March 26 2021

Disposable kits for surgery

For some years, disposable kits have been rapidly adopted by the market to reduce costs, eliminate the sterilization phase, improve patient safety, while reducing the risk of surgical site infection.

Research in this area has increased significantly especially in recent months, due to Covid-19. The demand for disposable kits for orthopedic surgery has increased exponentially, particularly in the US market.

The advantages of disposable kits for orthopedic surgery

Further advantages in using disposable kits are the great savings for hospitals and day hospital surgery centers. This is because the management costs of sterilization are saved and efficiency is increased, especially for those kinds of operations with a high number of daily interventions that can be planned without having to wait for the technical times for the reuse of instruments.

Another important benefit is the possibility of providing medical care, even in remote places where the fast sterilization of instruments is very difficult.

How disposable kits for orthopedic surgery are made?

 

These kits are able both to increase surgical efficiency, but above all to reduce the spread of infection, since the disposable instruments are prepackaged, sterilized and calibrated before the procedure.

 

 

Generally, disposable kits are designed in order to best optimize the components for a single use.

For the reason, if possible, many parts are made of plastic materials to reduce costs. These plastic parts are made of polymer. The materials can be various, including the most common ABS (medical), up to glass-filled polymers to improve resistance in the event of a more demanding task.

Thanks to injection molding it is possible to make lightweight, resistant and versatile components.

 

Injection molding

Injection molding machinery is required to produce components with plastic polymer.

The components of an instrument set, even if they are not implantable medical devices, require processing, controls and management that are very different from industrial products.

As we all know, in the last seventy years, plastic has entered our lives massively, replacing many other materials previously used.

In fact, there are a lot of companies specialized in plastic injection molding, but few have the know-how, technologies and environments for the production of medical components.

One of our ISO7 room machines

The main difference with industrial type productions is the positioning of the machinery in a controlled contamination environment. In such environments it is possible to manufacture any type of plastic medical device.

ISO5 room dedicated to packagin and linked to the press

 

Like any molding process, a mold must be made. The initial investment is however amply repaid, if the volumes are adequate, by the final cost of the piece.

Optimizing the design of disposable surgical kits for orthopedic surgeries

A careful design of the plastic parts is able to drastically reduce the components of the kit, taking advantage of the same component ina different way. For these reasons, the development of a kit requires a clear idea of the final use and, based on this, the right choices to minimize the components.

 

 

 

 

 

 

 

In the image you can see an example of this design for multiple uses.

The handle of the T-screwdriver becomes a handle for another screwdriver and, if necessary, also a measuring device.

This reduction must take into account that some parts will be used several times in the same surgical procedure so their mechanical strength must be well calculated. Minimal component sizing can be great for one use, but problematic for multiple uses.

In some cases, the convenience of the same part for a single operation is preferred to the possibility of interchangeability of the various components.

In this case, the overmoulding of the plastic material on the metal tool is another important advantage.

 

In the kit, in the image above, the choice of overmolding the screwdrivers (solid and cannulated) was the best choice for the type of use done by the customer.

Our engineers from the injection molding department have developed an important know-how on the choice of the most suitable materials for the various tools and also on their sizing that allows them to be optimally used throughout the operating phase.

As for the metal parts of the kit, there aren’t particular differences with the classic operator kits, both in terms of size and materials.

The economic advantage of disposable kits is linked only to an economy of scale that reduces the cost of the single piece.

 

Another important evaluation, in addition to the number of instruments required for a certain type of surgical technique, is their arrangement within the kit.

Only a careful analysis of the provision can lead to two advantages:

reduction of the space required for the storage of the kit

use of the various tools according to a pre-established logic which guarantees their easy removal from the container

 

 

How can we choose the most suitable material for the various components of the kit?

How can we choose the most suitable material for the various components of the kit?

Having defined the application parameters, designers can select special polymers appropriate to the healthcare environment, which meet regulatory requirements and end use requirements.

Single use medical devices are used for a single procedure. However, a couple of considerations are necessary: contact with the body and producibility.