Considerations for Using Biological Implants in Surgery

Considerations for Using Biological Implants in Surgery

There is no shortage of biological implant products on the market today. In fact, more than 20,000 products to date have been approved for marketing by the Food and Drug Administration (FDA). Although many of these products are highly regarded by surgeons and product manufacturers, it is important to understand the potential risks associated with biological implants.

We have chosen to discuss this topic in our newsletter as it has been our observation and experience that there is a lack of understanding of potential risks associated with biologics and a lack of education available to healthcare professionals.

What are Implants?

According to the FDA, “Medical tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Some implants are made from skin, bone or other body tissues.” (FDA, 2019).

Some of the major risks associated with the use of biological implants include infection, risk of rejection, and biocompatibility.

Additional considerations for product usage should be made from a cost-analysis perspective. Although a product may be registered for marketing by the FDA, it is not uncommon for insurance payors to reject claims where biological implants were used. Be sure that prior authorizations include the use biological implants in surgical cases to avoid non-payment from insurance payors.

When dealing with human tissue products, it is essential to make sure that the integrity of the product is maintained prior to implantation. How the product is maintained and transported should be carefully monitored.

Here are a few considerations for policy and procedure development:

Process for ensuring a product is registered with the FDA
The product is not manipulated and is maintained in its original sterile packaging
Temperature and humidity requirements are maintained according to manufacturer instructions
The product is not expired
Patient is fully informed about biological implant and has signed informed consent
A method of tracking is established for all biological and well as medical implants.
Create a log that includes product information and serial numbers
Documentation of biological implant is included in the patients medical record
Healthcare personnel have been educated on “gate-keeping’ strategies prior to biologic implants entering the operating room

In our experience, we have found that it is not uncommon for hospitals and ambulatory surgeries centers to not have policies and procedures in place for regulating the use of biological implants in surgical procedures. It is also not uncommon for Manufacturer Product Representatives to show up with products on the day of surgery wherein it is unclear how and in what condition the product has been transported. Additional observations have included that OR team members were completely unaware that a biologic was even planned to be used in a scheduled procedure.

We would like to emphasize that our intention for writing this article is not to take a position in favor or against the use of biological implants, but to help healthcare professionals have a better understanding of these products and encourage the development of policies and procedure that promote patient safety and help to mitigate risk.

This topic is one that we have done extensive research on. Subsequently, we have determined that there is a significant lack of guidance and educational material to help guide healthcare professional to manage use of biological implants in a safe and compliant manner.

If you find that your organization needs additional support, please contact us for assistance. We can provide education and assist with risk mitigation and policy/procedure development.

HCE Global is Here to Help

Our HCE Global experts understand the challenge that healthcare facilities are facing today. We are here to help. Using a customizable approach, we will help you navigate through even the toughest of challenges. We pride ourselves on helping our clients achieve and maintain a status of excellence in the healthcare industry.

Be sure to browse Our Website for a full list of services we provide.

References:

https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics#:~:text=Medical%20implants%20are%20devices%20or,support%20to%20organs%20and%20tissues.

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The Pulse: February 2026 Healthcare Compliance & Facilities Update

February 28, 2026

February may be the shortest month of the year, but in the world of healthcare facilities and regulatory oversight, it often feels like the longest. Between the launch of the Joint Commission’s Accreditation 360 and the sudden shifting of federal staffing mandates, your compliance "To-Do" list likely looks more like a "To-Don't-Panic" list. Below is your breakdown of the critical updates, deadlines, and strategic shifts defining February 2026. Regulatory Roundup: The "Great Repeal" of 2026 The most significant news hitting desks this month is the formal pivot in Long-Term Care (LTC) staffing. CMS Staffing Mandate Repealed : Effective February 2, 2026 , CMS officially rescinded the 2024 minimum staffing requirements (the 3.48 HPRD mandate). The Fine Print : While the "one-size-fits-all" numbers are gone, the Enhanced Facility Assessment requirements are still very much alive. Regulators are moving away from rigid ratios toward a "competency-based" model. You must still prove your staffing levels match your specific resident acuity. What it means for you : It’s time to double-check your assessment documentation. Auditors aren't counting heads as strictly, but they are scrutinizing the logic behind your staffing decisions. HIPAA & Privacy: The February 16th Pivot If you haven't updated your Notice of Privacy Practices (NPP) yet, you are officially behind. February 16, 2026, marked the deadline for compliance with the final rule aligning 42 CFR Part 2 (Substance Use Disorder records) with HIPAA. Lawful Holder Doctrine : Any practice receiving SUD records is now a "lawful holder," triggering new obligations for how those records are handled in legal proceedings. Reproductive Health Privacy : New prohibitions are in place regarding the disclosure of PHI for investigations into lawful reproductive healthcare. Security Rule Modernization : Th e HHS Office for Civil Rights (OCR) is phasing out the "addressable" vs. "required" distinction. By late 2026, every safeguard will be mandatory. Tech & Sustainability: Do Less with Less The 2026 facility mantra has shifted from "do more with less" to "do less with less"—meaning we are using data to eliminate wasted effort. Unified Platforms : The era of separate spreadsheets for maintenance, energy, and compliance is over. Integrated CAFM (Computer-Aided Facility Management) tools are now the standard for audit-ready reporting. The "Heart" of the Facility : Since it’s American Heart Month, it’s the perfect time to run a Life Safety check on AEDs and Cardiac Crash Carts. Ensure your battery replacement logs are digitized—paper tags are so 2024. A Note on Candor : Let’s be real—the repeal of the staffing mandate might feel like a relief, but it’s actually a trap for the unprepared. Without a fixed ratio to hide behind, your clinical judgment is the only thing standing between you and a "Statement of Deficiencies." Don't let the lack of a mandate lead to a lack of a plan.

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