6 Questions to Ask Before Buying a BFR System

  • Using a BFR system with automatic LOP measurement technology, that is supported by scientific, peer-reviewed, and published evidence, will ensure delivery of effective BFR therapy, leading to safe and predictable outcomes.
  • Using BFR systems with unsupported marketing claims may negatively affect BFR safety and effectiveness and will increase the risk of financial and legal liabilities for the therapist.
  • A BFR level based on a percentage of the individual patient’s limb occlusion pressure (LOP) enables those individual patients to receive safe and consistent BFR stimulus compared to other methods of setting the restriction pressure level [2].
  • Setting BFR pressure as a function of blood pressure, at a fixed pressure, or based on subjective pain-level, or tightness-level does not provide a consistent stimulus across patients because these methods neglect important factors that affect LOP, including limb circumference and cuff width [3]. Furthermore, these methods may result in insufficient pressure for BFR stimulus, or hazardously high pressure levels and pressure gradients that may result in harm to the patient [4, 5]
  • LOP can be measured manually by palpation or Doppler ultrasound. However, the accuracy of both manual methods is highly dependent on the operator skill, technique, and consistency, and thus can affect patient outcomes [6].
  • True LOP can be measured automatically using a special-purpose BFR tourniquet system in either of two ways: by using a distal photoplethysmographic probe or by using a special, surgical-grade dual-purpose cuff. While both methods have been shown to be clinically equivalent, automatic LOP measurement using a surgical-grade dual-purpose cuff is more convenient for most BFR settings since it does not require an additional sensor and sensor application step [7-9].
  • Example:
    • The PTS for BFR system from Delfi Medical Innovations Inc. can automatically measure a patient’s LOP using a surgical-grade dual-purpose cuff. The LOP measurement method is patented (US10646232) and has been shown in a study, published in a peer-reviewed journal, to be clinically equivalent to LOP measured using the Doppler ultrasound method by skilled operators [7]. Such a system can therefore be used to deliver safe and effective BR therapy with consistency and reliability, resulting in optimal, predictable patient outcomes.
  • [1] McEwen JA, Jeyasurya J, Owens J. Why is it crucial to use personalized occlusion pressures in blood flow restriction (BFR) rehabilitation?. CMBES Proceedings. 2017 May.
  • [2] Day, B. (2018) ‘Personalized Blood Flow Restriction Therapy: How, When and Where Can It Accelerate Rehabilitation After Surgery?’, Arthroscopy – Journal of Arthroscopic and Related Surgery, 34(8), pp. 2511–2513. doi: 10.1016/j.arthro.2018.06.022.
  • [3] Kerr J, McEwen JA. Personalizing Tourniquet Pressures–SBP-Based Estimation Methods are Unsafe, Unreliable, and Inconsistent. CMBES Proceedings. 2019 May 21;42.
  • [4] Masri, B. A. et al. (2020) ‘Tourniquet-induced nerve compression injuries are caused by high pressure levels and gradients – a review of the evidence to guide safe surgical, pre-hospital and blood flow restriction usage’, BMC Biomedical Engineering, 2(1), pp. 1–8. doi: 10.1186/s42490-020-00041-5.
  • [5] Graham, B. et al. (1992) ‘Perineural pressures under the pneumatic tourniquet in the upper extremity’, Journal of Hand Surgery, 17(3), pp. 262–266. doi: 10.1016/0266-7681(92)90111-E.
  • [6] McEwen, J. A. and Hughes, L. (2020) ‘Pressure Prescription for Blood Flow Restriction Exercise’, Medicine & Science in Sports & Exercise, 52(6), p. 1436. doi: 10.1249/MSS.0000000000002316.
  • [7] Masri BA, Day B, Younger AS, Jeyasurya J. Technique for Measuring Limb Occlusion Pressure that Facilitates Personalized Tourniquet Systems: A Randomized Trial. Journal of Medical and Biological Engineering. 2016 Oct 1;36(5):644-50.
  • [8] McEwen JA, Inkpen K, Younger A. Thigh tourniquet safety. Surgical Technologist. 2002;34(7):8-19.
  • [9] Hughes, L. and McEwen, J. A. (2021) ‘Investigation of clinically acceptable agreement between two methods of automatic measurement of limb occlusion pressure: a randomised trial’, BMC Biomedical Engineering, In press.
  • Purchasing a BFR system that unlawfully makes use of a patented invention will create the risk of financial and legal liabilities, and may require that usage of such a system stops.
  • For protection, make sure the manufacturer has legal rights to any patents covering the technology in its BFR system.
