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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.


Contact us today at (800) 813-7117 to schedule a free consultation.

NSHN and OSHA Reporting: Prepared to Meet the Deadline?

February 10, 2025
It is that time of year again. At least for acute care hospitals, long-term acute care (LTAC) hospitals and inpatient rehabilitation facilities (IRF) who report to The National Healthcare Safety Network (NHSN). If annual surveys are not reported by March 1 st , then your organization will not be permitted to enter monthly reporting plans until the annual survey has been completed. Although there are just a few weeks to go, early planning is the key. It is important to consider that responses to the Annual Survey questions are a collaborative effort. Planning a meeting in advance with key stakeholders will help to ease the stress of completing what some may consider to be a daunting task. Be sure to coordinate with Facilities Managers, Pharmacists, Laboratory, Nursing, Infection Prevention and Quality leaders on annual survey responses. Although individuals who are responsible for report submission may find that some of the data has not changed significantly from the previous year, we have identified that some questions have been removed while additional questions have been added. If you are new to NHSN reporting and have not yet completed an annual survey, you will find an alert reminding you on your dashboard upon logging in. Keep in mind that the survey you are completing requires data from the previous calendar year. You will be submitting data for 2024 due March 1 st , 2025. There are a variety of questions that will require information about metrics, facility type, infection prevention practices, laboratory testing methods, water quality management, and antimicrobial stewardship practices for example. Instructions on completing your organization’s annual survey click on the link below that corresponds with your facility type: Instructions for Completing Annual Hospital Survey Instructions for Completing LTAC Annual Survey Instructions for Completing IRF Annual Survey OSHA requires the following facilities to complete an annual occupational injury and Illness Report: Ambulatory Health Care Servies General Medical and Surgical Hospitals Psychiatric and Substance Abuse Hospitals Specialty Hospitals Skilled Nursing Facilities For a complete list of facilities required to report annually via electronic submission and for additional information on Standard 1904 Subpart E Appendix B click on the following link: OSHA Injury and Illness Reporting Requirements . Much like NHSN annual surveys, this reporting is also for the prior calendar year. Your deadline for submission is March 2, 2025. If your organization has not previously been reporting, please note that you will need to set up an Injury Tracking Application (ITA) account. For complete instructions, click on the following link User Guide . Individuals who are responsible for report completion and submission should have a clear understanding of criteria that constitutes a work-related injury. They will also need to know if the employee missed days of work because of injury or illness. If an employee was restricted from usual work activities or reassigned to a new role as a result of the injury or illness this information must be documented. If an employee required care beyond basic first aid, this will also need to be reported. Reporters should not include Protected Health Information (PHI). For a brief tutorial on OSHA annual reporting requirements, click on the following link OSHA Injury and Illness Reporting . Our experts understand the challenges that all healthcare facilities are facing today. Using a customizable approach, we will help you navigate through even the toughest of challenges. Whether you are in need of mock surveys, leadership training, corrective action plans or ongoing support services, we can help! 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. Contact us today at +1 (800) 813-7117 to schedule a free consultation. References: https://www.cdc.gov/nhsn/forms/instr/57_103-toi.pd https://www.osha.gov/laws-regs/regulations/standardnumber/1904/1904SubpartEAppB https://www.osha.gov/sites/default/files/ita_user_guide.pdf https://www.osha.gov/sites/default/files/osha_rktutorial.pdf
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National Patient Safety Goals: A Glimpse At 2025

January 13, 2025
In 2002 The Joint Commission (TJC) first established the National Patient Safety Goals (NPSG) Program. In 2003, TJC rolled out the first set of NPSG’s. Each year, TJC prioritizes patient safety goals for various healthcare programs.
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Radiologic Services: Refresher for Hospitals on CMS Conditions of Participation

December 9, 2024
When it comes to delivering radiologic and diagnostic services under The Centers for Medicare & Medicaid Services Conditions of Participation, hospitals need to have policies, procedures and safe practices in place that are centered around delivery of patient services, safety of patients and personnel, qualifications of personnel and record keeping practices.
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