Is the UDI System Beneficial for the Medical Industry?
UDI help track medical devices in commercial distribution. When included in the medical chart, a medical records review can help locate affected patients.
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Medical device tracking is a very important requirement when it comes to identifying recalled or defective medical devices that are used in patients’ treatment. The FDA requires the label of medical devices to carry a UDI or Unique Device Identification number that will help track the device. In case some risk is identified, the device will have to be recalled and the patients informed. If this number is included in the medical chart of the patient, a medical records review can help locate patients affected by medical device recalls. However, the industry and consumers are divided on the topic of medical device tracking and making the UDI number accessible to all concerned. •
The FDA requires the manufacturer of the device to submit product information concerning their devices to the FDA’s Global Unique Device Identification Database (GUDID), unless subjected to an
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exception or alternative.
The label and device package should include the UDI and each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology.
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If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI has to be directly marked on the device itself.
The main purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. The tracking information can be used to make easier the notifications and recalls ordered by FDA when any serious risk presented by these devices are identified. Proposals to allow patients and insurers access these UDI numbers have met with many obstacles. Patients have no idea about the make and model of the medical devices they are using. Manufacturers of the devices, insurers, patients, providers and consumer advocates all have definitive stands regarding the efforts to improve tracking of medical devices. According to manufacturers, there is no assurance of benefit in putting the device serial numbers into insurance claim forms, and it would cost additional time and money. However, auditors and consumer advocates believe that doing so would improve accountability and patient safety. Pacemakers, for instance, are devices that many cardiac patients use and failure of these devices could lead to cardiac arrest or heart failure and death of the patient. When the UDI number is not known or disclosed to the patient or insurer, there will be no way for government as well as private insurers to track down directly how many patients received such defective pacemakers. The same goes for other implanted medical devices as well such as
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artificial hip implant. In such instances, medical record retrieval and review becomes necessary to find the UDIs to track down faulty devices. Medicare’s inspector general office has found that Medicare spent around $1.5 billion over 10 years on surgeries and follow-up care for patients who had one of 7 specific heart devices made by Minnesota manufacturers. This statistics stresses the need to improve tracking of medical devices. Don May, executive vice president for AdvaMed, the Washington-based medical device manufacturer says that they support the collection of UDI in the electronic health record because it can actually be used to help track patient outcomes and be used in a more proactive way around post-market surveillance. Med-tech industry officials point out that the codes are too long and diverse to include in insurance claims. Hospitals may have to invest in new barcode scanners and find ways to transmit the data to insurers accurately. The AMA (American Medical Association) says that reporting UDI numbers in insurance claims could prove to be costly and inefficient for identifying widespread problems. The complete UDI number can extend up to 75 characters and comes in 3 different formats used by 3 different standards organization. The full UDI code contains not only model numbers, but also batch and lot numbers, manufacturing date, and other information that would identify which specific devices are faulty. CMS, Medicare Payment Advisory Commission and others recommend including a short section of the UDI known as the “device identifier (DI)” in Medicare claims forms. The problem with this, though, is that such short forms of the UDI codes could lead to inaccurate conclusions regarding devices and this could negatively affect both patients and medical device makers. The advantages of including UDI information outweigh the disadvantages, patient safety advocates assert. The safety issues with medical devices occur usually across the entire product line, and to identify such issues only the brand and model of the device is required. The entire product information as included in the full UDI may not be necessary. Personal injury and product liability attorneys, providers of medical record review for attorneys handling injury cases, patients, and insurers will agree with the FDA’s stand that “UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.”
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