  • A patent application is not a patent! Many patent applications never result in a patent.  A patent is only granted (issued) by the Patent Office after it has gone through a thorough examination process and determined to be novel, useful, and non-obvious.
  • Example:
    • The Mad-Up Pro device from Mad-Up does not have patents on any technology to automatically measure LOP. Applicants Delis Ahou, assignee Mad-Up, has filed a French patent application FR3084594 on August 6, 2018. However, it has not been determined by the Patent Office to be novel, useful, and non-obvious. Furthermore, it likely infringes on an existing granted patent with an earlier filing date (US10646232 – filing date of July 25, 2014).
  • A published review of reported side effects and safety considerations concluded that BFR therapy should be used with surgical-grade tourniquet equipment, with the therapy prescribed by a trained practitioner who uses clinical judgement, with knowledge of the appropriate protocols and possible contraindications, and who maintains personalized restrictive pressures [1,2].
  • Example:
    • Johnny Owens, of Owens Recovery Science (ORS), is a leader in BFR with extensive publications in peer-reviewed literature. He has been applying personalized blood flow restriction Training clinically since 2012 with his work featured on 60 Minutes, Time magazine, NPR, Discovery Channel, and ESPN. ORS provides education and certification in personalized blood flow restriction rehabilitation, and only recommends the PTS for BFR system manufactured by Delfi Medical Innovations Inc.
    • Delfi Medical Innovations Inc. has manufactured surgical-grade tourniquet equipment for over 20 years and continues to manufacture tourniquet cuffs and instruments for use in surgery as well as BFR. To date, Delfi’s surgical products have been used worldwide in hundreds of thousands of surgical procedures.
    • The Delfi PTS for BFR system was developed and designed for BFR therapy while meeting the same high quality and standards required for medical devices for use in surgery. The Delfi PTS for BFR system is the only surgical-grade BFR system available in the market and ensures safe and effective BFR therapies.
    • Both ORS and Delfi Medical Innovations Inc. have proven track records for safety and repeatable outcomes as evidenced through peer-reviewed literature, and multitude of organizations using the Delfi PTS for BFR system, including the US Department of Defense, New England Patriots, New York Yankees, UC Berkeley, and Los Angeles Lakers. The Delfi PTS for BFR is the only BFR device on professional workers compensation in the NFL, NBA, MLB, NHL, and MLS, and is used extensively across the league for player injuries.
  • [1] Day B. Personalized blood flow restriction therapy: how, when and where can it accelerate rehabilitation after surgery?. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2018 Aug 1;34(8):2511-3.
  • [2] Brandner CR, May AK, Clarkson MJ, Warmington SA. Reported side-effects and safety considerations for the use of blood flow restriction during exercise in practice and research. Techniques in Orthopaedics. 2018 Jun 1;33(2):114-21.
  • For optimal safety and effectiveness, prescribed restriction pressure should be applied to the patient throughout the entirety of the BFR therapy.
  • Without reliable, fast, and automatic pressure regulation, undesired cuff pressure variations due to limb movements during BFR therapy can result in the delivery of substantially high and occlusive pressures, or substantially low and ineffective restrictive pressures, resulting in unsafe and ineffective BFR therapy [1,2].
  • Example:
    • The B Strong Training System from B Strong uses a manual pressure gauge for pressure reading. Manual pressure gauges can become inaccurate over time, when dropped, or mishandled, without any visual indication that it is out of calibration. Furthermore, the B Strong Training System does not regulate cuff pressure to the prescribed restriction pressure. The cuff may apply insufficient pressure or excessively high pressure to the patient, resulting in a decrease in safety and effectiveness of the BFR therapy.
  • [1] Brandner CR, May AK, Clarkson MJ, Warmington SA. Reported side-effects and safety considerations for the use of blood flow restriction during exercise in practice and research. Techniques in Orthopaedics. 2018 Jun 1;33(2):114-21.
  • [2] Hughes L, Rosenblatt B, Gissane C, Paton B, Patterson SD. Interface pressure, perceptual, and mean arterial pressure responses to different blood flow restriction systems. Scandinavian journal of medicine & science in sports. 2018 Jul;28(7):1757-65.
  • Using a BFR system from a manufacturer without Quality Management System (QMS) registration and designing, manufacturing, and servicing under the QMS:
    • increases the risk of the product not meeting its specifications and claims;
    • increases the risk of decreased safety and effectiveness of the BFR therapy; and
    • increases the risk of financial and legal liabilities for purchasers and users.
  • Using a BFR system without a certification to a recognized international standard for electrical devices:
    • increases the risk of harm to the operator and/or patient; and
    • increases the risk of financial and legal liabilities for purchasers and users.
2021-05-20T13:36:18-07:00