The current state of the medical implant market sits in a precarious position, at best.  Unlike the auto or grocery industry, there is little standing in the way of counterfeit parts entering into the supply stream.  In Q4 2014, Spinal Solutions was found to be creating inferior and subpar parts that were being implanted in patients.  Those with the implanted parts are at an incredibly high risk for future complication or part failure.  As a result, revision surgery or other, more invasive procedures might have to be employed.  Hospitals didn’t have a clear or accurate way of identifying those who might’ve been affected.

As the hospitals didn’t have an accurate, serialized record of the implants, patients received impersonal and chilling letter.  These letters informed them that they might have one of these faulty parts.  The only way to tell if the patient had a faulty part was to go through an invasive exploratory surgery.  These revisions can be risky, dangerous, and lead to crippling complications.  The question becomes, why doesn’t the industry have a solution to stop this from happening?  The FDA has been working with manufacturers and stakeholders, requiring parts to have a direct part mark (UDI).  Despite there a solution using QR, data matrix technology, the industry has been given a requirement extension until 2016.  Despite this, the industry seems to have adopted RFID.  Unfortunately, RFID can’t enter the sterile field, and can’t be implanted into a patient.

In response to this problem, Matrix Medical has developed the Tractus implant tracker.  The optics based scanning solution sits in the sterile field and can scan data matrix (2D) codes.  This is the only product to date that satisfies the FDA’s direct part mark requirement.  This translates into a database of implants that can be checked against the national medical device recall database.  Matrix Medical is working diligently with manufacturers and supply chain companies, creating a seamless supply chain solution.  The chain of custody starts with the manufacturer and ends with the patient.  This represents several benefits, including part authentication, recall awareness, and the satisfaction of the FDA laws and regulatory mandates.

Matrix Medical has also announced that they’re working with strategic hospital partners.  The goal is to completely remove physical paperwork (prone to human error) with a completely electronic documentation system.  The Tractus product offering is unique in that there is a full integration with the hospital EHR.  All surgical implant data is seamlessly added to the patient chart, providing a simple and easy solution.  This helps hospital personnel with accurate record keeping and can notify manufacturers with an instant snapshot of implanted parts.

tractus-matrix-medical-fda-udi

For more information, Matrix Medical can be reached at 860-850-0083 or at www.matrixmedical.co/

REFERENCES

http://www.thedailybeast.com/articles/2014/11/03/patients-screwed-in-spine-surgery-scam.html

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/

https://www.matrixmedical.co/tractus