You might already be aware of this, but the recent FDA proposal in renewing Medical Device User Fee Modernization Act involves certain things. One of those is that congress is trying to push further legislation of medical devices. However, that comes in the form of a unique device identification system. As you already know, the bar-coding rules for drugs were established back in 2004. However, medical devices were somehow excluded from being legislated. Some of the known reasons for that were the size constraints, cost, number of devices available in the market, and the usual technical hurdles.
On that note, those concerns are still pertinent today. The same can be said when the unique device identification system was implemented for medical devices. However, the results of those make the benefits of healthcare providers and patients become unclear. That makes the recent push for the unique device identification system questionable.
In any case, the application of the unique device identification system is best suited for surgical sponges and in the field of retained foreign bodies. That said, the RIFD trackers and bar-coded sponges are being marketed to different healthcare institutions. Still, there are questions when it comes to the safety of the patients when it comes to using certain medical devices. The significance of the unique device identification system is also being questioned in the industry.
As for the implementation of the unique device identification system, it's estimated that it would cost the healthcare industry about $2 billion in total. There's also the fact that another $500 million is needed in order to maintain the unique device identification system. That also involves the training that will be needed to utilize such a system. However, it's also announced that with the use of the unique device identification system, the annual savings can reach up to $35 million. Most of the savings are also projected to come from the reduction of staff hours when it comes to the search and segregation of the medical devices. Still, evidence-based medicine is emphasized in the healthcare industry these days. That leads to the tendency of healthcare institutions to be reluctant in spending huge sums of money in the hope of reaching the said savings estimates.
In any event, the unique device identification system or Unique Device Identifier is necessary in order to reach noble goals in the health industry. Even if it is being questioned by many important figures in the industry, the unique device identification system has the benefits that they've always searched for.
Check out also this related link: https://www.britannica.com/technology/security-and-protection-system