OTHER ISSUES
2008
MDMA Joins the National Healthcare Career Network
April 9, 2008 - MDMA announced its participation in the National Healthcare Career Network (NHCN). The NHCN is an initiative that brings healthcare associations together to provide job placement and advancement opportunities; career development tools, training, scholarships and resources to alleviate employee shortages facing the healthcare marketplace. The NHCN promotes healthcare associations’ specialized job boards and online career centers as valuable resources for finding and developing industry-specific talent.
“We are excited to join our colleague organizations in taking the lead on this collaborative effort,” said Mark Leahey, MDMA Executive Director. “We want to be a valuable resource to the employers we serve, so they will continue
to seek out the association community as their first choice for recruiting.”
Visit the MDMA Career Center today to post your job or resume.
2007
President Bush Delivers State of the Union Address
January 23, 2007 -- The President addressed the nation in a 49-minute speech in which he reached out to the newly Democratic controlled Congress with two proposals to expand health-care coverage for the elderly, the diabled, and children of low-income households. The first proposal was a standard tax deduction for individuals and families that purchase health insurance, and the second proposal was to provide a subsidy to states that make basic private health insurance available to all their citizens. For an entire transcript of the speech, please click here.
It's a New Year and a New Congress
January 5, 2007-- This week, members of the 110th Congress were sworn in, and with it Representative Nancy Pelosi (D-CA) became the Speaker of the House and Senator Harry Reid (D-NV) became the Senate Majority Leader. Republicans elected Representative John Boehner (R-OH) to be the House Minority Leader and Senator Mitch McConnell (R-KY) to be the Senate Minority Leader.
2006
MDMA Issues Guidelines
On December 12, 2006, MDMA held a member-wide conference call to roll out its MDMA Guidelines. MDMA has long held that companies should take great care to ensure that their interactions with all parties in the healthcare system, especially healthcare professionals, are appropriate. In an effort to assist our members in this process, MDMA has developed a set of guidelines that will help companies create an effective compliance program. However, MDMA maintains that it is critical that each company review the applicable federal and state regulations while drafting their individual programs.
Please click here to view the Guidelines.
MDMA Presents at HHS Bioshield Meeting
September 25, 2006-- Today MDMA participated in the Department of Health and Human Services (HHS) Bioshield Stakeholders Workshop in Crystal City, VA. The workshop focused on ways to enhance the communication and interaction between the government and the private sector to develop and deploy medical countermeasures for future threats. Attendees heard from HHS Secretary, Michael Leavitt, FDA Commissioner, Dr. Andrew von Eshenbach, CDC Director, Dr. Julie Gerberding and many others. For more information please click here.
President Bush Issues Executive Order
August 22, 2006-- Continuing his agenda to move to a market driven system in which consumers make more informed choices, President Bush issued an Executive Order today requiring four federal agencies to do more to inform beneficiaries about the cost and quality of their health-care services. The steps required by the order include the sharing of information about the quality of care delivered by doctors and hospitals, as well as the prices paid to these providers. The order also requires agencies and their health care contractors to promote the use of interoperable health information technology products, so that data can be easily shared. In addition, it requires agencies to offer insurance options that reward consumers who exercise choice among health providers based on value and quality of care.
The
European Union's In-Vitro Diagnostic Medical Device
Directive (Directive 98/79/EEC)
As part of European
harmonization, the directive designates requirements for obtaining
the CE mark required to gain access to the European market.
The directive is designed to ensure the safety, health protection,
and performance characteristics of in vitro diagnostics. Devices
which conform to existing national legislation and are already
in the distribution chain at the end of the transitional period
can continue to be supplied to the end user for a further
two years, i.e., until December 7, 2005. General classes of
medical devices were covered by the Medical Device Directive
(Directive 93/42/EEC) which went into effect in June 1998.
Once a manufacturer determines that a device is covered under the directive, there are several steps required to ensure compliance with Directive 98/79/EEC, including a conformity assessment, quality assurance, and revised and translated labeling and instructions for use. According to the directive, "The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user."
MDMA has partnered with the Medical Translation Center (MTC), a leading provider of language translation and related services including compliance with all EU Medical Device Directives. MTC, operated by Linguistic Systems, Inc. of Cambridge, Massachusetts, can provide the services needed to guarantee full national language compliance. Click on the link below for more information about MTC.
For more information on the directive,
its compliance requirements, and which devices are covered,
please visit http://www.ts.nist.gov/ts/htdocs/210/gsig/eu-guides/gcr-817/ivdmd-guide-817.htm.