Advanced virtualization technology can help you adhere to safety standards in your devices. • IEC 61508 Safety Systems • Aspects of IEC61508 System Design • Advanced Concepts for Safety & Security Jeff Fortin, Director of Field Engineering, Wind River
This presentation will explore how additive manufacturing systems such as 3D printers and 3D production systems are changing the future of product developmen...
Microfluidics is an enabling technology which allows the development of highly integrated diagnostic or medical devices. We will present several examples of ...
Temporary Medical Devices (TMD) span a continuum of applications--from simple bandages to complex wound therapy systems, drug delivery patches, and passive a...
Toxikon at MDM East 2013, Philadelphia, PA
Biocompatibility testing involves the safety evaluation of medical devices and materials according to the guidelines set forth by regulatory bodies around the world such as ISO 10993, EP, USP, MHLW etc. Biocompatibility is typically performed on the final version of devices, although cases exist where specific tests are designed for the analysis of raw materials. The determination of which guideline to follow depends upon to which countries the devices will be submitted to, as well as the nature of what is being tested (medical device vs. raw material).
There are a number of low temperature sterilization options for medical device, pharmaceutical and biotech products. Today, the most common methods are: ethylene oxide (EO), gamma and hydrogen peroxide. EO is the oldest method, first used in the 1940-50's. Hydrogen peroxide was introduced in the early 1990's. Each method has its' strengths and weaknesses. With the rise of bioresorbable implants, drug-device combination products and prefilled syringes, more options are needed. This presentation will include the current sterilization technologies, and a discussion of the newest option, nitrogen dioxide gas. An overview of the strengths and weaknesses of NO2 will be discussed with a focus on the scientific data. One to two case histories will be shared demonstrating application to marketed products. In addition, a financial analysis will be presented contrasting the costs of contract sterilization vs. bringing sterilization in house. The intent is for this presentation will stimulate discussion in and questions from the attendees.
This presentation aims to remove the "magic" from gas plasma surface modification. How plasma creates a chemically reactive environment at low temperature is...
- Necessity and basics of cleaning and disinfection validations on reusable devices
- Non-patient contacting devices need cleaning and disinfection validations
- Simulated use of devices prior to the cleaning and disinfection validations
There are currently a number of innovative activities in the world of radiation sterilization. This presentation will provide an overview of those activities which include irradiation of tissue/biologics/combination products, new VDmax sterilization doses, discussions on use of SALs other than 10^-6 and a new approach to evaluating the potential impact that changes to SAL might have on patient safety.
Explains the mandatory removal of pfoa from the presently specified ptfe coatings [like Teflon(r)] and the EPA'a position. Then, covers the range of new coat...
This presentation will cover the basics of Very Long Fiber (VLF) reinforced thermoplastics and the unique performance benefits these compounds bring to metal...
Although the demand for reliability and safety has always been at the forefront in medical device design, the challenges of minimally invasive and micro/nano...
All materials used in medical device manufacturing must be proven to be safe. With improvements in device effectiveness comes more intricate, unique, novel and specialized technologies. As these advancements evolve, understanding their impact on safety becomes more critical. A primary measure of the safety associated with a device or material is biocompatibility. There are specific tests that are recommended by the regulations to determine the overall biocompatibility of the device. Upon successful completion of this testing, a device can be submitted for use in the industry. Select biocompatibility tests can be utilized as a screening tool prior to that biocompatibility testing used to meet the regulatory requirements. Understanding how the change of a material can impact the biocompatibility of the overall system can be achieved by determining the extractable and leachable profile of the device. Extractable and leachable determination essentially models the interacting compounds between device and patient. Understanding these interactions allows one to predetermine the expected impact. Additionally, identification of these compounds allows one to determine the source that may be affecting the biocompatibility of a material/device. Ultimately, this chemical characterization can be implemented to determine the source of a failure, as a screen measure to ensure optimized material selection during product development, maximize the efficacy of specialized devices, and/or to provide key input in a toxicological risk assessment. Along with demonstrating the usefulness of extractable and leachable determination, an overview of how this determination is made will be presented.
Accomplishing new minimally invasive procedures often requires the construction of complicated catheters to access different anatomies, deliver devices or drugs and incorporate sensors to assure proper results. This requires the combination of many materials to provide different flexibility, low friction, torsional resistance, multiple paths and functional components; all in small diameters. Materials commonly utilized to achieve the required results include Nitinol, polyurethane, high density polyethylene, stainless steel, silicone rubber, Pt-Ir, PTFE, conductive wires, etc. Techniques for assembling these complex catheters will be explained; to include braiding over multiple lumens, axial reinforcement, injection molded access ports integrated into the handles, silicone balloons bonded to polyurethane, release mechanisms and sensor integration.
Medical devices require cleaning, disinfecting and sterilization techniques to protect the patient from infections. A variety of sterilization methods have been used to condition medical devices over the years. Typically, devices were constructed of materials such as metal, glass and rubber. However, as devices became more intricate and higher performing, the types of materials used for construction were modified. Thermoset and thermoplastics have replaced the materials of a few decades past and the assembly methods used for medical device construction have also been modified. With development of reusable medical devices, sterilization between uses has become an important consideration in the development of medical devices. In May 2011, the FDA distributed the Draft Guidance for Industry and FDA staff, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. When finalized, medical device manufacturers will need to include validated labeling instructions for reprocessing reusable medical devices in premarket submissions. Medical Design Adhesive Solutions are used in the manufacture of medical devices because of design flexibility, stress distribution, bond dissimilar materials and seal simultaneously and can be automated. With the shift to reusable medical devices, these devices must be able to withstand the specified sterilization methods outlined by industry requirements. Testing has been conducted on the integrity of these products to several industry protocols. To meet the requirements of various types of medical devices different cleaning, disinfecting, and sterilization techniques were tested including steam, radiation and chemical immersion.