From January 2002 through the end of December 2007 a total of 6,072 recall notices were issued for medical devices. This represents 5.52 notices per working day and a total of 600 million shipped units during that 5 year period and 544,600 units per work day. That is just the shipping units. When we break that down to the patient unit of use, it represents 3.9 billion units total or 3.5 million units per working day. To further demonstrate the seriousness of the problem, the Food and Drug Administration says that less than 5 percent of the recalled products are accounted for. So what happens to the other products? There are three major activities that account for the total number. First, there is the consumption prior to the recall. Second, there is the quantity accounted for during the recall period. The last includes two parts; one being continued consumption and the second the product remaining in the field waiting to be used. Therein lies the danger.

Recalled products used on a patient can cause adverse outcomes. For example, a woman in Virginia Beach, VA, had a hernia repaired in 2007. After the surgery she continued to experience pain. Upon examination of her medical records it was determined that the surgical mesh used to repair her hernia had been recalled six months prior to her surgery. Unfortunately for her, the mesh had adhered to several organs and surgeons were reluctant to do additional surgery due to the high risk to the patient.

Through Congressional testimony, the Food and Drug Administration and others were able to move Congress to pass legislation, called the "FDA Amendments Act of 2007." This legislation, which passed through both houses and was signed by then President George W. Bush in only 17 days, provides for three critical things to happen:

• The FDA must develop a standardized system to uniquely identify unique medical devices, Unique Device Identifier (UDI)

• Manufacturers must place the UDI in human readable and/or AutoID formats on a device, its label (packaging) or both

• The FDA must create and maintain the UDI database.

This is a tremendous step in the right direction. In essence, the manufacturers will develop and label the products with the Universal Product Number (UPN), plus the lot/batch number, expiration date and where required, the serial number. This will allow the users to take advantage of the bar-code technology, scan the product, check against a database to determine if the product has been recalled and then take the necessary action. The UDI can be viewed as an expansion of the UPN concept in that it includes UPN information plus additional data that could identify safety issues, expiration dates, device usage, facilitate recalls, potential allergic reactions such as latex content, and reduce product counterfeiting.

The FDA is working on the final regulations now and will publish them for public comment soon after a meeting held in February. The key is that the entire process is based on standards. This is critical in that it outlines exactly what the manufacturers must put on the labels and in what format. In order for it to work, it must be in a format that can be read by the scanners and by humans.

Given that drug errors are the most significant impact on the 100,000 medical error deaths each year, implementation of the UDI will be a substantial improvement in patient safety. In addition, hospitals are no longer reimbursed for hospital-acquired infections (HAI). There are more than 1.7 million such events each year resulting in approximately 90,000 deaths. We have to be concerned where these infections arise from. If the provider is unknowingly using products that have been recalled due to questionable sterility or known pathogens or contaminants existing in the product, there is a high probability that the product could be the source of the infection. We do not have an efficient way of finding this information out today. The patient suffers the ill effects of an infection and the hospital has to absorb the additional costs of treating the infection without the benefit of reimbursement.

There are many benefits to be derived from this new legislation. Having a record of every item, specific to the manufacturer, product number, lot/batch number in the electronic medical record (EMR) will be beneficial in determining the effectiveness of a product and the potential adverse effects being experienced. Every sector of the U.S. health system, once the UDI and associated UDI-compliant software is in place, will be able to identify where the product was used and is being used.

In order to gain the full benefit of the UDI implementation, changing all the software in all areas of the healthcare system to accommodate the functionality provided by the UDI is necessary. If I give you a scalpel handle without the blade, you can only do make believe surgery. If I give you a scalpel handle and the blade, you can do the surgery. Now, the UDI without the UDI-compliant software is the same thing. Manufacturers label the products with the UDI, but if the provider does not have the technology at the point of care to read the information and check against a database, the process will not work.

So what do we do? We have to go back to Congress and expand the legislation to require all clinical software, from Materials Management Information Systems to Clinical Systems including Laboratory, Radiology, Imaging, and Billing Systems to include the capability to use the UDI. We are celebrating the 15th anniversary of the UPN, and it still has only limited implementation in the field. The reason: The software was not changed to be UPN-Compliant. So, without the software changes we are not getting the benefit of the UDI, and we continue to harm patients through the use of recalled medical devices and continue with drug related errors. The industry cannot be left to do this on its own. When the Health Insurance and Portability Act (HIPAA) was passed in 1996, standards were issued by the federal government in order for software to be considered to be HIPPA Compliant. A similar process has to occur for the industry to benefit from the UDI implementation.

This problem evolved over a long period of time and it will take some time to get the solutions in place. The FDA, Congress and former President Bush, are to be commended for their efforts to approve and implement this critical legislation. The current political environment and focus on quality healthcare makes me very optimistic that this legislation and implementation will be successful. It will not happen overnight — probably more like five to six years — but it will happen.