BioAccess is pleased to announce successful registration of its Marrow Collection Kit in Brazil.
"Brazil is the largest market for medical devices in South America. It has taken four years to clear Brazil's regulatory hurdles and we look forward to shipping product in the first quarter of 2014."
The BioAccess Marrow Collection System was presented at a previous National Marrow Donor Program Be The Match annual Council Meeting. The presentation detailed an evaluation of the BioAccess Bone Marrow Collection Kit by the authors, Ellie Hamilton, MT (ASCP), Edmund K. Waller, MD, PhD, from the Bone Marrow and Stem Cell Transplant Program, Emory University Hospital, Atlanta, GA. The presentation titled ‘Single Bag Closed Collection System for Bone Marrow Harvest’ compared clinical data and user feedback from the BioAccess Bone Marrow Collection System (MH-2150) to historical controls. Results of the investigation showed the BioAccess Bone Marrow Collection Kit was an improvement over past methods according to the study.
The features of the Bone Marrow Collection Kit (MH-2150) allow bone marrow harvesting, bone marrow collection and bone marrow filtration to occur while eliminating steps such as spraying of a blood product. Predicate and competitive devices require the healthcare worker to spray the bone marrow during the bone marrow collection.
The BioAccess Bone Marrow Harvest System has been recognized as a Safety Device by several organizations. The International Healthcare Worker Safety Center at the University of Virginia Health System has placed the marrow collection kit on the International Healthcare Worker Safety Center Safety Device List. CalOSHA, Frontline Healthcare Workers Safety Foundation and International Healthcare Worker Safety Center also recognize the BioAccess Bone Marrow Collection Kit as a safety device. The United States Army Public Health Command lists BioAccess in their Technical Guide, TG 190 Guide to Managing Occupational Exposure to Bloodborne Pathogens.