James Mazzo, president of Santa Ana eye device maker Abbott Medical Optics Inc., recently put on his hat as chairman of medical device trade group AdvaMed during a visit to China.
Mazzo visited Chinese officials in Beijing to discuss the country’s healthcare reform effort, including promoting access to medical devices and technologies.
China’s medical device regulatory system has been on the mind of AdvaMed members for some time. Mazzo said in August the Washington, D.C.-based trade group has “two key concerns” about the system currently in place in China.
One concern is a country-of-origin registration requirement for imports that would prevent a medical device maker from selling products in China unless they are approved for use in the company’s home country.
AdvaMed also has concerns about a proposal that would bar the use of foreign trial data in China.
Mazzo’s visit led to a memorandum between AdvaMed and the Chinese Association of Medical Devices Industry to “harmonize” standards for China’s device industry.
Business wasn’t the only thing on AdvaMed’s to-do list. The group also plans to donate money and start a formal cooperation agreement with the China Youth Development Foundation.
The foundation is starting an initiative to build hospitals in rural parts of China. AdvaMed said it was supporting the initiative through money, in-kind donations and the training of medical professionals to practice in rural areas.
AdvaMed raised about $300,000 from its members to be used for the construction of rural healthcare facilities in China, according to Mazzo.
Huimin Wang, corporate vice president of Asia and Latin America for Irvine heart valve maker Edwards Lifesciences Corp., also made the trip to China with AdvaMed.
Separately, the Food and Drug Administration recently cleared a product from Mazzo’s day job—RevitaLens Ocutec—a multipurpose contact lens cleaning and disinfecting solution for conventional soft contacts and silicone hydrogel contacts.
UCI Researcher Funding
Susan Huang, an infectious disease specialist at the University of California, Irvine, received a $10 million, three-year grant to look at ways of preventing antibiotic-resistant staph infections in people discharged from hospitals.
Huang, medical director of epidemiology and infection prevention at UCI Medical Center, got the money from the Federal Agency for Healthcare Research and Quality.
The agency has a program that’s funded by money from the economic stimulus bill signed in 2009.
Grants made through the program are intended to support large projects whose research will aid decisions in priority areas of clinical healthcare.
Figures show that 1.8 million Americans carry methicillin-resistant Staphylococcus aureus bacteria, which cause staph infections. Methicillin-resistant staph infections are highly contagious and resistant to antibiotics used in ordinary staph infections. Most of those cases occur in people who’ve recently been in the hospital or another healthcare setting, such as a nursing home or dialysis center.
The study might provide the first post-discharge preventative treatment for those people.
About a quarter of patients who carry methicillin-resistant staph will develop an infection within a year of discharge, according to UCI. These infections require costly medical attention, including frequent hospital readmission.
Cortex Regains Rights
Cortex Pharmaceuticals Inc., an Irvine drug maker, said it regained the rights to develop and commercialize a neurology drug candidate.
In a statement, Cortex said that Merck & Co. has returned the exclusive rights to de-velop Ampakine compounds for treating depression and schizophrenia. The former rights holder, Organon NV, now is a Merck subsidiary.
In 1999 Cortex entered into a licensing and research deal with Organon, which was based in the Netherlands.
Bits and Pieces
Quality Systems Inc., an Irvine healthcare software maker, said the Ohio Health Information Partnership named its NextGen Healthcare Information Systems Inc. division as a preferred electronic health record vendor … CalOptima, the county healthcare agency in Orange, said it received a $4.6 million federal grant to help primary care doctors switch to electronic medical records. The money will allow CalOptima to serve as a regional extension center that provides education and technical assistance to local doctors … Kimberlie Rogers-Bowers, senior vice president of regulatory affairs and acquisition integration at Lake Forest-based Apria Healthcare Group Inc., was among several home healthcare professionals invited to review and provide feedback on a report that the General Accounting Office is expected to issue in November on the cost of providing in-home oxygen therapy. The delegation is part of the American Association for Homecare … Alliance HealthCare Services Inc., a Newport Beach provider of medical imaging and cancer treatment services, said it received an award for exceeding patients’ expectations for the third consecutive year from Avatar International LLC, a Lake Mary, Fla.-based healthcare quality improvement group.
