The US Food and Drug Administration (FDA), which takes care of “the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices,” has warned against these complex technologies, and in their evaluation of adverse event reports, the FDA identifies those design features that are raising concerns about cleanability, debris retention and its impact on patients. This is important since many countries use the FDA guidelines as a reference for their own policies on medical devices.

As recommended by the FDA, “manufacturers of reusable devices should consider device designs that facilitate easy and effective cleaning, as well as any necessary disinfection or sterilization by the users. Some complex device designs present particular challenges to cleaning and cleaning validation (e.g., shaft-within-lumen configurations, elevator channels, fine channels, seals and mated articulating surfaces). From the earliest stages of device design and engineering, manufacturers should consider alternative designs to facilitate effective reprocessing.”

Medtech companies are now looking for updates on their instruments or new technologies to replace their current offers in order to comply with the FDA’s recommendations, and Surge-on Medical is way ahead of them. Our innovative instruments were designed taking into account the new FDA and CE guidelines for cleanable and reusable medical devices.

Performance-wise, the instruments are known as free-dimensional, meaning they can steer in multiple degrees of freedom, in order to achieve more comfort for the surgeon and less tissue damage for the patient.
Structure-wise, Surge-on Medical’s instruments match the design envisioned by the FDA as the next generation of reusable medical devices. Our surgical instruments are the only ones that are simultaneously steerable, detachable and cleanable. Such portfolio of instruments comprises the areas of arthroscopy, laparoscopy and robotic surgery, with the potential to expand to all surgical areas.

The following unique combination of features makes Surge-on Medical’s instruments the ideal solution for surgical and regulatory needs:

  1. Cable-free: This allows for easy detachability of the instrument for an easy inspection and cleaning process. This also allows the instruments to be modular.
  2. Steerable: The instruments can easily reach difficult-to-access surgical areas, minimizing portal pressure on patients and improving the surgical workflow for surgeons.
  3. Cleanable: This allows for economical cleaning through standard cleaning processes.
  4. Reusable: This minimizes recurrent costs for hospitals.
  5. Affordable: Steerable instruments replace multiple pre-bent instruments (in arthroscopy), lowering the purchase and sterilization costs for hospitals.
  6. Green technology: The designs are optimized, with up to 80% fewer parts than traditional instruments.

And how does all this translate compared to our competitors? Well, have a look at the following comparison table and you will see more clearly our value proposition.

* For arthroscopy, there are no steerable alternatives on the market, while there are for laparoscopy.

The same principle applies to the Steerable Punch and Steerable Grasper as compared to the competition. The combination of all the above is unique and multi-patented by Surge-on Medical, making their technology very cost-effective (lower total price per surgery) and improving the usability of the instruments by surgeons.

Are you ready to make the switch to better, more comfortable and more efficient instruments? Invest in Surge-on Medical and be part of the improvement in healthcare!

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