Author Archives: IAMERS

7.26.12 – GAO report on the ACA implementation of “Meaningful Use” show few hospitals and professionals qualify

http://www.gao.gov/assets/600/593078.pdf

In case you forgot what it means here’s a working definition for Meaningful Use. From a publication of the Robert Woods Johnson Foundation: Glossary of Health Care Quality Terms, Meaningful use— Meaningful use is a qualification to receive federal funding for health information technology. For instance, if a health information technology (HIT) system is used in a meaningful way to provide better patient care, a health system can qualify to receive federal subsidies to help to pay for the technology.

Study shows diagnostic imaging slowed markedly after 2005

Health Imaging an online medical news magazine on July 25th reported on a study done by GE and MIT. They examined the reasons for the slowdown in medical imaging that began in 2006. It’s an interesting read and relevant to all sellers and users of medical imaging devices.

Here’s the link:
http://www.healthimaging.com/index.php?option=com_articles&article=34664

Diana Upton, IAMERS President and Casper Uldriks, FDA expert and former Associate Director at the FDA, team up in a recent DOTmed News interview

In the interview they discuss the FDA UDI (unique device identifier) regulation and the 2.3% excise tax on capital equipment imposed under the ACA and the potential for each to affect the medical equipment markets. If you missed the interview on DOTmed News here’s a second chance to follow this interesting discussion with the experts.

http://www.dotmed.com/news/story/19209?utm_campaign=2012-07-26&utm_source=DOTmed+News&utm_medium=email

UDI Proposed Rule Announced

The IAMERS FDA Committee has also been reviewing the proposed regulations concerning the Unique Device Identification System. The proposed rule was published for comment in the July 10, 2012 Federal Register. Comments on the proposed  rule are due by September 10 as they pertain to information collection issues under the Paperwork Reduction Act of 1995 and by November 7, 2012 for the substance of the proposed rule. In many ways the proposed rule follows the general tenets of the Global Harmonization Task force by requiring that each medical device be labeled and that information on the label (e.g., type of device, lot, batch number) be captured in plain text and in a form that automatically identifies and captures information (bar code). Little is said as to when the UDI is to be changed and how the UDI is to be captured on large equipment purchases. While the expected implementation date for Class II devices is expected to be three years after the final rule, the IAMERS FDA committee is working with the FDA on addressing issues of particular concern to our industry. The full proposed rule and comment are readily accessible on the FDA website. (Caution: its lengthy). IAMERS welcomes comments concerning the proposed rule and the proposed requirement of post market surveillance (whereby information concerning the equipment is kept for purposes of product recall).

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