The term “generic” in this context does not necessarily refer to the use of single use instruments in all types of surgery, but rather to a surgical specialty that primarily focuses on the contents of the abdomen. Each instrument used in general surgery is intended to serve a specific purpose. Some instruments were designed well over a century ago, but they are still in use today because they perform their duty so well. The majority are named after the surgeon who created them.
What Do Single Use Instruments Entail?
This page provides a quick overview of numerous regularly used pieces of equipment, but it is not a full list of Single Use Instruments. there are hundreds of tools for a variety of specialized uses.
Reclassification of MDR
Many of the devices discussed in this article would have previously been classified as Class I MDR. However, many medical devices have now been reclassified to a higher risk class under the EU 2017/745 Medical Device Regulation (MDR), with a new classification (Class Ir) being introduced for reusable surgical tools like the ones indicated above.
Class Ir medical device makers will need to update their data and documentation (including reprocessing instructions, which will be discussed later in this article), as well as designate a notified party to audit the device’s reusable aspect. As part of this, the notified body will evaluate evidence regularly to verify that all general safety and performance requirements are met before the product is put on the market. Beyond reprocessing, there’s a lot more to the process. See our IFU validation standards for Class Ir Medical Devices article for more information.
- In general surgery, there are five different types of instruments.
- Cutting devices are used to make incisions or remove tissue.
- Grasping instruments are used to hold or manipulate tissue.
- Hemostatic instruments are used to stop bleeding.
- Instruments that retract to expose underlying tissue or organs.
- Tissue unifying equipment is used to reassemble tissue.
Instruments in the aforementioned categories are typically composed of stainless steel (usually 400 grade because it is particularly resistant to wear, but 300 grade is also used), but depending on the environment and application, they may also be made of titanium or alloys containing titanium, chromium, vanadium, or molybdenum. These materials are commonly utilized because of their corrosion resistance and toughness.
The Importance of Validation for Reusable Surgical Equipment Reprocessing
Given the conditions in which single use instruments are used, it is critical that reusable equipment be safe to use. These devices are reprocessed to assure their safety: a complete decontamination procedure that includes cleaning, disinfection, and sterilizing. Cleaning is frequently mechanized, primarily through the use of washer disinfectors and ultrasonic cleaners, but some equipment requires manual cleaning. The goal of this procedure is to remove any remaining solutions or materials from the instrument. The goal of disinfection is to limit the number of live microorganisms that remain on the devices. This is usually accomplished by cleaning or rinsing the equipment with hot water or by employing chemical solutions. The final stage of the procedure is sterilization, which often involves the use of pressurized steam to kill any leftover microorganisms.
As stated at the outset of this article, the Medical Devices Regulation (MDR) 2017/745 requires manufacturers of processable medical single use instruments to provide instructions for the aforementioned steps (Instructions For Use, or IFU) and to demonstrate the effectiveness of their instructions by having their processes validated.
Allis Forceps is a grabbing tool:
Allis forceps have ratcheted jaws and are used to hold hefty tissue. Because they can be harmful, they are frequently utilized to capture tissue that needs to be removed.
Babcock Forceps is a gripping tool:
Babcock forceps have looping, curved jaws and are used to grip delicate tissue without injuring it.
Debakey Forceps is a gripping tool:
Dekabey forceps are typically quite big and non-ratcheting. They are utilized to manipulate tissue without causing any damage to it.
Dunhill Forceps is a hemostatic tool:
Dunhill forceps are small and ratcheted, with curved, textured jaws for a better grip. They are typically used to seal blood arteries.
Gillies Forceps is a gripping tool:
Gillies’s forceps have narrow, textured jaws for grabbing more delicate tissues in small surgical locations and are not ratcheted.
Lane Dissecting Forceps are a tool for grasping:
Lane dissecting forceps are normally textured with teeth at the tip and are not ratcheted. They are employed in the grasping of stiff tissues.
Lane Tissue Forceps are a tool for grasping:
Lane tissue forceps have looping, curved jaws, and an interlocking tooth to provide a better grasp on difficult or slippery tissue.
Langenbeck Retractors are retraction tools:
Langenbeck retractors have a right-angled end and are typically used to separate the edges of an incision, but they can also be used to hold back tissue and organs.
Littlewood Forceps are a tool for grasping:
Littlewood forceps, like Lane tissue forceps, are ratcheted and end in interlocking teeth to hold difficult or slippery tissue. Littlewood forceps, on the other hand, have thinner jaws with many interlocking teeth.
Mayo Scissors is a cutting tool:
The semi-blunt points of Mayo scissors are typically employed to cut thick tissue. They may be straight or curved.
McIndoe Scissors is a cutting tool:
McIndoe scissors are used to cut soft tissue and have long handles with curved blades. Needle Holders is a tissue-unifying device. Needle holders have ratcheted clamps that are used to keep suturing needles in place. Many needle holders feature a scissor-like form, while others resemble tweezers.
Norfolk and Norwich Retractors are retraction tools:
To assist keep deep wounds and incisions open, Norfolk and Norwich retractors are connected and end in a set of bent prongs. They “self-retain” due to a ratchet device in the handle.
Rampley Sponge Holders is a gripping tool:
Rampley sponge holders are long and ratcheted, having looping jaws for securely grabbing sponges and swabs, however, they can also retain tissue if necessary. Sawtell Forceps are hemostatic tools. Sawtell forceps have curved, rough jaws and are used to clamp blood arteries shut.
Spencer Wells Forceps are hemostatic tools:
Spencer Wells forceps have straight or curved jaws with ridged teeth and are used to clamp shut blood vessels.
Towel Clips is a grabbing tool:
Towel clips are ratcheted clamps that are used to hold drapes in place during surgery, but they can also be used to hold tissue if necessary. Jaws can be pointed or have a ball and socket joint.
Travers Retractors are retraction tools:
Travers retractors are similar in appearance to Norfolk and Norwich retractors but have shorter prongs. They are intended for use on shallower wounds and cuts.