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Packaging and sterilizing implants and instruments together yields advantages: Part I

Xenco Medical’s innovative approach to gamma-sterilizing spinal implants and instruments at the same time delivers multiple benefits to surgical facilities.

Sterile packaging its single-use instruments and implants together provides hospitals and healthcare facilities by reducing their overall sterilization volume.
Sterile packaging its single-use instruments and implants together provides hospitals and healthcare facilities by reducing their overall sterilization volume.

Spinal implants and instruments typically arrive at a hospital or clinic in metal trays, without any sterile barrier system to protect them against pathogens. As such, they require medical facilities to sterilize them prior to use. Combine that with the growth of surgery centers and the need for facilities to better manage their purchasing and operational costs, and it becomes evident that the timing is perfect for packaging to step up to the plate and address these medical device sterilization challenges.

Enter Xenco Medical. The San Diego-based medical device company designs, manufactures, and markets composite-polymer spinal instruments with spinal implants pre-attached. The company sells 14 products, 536 product variations, and 18 packaging configurations.

Says Jason Haider, the company’s CEO, “We are the first spinal company to commercialize this technology and have had traction across the country. Sterile packaging both our instruments and implants together has transformed the logistics landscape for both hospitals and surgery centers,” he contends.

Haider, who founded the company in 2011, says, “As devices that deteriorate with steam sterilization cycles, reused instruments and their corresponding implants arrive at each surgery less precise than their original condition and with slightly altered surface properties through the accumulation of fine minerals found in the steam. With the proper calibration of instruments being critical in the surgical setting, this deterioration of reused instruments is, unfortunately, often discovered through a mechanical failure during surgery. By bridging materials science, mechanical engineering, and sterile-packaging, Xenco Medical’s single-use systems are the first composite-polymer systems of their kind.

In the following Q&A, Haider discusses medical device packaging and sterilization issues.

Healthcare Packaging: What are some of the dangers associated with reused surgical instruments/devices?

Haider: Tasked with sterilizing increasingly complex surgical devices using the same limited equipment and procedures developed years earlier, healthcare facilities across the U.S. have reported numerous incidents of infection-risking sterilization failures. This was apparent in 2015 when the Centers for Disease Control released an urgent public health warning through HAN 00382 to alert healthcare providers and facilities about a rise in infection control lapses due to the improper sterilization of reusable medical devices across the country.

The CDC alert was motivated by a rise in instances in which patients were notified that they were at increased risk of infection due to failures in disinfection and sterilization of medical devices. This was also apparent in June of this year, when the Colorado Department of Public Health investigated a major incident at a hospital in which around 5,800 patients were notified that they may be at risk of surgical site infections or exposure to hepatitis B and hepatitis C because of improperly sterilized medical devices.

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