484 FDA cleared devices produce inconsistent platelet-rich plasma product

Abstract

Platelet-rich plasma (PRP) has emerged as a novel option to treat androgenetic alopecia. However, data focused on quality of product from FDA cleared devices is lacking. Herein, we assessed and compared cellular PRP content produced from FDA cleared devices. Within one academic institution, white blood cell (WBC) counts and platelet counts from whole blood and resultant PRP were retrospectively reviewed. Institutional quality control (QC) procedures were utilized to obtain counts. Of the fifty-two PRP samples assessed, only 2 met the Insitutions QC standard (defined a 3-fold increase in platelet concentration). Paired analysis demonstrated similar platelet counts in whole blood and PRP. Platelet counts from individual devices were significantly different. Within the devices, platelet counts from PRP samples were inconsistent, failing the Shapiro-Wilk test. The Emcyte device demonstrated the highest capacity to concentrate, even though mean enrichment was just 2.9-fold and capture efficiency was found to be 34%. WBC numbers were negligible in Eclipse and Selphyl final PRP samples. However, the Emcyte device enriched PRP with WBCs similar to or greater than whole blood. These results demonstrate inconsistent PRP end product with variable platelet counts among multiple devices and within devices. QC testing standards were not passed by most samples. Efficiency of platelet capture was lower than that claimed by device manufacturers. WBC content varied by device used for preparation. Of note, no patients worsened while receiving these treatments. This study presents an additional variable in PRP preparation – inconsistent PRP product from FDA-cleared devices. Additionally, clinical improvement despite QC failure suggests platelet numbers may not be vital for clinical improvement.