Spinal Implant Quality Assurance with BODi™

Monday, 01. February 2021 15:30

DALLAS, Feb. 01, 2021 (GLOBE NEWSWIRE) -- More than 1.62 million instrumented spinal implants occur every year in the US. Well, that's the tally if we consider hundreds of CPT and ICD codes.

  • It's impossible to quantify how many people are walking around with a spinal implant (or more).
  • It's equally impossible to discover the model or manufacturer of the devices.
  • Patients don't know this information, and up until now, there has been no database available.

The team at MedWell Solutions and Imperium Surgical Partners has solved that problem. We bring you BODi™, a spinal implant registry and credentialing system. The only spinal implant database in the US that adheres to CDC, JCAHO, HHS, and FDA guidelines.

Problems Associated with Spinal Implant & Removal

Any time a patient goes "under the knife" there are inherent risks. Infection, complications, secondary infections, and hospital-acquired pneumonia all come to mind. Surgeons have enough on their minds, even before puzzling out the spinal implants they are seeking to fix or remove.

As an orthopedic surgeon, you already know there is a problem identifying and recording spinal implants in the US.

Patients present at the OR with broken screws, loose screws, and broken rods. Previous OP notes don't mention anything about manufacturer, system name, sizes, or serial numbers. It's incredibly frustrating.

You already know that:

  • Per FDA CFR 801.109, medical devices like spinal implants must be prescribed, like medications.
  • Most spinal implants are prescribed primarily for stability.
  • Per the manufacturer's instructions for use (IFUs), most should be removed within a year.

Furthermore, guidelines for device tracking systems insist manufacturers comply with FDA's medical device tracking regulations (FDA 21 CFR 821.25) requirements like:

  • Obtaining the lot number
  • Batch number
  • Model number
  • Or the serial number of the device

All this helps to provide effective tracking of devices, particularly in the case of recalls. It's also essential to record the shipping date, the prescribing physician's contact information, and the date the device was supplied to the patient.

Now, let's take a closer look at hospitals and compliance.

The Hospital View: On Spinal Implant Device Recalls and Compliance

"It is more likely for Toyota to know about faulty exhaust pipes in a Prius than DePuy to understand how a new hip implant is performing in the [US]." said orthopedic surgeon David Schneider.

Know that if a device was sold before 1976, an updated version could be released without new clinical trials if the manufacturer deems it "substantially equivalent" to the existing device.

  • The FDA has approved more than a thousand high-risk devices.
  • But only 16% of them have gone through rigorous clinical testing before sale.

That's why so many recalls happen. And when they do, many hospitals discover they're not in compliance.

The Patient Perspective: It's About Safe Healthcare and Pain Resolution

"When we submit to being cut, and to having something implanted in our body, we have a right to feel some level of confidence that it is safe and beneficial." - Dr. David Schneider.

The problems that brought your patient to the OR were severe and undoubtedly painful. When an implanted device is recalled or doesn't work as hoped, patients lose faith in your ability as a provider and the healthcare system as a whole. Their negative feelings can result in bad press, negative social media reviews, and malpractice lawsuits.

  • Patients undergoing orthopedic surgery are a litigious bunch.
  • Orthopedic surgeons are among the top four types of surgeons likely to be sued for malpractice.

Dr. David B. Troxel, medical director of The Doctors Company in Napa, CA -- the nation's largest insurer of surgeon and physician medical liability, said, "if you practice orthopedic surgery long enough, the odds are good that someone will hit you with [a] lawsuit."

All the more reason to have all your "ducks in a row" regarding implant tracking and identification. Access to accurate dates, prescribers' information, and model or serial numbers are crucial.

The Solution: BODi™ a Spinal Implant Registry and Credentialing System

We are proud to offer BODi™, the only spinal implant registry. It's designed to help surgeons and hospitals:

  • Locate surgical tools and medical devices
  • Identify and plan for the life cycle of devices and implants
  • Track model numbers, serial numbers, lot numbers, EXP dates, and order/shipping information
  • And outlines manufacture specific IFUs

Perhaps most important to your practice or organization, the database is entirely HIPAA compliant and secure. Plus, it adheres to FDA, JCAHO, HHS, and CDC guidelines.

If you're concerned about your medical liability or have been dealing with a rash of spinal implant recalls, it's time to consider BODi™. Look into the regulations we've cited. Then, contact us to learn more or receive a complimentary audit provided by our professional — and JCAHO approved — consultants. We can help you reduce the risks to your practice, hospital, and patients.

Contact Information:
Marcus A. Curtis, Communication Director
Email: info@medwellsolutions.com
Phone: (214) 792-9064


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