PubMed · 1297582
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P Lemoine. [Rhythms and blues].. https://pubmed.ncbi.nlm.nih.gov/1297582/
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A disposable, transcutaneous oxygen sensor has been designed and implemented using screen-printing technology for all fabrication stages. The sensor incorporates an integral heating element to promote transcutaneous diffusion of blood gases so that a reliable estimation of arterial blood gas concentration can be obtained. The oxygen sensing part of the device consists of a screen-printed Clark cell implemented as electrodes, electrolyte and membrane. A three-electrode configuration is employed with gold working and counter electrodes and a silver/silver chloride reference electrode. Several different polymer electrolyte and membrane materials were evaluated in the construction of the device, and their performances were compared. A fully automated gas testing rig was constructed to enable oxygen levels to be varied under computer control. Cyclic voltammetry and static analysis of the sensors were carried out at different oxygen concentration levels and in various test environments. Linear relationships were established with an averaged sensitivity level of 0.02 microA(mmHg)(-1) and high regression coefficients of 0.99. The prototype covered with a polytetrafluoroethylene membrane gave the experimental result of I (microA) = -0.025PO2 (mmHg) - 0.085. Several factors influenced the performance of the sensors. The investigations have greatly contributed towards an understanding of the suitability of the materials in achieving a viable, low-cost sensor.
Problem wounds, which fail to respond to traditional medical and surgical therapy, can be challenging to the plastic surgeon. Surgical, outpatient, and inpatient wound care costs can be exorbitant. Indirect costs, such as those related to patient productivity, disability, and premature death, can also be significant. The underlying problem in failure of a wound to heal is usually hypoxia and infection. HBO treatments in selected patients can facilitate healing by increasing tissue oxygen tension, thus providing the wound with a more favorable environment for repair. Therefore, HBO therapy can be an important component to any comprehensive wound care program.
The Food and Drug Administration (FDA) is reclassifying the cutaneous carbon dioxide (PcCO2) monitor from class II (performance standards) into class II (special controls). FDA is also reclassifying the cutaneous oxygen (PcO2) monitor for an infant patient who is not under gas anesthesia from class II (performance standards) into class II (special controls) and is reclassifying the cutaneous oxygen (PcO2) monitor for all other uses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II [[Page 76679]] Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA" that will serve as the special control for the devices. These reclassifications are taken on the agency's own initiative based on new information. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act.