Here is a quick video showing the AAMI 2010 Conference.

AAMI 2010 Expo Highlights from CTI Productions on Vimeo.

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.   

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

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.

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.

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.

PLYMOUTH MEETING, PA—ECRI Institute® (www.ecri.org), a nonprofit healthcare organization that researches the best approaches to patient care, announces its recent purchase of the Biomedtalk Listserv, a popular email subscription service for biomedical and clinical engineering professionals where they can connect to share information and advice. 

Founded in 1997 by Mike Kauffman, assistant director of facilities for the Reading Hospital and Medical Center in Reading, PA, Biomedtalk became an active forum for discussion across all members of the biomedical and clinical engineering profession. 

The listserv now has over 1,700 members, having attracted over 100 new members since March 1, 2010, when ECRI Institute took the reins and discontinued the membership fee.

The FDA unveiled the Center for Devices and Radiological Health (CDRH) Transparency Web site to provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

Part of an ongoing effort within CDRH, across the FDA, and across the Department of Health and Human Services to enhance public communication and transparency, the new site includes features from the previous CDRH site that provided information about approved products, industry guidance, medical device safety, and adverse event reports. In addition, the new Web site features extra information displayed in a more user-friendly format.

As every BMET knows, Infusion pumps are one of the most ubiquitous, time consuming, and problem prone devices in the hospital environment.  In an effort to improve the quality and design of infusion pumps the FDA has started an initiative to improve their pre- and post-market assessment of these devices.  On April 23, 2010 the FDA issued the following letter to manufacturers of infusion pumps:

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 23, 2010

Dear Infusion Pump Manufacturer:

FDA’s records have identified you as the “Official Correspondent” to the Medical Device Manufacturer stated above. Please ensure that the following message is relayed to the Most Responsible Individual at the Medical Device Manufacturer.

The Food and Drug Administration (FDA) is notifying you of our intent to improve the current premarket and postmarket regulatory processes associated with infusion pumps. These actions are being taken in light of serious adverse events noted in Medical Device Reports and an increasing number of recalls involving several different types of infusion pumps. The FDA believes that this effort will help mitigate current risks and reduce future risks associated with infusion pumps.

FDA has seen an increase in the number and severity of infusion pump recalls. Analyses of MDRs have revealed device problems that appear to be a result of faulty design. Between January 1, 2005 and December 31, 2009, FDA received over 56,000 MDRs associated with the use of infusion pumps. Of these reports, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions.

The most frequently reported external infusion pump device problems are: software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown”. Subsequent root cause analyses revealed that many of these design problems were foreseeable and, therefore, preventable.

We have evaluated and analyzed a broad spectrum of external infusion pumps across manufacturers and concluded there are numerous, systemic problems with device design, manufacturing, and adverse event reporting. We believe these types of problems are preventable. To address these device problems, manufacturers may need to conduct additional risk assessments of new products or changes to products currently being marketed.

Given the concerns involving software errors, we offer, on a voluntary basis, a static analysis of your software for a new or changed infusion pump. The analysis can help manufacturers identify potential defects earlier in the product development cycle and support validation of the software. This analysis can be performed in conjunction with or in advance of a premarket submission for that device. We believe this action can facilitate the development of safer infusion pumps while reducing costs to manufacturers. For further information, please contact Mr. Richard Chapman, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories at (301) 796-2585 or Richard.Chapman@fda.hhs.gov.

We strongly recommend external infusion pump manufacturers meet with the Agency early in the device development process to discuss submissions regarding new infusion pumps or changes to existing devices. For further information, please contact Mr. Anthony Watson, Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation at 301-796-6296 or Anthony.Watson@fda.hhs.gov.

FDA believes these actions, early communication between the FDA and infusion pump manufacturers, and additional actions being announced by the agency today will result in safer and more effective infusion pumps. We look forward to working with you on this important public health issue.

Sincerely,

Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration

Additional information on this initiative can be found here