Packaging Advice for OEMs
• Do Your Research—Gerry Gunderson, Vice President, Systems at QTS Package: “Customers will assume that they need a double-barrier system. They don’t think through that decision, or question the reasons why. As a contract manufacturer, we see very similar devices from different customers and we see a wide variety of packaging styles for, essentially, the same device—a device intended for the same surgical site.”
Unique Device Identification (UDI) and sterilization should be driving influences for orthopaedic device packaging in 2016 and beyond. With increased regulatory guidelines in the form of FDA’s UDI guidance on convenience kits, along with tightening price pressures, the way device packaging is done will change.
“We’ve seen a considerable push to move from hospital-sterilized product to single-use terminally sterilized devices, taking things that normally would be autoclaved at a hospital and instead providing that device directly to the hospital, already packaged and sterilized,” says Brian Nissen, Principal Project Engineer at Quality Tech Services.
Additionally, getting a product to market is a long process, says Stu Krupnick, Director of Marketing at UFP Technologies. “Anything that we can do as a supplier to speed up the process is of value,” he says, and as more implants move toward sterile packaging, “That requires that the packaging maintain the sterile barrier, which can be challenging, because some of these items are sharp or abrasive.”
The Impact of UDI
Developments in UDI regulations are driving change in the packaging market.
In January 2016, FDA released a draft guidance document titled UDI: Convenience Kits. The document was meant to clarify the definition of convenience kit, reducing the number of accepted exemptions and requiring more individual devices to be marked with UDIs. Specifically, it noted that a non-sterile orthopaedic device tray or set would not be a convenience kit. FDA states that, because the implants and devices contained within are not meant to remain packaged together, that kit cannot qualify for the exemption.
This document followed the July 2015 draft guidance that indicated that direct marking on the device itself is required if the device is intended to be used more than once and intended to be reprocessed before each use, in order to ensure identification of the devices through their distribution and use.
Nissen’s colleague, Gerry Gunderson, Vice President, Systems, says that pending UDI labeling regulations are part of the reason for the push toward terminal sterilization. “I think industry had hoped that, for a hospital sterilized procedure kit, a single UDI would be sufficient. Recent guidance has squashed that,” he says.
Tom Williams, Senior Vice President of Marketing and Strategy at Millstone Medical Outsourcing, says that new obstacles have surfaced for packaging companies. “The latest guidance surrounding what constitutes a ‘convenience kit’ may provide some challenges to the current delivery model of implants and instruments being provided in a non-sterile kit, especially within the spine and trauma markets,” he says.
Gunderson agrees. “That small requirement, that medical devices bear a UDI and a human readable, set off a whole chain of events in terms of label layout and label size selection,” he says. “Suddenly, you have a need in label validation and production to have a tool that could interpret machine readable codes.”