Medical devices are an integral part of the health care system. Advances in devices and implants has led to a longer and improved the quality of life for countless patients. However, not all interactions with medical devices has proven trouble-free. Recalls, Adverse events, and post-market surveillance of medical implants have been cumbersome and marginally effective in the healthcare industry. Documenting and identifying which patient has what implant has been accomplished through mainly human data entry.
In 2012 the FDA enacted the UDI final rule which requires that every medical device have a permanent marking as the first stage in developing an automated medical device tracking system. By mandating UDI’s, the FDA is able to better detect adverse events, reduce counterfeits, improve product recalls, and enable a robust post-market surveillance program. By September 2016, all class II devices need to bear a permanent human and automated markings to satisfy the UDI requirements.
Undertaking such an aggressive and multi-stakeholder effort has been daunting. There have been multi-stakeholder committees formed to develop industry standards and utilization throughout the supply chain up to the point of implant. Automated programs are beginning to become more common-place for tracking medical devices from the manufacturer to end user. However, documentation at the point of implant has been the most problematic for accurately matching patients to their specific implants. Even though most of the procurement of medical devices is automated a fair amount of the surgical documentation of patients to their implants is manual and prone to human data entry errors.
Automation and integration of implants in the sterile field is now possible. Matrix IT Medical Tracking Systems, Inc. has created TRACTUS, a high speed scanner that is used in the sterile field to track the implant’s unique device identifier (UDI) information, including: Manufacturer, device, lot, serial and expiration. The scanner works real time during surgery and accurately identifies each implant as well as placement of the implant in the patient.
The surgeon scans the implant, and then identifies the implant’s placement inside of the patient. Because the sterile-covered scanner is placed next to the patient during surgery, each implant is identified on an “as you go” basis.
Surgery time is reduced because hospital staff don’t need to pause during surgery to record implant information, which saves money and is safer for patients.
After surgery, hospital departments such as central supply, sterile processing, patient financial services and medical records must each manually input this information into their computers. With TRACTUS, the data is electronically sent to the corresponding departments, saving the hospital labor costs.
Coupled with UDI tracking software that documents every implant from the manufacturer to the hospital, TRACTUS verifies that each device is FDA approved before it is implanted and provides the hospital with instant results of the implanted devices. In the event of a recall, the hospital may instantly alert affected patients.
TRACTUS also provides accurate implant utilization information so that the hospital may accurately charge for their services as well as verify manufacturer charges for implants used during surgery.
TRACTUS offers utilization data that may be parsed such as a comparison of surgeons and how long a particular device takes to be implanted, cost by surgeon or procedure, as well as many other capabilities.
Future capabilities will allow the study of long term patient outcomes, providing important information on how each device and surgeon performs in multiple categories, including age groups, gender or diagnosis.
For more information, go to www.matrixmedical.co/ or contact Pat Cairns at 860-850-0083.