BMETworld

July 30, 2010?CHELMSFORD, MASS.–ZOLLMedical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin distribution of the new Propaq^®MD Monitor/Defibrillator that was developed specifically to meet the special needs of military customers and air medical operations worldwide. Development of this product was a joint undertaking between the Department of Defense and a cooperative arrangement between Welch Allyn and ZOLL. Development was facilitated with grants from the U.S. Army Medical Research and Development Command.

The Propaq MD is a new ultra-lightweight compact device with highly sophisticated, advanced capabilities that combine the well-accepted and proven features of the Propaq monitors with the clinically superior therapeutic capabilities of ZOLL defibrillation and non-invasive pacing technologies. The Propaq MD is 60 percent smaller and 40 percent lighter than other similar monitor/defibrillators. It is two pounds lighter than the current military vital signs monitor, the Propaq 206, even with defibrillation and pacing added.

Cardiac Science Addresses FDA Recall Concerns

Posted: Wednesday, July 21, 2010

BOTHELL, Wash., July 19 /PRNewswire-FirstCall/ -- Cardiac Science Corporation (Nasdaq: CSCX), a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, announced it has addressed outstanding issues with the Food and Drug Administration ("FDA") relating to the corrective AED field action announced on November 13, 2009. The FDA has issued an updated communication on this matter which may be viewed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm.

New Report Helps Mitigate Wireless Device Risk

Posted: Tuesday, July 13, 2010

It seems like a normal situation. A doctor making rounds in a hospital intensive care unit (ICU) leans against a bedside table that has a telemetry transmitter. The doctor’s mobile phone rings, subsequently causing the telemetry transmitter to lose its signal and inadvertently interfere with the entire ICU telemetry system.

An updated technical information report (TIR) developed by the Association for the Advancement of Medical Instrumentation (AAMI) offers guidance on how to prevent this and other instances of electromagnetic interference (EMI) of medical devices and systems. The report, ANSI/AAMI TIR18: 2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities, includes a template for a wireless and electromagnetic compatibility (EMC) policy. It also offers recommendations on ad-hoc testing of devices to estimate their immunity to EMI.

The TIR is primarily geared toward clinical and biomedical engineers to help them assess the electromagnetic environment in their facility and implement actions that minimize electromagnetic interference (EMI) problems. The new edition also has been rearranged to make it easier for non-engineers to find and understand recommendations.

“We are also trying to reach the hospital administrators because they make all the decisions on resources, and it is important that resources be allocated to this activity,” says Jeffrey Silberberg, a senior electronics engineer for the U.S. Food and Drug Administration (FDA), and a member of the AAMI Electromagnetic Compatibility Committee, which drafted the TIR.

The updated TIR contains new information on development of a wireless/EMC policy for a healthcare facility. A model policy will help to mitigate risks associated with medical device EMI and to address the use of radio frequency (RF) wireless technology, according to the TIR.

The model EMC and RF wireless policy is organized into six sections in the TIR: purpose, applicability, responsibilities, abbreviations and definitions, EMI mitigation and EMC management, and references.

A policy tailored for a specific institution should include examples of the problems that could arise from medical device EMI and RF wireless and why they are important, according to the TIR.

Visit AAMI online for pricing and order information

ECRI Institute Adds 4,000 New Terms to Universal Medical Device Nomenclature System™

Posted: Friday, July 09, 2010

PLYMOUTH MEETING, Pa., July 8 -- ECRI Institute's Universal Medical Device Nomenclature System™, the most comprehensive medical device taxonomy, announces the expansion of its database to include thousands of new terms for medical devices, genetic tests and medical device software.

The 2010 Universal Medical Device Nomenclature System (UMDNS) now contains 24,544 terms covering the expanse of medical devices and equipment used for modern healthcare delivery, including information systems, software, in vitro diagnostics, molecular and genetic tests, capital equipment, implantable devices, assistive devices, and consumables.

AAMI 2010 Annual Conference

Posted: Monday, June 28, 2010

Here is a quick video showing the AAMI 2010 Conference.

AAMI 2010 Expo Highlights from CTI Productions on Vimeo.

AAMI Releases New Edition of Clinical Engineering Collection

Posted: Tuesday, June 22, 2010

The Association for the Advancement of Medical Instrumentation’s (AAMI) most comprehensive collection of clinical engineering publications has been updated to include new IT, career, and imaging related tools and resources.

The 2010 edition of the Clinical Engineering Collection CD features hundreds of articles and publications all on one convenient, searchable and easy-to-use CD. It’s designed expressly for clinical engineers, biomedical equipment technicians (BMET), and other medical technology professionals.

220-701: 1.2 – Chipsets

Posted: Tuesday, June 22, 2010

For more check out http://www.professormesser.com/

FDA Advisory Panel to Review Dental Amalgam

Posted: Sunday, June 13, 2010

Agency to consider risks to vulnerable populations

The U.S. Food and Drug Administration today announced plans to hold an advisory panel on Dec. 14-15, 2010, to discuss several scientific issues that may affect the regulation of dental amalgam, used for direct filling of carious lesions or structural defects in teeth. The panel meeting will focus particularly on the potential risk to vulnerable populations, such as pregnant women, fetuses, and young children.

