http://www.fda.gov/oc/initiatives/HR3580.pdf

Once finalized, the new requirements, could speed up the reporting of adverse events.
Copyright RFID Journal LLC 2008, Used With Permission

RFID Journal, by Beth Bacheldor, Nov. 5, 2007—In late September 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law, charging the FDA with establishing a UDI system. Once implemented, the system will require that a label bearing a unique identifier be placed directly on a device, unless an alternative location (such as on the device’s packaging) is specified by the FDA, or unless an exception is made for a particular device or group of devices. The unique identifier must be able to identify the equipment and supplies throughout their distribution and use.

While the law does not specify a deadline, the FDA’s Center for Devices and Radiological Health (CDRH) is “working diligently” to develop draft regulations to implement the new requirements, says Jay Crowley, CDRH’s senior advisor for patient safety.

The act also does not specify any technologies. “Congress gave us latitude,” Crowley says, adding that flexibility is important because of the broad array of medical devices. “It allows for the UDI to be on the device itself, or on the box or packaging. It also gives us flexibility to exempt devices or device types that we don’t think need to be included under this specific regulation. And we will try and remain as technology-agnostic, or technology-neutral, as possible. With RFID, I see that being useful for devices in hospitals, such as infusion pumps, but that technology probably doesn’t make much sense for a box of gloves.”

CDRH oversees the current MDR requirements of the Federal Food Drug & Cosmetic Act. The MDR system is designed to help the agency more easily identify patterns in adverse events of medical devices, such as device-related deaths. Currently, the reports come primarily from manufacturers and user facilities such as hospitals. For instance, user facilities are required to file a report whenever an adverse event occurs that might be connected to a patient death.

The electronic Medical Device Reporting (eMDR) process is an optional electronic filing component of the required MDR. Electronic filing would enable CDRH to more quickly review and act on the reports, says Indira Konduri, eMDR project manager with CDRH, because “it takes time to get these reports into the system. Also, we’d be able to save [on] the costs associated with manual entry.” CDRH receives hundreds of thousands of such reports each year (in 2005, it received more than 200,000), all of which are filed manually.

CDRH has developed two methods to submit reports electronically. The first, designed for reports to be submitted one at a time, leverages an XML-based application that can be downloaded from the Web. The second, for batch filings, requires some software coding; to that end, CDRH is offering a detailed implementation guide containing technical specifications.

The eMDR rules do not call for any automated identification mechanisms. However, each filing must include information specific to the device involved in the event, including its model number, lot number, expiration date and serial number.

The UDI system has the potential to ensure that the device-specific information is consistent and detailed enough to help narrow efforts in the event of a recall. “I can see a link between UDI and eMDR,” Konduri says. “Suppose a device is truly defective and recalls need to be done. If, for example, we have more specific information about the device, we can narrow down on lot numbers and find out if there’s just one device involved, or an entire lot. UDI makes the information more helpful.”

CDRH is encouraging device manufacturers to begin testing eMDR by either downloading the XML-based application or following the technical guide for software coding to allow electronic filing of batch reports. The agency is now conducting pilots and is already receiving electronic reports from at least one company.

What’s more, CDRH is working on a draft rule to make it mandatory for MDRs to be submitted electronically. The draft is not yet complete, and will first have to go through a normal process of soliciting comments and revisions before it is adopted, which may happen in 2008.

—The U.S. Food and Drug Administration (FDA) may soon require manufacturers of medical devices and supplies to apply unique device identification (UDI) mechanisms to individual items so they can be automatically tracked and traced in the supply chain. The agency is also urging companies to file reports electronically whenever an item is involved in an adverse event. Currently, such reports are filed in paper format and must then be manually entered into a computerized system.

Although not directly connected, the two efforts are related. Both are intended to improve the collection of critical information regarding medical devices, ranging from infusion pumps to latex gloves, and both could help drive the adoption of radio frequency identification.

More than a year ago, the FDA began investigating how a UDI system might help automate the collection of information about various devices, such as the manufacturer, make and model, unique attributes, serial numbers, identifying lot and manufacturing numbers, and expiration dates (see FDA Seeks ID System for Medical Devices and Supplies. In addition, a UDI system could be used to facilitate product recalls, improve the consistency of medical device reports (MDRs) and identify device incompatibilities or potential allergic reactions. Such a system would rely on automatic-identification technologies, including RFID and serialized bar codes.

First for Canada: Cancer Research Teams Using IBM-Sponsored Computer Grid to Speed Treatment Studies

CNNMoney.com, November 6, 2007 – Canadian researchers expect to accelerate the war on cancer by tapping into a global network of hundreds of thousands of people who volunteer their idle computer time to tackle some of the world’s most complex problems.

The research team, led by Dr. Igor Jurisica at the Ontario Cancer Institute (OCI), and scientists at Princess Margaret Hospital and University Health Network, are the first from Canada to use IBM’s (NYSE: IBM) World Community Grid, a network of PCs and laptops with the power equivalent to one of the globe’s top five fastest supercomputers.

The team will use World Community Grid to analyze the results of experiments on proteins using data collected by scientists at the Hauptman-Woodward Medical Research Institute in Buffalo, New York. This analysis would take conventional computer systems 162 years to complete. However, using World Community Grid, Dr. Jurisica anticipates the analysis could be finished in one to two years, and will provide researchers with a better way to study how proteins function, insight that could lead to the development of more effective cancer-fighting drugs.

“We know that most cancers are caused by defective proteins in our bodies, but we need to better understand the specific function of those proteins and how they interact in the body,” said Dr. Jurisica. “We also have to find proteins that will enable us to diagnose cancer earlier, before symptoms appear, to have the best chance of treating the disease — or potentially stopping it completely.”

The research team now has more than 86 million images of 9,400 unique proteins that could be linked to cancer, captured in the course of more than 14.5 million experiments by colleagues at Hauptman-Woodward.

This comprises the most comprehensive database on the chemistry of a large number of proteins, a resource that will help researchers around the world unlock the mystery of how many cancers, such as breast, prostate or childhood leukemia, grow.

Approximately 150,000 Canadians will be diagnosed with cancer and more than 70,000 will die of the disease in 2007 alone.

World Community Grid, sponsored by the IBM Corporation, uses grid technology to establish a permanent, flexible infrastructure that provides researchers around the world with a readily available pool of free computational power that can be used to solve problems plaguing humanity.

Individuals can donate their computers for this project by registering on www.worldcommunitygrid.org, and installing a free, secure, small software program on their computers. The computer requests data from World Community Grid’s server when it is idle, for example a user is at lunch, and performs the cancer-related protein computations. A screen saver will tell individuals when their computers are being used.

World Community Grid is the largest public humanitarian grid with more than 333,000 members and links to more than 780,000 computers. However, it’s estimated that there are one billion computers worldwide, underscoring the potential for the grid and its computational power to significantly expand. Eight projects have been run on World Community Grid to date, including protein folding and FightAIDS@Home, which completed five years of HIV/AIDS research in just six months. Additional projects are in the pipeline.