PRF is used in invasive surgery – PRF is a blood component with direct contact with patients
PRF USE REQUIRES A SURGICAL INFECTION CONTROL & PLAN
The manufacture of PRF at the patient’s point of care requires sterile surgical field protocol for aseptic techniques. Sterile and bio-compatible plain tubes supplies should be part of the PRF procedure (same as for bone grafts and implants) for patient safety and to follow OSHA, FDA, NIOSH and CDC recommendations for infection control. Blood collection tubes shall be sterile inside and outside the tubes in single patient pack for improved safety and PRF regulations compliance.
PRF contamination risk:
AEROSOLS AND SPLATTER IN DENTISTRY
Many dental procedures produce aerosols and droplets that are contaminated with bacteria and blood.
Surface and air contaminants are contributors to infections. See below for information on Micro-organisms’ life span with statistics:
“Healthcare-associated infections (HAIs) are a major problem worldwide. The Centers for Disease Control and Prevention (CDC) has estimated that, in the United States, approximately 99,000 deaths each year are related to HAIs.”
Silica and additives in blood collection tubes contaminate the PRF purity
Read more about the cytotoxic effects of Silica in blood collection tubes associated with PRF use: PRF and Silica Tubes. Click Here
Source: https://www.ncbi.nlm.nih.gov/pmc/?term=prf+and+silica+tubes
PRF is used in invasive surgery
Maxillary Sinus Lift procedure
PRF is used to mix with bone graft materials prior to application to a bony defect including sinus augmentation surgery. Maxillary sinus presents direct contact with critical structures including nasal sinuses, ethmoid and sphenoid sinus..
Maxillary-Sphenoid Sinus Communication
The sphenoid sinus is anatomically in close relationship with the brain, meninges, optic nerve, internal carotid artery (ICA), cavernous sinus, and cranial nerve (oculomotor, trochlear, ophthalmic, and maxillary branches of the trigeminal nerve and abducens). In some cases a simple upper molar extraction has sinus communication specially when apical lesions are present.
PRF Aseptic Technique is Mandatory
PRF Sterile procedures protocols must be followed using sterile non pyrogenic devices and materials that could cause fever and inflammation in all bone graft procedures that includes PRF use.
PRF requires Biocompatibility testing for medical devices that enter in direct or indirect contact with patient blood (circulatory system)
Figure: Schematic representation of major reactions in blood induced by biomaterial surface. The hemocompatibility of blood-contacting biomaterials is one of the most important criteria for their successful in vivo applicability. Source: Research Gate
Thus, Six biocompatibility tests are part of the extensive in vitro analyses according to FDA and ISO 10993-4 that is required prior to clinical applications of medical devices that have components in contact with patients’ blood (circulatory system).
The PRF blood collection tubes biocompatibility can be compromised if the tubes have coats or additives that could affect the PRF blood purity.
The PRF-BRGF system from Biomedical RGF includes a sterile pack and plain no additive tubes for a safer PRF device & all biocompatibility testing