There are millions of medical devices at use at this very moment across the world, many of them necessary to sustain patients’ lives. The medical device industry serves not only hospitals, but individuals receiving home care and those with chronic disease, such as diabetes. But how are all these devices tracked and monitored? If new proposed rules by the FDA go into effect, each medical device used for certain purposes will be required to carry a unique device identifier (UDI).
If implemented, the UDI system would go into effect in phases based on risk, and would likely include the use of asset tags meeting UDI compliance standards. The lowest-risk devices would initially be exempt. The plan would provide a number of benefits, including:
- More accurate adverse event reporting and analysis.
- Reduction in medical errors.
- Providing a consistent data collection system across the industry.
- Creates a standard identification system to streamline recalls.
- Support a global, standard distribution chain to reduce counterfeiting and improve emergency preparedness.
Regulatory compliance may be initially cumbersome for device manufacturers, and for some providers in terms of learning new documentation standards. Once in place, however, UDI stands to provide tremendous benefits both in terms of meeting regulatory requirements and patient safety.
Adverse Event Reporting and Device Replacements Streamlined
The first major benefit of UDI is improved reporting of adverse events. Without a UDI system, properly documenting adverse events leaves room for human error and can prove challenging to identify the specific devices in question. But with a standardized identification system, suppliers and providers can rapidly identify problematic devices, offer adequate alternatives to patients and minimize the unnecessary pulling of non-related products out of the market.
This will mean less disruption for patients who are using similar, but unaffected devices. For patients who rely on medical devices to sustain life, a device recall can be intensely unnerving. UDI-compliant healthcare asset tags will allow providers to quickly identify the most comparable devices to minimize risks to patients, as well as reduce the lag time to provide an acceptable alternative by tracking replacement devices through the supply chain and obtaining the closest available replacement device.
Medical Errors Reduced
Documentation mistakes are one of the most common causes of serious medical errors within the healthcare industry. UDI would offer a level of protection for providers, enabling the most accurate device identification possible. Data collection and reporting would also be less error-prone, with the ability to scan asset tags or bar code labels to assign specific devices to individual patients instead of manual documentation.
This particular benefit does, however, bring up some concerns regarding patient confidentiality. The FDA is also proposing a national database for ease of device identification and data analysis related to adverse events. At first glance, it seems that information for millions of patients could be widely accessed by any authorized healthcare practitioner. In actuality, the data which would be contained in the central database would not contain any unique patient identifying information—only information regarding the device, uses, history, maintenance and any adverse events reported.
It’s common for new technology, such as UDI, to introduce some potential privacy concerns while offering benefits that clearly outweigh the risks. But with proper planning and precautionary measures, UDI stands to transform the medical device industry, making the jobs of providers easier and enhancing the safety of patients.
Katelyn writes for Camcode, a company helping users stay systematized and updated on new ways to keep inventory, clients, and employees organized in the work place. Visit their website and try Camcode’s foil labels.