News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules

Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.

The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.

All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label.

This new requirement includes medical devices licensed under the Public Health Service Act  (PHSA). As of last September 1, these devices must be labeled with UDIs directly.

Additionally, over a specified period of time, the law requires healthcare facilities—hospitals, ambulatory surgery centers, and nursing homes—and manufacturers to report adverse events involving malfunction of medical devices that led to patient deaths. In the report filed with the Food and Drug Administration,(FDA) the provider and the manufactures must include the UDI of the device involved in the adverse event.

unique device identification

Above is an example of a unique device identification (UDI) label. These are similar to the universal product codes (UPCs) that appear on most consumer products. UDIs contain information about medical device products, including the product name, expiration date, reference and lot numbers, manufacturer information, bar code, and details about the item. (Image in the Public Domain)

UDI System Will be Useless Without Buy-in by Hospitals

The FDA proposed the UDI concept in 2012. At that time, medical device manufacturers and patient advocacy groups questioned the value of the system if healthcare providers were not required to use the system.

Having providers use the system is “the whole point of having the UDI,” remarked Diana Zukerman, Ph.D., President of the Washington, D.C.-based National Center for Health Research, one of many advocacy groups pressing hospitals to rapidly implement this system. She was quoted in a story published by Modern Healthcare. “If something goes wrong, you can’t have to recall every single heart valve, just the ones that are causing a specific problem,” she said.

Diana Zuckerman Ph.D

In order for universal device identification labels (UDIs) to play a role in helping federal regulators track adverse patient events, including deaths, providers must include the UDI information in their reports about adverse patient events. Diana Zuckerman, Ph.D. (pictured above) is President of the National Center for Health Research. She recently stated that it was essential for providers to use the UDI system to make adverse patient event reporting successful. (Photo copyright by National Center for Health Research.)

When equipment isn’t labeled with UDIs or hospitals don’t record them, it is difficult to track down patients who received faulty implants under recall, pointed out the Modern Healthcare report. UDIs also can benefit hospital material managers because it enables them to electronically track usage and inventory of medical devices.

Not all hospitals have begun to use the system. Other sectors of the medical device industry will implement the UDI system over the next seven years. If providers don’t use the system, but manufacturers are required to mark their devices, it will “add costs and regulatory burden to the healthcare system,” observed Karen Conway, Executive Director of Industry Relations for GHX, a trading exchange based Louisville, Colorado, concerned with reducing costs for medical suppliers and hospitals. She pointed out that the only piece of this legislation impacting providers is that they must notify the FDA when a patient’s death involves a faulty device, such as pacemakers and defibrillators.

UDI System Aimed at Improving Patient Safety Worldwide

The FDA receives about 50,000 reports of serious adverse events involving medical devices annually, including about 3,000 deaths. The intent of the UDI system is to improve the reporting of adverse events. This will help the FDA and device manufacturers to more accurately identify and track problem products quickly. Officials at the FDA also believe the UDI reporting system would make it easier to better target and manage recalls designed to improve patient safety.

Other benefits touted about the UDI reporting system is that it would:

  • Reduce medical errors by allowing healthcare professionals to rapidly identify a device and obtain information about it;
  • Enhance analysis of devices and provide a standard for documenting device use in electronic health records (EHR), clinical information systems, and claim data sources and registries;
  • Provide a secure global distribution chain, help to address counterfeiting and diversion, and prepare for medical emergencies; and,
  • Lead to the development of a medical device identification system that is recognized worldwide.

CMS May Require UDI Adoption in Next Stage of Meaningful Use 

Some providers and purchasing organizations are pushing the FDA to made UDI a requirement for Health and Human Services’ (HHS) Stage 3 Meaningful Use EHR criteria, which the Center for Medicare and Medicaid is expected to propose next year, noted the Modern Healthcare report. At the request of the FDA, the Health and Human Services’ Office of the National Coordinator for Health Information Technology has proposed that EHR vendors update their systems with UDIs for implantable devices.

Global UDI Database Offers Public Access to Medical Device Information

Providers may be further pressed to adopt the UDI system as consumers using the devices become aware of the FDA’s Global Unique Device Identification Database (GUDID), a publically, searchable database of UDIs. Under the UDI final rule, the device manufacturer must enter the device identifier (DI) and information about their device into this system.

UDIs represent another dimension in the effort to develop international standards for supply chain functions in healthcare, including the medical laboratory sector. Readers of Dark Daily may recall the GS1 Global Location Numbers (GLNs) system that has been adopted for use in healthcare. The GLN system identifies the locations of businesses and healthcare providers. (Dark Daily, “Hospitals, Clinical Labs, and Pathology Groups Will Soon Adopt Global Location Numbers,” June 10, 2010.)

Future Expansion of UDI System Likely to Impact Medical Labs

Although many clinical laboratory testing devices are not targeted for this reporting/tracking system, medical laboratory managers should expect that, in the future, reporting rules will be expanded to include other types of medical devices associated with adverse patient events. This may bring clinical laboratory testing equipment registered with the FDA as Class III under the reporting requirement.

Additionally, pathology groups and anatomic medical laboratories involved in creating laboratory-developed tests (LDTs) should be aware that the federal agency’s proposed LTD guidelines call for labs to report adverse patient events associated with their LDTs.

—by Patricia Kirk

Related Information:

Era of medical-device tracking finally arrives

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

Clinical Pathology Laboratories File Petition Against Threat of Regulation of Laboratory-Developed Tests