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Articles Tagged "sterilization"

Crucial Validation Considerations for Instrument Cases and Trays

by BONEZONE | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »

Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning

by BONEZONE | Oct 2018

Recent updates to standards and regulatory guidance have made these processes more complex: “When you look at [sterilization] as a process, rather than a step, you’re much more capable of avoiding problems rather than reacting to them when they happen."... Read more »

Nelson Laboratories Purchases Gibraltar Laboratories

by BONEZONE | Aug 2018

This acquisition expands the U.S.-based analytical testing capabilities of Nelson Laboratories.... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Mar 2018

Increased infection rates at hospitals, regulatory implications on cleaning and the efforts of hospitals to cut costs have all driven sterilization changes in device packaging.... Read more »

Millstone Medical Adds Microbiologist to Sterile Packaging Facility

by BONEZONE | Oct 2017

Joshua Browning's experience includes Quality Control Analyst, Microbiology at Nanotherapeutics and R&D Analyst at NovaBone Products.... Read more »

Plasma Biotal Opens India Facility for HA Coatings

by BONEZONE | Aug 2017

The entity will supply HA coatings, packaging and sterilization to the Indian orthopaedic device market and international mid-tier market.... Read more »

Arcamed Expands Operations with Facility Purchase

by BONEZONE | Apr 2017

Arcamed supplies case and tray systems to orthopaedic OEMs.   ... Read more »

Simplify to Succeed: Instrument Reduction in the OR

by Chris Mosby | Aug 2016

As the workload increases for orthopaedic surgeons, there is a greater need for effective surgery sets. Finding a way to reduce the burden that instrumentation can place on the system is a focus for much of the healthcare system.... Read more »

TSO3 Offers Single-Cycle Sterilization of Heavy-Duty, Battery-Powered Orthopaedic Instrument Sets

by BONEZONE | Jul 2016

TSO3 completed sterile efficacy validation for multiple heavy-duty battery-powered orthopaedic instrument sets in a single sterilization cycle.... Read more »

Noxilizer Announces First 510(k) Clearance for a Device Sterilized Using Nitrogen Dioxide

by BONEZONE | Jun 2016

Noxilizer, a sterilization company with a focus on advancing the NO2-based sterilization process for medical device manufacturers, announced FDA 510(k) clearance for a medical device terminally sterilized using Noxilizer’s nitrogen dioxide sterilization process.With this clearance, Noxilizer has e... Read more »

FDA Issues Draft Guidance on Additive Manufactured Devices

by BONEZONE | May 2016

FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices.... Read more »

Lucideon to Host Cleanliness of Reusable Devices Webinar

by BONEZONE | May 2016

Lucideon will host a webinar titled Cleaning Validation of Reusable Medical Devices on June 9 at 10 a.m. (EST). Medical devices need to be cleaned thoroughly and effectively to ensure their safety in use. Reusable devices (such as surgical tools) require reprocessing (cleaning and disinfection/ster... Read more »

Identifiable and Sterile: Trends Driving Device Packaging

by Chris Mosby | Feb 2016

Unique Device Identification (UDI) and sterilization could be driving influences for the orthopaedic device packaging industry in 2016 and beyond. With increased regulatory guidelines in the form of FDA’s guidance UDI: Convenience Kits, along with tightening price pressures, more companies are loo... Read more »

UDI Update: Trays and Kits

by BONEZONE | Jan 2016

FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions an... Read more »

Master Your Sterilization Process

by BONEZONE | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

MNX Global Logistics Renews Multi-year Contract with NuVasive

by BONEZONE | Aug 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Nelson Laboratories Joins the Orthopedic Discussion on Sterile Packaging Validation at OMTEC 2014

by BONEZONE | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Sterilization: How to Validate Novel and Non-Traditional Processes

by Robert Packard | Apr 2014

Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »

Cadence Facility Receives 13485:2012 and ISO 9001:2008 Certification

by BONEZONE | Jun 2013

Cadence, a provider of medical device outsourcing solutions, received ISO 13485:2012 and ISO 9001:2008 certification through BSI for its Pittsburgh, Pennsylvania location.  Cadence's new facility offers turnkey finished medical device assembly and sterilization management capabilities, allowin... Read more »

Case Study: Moist Heat Sterilization of Reusable Device and Tray System

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Symmetry Surgical Enhances Immediate-Use Sterilization Portfolio With Launch of FlashPak Evolution Valve

by BONEZONE | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Solvay Study Affirms Compatibility of Medical-Grade Polymers with Sterrad Sterilization

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »