer, make sure the lens head is not directly in the path of the radiant heat rays since this will block heat to the infant and may damage the lens head.
- Consult the user manual for instructions about proper use and information about using any phototherapy lights with a radiant heat warmer.
- Contact device manufacturer if further assistance is needed.
How can I report problems to FDA?
If you suspect a problem with a medical device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.