59MDWI44-156 governs the Tissue Implant Program, including the qualification, procurement, storage, use, disposition, and recall of tissue.
View 59MDWI44-156 on armypubs.army.mil
The publication addresses supplier qualification, tissue receipt and tracking, storage conditions, implantation documentation, disposition, adverse events, recalls, and training. It requires annual training, documented tissue traceability, and retention of tissue records for at least 10 years beyond the latest specified event.
Applies to: This instruction applies to all Military Medical Treatment Facilities (MTFs) and Clinics under the Authority, Direction, and Control of the Director, Wilford Hall Ambulatory Surgical Center, to include the 59th Medical Wing (MDW) medical staff while performing Defense Health Agency duties.
Tissues will only be procured from source facilities that are validated as licensed by their respective state agencies and/or are registered as a tissue establishment by the FDA. (paragraph 1)
The 59 MDW retains tissue records, tissue manuals/guidance/publications to include outdated guidance, for a minimum of 10 years beyond the date of distribution, transplantation, disposition, or expiration of tissue (whichever is latest). (paragraph 3)
Items received on dry ice are to be delivered immediately to the end user and placed in a controlled environment. (paragraph 3)
Tissues stored at frozen temperatures will be monitored 24/7 and temperature will be recorded on a daily basis. (paragraph 3)
Quarantine any tissue that is questionable until inspected by provider and decision about acceptability or rejection is documented. (paragraph 3)