RESUMO
By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices have begun to be used to support diagnosis, patient monitoring, and decision-making of diseases, and recently software medical devices for the purpose of preventing, managing, or treating disorders or diseases have become popular. The aim of this article is to understand the current concept and status of Software as a Medical Device (SaMD), which are actively being carried out in the United States, and to find out what fields can be applied in the future. In addition, it intends to find out the Korean domestic policy trends related to smart healthcare and find out the application of digital software as a medical devices that can be used in dental clinic to keep pace with the upcoming changes in the medical field.
RESUMO
By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices have begun to be used to support diagnosis, patient monitoring, and decision-making of diseases, and recently software medical devices for the purpose of preventing, managing, or treating disorders or diseases have become popular. The aim of this article is to understand the current concept and status of Software as a Medical Device (SaMD), which are actively being carried out in the United States, and to find out what fields can be applied in the future. In addition, it intends to find out the Korean domestic policy trends related to smart healthcare and find out the application of digital software as a medical devices that can be used in dental clinic to keep pace with the upcoming changes in the medical field.
RESUMO
BACKGROUND: Fresh platelet rich plasma (PRP) gel has been reported to have anti-bacterial properties. We evaluated the anti-bacterial effects of liquid type activated PRP (tAPRP) using thrombin and heparin treatment after a freezing-thawing (F-T) procedure, using a disk diffusion method. METHODS: PRP and platelet poor plasma (PPP) were prepared from CPDA-1 anticoagulated blood received from 20 donors. PRP was concentrated to 8 times the base platelet counts of donors for the first trial and to 11 times the base platelet counts of donors for the second trial. Both F-T PRP and F-T PPP were divided into a nonactivated group and an activated (tA) group, which was then treated with bovine thrombin and CaCl2, and heparin was added to prevent gel formation. The anti-bacterial effects of F-T PRP, F-T PPP, F-T tAPRP with heparin and F-T tAPPP with heparin on S. aureus and P. aeruginosa were evaluated using a disk-diffusion and direct dropping method. All experiments were duplicated. RESULTS: The inhibited diameters resulting for S. aureus and P. aeruginosa, using the disk-diffusion and direct dropping method, were zero for all 20 sets of results for F-T PRP, F-T PPP, F-T tAPRP with heparin and F-T tAPPP with heparin. CONCLUSION: No anti-bacterial effects were detected for S. aureus or P. aeruginosa in the F-T PRP, F-T PPP, F-T tAPRP with heparin and F-T tAPPP with heparin. This negative result may be due to the F-T treatment and/or because liquid instead of gel form of PRP was used. The use of the disk diffusion method for the determination of anti-bacterial ability of PRP may also be a factor in the negative study results.