Joint Commission Alert: Violence Rising at Health Care Facilities

Posted: Friday, June 04, 2010

Controlling access, greater staff vigilance urged

(OAKBROOK TERRACE, Ill. – June 3, 2010) A new Joint Commission Sentinel Event Alert warns that health care facilities today are being confronted with steadily increasing rates of crime, including assault, rape and murder.

The Sentinel Event Alert urges greater attention to the issue of violence and to controlling access to facilities to protect patients, staff and visitors, noting that assault, rape and homicide are consistently in the top 10 types of serious events reported to The Joint Commission. The Alert cautions that the actual number of violent incidents is significantly under-reported and advises organizations to mandate the reporting of all real or perceived threats.

To prevent violence in health care facilities, The Joint Commission’s Sentinel Event Alert newsletter suggests that facilities take a series of 13 specific steps, including the following:

Evaluate the facility’s risk for violence examining the campus, reviewing crime rates and surveying employees about their perceptions of risk.
Take extra security precautions in the emergency department, especially if the facility is in an area with a high crime rate or gang activity. Precautions might include uniformed security guards, scanning people entering the building for weapons and inspecting bags.
Conduct thorough background checks of prospective employees and staff.
Report crime to law enforcement.

“Health care facilities should be places of healing, not harm. But, unfortunately, health care settings are not immune from the types of violence that are found in the other areas of our lives,” says Mark R. Chassin, M.D., M.P.P., M.P.H., president, The Joint Commission. “The recommendations in this Alert give health care institutions and caregivers specific strategies to take action that will keep everyone safer.”

In addition to the specific recommendations contained in the Alert, The Joint Commission urges hospitals to comply with the requirements described in its accreditation standards to prevent violence. The standards require accredited health care facilities to have a security plan as well as conduct violence risk assessments, develop strategies to prevent violence and have a response plan when a violent episode occurs. The Joint Commission’s standards also are clear that patients have a right to be free from neglect, exploitation, and verbal, mental, physical and sexual abuse.

The warning about violence in health care facilities is part of a series of Alerts issued by The Joint Commission. Much of the information and guidance provided in these Alerts is drawn from The Joint Commission’s Sentinel Event Database, one of the nation’s most comprehensive voluntary reporting systems for serious adverse events in health care. The database includes detailed information about both adverse events and their underlying causes. Previous Alerts have addressed maternal deaths, health care technology, anticoagulants, wrong-site surgery, medication mix-ups, health care-associated infections, and patient suicides, among others. The complete list and text of past issues of Sentinel Event Alert can be found on The Joint Commission Web site at www.jointcommission.org.

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Founded in 1951, The Joint Commission seeks to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission evaluates and accredits more than 17,000 health care organizations and programs in the United States, including more than 9,500 hospitals and home care organizations, and more than 6,300 other health care organizations that provide long term care, behavioral health care, laboratory and ambulatory care services. In addition, The Joint Commission also provides certification of more than 1,000 disease-specific care programs, primary stroke centers, and health care staffing services. An independent, not-for-profit organization, The Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care. Learn more about The Joint Commission at www.jointcommission.org.

Baxter to Recall COLLEAGUE Infusion Pumps in U.S.

Posted: Tuesday, May 04, 2010

DEERFIELD, Ill, May 3, 2010 - Baxter Healthcare Corporation today announced that it will recall COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients' needs.

As previously disclosed, Baxter entered into a consent decree with FDA under which the company has been pursuing remediation of the infusion pumps. The decree permits FDA to require the recall of the pumps, and FDA has communicated to the company that it will require such a recall, with the company providing monetary consideration or replacement pumps to customers on a timeline to be determined with FDA and based on medical need. Baxter intends to work with FDA to minimize disruption to healthcare facilities using COLLEAGUE pumps. Baxter anticipates that, among alternatives to be provided to customers, the company will offer to exchange Baxter's Sigma SPECTRUM infusion pumps for COLLEAGUE infusion pumps without charge to customers.

The consent decree permits Baxter to propose alternative actions to achieve the FDA's objectives under the decree, which the company intends to do. The final nature of the recall and offer to customers remain subject to that ongoing dialogue. Once final, Baxter will notify customers and make information available on www.baxter.com.

Notwithstanding that uncertainty, the company currently anticipates that it will record a pre-tax special charge of $400 to $600 million in the first quarter for the reasonably estimable cost of the recall. The company is not otherwise revising its earnings guidance for the year in connection with the recall.

About Baxter

Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the Company's recall of its COLLEAGUE infusion pumps from the U.S. market, including expectations with respect to the implementation of the recall and the amount of the related charge. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: resolution of the final nature of the recall; future actions of the FDA with respect to the Company's implementation of the recall pursuant to the Consent decree, including any sanctions available under the Consent Decree; future actions of the FDA or any other regulatory body or government authority that could delay, limit or suspend product development, manufacturing or sale or result in seizures, injunctions, monetary sanctions or criminal or civil liabilities; product quality or patient safety issues; the financial impact of the recall; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.