The time spent at the FDA workshop for modernizing evidence generation provided an excellent state of affairs and the struggles of the industry. The necessity for a unique data identifier is not only viewed as a way to streamline the supply chain but also as a way to improve outcomes and save patient lives. But progress is slow, and there is still a significant degree of incohesive segregation in a movement that is specifically tasked with freeing data and improving the accurate dissemination of information. So what are the goals and hurdles?

Technology

Technology is viewed as a great equalizer, aiding care providers in providing a uniform degree of aid with an evidence-based formulary. But with 49% of a physicians time spent on data entry with little incentive to do so, errors occur. Because of this, up to 79% of adverse reactions are incorrectly documented. The goal of technology is to aid in providing a small change of habit but creating a significant benefit to streamlining the process of data collection.

Part of the problem is that the industry is lagging behind retail and aerospace industries that have successfully deployed solutions for years, if not decades. As an example, laser marking technology has been able to mark products with a unique data matrix code with fiber or UV marks for quite some time now. The sterile field scanner that is now available (www.matrixthis.com) can scan data matrix codes as small as 0.5mm^2. But some of the standards that have been written in the past, creating unnecessary limitations that result in inhibitive barriers. HIBCC as an example, a standard largely used in Europe, allows for scalable cell sizes whereas other standards do not.

This is to say; technology needs to be accessible, affordable, and the benefits must be tangible. Scanning and marking technologies and standards need to provide ways in which the data can be collected and shared throughout the disparate software systems that are used in entire the supply chain. Hardware must not be viewed as an inhibitive experience, rather the end user should intuitively reach for a scanner or capture device before the idea of manual entry ever enters their mind.

Systems

Systems need to communicate, and due to data segregation and capitalized information mining, actual efficacy can not be attained. There is a call for government-funded healthcare to openly provide statistical data, generating a sufficient sample size for accurate post device evaluation and safety assessment, leading to greater patient safety.

Rather, EHR systems, databases, and health systems sit on data, make data private, and within the context of an implant, there is little done in the way of accurate entry or transmission of device identifiers for proper surveillance. If a common data model has already been adopted and the GUDID is used to provide the device data publically, the information should follow the patient.

With the reform that UDI promises is also that of simplifying the requirements and the overall burden on the supply chain. A single identifier can be marked on the packaging and the medical device with a direct part mark. This will allow the reorganization of the supply chain to optimize inventory, ensuring device identification capture, with linear barcodes, data matrix codes, and RFID.

Inventory management systems, EHR’s, data documentation, post-market surveillance systems, and databases need uniformity.

Conclusions

The full impact of UDI still has time to come, and the FDA has made the right decision to begin enforcement. Practical and readily available technology will act as an aid to reduce data entry errors, invest the physician and medical staff with what is being recorded, and allow for dramatically increased data entry collection. Technology has to be efficient, practical, and the affordable. From the start of the devices life to the moment of implantation a digital trail can be generated and quickly ensure that in the event of a recall that the right people are informed to ensure the reduction of complications as the result of inaction.