With the regulatory recommendations to switch towards cleanable and reusable surgical instruments, several medical companies find themselves struggling to adapt. Most of the already established medical companies supply robust and stiff instruments, while others offer a few complex steering systems that must be discarded after a couple of uses. 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 identified 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 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 offer to comply with the FDA’s recommendations.
And Surge-on Medical is way ahead of them. Our innovative instruments were designed considering the new FDA and CE guidelines for cleanable and reusable medical devices.
Performance-wise, the instruments are known as freedimensional, meaning that they can steer in multiple degrees of freedom, to achieve more comfort of the surgeon and less tissue damage for the patient.
Structural-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 a 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 make Surge-on Medical’s instruments the ideal solution for the surgeons’ and regulatory needs:
- Cable-free: Allowing easy detachability of the instrument for an easy inspection and cleaning process. This also allows the instruments to be modular.
- Steerable: To easily reach surgical areas difficult to access, minimizing portal pressure in patients and improving the surgical workflow for the surgeons.
- Cleanable: For an economic cleaning through standard cleaning processes.
- Reusable: Minimizing recurrent costs for hospitals.
- Affordable: Steerable instruments replace multiple pre-bent instruments (in arthroscopy), lowering the purchasing and sterilization costs for hospitals.
- Green technology: Optimized designs 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’ll see more clearly our value proposition.
Are you ready to make the switch towards better, comfortable and efficient instruments?
(Updated on June 9th, 2020. Links to the funding page removed as funding successfully completed).