title: The case for regulatory compliance of electronic medical records about human tissue intended for transplantation.
abstract: It is vital that patients receiving human tissue by transplantation be able to trust in the suitability of the product. In short, patient safety must be ensured to the highest degree possible. To this end, firms operating tissue banks and those providing tissue donor coordination services are inspected by the U.S. Food and Drug Administration (FDA). The suitability of tissue for transplantation is objectively documented at all phases, beginning with donor screening. This process often involves the use of custom software applications that produce electronic medical records (EMRs) and databases that store the results. When a firm elects to keep the medical records relevant to human tissue products in electronic form, the record system must comply with applicable codified regulations. Unfortunately for the patient, many firms have yet to achieve regulatory compliance, and FDA enforcement is only beginning to approach the intensity appropriate to regulate this fast-growing industry. This article discusses current FDA trends in enforcement and rule-making related to human tissue intended for transplantation, as well as expectations the FDA has during an inspection.
authors.affiliation: IMIT Consulting, LLC, Boulder, CO, USA. robert@21cfr1270.com
authors.forename: Robert
authors.initials: R
authors.lastname: Carrier
mesh_terms: D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence*; D014019:Tissue Donors; D016378:Tissue Transplantation; D014481:United States; D014486:United States Food and Drug Administration