Are Your Sterile Implants Really Sterile?

Are Your Sterile Implants Really Sterile?

 

I have been on both sides of patient safety for over 13 years.

On the one side, I am a harmed patient who suffered a multitude of adverse events stemming from pharmaceuticals and medical devices, including contracting Methicillin-resistant Staphylococcus aureus (MRSA) and Sepsis. In addition, I have had over 3 dozen surgeries, some of them resulting in errors and infections.

On the other side, I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration’s Center for Device and Radiological Health (CDRH). As the consumer representative on the Advisory Committee, my role is to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of medical devices under review.

I was recently contacted via LinkedIn by Dr. Aakash Agarwal, Director of Research and Development for Spinal Balance Inc. at the University of Toledo to tell me about the growing problem of device contamination. After a brief phone call, Dr. Agarwal sent me research literature. I was alarmed by what I read and I feel that this matter needs to be brought to the public’s attention, including patients, physicians, and regulators. I agree with Dr. Agarwal that a public hearing needs to be held at the FDA to discuss the pedicle contamination. This is a matter that is not talked about and it should be.

Pedicle screws are used in spinal fusion surgeries to add extra support and strength to the fusion while it heals. The screws are placed above and below the vertebrae that were fused. A rod is used to connect the screws which prevents movement and allows the bone graft to heal. They can become contaminated and it is a growing problem in the United States; a fact that most people don’t know.

Bacterial infections following spinal surgery are estimated at 12.7% according to Dr. Agarwal.

The average hospital bill following such infections is $63,000, with hospitalization being necessary in 5.5% of those cases.

Pedicle screws are the most common implant used in spinal fusion surgery. A surgeon will typically have over a hundred screws available for use during surgery, but actually uses a small amount.

The pedicle screws’ low usage rate leads to these screws being repeatedly reprocessed—or “automated washing with contaminated instruments from theatre and then sterilized without prior inspection by hospital staff” by the sterilization processing department (SPD).

In essence, these “sterile” implants, alarmingly, have been found to contain contaminants.

Furthermore, unused pedicle screws are subject to contamination during surgery.

Pedicle screws are linked to MRSA infections during their handling during the procedure, and during the reprocessing before and after surgery. MRSA is a bacterium that causes infections in different parts of the body and it is tougher to treat than most strains because it is resistant to some commonly used antibiotics. Re-processed screws have been found to harbor corrosion, biofilm, endotoxins, fatty tissue, and soap residue mixed with fat, whereas exposed pedicle screws in “sterile-field” become contaminated. These infections were present in at least 10% to 30% of patients with chronic pain and were detected only during revision spine surgery.

In order to keep pedicle screws from becoming contaminated, researchers are suggesting providing the implant in an individual sterile pack (single-use and ready for implantation), and each implant should have a functional guard around it to protect from direct exposure during handling. Dr. Agarwal and his colleagues co-authored a study to determine the magnitude of the issue, and how to prevent surgical site contamination linked to pedicle screws in spine surgery.

Dr. Agarwal explains it like this:  “The single center study as well as our multicenter study, showed that all unguarded screws resulted in bacterial contamination inside the “sterile field” during live surgeries, whereas guarded screws had no such contamination. The key constituents that define the pathogenesis of SSI (Surgical Site Infection) are the virulence, host-site immunity, and dosage. We demonstrated the preventative method effective on reducing the dosage of bacteria.”

The guards used on the single-use pedicle screw are commercially available.

Dr. Agarwal has filed a Citizens Petition with the U.S. Food and Drug Administration calling for a ban on the reprocessing of pedicle screws in the U.S. It is currently under review, a process which could take a year or longer. Agarwal requests “the Commissioner of Food and Drugs to cease clearing 510(k)s and approving PMAs [pre-market approvals] for reprocessing of pedicle screws and other implantable orthopedic devices and cease clearing 510(k)s for re-usable implantable orthopedic device[s].”

In addition to asking for the cessation of approvals for reprocessed pedicle screws and interbody cages, the petition requests that every implantable orthopedic device should be provided “such that it is not touched or exposed before implantation, by the operating room staff, in the sterile field.”

I am a patient who has undergone dozens of surgeries and have several medical implants. This is all information I wish I had known prior to my surgeries. Contamination is preventable and reprocessing needs to be banned.

Your life could depend on it.

About The Author

Rachel Brummert is a Special Government Employee at the U.S. Department of Health and Human Services and the Patient Safety Director at ION Medical Safety. She is also CEO of Patient Safety Impact, headquartered in Charlotte, North Carolina.

Media Inquiries: rachel@rachelbrummert.com

 

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