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PRF Laws & Blood Regulations

PRF BLOOD REGULATIONS APPLY

PRF is a blood component used in invasive surgery in direct contact with the circulatory system and is regulated by: FDA, NIOSH, OSHA, CDC & state Board

Compliance with all federal regulations is important for safety of patients & employees and to avoid doctor’s liability risks – PRF sterility and free of contaminants are mandatory

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Sterility and Blood Purity Law

1 and 2: blood sterility and blood purity (tubes sterile single patient use pack and no additives – No silica coat): “All surfaces coming in contact with blood and blood components intended for PRF (transfusion) shall be sterile, pyrogen-free, and shall not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the product”.

Our PRF blood collection tubes single packs are claimed and documented as being safe, bio-compatible, sterile and pure by passing the Bacterial endotoxin, biocompatibility, package integrity, transportation and distribution tests before and after package integrity shelf life aging tests. Such tests are required for all autologous blood supplies including PRP and PRF in order to demonstrate safety.

Glass Tubes Law

3- FDA, CDC, OSHA and ISO-FDA guidelines: No glass tubes usage due to breakage and injury risk: No glass tubes shall be used unless protected with a puncture-resistant cover. This law is effective since 1990’s due to a doctor’s death after a glass tube breakage led to his death due to blood contamination with HIV.
4- OSHA law mandates replacement for new safer medical devices. Employers shall re-evaluate the Exposure Control Plan annually. OSHA requirements are set by statute, standards and regulations: 1) annual reviews and updates of ECPs reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens; and 2) employers document annually their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(A-B)].

Dental Boards Laws

5- State Dental Boards: All state boards follow the 1 to 4 federal regulations and will enforce the laws with licenses probation and suspension after 3 violation cases. Plus dentists can be liable if using supplies that do not comply with the regulations. Watch the PRF contamination video
6- Biocompatibility tests: Doctors can check FDA CFR 21 regulations for PRF medical devices to confirm compliance. PRF blood tubes and instruments have direct or indirect contact with the patient, have to be sterile-packed for single-patient use and shall not contain any additives that affect blood purity to pass the required Biocompatibility and sterility tests.

1- cytotoxicity;
2 – sensitization
3 – irritation/intracutaneous reactivity
4 – acute systemic toxicity
5 – hemocompatibility
6 – material-mediated pyrogenicity
Biocompatibility tests for Tubes and Instruments

The PRF-BRGF system complies with all test regulations for safety and blood purity including Bacterial Endotoxin tests.

prf-plain-tubes,prf-sterility,prf-purity
prf-plain-tubes,prf-sterility,prf-purity
Dual Tubes – Plain Glass tubes with Puncture resistant tube protection

Critical Anatomy sites

PRF & BONE USE

BONY DEFECTS – MAXILLARY SINUS

Invasive Surgery in close relationship to 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).

Compliance with PRF regulations is mandatory
for patients and employees safety to avoid PRF contamination risks

PRF Brgf System
PRF Brgf System

There are a variety of circumstances which can lead to the use of dirty surgical instruments or non sterile supplies for surgery. Healthcare providers have a duty to maintain policies and procedures which will ensure patient safety, including proper sterilization procedures and supplies. Some doctors and healthcare centers staff try to cut corners by reusing instruments intended for one-time use. In some cases a breakdown in procedure or simple human error can be the cause.
Even when adequate policies and procedures are in place and followed properly, equipment failure can be the culprit. Liability risks due to negligence cases include:

  • Inadequate policies and procedures
  • Failure to follow procedures
  • Failed sterilization equipment or using non sterile or contaminated devices for surgery
  • Reusing one time use instruments or supplies
  • Intentional misconduct
  • Failure to properly count instruments after surgery
  • Accidentally or intentionally using instruments which were used for a previous surgery
  • Manipulation of blood, surgical opened supplies and PRF with non sterile gloves or technique

Patients or employees injury due to non compliance devices use is a risk of liability to doctors. Most patients know that single use package for supplies is the new trend even for food and snacks after covid. The use of blood collection tubes and needles that are not single patient use sterile package is a non compliance to the regulations and could make the doctor liable due to failure to follow surgical standards and regulations including PRF Laws. Dentist should consult their professional liability insurance support attorneys for more information on malpractice cases and risks.