This invention relates to medical devices with accompanying forms and, more particularly, to combined medical devices and forms.
Every year millions of biological specimens are taken from test subjects for various purposes including HIV testing, insurance qualification, diabetic monitoring, infant blood screening, etc. It is critically important for all types of blood testing that the specimens are properly identified with the correct test subject, yet misidentifications occur all too frequently. Misidentifications are extremely difficult to find and often go undiscovered, and when one is found, another test must be performed.
Using infant blood screening as an example, dry blood spot (DBS) packets, which are considered medical devices by the FDA, are frequently used to take blood specimens. A medical care giver records necessary biographical information about an infant on at least one form and pricks the infant, usually on the heel. The medical care giver then applies blood from the prick to fill a plurality of designated circular areas on an absorbing blood application sheet of the DBS packet. To try and prevent misidentifications, the medical care giver applies duplicate identification stickers to the form and to the DBS packet. The DBS packet and the accompanying form are returned to a test lab for processing. All to frequently, the wrong stickers are applied to the form and DBS packet. Because the form is independent of the DBS packet, it is now impossible to properly match the specimen and the infant thus, requiring retesting.
If the blood screening of the tested infant reveals a need for further procedure or testing, the wrong infant may receive such procedure because the identification stickers were misapplied. Further, the infant needing the procedure may not receive it until additional symptoms are manifested. Clearly, even one misidentification is unacceptable.
The scope of the misidentification problem is not limited to infant blood screening. Misidentifications can and do occur in other contexts, and because the forms are independent of the packets and are numbered at different times during the production process, these misidentifications are also nearly impossible to find prior to specimen collection.
A problem encountered, specific to DBS packets, is contamination. A large majority of the rear of a DBS packet is left open, so that blood applied to the circular areas can dry. Thus, when the packet is set on a surface, the blood application sheet contacts that surface potentially contaminating the sample, and contamination leads to expensive and unnecessary retesting.
Thus, reducing the chances of contamination is desirable to avoid retests and associated costs. Further, reducing occurrences of misidentifications is desirable to enhance the quality of medical care and reduce the number of retests thereby cutting medical costs. It is also desirable to reduce the application of identification stickers by medical care givers to save time, increase identification accuracy, and reduce cost.
USPTO Backgrounds
USPTO Backgrounds