ECPI launches online hazard and recall management system.
Antenna and Intermec offer wireless application for mobile workforce

Fluke Launches Online Resource

Fluke Corp (Everett, Wash) has introduced FlukePlus, a free online program designed to offer assistance to its customers. FlukePlus provides online technical information, product-specific tips, and how-to instructions for using Fluke products. In addition, FlukePlus offers access to a library of Fluke archives and to articles about how to do more with test tools and accessories. FlukePlus members will also have an opportunity to submit suggestions on how Fluke products can be improved, find out where to see Fluke products at trade shows, and learn the locations of Fluke-sponsored training events. Perhaps most valuable, FlukePlus members will have advance notice of new products and priority email and telephone support. Those who sign up for the program are eligible to win one of three getaway vacations or $4,000 in cash.

Meeting Attendees Discuss Future Direction of HACCP
The Medical HACCP (hazard analysis and critical control points) Alliance held its annual meeting in Williamsburg, Va, on August 19th. The meeting was followed by a 3-day workshop on the application of HACCP to medical devices and other industries. The principal businesses of the meeting were a discussion of future directions for the alliance and the scheduling of nationwide workshops for 2004.

An interesting aspect of the future-directions discussion was whether to extend the alliance’s industry focus beyond medical in order to bring HACCP to other industries that have an interest in its principles and can benefit from them. Another ongoing issue is distinguishing between HACCP as a regulatory requirement (which it currently is not for medical devices) and HACCP as an effective risk management practice (which it is).

HACCP (pronounced ha-sip) is a systematic risk-management technique that requires the identification of hazards, the assessment of risk, and the determination of where in a system or process the risk will be controlled (the critical control points). Also included are how the risk will be controlled, what system parameters are relevant to the risk, the acceptable limits for those parameters, and how they will be measured. The predetermination of what will be done when those limits are exceeded is also critical, and, of course, there must be documentation and verification that the process actually works.

The Medical HACCP Alliance grew out of an earlier US Food and Drug Administration investigation into the desirability of requiring HACCP plans in the medical device industry and, in turn, basing inspections on a review of such plans and their implementation. While the FDA has not pursued a HACCP regulation for devices, it remains interested in promoting risk management. The proponents of HACCP cite its fundamental value and have continued to support and promote HACCP. The current objective of the alliance is to encourage the application and implementation of risk management using HACCP principles through industry, government, and academic cooperation.

The Medical HACCP Alliance is on the Web at http://medicalhaccp.ag.vt.edu/.

24x7 thanks William Hyman, ScD, PE, head of the biomedical engineering department at Texas A&M University and vice-chair of the Medical HACCP Alliance, for contributing this report.

Antenna and Intermec Offer Wireless Application for Mobile Workforces
As a participant in Intermec Technologies Corp (Everett, Wash) Honors Partners Program, Antenna Software (New York City) will provide mobile workforces with wireless automation software that is designed to improve the effectiveness of field-service organizations.

Antenna’s A3 wireless software applications will run on handheld mobile computers and will extend existing CRM, ERP, legacy, and custom enterprise systems to the field by enabling mobile workers to access service, inventory, and logistics information; manage activities; order parts; and update calls in real time.

Jim Hemmer, Antenna Software chief executive officer says, “The partnership will give companies that use Intermec devices a powerful, cost-effective way to provide wireless capabilities and rich field-service management functionality to their mobile workforce.”

Intermec’s Honors Partner program was introduced in November 2002 in response to a meeting of Intermec’s Partner Advisory Council, Lois Fenimore of Intermec says. Partners benefit by participating with Intermec in joint marketing, trade shows, and mail campaigns. They also have access to case studies and Real Time, Intermec’s in-house publication.

Phoenix Data Systems Inc Critical Alarm Software
Phoenix Data Systems (Southfield, Mich) has enhanced its AIMS software to meet its customers’ critical alarm needs.

All equipment that contains a critical alarm must be inspected to make sure that the alarm is activating appropriately and is at a sufficient audible level. The Joint Commission on Accreditation of Health Organizations recommends regular preventive maintenance and testing procedures be developed to assist in this process.AIMS Critical Alarm features facilitate the flagging and tracking of equipment that contains critical alarms.

For additional information about AIMS software, call (800) 541-2467, email info@goaims.com, or visit their Web site at www.goaims.com.

