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Patients who have undergone a heart attack often have thinned-out or otherwise weakened heart walls, which can result in inefficient blood circulation and/or regurgitation, leaving the patient weakened and out of breath. Researchers at the University of Pennsylvania have developed a biodegradable hydrogel based on hyaluronic acid that can be injected into the walls of the heart in a patient who has undergone a heart attack. The liquid gels in the damaged walls of the heart through the addition of thiol and methacrylate groups, which crosslink the hyaluronic acid. The UPenn team hopes that the approach will result in a stiffened, and therefore more reliable, heart wall.

Injectable hydrogels have been used to improve heart function for several years, including work done at Cambridge Polymer Group. Since 2006, CPG has collaborated with cardiovascular researchers at the Massachusetts General Hospital. In several studies, this collaboration has demonstrated that a novel injectable hydrogel developed at CPG can be injected into the hearts of sheep with induced ischemic mitral regurgitation, and the hydrogel-strengthened heart walls can reverse the effects of the mitral regurgitation. 

The hydrogel is based on polyvinyl alcohol, and undergoes no chemical reaction to form the gel, which helps in its safety profile. This approach is minimally invasive, and provides a potential long-term solution to hearts damaged from cardiac events. Read more about the publications by CPG and MGH on this subject here.

On Friday, September 2^nd 2016, the FDA issued a final rule banning the use of 19 different chemicals in antibacterial soaps. The final rule applies to consumer wash products containing one or more of the 19 banned chemicals including the most commonly used ingredients in liquid and bar soaps, triclosan and triclocarban.

According to the U.S. Food and Drug Administration (FDA), there is lack of scientific evidence to support the claim that antibacterial soaps are more effective than plain soap and water. In addition, there is some data suggesting long-term exposure to certain antibacterial chemicals can pose health risks such as bacterial resistance, muscle weakness, and hormone cycle disruption.

In December of 2013, due to consumers’ extensive exposure to the chemicals, the FDA issued a proposed rule requiring manufacturers to provide safety and efficacy data on their products. Several companies began phasing out these chemicals; however, those still utilizing them were required to prove the long-term safety for daily use as well as greater effectiveness in comparison to plain soap and water.

Upon finalization of the rule on September 2^nd, 2016 no manufacturers had provided the minimum data necessary to prove the safety and efficacy of any of the 19 banned chemicals. Therefore, the FDA lacked evidence to find the chemicals Generally Recognized as Safe and Effective (GRAS/GRAE). Companies currently using the banned ingredients will have one year to eliminate them or remove their products from the market altogether. The rule does not apply to hand sanitizers or antibacterial agents used in healthcare settings.

If you are seeking to identify triclosan or other antibacterial agents, GC-MS can be used to detect trace levels of antibacterial chemicals in municipal water, soils, and consumer products. CPG performs routine and custom GC-MS, and can assist in determining quantitative levels of antibacterial agents in materials. 

CPG President Stephen Spiegelberg will be chairing the ASTM workshop "Reprocessing of Re-Usable Medical Devices" on November 15, 2016 in Orlando, Florida.

A recent article in Medical Processing Outsourcing (June 2, 2015) estimates that reprocessed medical devices will grow by 19% annually to reach $2.58 billion in 2020. A key element of this successful growth is assurances of cleanliness and safety standards.

Recently, the FDA released a guidance document on reprocessing of reusable devices (March 12, 2015) and held a public meeting on May 14-15, 2015 to discuss infections associated with the use of duodenscopes. 

Workshop registration ends November 9, 2016.

If you watched the 2016 Summer Olympics in Rio, you probably noticed the diving pool turn a mysterious green midway through the games. Athletes have complained that it was difficult to see in the murky water, and some complained of irritated eyes. The director of the Olympic venues at Rio finally indicated that someone had mistakenly added 160 liters of hydrogen peroxide to the pool, which neutralized the chlorine already in the pool. Subsequent algae growth resulted in the green color pictured above.

