Packaging & Kitting for Loaner Kit Programs

Packaging and kitting refer to the structured assembly, verification, and protection of reusable medical devices into defined loaner sets. Unlike packaging for new product, loaner kits are repeatedly disassembled, reconfigured, and redeployed, requiring ongoing verification between uses. Each kit is assembled according to OEM-approved bills of materials and configuration requirements. LSO executes packaging and kitting activities but does not define kit composition or configuration authority.

Packaging and kitting services are used by medical device manufacturers managing reusable loaner kits that support surgical procedures. These services are commonly utilized by OEMs with orthopedic, spine, or other procedure-specific instrumentation and implant systems. OEMs may engage packaging and kitting support to address variability in kit configurations, turnaround time requirements, or internal capacity constraints while retaining ownership and oversight of their loaner programs.

Reusable instruments and implants are exposed to repeated transport, handling, and clinical use. Packaging configurations are selected to protect devices from damage, reduce the risk of component mix-ups, and preserve organization across multiple loaner cycles. Packaging methods are evaluated to support efficient kit use in clinical environments while maintaining protection during storage and shipment.

Packaging and kitting activities performed by LSO are governed by its FDA-registered, ISO 13485-certified quality management system. Applicable controls and documentation requirements may vary based on the level of outsourcing selected and the scope of services provided. All activities are executed in accordance with OEM-defined requirements and documented to support traceability and audit readiness.

When packaging and kitting are integrated into an SVS-supported loaner kit processing model, OEMs can reduce operational burden while maintaining control over kit configuration and program governance. This approach supports scalability without altering validation ownership or regulatory responsibility.