Kelly Lucenti, Millstone Medical Outsourcing02.21.14
As defined by the U.S. Food and Drug Administration (FDA), HCT/P refers to any articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.1 Bone and tissue products have long been used as substitutes for diseased or damaged tissues. However, their medicinal functions continue to expand as scientific developments around their uses surge. In today’s operating rooms, cornea grafts restore eye sight, burns are treated with skin processed dermal matrices, and biomaterials are used to repair skeletal defects and regenerate bone and tissue damaged by trauma or infection.
Just like any new product in the medical industry, manufacturers are eager to get their hands on such unique products. However, as HCT/P becomes more prominent in surgical procedures, federal regulations and state mandates surrounding the products become overwhelming and challenging. To ensure that anyone involved in the manufacture, processing, and distribution of HCT/P maintains current good tissue practices, the FDA established 21 CFR Part 1270 and 1271.
These governing documents provide specific guidelines as to how HCT/Ps must be registered, listed, processed, stored, labeled, packaged and distributed and led to the significant issue of how manufacturers will ensure the most effective means of processing and handling these delicate products. While some manufacturers are developing the capabilities in-house, many choose the high-quality, cost-effective alternative: to outsource.
Photo (left): A Millstone employee working with dry ice as part of the HCT/P handling process. Photo courtesy of Millstone Medical Outsourcing.
State licensing is disparate where each state’s requirements and deadlines are handled differently. On federal and state levels, licensing is very extensive and necessitates dedicated personnel to manage its progression and ensure continued management of all requirements and mandates. Companies that provide such services are FDA registered under 21 CFR Part 1270 and 1271 as human cell and tissue establishments. Under American Association of Tissue Banks guidelines, these companies also are classified as distribution intermediaries—agents who acquire distributed tissue for storage and further distribution. As intermediaries, these service providers are required to establish policies and procedures regarding receipt, storage and final disposition of HCT/Ps, to ensure the safety and traceability of tissue from receipt through distribution or destruction. Processing HCT/Ps for storage and distribution is just as extensive, if not more, as the licensing aspect. This can involve the purchase and maintenance of specific temperature controlled storage freezers, the hire and in-depth training of additional personnel, 100 percent product traceability down to the donor level, and state-of-the-art ordering and processing systems.
The FDA requires that establishments registered for HCT/P storage and distribution maintain control over storage areas and stock rooms to prevent mix-ups, contamination, and cross-contamination of HCT/Ps, supplies and reagents.2 They must follow all guidelines to prevent HCT/Ps from being improperly available for distribution, regulate appropriate temperatures, assign expiration dates where necessary, document corrective action procedures, manage product recalls and establish acceptable temperature limits for storage of HCT/Ps at every stage of the process. All current good tissue practice requirements must be followed in order to prevent the introduction, transmission, or spread of communicable disease.3 Any deviation in HCT/P processing must be documented and corrective action must be taken whenever proper conditions are not met. Each facility follows rigorous guidelines relating to receipt, inspection, labeling, storage, distribution, records, tracking and complaints of HCT/P, all outlined in 21 CFR Part 1270 and 1271.
As the world of medicine continues to evolve and grow, manufacturers face significant pressure to reach the market with innovative products at a faster pace than ever before. Outsourcing can help OEMs meet these demands by providing consolidated resources and cost-effective, quality-driven solutions. For medical device companies focused on the quality manufacture of their products, producing the capabilities to house HCT/P and do so efficiently, accurately and without error, is time consuming and challenging. A dependable partner with top-notch quality systems, the flexibility to accommodate customer needs, and the experience that leads to best practices in every aspect of day-to-day operations is an advantageous solution. Strong, mutually beneficial partnerships are the way medical device and product manufacturers’ help patients get the products they need; and the way OEM’s get their product to market safely and more efficiently.
(Edited by C. Delporte)
References:
1. CFR Section 1271.3 (d).
2. CFR Section 1271.260 (a).
3. CFR Section 1271.150 (a).
Kelly Lucenti joined Fall River, Mass.-based Millstone Medical Outsourcing in 2004. Prior to Millstone, he served as director of worldwide operations for Flexcon Industries. Before Flexcon, Lucenti worked in a variety of capacities, including production supervisor and quality systems manager, for several operating divisions of the Johnson & Johnson family of companies, including Codman and Orthopaedics, now DePuy Synthes. Kelly received a Bachelor of Science degree in industrial engineering and operations research from the University of Massachusetts at Amherst and a Doctorate of Law from Southern New England School of Law.