We were interested in this from a chemistry point of view. Chlorine is often used to disinfect municipal water, killing microorganisms in the water to make it potable. However, the chlorine itself could be unacceptable if the levels are too high. As a result, de-chlorination is often required before reintroduction of the treated water into the public water supply. And de-chlorination is often accomplished by the addition of hydrogen peroxide. 

To disinfect water, chlorine gas can be added to water, and is hydrolyzed to form hypochlorous acid (HOCl). The hypochlorous acid can further ionize into hydrogen and a hypochlorite ion. The extent of the ionization depends on the pH of the water. 

Cambridge Polymer Group is proud to be celebrating its 20th anniversary this summer. Started in the front room of an apartment in Arlington, MA by three MIT alumni, CPG has established an international reputation as a contract research and testing laboratory, with almost 900 clients. All three founders are still actively involved with the company.  Over the subsequent years, we have had the pleasure and opportunity to work and collaborate with many excellent employees, but we now have one of the best collections of researchers assembled in the history of the company.

CPG started with an NIH SBIR grant to develop an add-on feature for a rheometer, and have used this funding mechanism occasionally over the years to help fund speculative internal research.  We quickly realized that instrumentation was not where our primary interests lay and we soon began providing testing and consultation in orthopedics materials and devices. This work translated into other biomedical fields, including cardiovascular, ophthalmology, spine, women's health, gastro-intestinal, and general soft tissue applications. Our clients grew to rely on our expertise in test design coupled to our deep fundamental material understanding, all presented in detail-oriented, clear written, reports. CPG researchers also began to innovate on test methods and materials as part of our internal research efforts, and invented extensional rheometers, hydrogel formulations and constructs, surgical tools, and polyethylene formulations for total joint replacements. Many of these inventions have been licensed and are on the market.

We have continuously added on new capabilities and expertise to help our clients and to support our internal research efforts. In the past 5 years, we have built a chromatography lab to support our work in product formulation, medical device cleaning assessment, unknown analysis, and degradable polymer characterization. Our hydrogel team has developed expertise in tissue phantom development, and have created realistic tissue models for training and testing. Our chemistry team has developed new polymer systems for clients. Our engineers have assisted clients with the design and development of new tools, instruments, and medical devices, from original concept, to material selection, to proof-of-concept testing. And our testing team, arguably the core of CPG, continues to provide rapid, high quality and value added testing services to our clients.

We are pleased to be celebrating 20 years with our clients, and look forward to many more years of service.

Sterilization modalities for medical devices include ionizing radiation (gamma or electron beam), ethylene oxide (ETO), autoclaving (high temperature), and gas plasma. Gamma and ETO sterilization are the most popular techniques. Gamma has the advantage that devices can be sterilized in conventional packaging, and hidden surfaces in the devices can be reached by gamma. Gamma has the disadvantage that it can chemically alter some materials, such as some polymers, which may result in property changes. ETO does not have the issue with chemical modifications of most materials, but does involve the use of gas-permeable packaging. Additional ETO is a carcinogenic chemical, and residues must be carefully monitored following sterilization. Both ETO and gamma require custom facilities to perform the sterilization, which involves shipping and quarantine times.

Autoclaving and gas plasma can both be done at manufacturer's facilities. Autoclaving is not suitable for most polymeric devices, as the temperatures used would result in device distortion. Gas plasma does not have this issue, but is limited to surface sterilization.

Vaporized peracetic acid (VPA) sterilization is an alternative method to gas plasma. In VPA, the peracetic acid, which is produced by reacting acetic acid with hydrogen peroxide, acts as a strong oxidizer, and is believed to denature protein and oxidize sulfide bonds. It can also disintegrate the cell walls of bacteria. Similar to gas plasma and ETO, VPA is a surface sterilant only. An advantage of VPA over ETO is the lack of toxic compounds. VPA can be safely performed in conventional manufacturing spaces, and requires less time to remove the sterilization by-products compared to ETO.