Optical radiation safety considerations for ocular glucose monitoring.
The potential for noninvasive detection of blood glucose is an area of intense academic and commercial research and a subject of keen interest in the diabetic and healthcare communities. A number of techniques are under investigation that attempt to infer blood glucose levels from measurements of optical signals. Frequently, these techniques are based on laser sources that may, under certain circumstances, be capable of inducing ocular injury. This article provides an overview of ocular damage mechanisms and the international standards for laser exposure limits that have been developed. The application of relevant standards to specific implementations of lasers in optical glucose sensing is presented. In addition, the concept of risk versus benefit for consideration of new medical devices is also discussed.
Ediger
M N
MN
Food and Drug Administration, Center for Devices and Radiological Health, Rockville, Maryland, USA. woody@eob.cdrh.fda.gov
Landry
R J
RJ
Sliney
D H
DH
D000818:Animals; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D005123:Eye / Q000528:radiation effects*; D006801:Humans; D007834:Lasers; D011835:Radiation Protection
D001786:Blood Glucose