August 21, 2014
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2014-D-0798 “Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.”
Dear Dockets Manager:
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies about 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. About 5.6 million units of whole blood are collected from roughly 3.3 million Red Cross volunteer donors, separated into 8 million transfusable blood products and supplied to approximately 2,700 hospitals and transfusion centers across the country for patients in need.
We appreciate the opportunity to provide comments on the Agency’s proposed compliance policy contained within the “Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.” AABB’s Information Systems Committee has been following this topic for several years.
AABB and the American Red Cross agree with the Food and Drug Administration’s (FDA) proposed policy to not enforce compliance with regulatory controls that apply to Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communications Devices as stated in Section III of the draft guidance document. Recommendations as drafted in the guidance document propose that MDDS, and other listed devices, would not be subject to medical device general controls including design controls and quality system regulations. The recommendations would also remove the requirement that blood establishments that create MDDS, or other listed devices, register as medical device manufacturers. Full compliance with these regulatory requirements would place an undue burden on many resource limited blood donor centers, transfusion services, and small hospitals without significantly improving patient or donor safety.
The FDA’s efforts to provide a regulatory environment that allows blood centers and hospitals to reap the patient safety benefits afforded by advancements in digital health are appreciated. Digital data transfer prevents transcription errors introduced when information would otherwise be transferred between medical devices manually, e.g., keyboard entry. It also reduces the time required to document blood product, donor and recipient processing, improving compliance and increasing blood center, laboratory, and transfusion service efficiency. Improvements in accuracy and efficiency of documentation improve blood product availability and patient safety.
Should you have any questions regarding these comments or would like additional information, please contact Elizabeth Barrows at email@example.com.
Deputy Director, Regulatory Affairs