News & Insights

Medical Device Recall Fictions: Is Your Hospital Prepared for the Facts?

April 09, 2018

By Joseph T. D. Tran, Attorney at Law

Medical Device Recall Fictions: Is Your Hospital Prepared for the Facts?

One reason spy action movies are popular is the never-ending supply of unbelievable gadgets and devices. Most of these spy gadgets are science fiction, but some are becoming science possibilities.

For example, the movie adaptations of Ian Fleming’s “James Bond” regularly employs classic spy gear like exploding time pieces, but it also takes gadgets to the edge of reality. In “Spectre”, Secret Agent Bond is implanted with a small device that tracks his location while monitoring his vitals. Sound familiar?

Recently, there has been a burst of new medical devices on the market. In December 2016, Congress enacted the 21st Century Cures Act, which is intended to accelerate the FDA approval process for new medical devices. Faster approval and more medical devices may be good news to patients who will have more options for treatment. However, it also means that hospitals must work harder than ever to track the influx of medical device communications and recalls.

Effective Medical Device Recall Management: Fact or Fiction

The FDA defines a recall as “a method of removing or correcting” a product that is in violation of the laws. But not all recalls are created equally.

The FDA classifies recalls using one of three classes that relate to the level of hazard, not the type of device. For example, a Class I recall for a defibrillator might be issued because the instructions included with the device are erroneous and could be fatal to patients and users if not immediately corrected. Meanwhile, a Class III recall for the same defibrillator might be issued because of a minor error in labeling where the Date of Manufacture is in the wrong format.

Thus, a recall communication can be as trivial as incorrect labeling to more severe when devices have known potential to cause injury or death. In all cases, recall communications should explain the actions required of the hospital.

Fact or Fiction

There are some general medical fictions that should be addressed and some best practices that should be considered when hospitals update their recalls management procedure.  

Fact or Fiction: Recalls
Fiction: Recall communications require users to stop using the device or equipment.
Fact: The majority of recalls are actually safety notifications that don’t require anything drastic, but do require a process to follow the actions required in the notice.

In addition to receiving recall communication, providers should report any device defects or concerns to the FDA.

Fact or Fiction: MedWatch
Fiction: Hospitals don’t have to report any problems with medical devices or equipment to the FDA.
Fact: Hospitals are required by the FDA to send annual medical device reports on device-related deaths and serious injury to the agency and to the manufacturer.

Medical device and equipment manufacturers are in the best position to evaluate the future potential for harm from a given problem. Inadequate reporting of even non-mandatory problems deprives the manufacturer of valuable information and ignores an important patient safety safeguard.

Reporting is easy through the MedWatch app and can even be done on a smart phone. MedWatch asks that the report be made quickly – within 10 days of discovery of the problem. MedWatch emphasizes that reporting a device problem may be “…the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.” Yet, according to the FDA,  medical device problems are consistently underreported. As one former hospital risk manager confesses, her hospital would report most but certainly not all reportable incidents.

In order to receive and act on device reports, or to report a problem to the FDA, a facility must start with the most fundamental facts, but knowing which and how many devices are in the building can be a daunting task.

Fact or Fiction: Tracking
Fiction: There is no way to track all medical devices or equipment because manufacturers can use different coding systems.
Fact: The FDA has issued the “UDI Rule”, which will soon require manufacturers to use a single coding system and simplifies the tracking and inventorying of medical devices and equipment.

Many hospitals already utilize Electronic Medical Records (EMR) and can currently keep track of which medical devices are being used on which patients. Medical device incident and hazard reporting software from third parties can also help.

The federal government recognized the difficulty in tracking and has developed the unique device identifier (UDI) solution. On September 24, 2018, the FDA will begin requiring medical devices and equipment to be labeled with a UDI, stored and accessible through a free and shared database for anyone to use. When embraced by hospitals, this solution can improve patient safety by being quicker and more efficient than current methods of reporting, tracking, and disseminating critical medical device and equipment information.  

Best Practices for Tracking Medical Devices

  1. Now is the time to update your hospital policies. Regulations constantly change, and policies can become ineffective without regular evaluation. Provide adequate training to all new staff and inform all staff on where to find the relevant policies.
  2. Consider funneling all medical device recall communications to a single point of contact, preferably someone who can quickly forward the recall to the appropriate department leader for further processing.
  3. For some hospitals, risk managers should consider including recall notifications and actions in their annual or quarterly reports to the Executive Board.
  4. Consider implementing policies requiring every department leader to be responsible for where equipment or devices are stored, and when and where they are used.
  5. In some cases, recall notifications should be communicated to people outside of the recall management process. One department should be responsible for disseminating recall notifications to patients, physicians, and other third-parties.

Recall management has many moving parts: handling the recall communication, reporting on recalls, and tracking devices and equipment. These processes should all work together and be constantly updated to accommodate changing hospital staff.

For more information on how to tailor your recall process, contact the LAMMICO Risk Management and Patient Safety Department at 504.841.5211.

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