Author Archives: IAMERS

Limbo for CT Dose. How Low Can It Go?

The radiology community over the past three years has really taken it on the chin for unnecessary patient exposure to ionizing radiation. The report from HealthImaging this morning and linked here is the latest of many showing how to alter the dose to the patient and still get acceptable diagnostic scans. We’re heading in the right direction.

CCTA, SPECT or PET Which One Is Best for Diagnosing CAD?

The latest article from Radiology, August 8, 2012, was reported on by HealthImaging.  The results seem conclusive that CCTA can now be depended upon for raising the bar for diagnosing CAD in patients with previously abnormal SPECT scans. But do the results tell the whole story? That’s the question to be answered. Clearly the specificity is better with CCTA but the authors admit the SPECT studies were performed at many sites and not standardized by equipment or protocol. The CCTA was done in a standardized manner. PET might have provided a better result than the other two but what are we seeking? It appears we are still technology centric rather than disease centric.

Read the report at HealthImaging and think about where we go from here.

I Always Thought MRI Was Safe

AHRA reports that ICDs and other causes of accidents and personal injury from the use of MRI have improved remarkably. After reading this report your shoulder or back may suddenly improve and no longer require a scan.


Apples to Apples Regulatory Approval Times No Less In Europe

A study recently appeared in the NEJM comparing the average approval times for innovative, high risk medical devices in the U.S. and in Europe. It appears for new devices the approval times are similar overall. I think the key is that these are innovative (new technology) rather than more of the same. The authors of this Perspective study, “based their case on data showing that reimbursement decisions figure as prominently as regulatory ones in delaying—or expediting—patient access to innovative, high-risk devices.”

Another standard test is questioned after a study shows there is little benefit for the patient

Grant money is growing for studies examining how we spend our health care dollars. A short while back two different studies questioned the wide spread use of mammography. Last week a study questioned the growing use of imaging in stage 4 Medicare cancer patients. As pressure grows to decrease the cost of health care more studies will question the way we conduct health care as we try to determine a value proposition for each and every test conducted.

Study Finds Advanced Imaging Growing Fastest in Stage 4 Cancer Patients.

We all know that most of our medical expenses occur at the end of life. This study reported by AuntMinnie showed that stage 4 Medicare cancer patients were being sent for advanced imaging studies more frequently than those with earlier stages of disease. The conclusion drawn by the investigators was that guidelines have to be developed for the appropriate use of advanced imaging in stage 4 cancer patients. I suspect the Government and other payers will be looking closely at the results of this investigation.

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

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:

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.

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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