ECC Announces Price Reduction on X-Ray kV(p) Meter

Electronic Control Concepts (Saugerties, NY) is offering a price reduction on the kV(p) Meter Model 815. The meter is designed for those who require high-quality, noninvasive, x-ray quality-control testing instrumentation: service and biomedical engineers, medical physicists, and QC technologists. The model 815 is a multifunction meter that measures peak accelerating voltage and exposure time simultaneously on all types of x-rays. The meter has a connector for radiation waveform display on a storage oscilloscope. The 815 is a portable, battery-operated instrument with a plastic case. The instrument covers a range of 45 kV(p) to 120 kV(p) and is accurate to within 2%. The meter comes with a 2-year warranty. For more information on the price reduction, contact ECC at (800) VIPXRAY, or visit the Web site at: www.eccxray.com.

AAMI Offers Course in Risk Management for Medical Device Manufacturers

The Association for the Advancement of Medical Instrumentation has announced that there is still time to enroll in its 2-1/2–day course in risk management. The course covers basic risk management concepts, ISO standard 14971:2000 (application of risk-management to medical devices), the regulatory and business perspectives surrounding risk management, and methods of performing risk management throughout a product’s life cycle. According to AAMI, the material is useful for those responsible for quality systems and regulatory compliance and others interested in a basic understanding of risk management. The course will also include hands-on class exercises that will allow participants to work through risk-management scenarios involving the life cycle of a fictitious medical product. The medical product will include aspects of electronics, software, sterility, biological evaluation, drug delivery, and others. These class exercises are useful for those who have direct responsibility for applying risk management principles and activities in technical areas. The course will be given November 12–14 in Washington, DC. For more information on the course, visit AAMI at www.aami.org/meetings/courses/risk.html, or contact customer service at (800) 332-2264, ext 217.

For Your Bookshelf

Information technology is changing the face of medical technology, from state-of-the-art medical devices to cutting-edge processes that manage and maintain medical technology. To help medical technology managers and technicians keep up-to-date with these changes, the Association for the Advancement of Medical Instrumentation will release a special publication focusing on IT trends in health care. IT Horizons will cover issues such as best practices on how to implement the changing technology and present articles that provide practical information to medical technology professionals. The publication will be distributed to the 6,000 AAMI members and nonmember subscribers of the AAMI journal. An additional 1,000 copies will be sold and distributed at special events. Device Inspection Guide, a new resource from Washington Business Information Inc/FDAnews, incorporates US Food and Drug Administration guidance (including the new third-party inspections guidance and new guidance on 510 [k] sterility review), inspection documents, citations from warning letters, and 483s from recent FDA inspections. The guide shares tactics on how to achieve a first-rate inspection, investigator management tips, and the latest inspection trends. To order, go to www.fdanews.com/wbi/bookstore/36-1.htm.

ECRI Launches Online Hazard and Recall Management System
According to The Wall Street Journal (July 1), the number of recalls by the US Food and Drug Administration has increased by 42% over the past 4 years. Managing the information and ensuring that recalls reach the right staff members are challenges for hospitals, but the potential for patient harm and death as a result of a missed product recall makes doing so crucial.

To help hospitals handle the more than 500 recalls issued by medical device manufacturers each year, as well as other hazard and safety notices, ECRI (Plymouth Meeting, Pa), a nonprofit international health services research agency, has launched Alerts Tracker, an online hazard and recall management system.

Alerts Tracker automates the hazard and recall management process by relaying hazard and recall alerts throughout the hospital via automated weekly emails containing information customized to each staff member’s professional area. Recipients can review their assigned alerts, decide whether they apply to them, and then update online records of actions taken to resolve each alert. Thus, it is possible for hospital administrators and patient-safety personnel to access real-time usage reports and to-do lists that show individual and hospitalwide actions taken to resolve critical issues. This facilitates compliance with Joint Commission on Accreditation of Healthcare Organizations requirements for managing hazard and recall information.

To ensure the accuracy of Alert Tracker’s content, ECRI draws from a variety of national and international patient safety organizations, ECRI product evaluations, member hospital reports, and accident and forensic investigations, as well as US Food and Drug Administration enforcement report data and manufacturer notices. The information is verified, and complex language and product names are clarified. ECRI also adds expert advice about the steps hospitals should take to resolve the recall or hazard alert.

For more information about ECRI Alerts Tracker, visit www.ecri.org/tracker.