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If you were not able to attend the FDA workshop on "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers" last October, the video and transcript are available here. 

CPG President Stephen Spiegelberg speaks during October 28, Part 4.

Silk is recognized as an expensive, luxury textile material, having been used for several thousand years for fine fabrics, tapestries, clothing, and runs. Silk is a protein-based fiber produced by the larvae-form of several insects, most notably silkworms, but also by spiders, bees, beetles, and other insects. The mechanical properties of silk can rival synthetic fibers such as Kevlar. CPG co-founder Gareth McKinley, a professor at MIT, is doing research on spider silk in an effort to make military armor lighter and more flexible. CPG researchers McKinley and Braithwaite also have experience developing artificial spider silk.

Researchers from China discovered that feeding silk works carbon nanotubes permitted the natural production of reinforced silk fibers.  A portion of the nanotubes fed to the silkworms was incorporated into the silk fibers, which modified the structural conformation of the silk fibroin, increasing the elongation at break and toughness.

Contact CPG for more information on custom chemical formulations and electrospinning.

You may have heard the expression ‘tickling the ivories,’ referring to someone playing the piano. This expression of course results from the original coverings on the white keys of a piano, which were ivory chips from the tusks of elephants and walruses. White piano keys were usually made of spruce or basswood so that the key was light and could provide a fast action, and then clad in ivory on the top and front of the key only. The black keys were made of ebony, a dense hardwood. Ivory was abandoned by the piano industry in the 1970s, and any imported piano containing ivory keys must have providential documentation showing it was made prior to the importation ban, or it will have the ivory removed from the piano. 

Synthetic Piano Key Formulations

For a while after the ivory ban, keyboard manufacturers simply used injection molded plastic as the white keyboard cover, but the material, usually ABS, did not have the same feel as ivory, and piano-players became disgruntled due to the slipperiness of the plastic keys. In response, material scientists began experimenting with alternative synthetic formulations that would yield a similar feel as ivory. Yamaha produced a material called Ivorite, which is believed to be made from ABS with mineral reinforcement. A few manufacturers use nitrocellulose fiber reinforced with silica filler (Kawaii’s Neotex and a material called Pyralin). Various other ivory-replacement compositions include Ivorine and Ivoplast. Yamaha also experimented with white keys made from casein (from animal milk), reinforced with elastomers for improved impact strength, and then hardened with formalin. In addition to the formulations, manufacturers worked on micropatterning the surface of keys, adding porogens to create porosity, and inducing specific surface roughness during molding so that the keys have a similar friction to ivory, and will also have some absorptivity of perspiration and skin oils to reduce the slick feeling of plastics. This micropatterning provides a similar tactile action to ivory keys, according to these manufacturers.

Benefits of Non-Ivory Keys

One key (sorry) benefit of the non-ivory keys is their resistance to yellowing, an issue with the older ivory keys. Additionally, it was always challenging to match the color and porosity of ivory keys, in addition to the size of each key, so ivory keyboards tended to have a non-uniform appearance. For those who still clamor for the feel of ivory in a non-synthetic source, some piano companies will make key covers out of oxbone or other non-endangered animal bones. Most piano players prefer tickling the white uniformity of synthetic keys.

Join Cambridge Polymer Group scientists Adam Kozak and Stephen Spiegelberg for a webinar on how to establish and mitigate the risks of degradable products in medical devices.

This webinar will focus on techniques to identify and quantify degradation products in in vitro and in vivo environments. Knowledge of the kinetics of degradation products and the degradation pathway will allow researchers to validate simulated in vivo environments and to establish risk profiles for degradable products based on biocompatibility concerns. The techniques are applicable to materials for permanent implants and to biodegradable materials.

This webinar is targeted towards:

• Biomedical engineers
• Medical product designers
• Material engineers
• Regulatory personnel

Duration: 30 minutes

Degradable Products in Medical Devices Webinar 

Thursday, December 8, 2 p.m., Eastern Standard Time

To register, click here.

With the upcoming ASTM workshop on reprocessing of re-usable devices, we thought a primer on this important area of the health care industry would be in order. Reprocessing is a set of procedures that will take a previously used medical device and return it to a state fit for a subsequent clinical use. Usually, the most important steps in reprocessing include (1) cleaning; and (2) disinfection or sterilization.  

Cleaning

The cleaning step should remove biological soils, such as blood and tissue, as well as any other materials that may have contacted the medical device, such as hospital disinfectants, lubricants.

Disinfection

The disinfection or sterilization step is a completely separate step from cleaning, and neither can be substituted for the other. The choice of disinfection (the killing of some or most microorganisms, with the exception of bacterial spores, depending on the level of disinfection) or sterilization (killing all microorganisms to a log reduction, typically 1E-6) depends on the application area where the medical device is used.

Re-usable Medical Devices

A re-usable medical device is one that is intended to be used on multiple patients with reprocessing between each patient. Examples of reusable devices include forceps, stethoscopes, endoscopes, scissors, arthroscopic shavers, and suction tubes. Reprocessing is often conducted either at hospitals or by third body reprocessors. It is up the reprocessor to demonstrate a validated reprocessing procedure for each medical device, which involves demonstration of adequate cleaning through verification tests. The original equipment manufacturer should ensure that the device is designed and constructed to allow reprocessing, and provide adequate instructions on how to reprocess the device, along with appropriate labeling. Proper selection of materials that can undergo repeated reprocessing is an important consideration as well.

The FDA issued a guideline on reprocessing of re-usable medical devices in 2015. 

CPG TRANSITIONS FROM ISO 9001:2008 TO THE UPDATED ISO 9001:2015 STANDARD

Cambridge Polymer Group is pleased to announce that it is now certified as an ISO 9001:2015 compliant organization by International Certifications Ltd. 

CPG is certified as meeting the requirements of ISO 9001:2015 for the following activities:

• Contract Research and Analytical Testing Laboratory
• Design and Manufacture of Custom Materials and Instrumentation

Previous to transitioning to the ISO 9001:2015 standard this November, CPG has maintained ISO 9001:2008 certification since 2010.

ISO 9001:2008 vs. ISO 9001:2015

In September 2015, the International Organization for Standardization released a new revision of the ISO 9001 standard, giving ISO 9001:2008 certified organizations three years to transition. 

In addition to the rigorous quality requirements of ISO 9001:2008, ISO 9001:2015 stipulates that certified organizations assess risk, not only to themselves but also to customers and stakeholders. The updated standard ensures that ISO 9001:2015 certified organizations pay greater attention to the external perspective of customers. 

Cambridge Polymer Group's Commitment to Quality

CPG's early attainment of ISO 9001:2015 demonstrates our commitment to our customers and to quality. We strive to understand our customers' needs and to meet and exceed expectations. Our quality policy is an integral part of our strategy of being recognized as the premier contract research organization in North America, offering a full range of contract research services, excellent technical support and innovative products.