BMETworld News and Information

Certification Eligibility Requirements Eased for Military

Sat, 28 Aug 2010 15:48:00 -0700

A change in the eligibility requirements for certification from the International Certification Commission for Clinical Engineering and Biomedical Technology (ICC) will allow military personnel to take medical technology certification exams earlier.

At their June meetings, the United States Certification Commission (USCC) and ICC recognized the diploma from the U.S. military biomedical program as equivalent to an academic associate degree in biomedical technology for ICC’s eligibility purposes. The ICC offers certifications for certified biomedical equipment technician (CBET), certified radiology equipment specialist (CRES), and certified laboratory equipment specialist (CLES).

The change means military personnel that have successfully completed the U.S. military biomedical equipment technology program can sit for the exam for CBET with only 2 years of work experience.

Previously, military personnel were required to gain a civilian associate’s degree or have 4 years of work experience in the field in addition to completion of the military biomed program. The result was a disparity of 4 years before military personnel could take the exam versus a civilian.

After a detailed review of the program, the U.S. BMET Board of Examiners, which develops and administers the certification exams three times a year, found that the military program was very extensive, and comparable to an associate degree from accredited colleges and made the recommendation to make the change to the USCC and the ICC.

The next certification exam is scheduled to take place on November 6 in various locations. The deadline to register for the exam is Sept. 25. For more information on the certification program, visit www.aami.org/certification or call 703-253-8275.

FDA Recognizes AAMI Version of Electrical Equipment Standard

Wed, 18 Aug 2010 06:08:00 -0700

The U.S. Food and Drug Administration (FDA) has formally recognized the Association for the Advancement of Medical Instrumentation (AAMI) version of an international standard on medical electrical equipment.

FDA’s recognition of ANSI/AAMI ES60601-1:2005 — Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and other collateral standards — comes as welcome news to the medical technology community.

The standard — which is the U.S. adoption of IEC 60601-1/Ed.3:2006 — contains required national deviations to comply with the National Electrical Safety Code, says Charles Sidebottom, director of corporate standards for Minneapolis-based Medtronic and secretary of IEC/Subcommittee 62A, which developed the IEC standard. [More]

Midmark Announces Launch of Two New IQ Devices

Tue, 10 Aug 2010 13:09:00 -0700

Expanding its diagnostic product offering with IQvitals™ and IQvitals™ PC automated vital signs devices

VERSAILLES, Ohio – (August 2, 2010) – Midmark Corporation, the industry leader in integrated digital diagnostic devices for ambulatory care, announced the launch of IQvitals™ and IQvitals™ PC automated vital signs devices.

IQvitals is an automated vital signs device, based on the Windows® CE operating system, that measures noninvasive blood pressure, heart rate, and body temperature. It features a full color touch screen with an easy-to-use, intuitive user interface including multiple dedicated, one-touch operating controls and a QWERTY keyboard for patient data entry. IQvitals is a lightweight, highly portable device with an internal battery that supports up to eight hours of operation before requiring recharge. It may be used as a standalone device or in conjunction with Midmark’s proprietary IQmanager™ software for digital data collection and management. [More]

Hologic Completes Acquisition of Sentinelle Medical

Mon, 09 Aug 2010 09:35:00 -0700

BEDFORD, Mass., Aug. 5 /PRNewswire-FirstCall/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today the completion of its acquisition of Sentinelle Medical Inc. (Sentinelle Medical), a leading provider of Magnetic Resonance Imaging (MRI) breast coils, tables and visualization software.

"We are extremely pleased we have finalized the acquisition of Sentinelle Medical," said Rob Cascella, President and Chief Executive Officer. "We believe MRI will be an important standard of care for breast screening of women indicated as having a high risk of developing the disease. Adding Sentinelle Medical's products to Hologic's best-in-class portfolio of product offerings in the areas of breast cancer detection and intervention will enhance our Company's presence as a leader in women's healthcare." [More]

Joint Commission Publishes New Guide for Advancing Patient-Centered Care

Fri, 06 Aug 2010 12:20:00 -0700

(OAKBROOK TERRACE, Ill. – August 4, 2010) A free monograph released today by The Joint Commission, entitled “Advancing Effective Communication, Cultural Competence, and Patient-and Family-Centered Care: A Roadmap for Hospitals,” provides recommendations to inspire hospitals to address unique patient needs and comply with new standards for patient-centered communication.

In August 2008, The Joint Commission, with funding from The Commonwealth Fund, began an initiative to advance the issues of effective communication, cultural competence, and patient- and family-centered care in hospitals. The project was directed by Paul Schyve, M.D., senior vice president, The Joint Commission, and Amy Wilson-Stronks, M.P.P., project director, Division of Quality Measurement and Research, and principal investigator for The Joint Commission study Hospitals, Language, and Culture. The focus of the project was to develop accreditation standards for the hospital program and a monograph to help hospitals better meet patient needs. The Joint Commission collaborated with the National Health Law Program to develop the Roadmap for Hospitals. [More]

Focus On: Social Networking

Mon, 02 Aug 2010 17:11:00 -0700

24x7, July 2010
by Stephen Noonoo

For many of us, social media sites like Twitter and Facebook have radicalized how we keep up with our personal lives. Lately, those same networks have begun to creep into the professional world as well, unleashing new opportunities for gathering information and staying connected. While some have embraced the changes, others may be wondering if it is worth the trouble. These days, however, a number of biomedical professionals are using social media sites both to keep track of industry peers and to help digest the deluge of regulatory, safety, and device information uploaded to cyberspace every day.

Read the entire article at http://www.24x7mag.com/issues/articles/2010-07_07.asp

Zoll Propaq MD Monitor/Defibrillator Granted 510(K) Clearance by U.S. Food and Drug Administration

Fri, 30 Jul 2010 09:40:00 -0700

New Ultra-Rugged Device Designed Tough for Military and Air Medical Operations

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. [More]

Cardiac Science Addresses FDA Recall Concerns

Wed, 21 Jul 2010 09:19:00 -0700

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.

[More]

New Report Helps Mitigate Wireless Device Risk

Tue, 13 Jul 2010 10:45:00 -0700

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™

Fri, 09 Jul 2010 09:38:00 -0700

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. [More]

AAMI 2010 Annual Conference

Mon, 28 Jun 2010 07:02:00 -0700

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

Tue, 22 Jun 2010 08:44:00 -0700

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. [More]

220-701: 1.2 – Chipsets

Tue, 22 Jun 2010 07:56:00 -0700

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

FDA Advisory Panel to Review Dental Amalgam

Sun, 13 Jun 2010 06:34:00 -0700

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. [More]

Joint Commission Alert: Violence Rising at Health Care Facilities

Fri, 04 Jun 2010 13:08:00 -0700

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.