Packaging for surgical instruments is to retain sterilization for prolonged periods of time.
Photo credit: Amac Technologies
The packaging is defined as the element that contains the material to be sterilized and has the properties to maintain it in this way; the quality and type of packaging are highly dependent on the preservation of the sterile material and its durability.
The objectives of the packaging are to retain sterilization for prolonged periods of time, allow the penetration and diffusion of the sterilizing agent, constitute an effective barrier against microorganisms and facilitate and allow the handling of its contents in an aseptic manner. It should also allow the transport of the sterile material without risk of contamination.
The packaging should be light.
It should be friendly for the personnel that use and prepare it.
It should be permeable so that it allows the sterilization process in all its phases.
It should have adequate porosity; the pore size of the material should not exceed 0.5 microns. The smaller the pore size, the greater the assurance of not contaminating the contents.
Ideally, it should be airtight, so as to prevent the passage of microorganisms.
It should be resistant to high pressures, air and product handling, without damage or rupture.
It must also be resistant to the passage of moisture and microorganisms. This is very important nowadays since our environment is very polluted.
In turn, it must be non-toxic and free of substances that harm the patient or the person handling it.
It must also be memory-free, which means that when it is folded it should not produce marks that could alter its surface.
There are medical-grade soft packaging and non-medical grade soft packaging; however, most of the personnel working with these materials are unaware of this classification.
Crepe paper is a non-woven fibre, compatible with autoclave, steam and ethylene oxide, possessing properties of flexibility, resistance and moldability, being also water repellent. It has no memory and becomes porous during sterilization. It is generally used to wrap packages of larger volume, replacing cloth. Its characteristics were defined in British standards.
Cellulose paper, or cellulose plus plastic, which is the mixed paper, is the most used in hospitals and private clinics in Chile. It is a combination of medical-grade paper and transparent polymer, compatible with steam autoclave, ethylene oxide and formaldehyde vapour and resistant to tension, explosion and cracking. It is heat-sealed and has built-in chemical indicators. They come with sleeves adaptable to materials of different sizes.
Then there is polypropylene, a non-woven paper compatible with autoclave, ethylene oxide and hydrogen peroxide. It is moldable, non-toxic and water repellent. There is also a synthetic polymer, typer Müller, which is also compatible with ethylene oxide and hydrogen peroxide, moldable, non-toxic and water repellent.
A material that is widely used in our environment is the textile fabric, canvas, which is used to assemble the packages of clothes that go to the surgery itself. This material, which is compatible with steam autoclaves, must have a minimum of 140 threads per square inch. It is generally recommended to be used as a double layer or second wrap. It should be washed between each use, but care must be taken, because with continuous washing the weft is lost, leaving openings through which particles could penetrate and contaminate the package.
The person who assembles a package of clothes should always check very well that the fabric is not torn or torn, in which case it should be darned, but put adhesive patches. All this, of course, is not water repellent.
Another widely used wrapping is kraft paper, a white paper, with controlled porosity. Its manufacture is standardized in terms of additives; it is water repellent and very resistant.
Finally, there is the classic plain paper, widely used by our health services. It is compatible with autoclaving; it is not considered an efficient barrier; it has memory and is not waterproof, and also generates lint. Its porosity is not standardized and it can be toxic in its composition. This material is recommended for wrapping smooth surfaces, such as trays and kidneys, but it is not recommended for wrapping surgical instruments, since they have a rough surface, and as this gives off lint, it stains the material and contaminates it.
Rigid packaging includes containers. Aluminum containers are easy to identify since they use coloured plates or grey-coloured lids, with which they can be easily identified. They have another sector where the control and seal are placed and have a filter system, which can be made of Teflon or paper.
There are non-perforated or closed containers, which do not have a filter and use dry heat. They are currently discontinued in our services.
Then there is the perforated container with a filter, which goes to steam autoclave and is resistant to pressures. Its characteristics are that it only operates with steam autoclave, the material is ionized aluminum, it has upper and lower perforations, according to the choice of each sterilization service and has paper filters, which must be changed every day, or Teflon filters, which have a duration of one thousand cycles.
The rigid packaging is airtight, light, given its material, water repellent, easy to identify and handle.
With regard to textile packaging, the ideal for the elaboration of the box with this material is to label it, close it and put its control; it is not appropriate to put the classic ties, and the weft must be well dense. It is not good to write on the clothing packages; it is better to put a ribbon for eventual identification.
The success of sterilization depends to a great extent on the choice of packaging. For example, it is optimal to keep surgical instruments in perforated containers, and delicate material or certain instruments in mixed cellulose paper.
The most secure packaging is airtight; soft packaging may be economical but over time rigid packaging is a better investment.
New and good sterilization is obtained through responsible and correct preparation by the user, an aspect that is undoubted of great importance.
The training and education of the personnel in this respect are relevant factors in this essential area in the ward; with all this, we will be able to provide a better service to the users, who are the patients.
In terms of hygiene and infection prophylaxis, sterile material should not be contaminated during transport, nor should there be any possibility of contaminated material endangering the environment or the staff.
With regard to handling, the handling of sterile material must be simple, fast and safe.
With regard to financial requirements, supply and removal must be economical.
In the past, sterile material was usually stored for the day in a few sterile containers, which consisted of perforated drums that had to be repeatedly opened and closed. With this procedure, the danger of recontamination of the sterile material was obvious.
In the 1970s, another method of preparation was introduced: the set-system, in which instruments, textiles and drapes were placed in the same set for each procedure. The instruments were defined for each set, and therefore this was also standardized. After the operations, the entire set could be removed and then prepared again, so that the next patient received a new set.
Originally, soft packaging, such as cotton cloths or paper in different combinations, was used as the material for wrapping the sets, but there was a disadvantage, as the soft packaging proved to be flimsy and easily moistened in the presence of condensed water, and the single containers were very expensive.
With the introduction of containers, the disadvantages of soft packaging were eliminated; hard packaging allowed for more stable and safer storage and transport and also ensured that the material was disposed of under sterile conditions, raising the level of hygiene.
Another advantage is that the textiles of the instruments are always kept dry, since aluminum has better drying properties than stainless steel or synthetic material.
Jensen Instrument Technologies is a long-established company distributing precision surgical instrumentation across Australia and New Zealand. Our company specialises in the supply of maintenance of precision mechanical, optical and power surgical instruments for surgical theatres. Learn more about us here.