European Expert Condemns the Re-use of Sterilization Packaging
SteriView interview on sterilization packaging with Tim Galekop
Tim Galekop, who is employed by
Ahlstrom FiberComposites as a Director of Global Business Development, Medical Fabrics responsible for Europe, Global Technical Support and Regulatory affairs recently visited South Africa to present a paper at the SATS Congress in Cape Town. He also did a series of joint presentations with René Vis on sterilization matters at the major centres in South Africa. Rene is the Sterilization Quality manager for Sterile Medical Devices at the VU University Medical Centre in Amsterdam, the Netherlands and his visit was sponsored by Ahlstrom FiberComposites and Safmed. SteriView interviewed Tim while he was in South Africa and asked him the following questions:
You have been a member of the Dutch Norm Standards Group from the day of its foundation and serve as an expert to the EN Standards Committees for Packaging Materials, Drapes and Gowns. Why are you so involved with standards and why are they important to hospitals?
TIM Individual technical experts are appointed by the CEN parent body or by National members, to serve in a personal capacity.
The Working groups may also include experts from organizations, which have only observer status in the parent body.
To answer the second part of your question, it really started years ago. The Netherlands was the first country to publish a law regulating medical devices in 1983. This occurred, of course, after something terrible happened, and was certainly a case of "locking the stable door after the horse had bolted". The Dutch National Institute of Public Health and Environment (RIVM) started work on the Dutch norms for sterilization in 1980's. The Dutch Guidelines "Richlijnen Steriliseren Steriliteit" were established as a result of the devotion of Jack van Asten, who worked for the RIVM for 17 years. Jack sadly passed away suddenly on February 24, 2002. At the same time, a group of experts wanted to improve the quality and image of the sterilization departments in the Netherlands and the British and the Germans had published some standards dealing with packaging materials.
The reason why I got involved was mainly due to the fact that the management of the company I was working for in the Netherlands at that time; saw the importance of having standards.
The first department they will investigate, if there is an infection problem in the operating room is the CSSD "the heart of the hospital" if there is an infection problem in the operating room. A regular question that I am asked during my travels is: "Where is the published information and how can I convince to my management that we have to follow correct procedures?" The hospital has something to work with, if they can refer to standards. Let us not forget that standards are written for patient and staff safety.
Today, I am the last and only person left from the day of foundation of the Dutch Norm group, in other words "the last of the Mohicans"
Why do you think that linen should not be used as a sterile barrier material in hospitals?
TIM The CEN Working group TC 205 WG 14, of which I am an expert member,
(An expert is normally appointed by a National Body) has written a New European Standard -EN 13795: "Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment". Part-1 contains General requirements for manufacturers, processors and products. This European standard EN13795 is a serie of standards, which will consist of 3 parts and is likely to be completed within the next 2 years-This EN 13795 part 1standard has now been accepted, and conventional textile drapes and gowns will not meet the performance requirements relating to microbial penetration (wet/dry), linting, etc.
Prof. Dr. med. H-P. Werner the convenor of the CEN TC 205 WG14: has stated that in many studies it has been proved that under surgical conditions, conventional textile is not a bacterial barrier to microorganisms.
As mentioned "It is time for a fundamental change: Conventional drapes and gowns must be replaced by standardised medical devices with adequate barrier properties." It is the responsibility of a hospital to assure optimal protection of patients and users. What is the difference between draping a patient and wrapping a medical device? In several European countries we hardly find any textile being used for wrapping purposes any more.
The purpose of single-use packaging materials, drapes and gowns is to prevent the migration of microorganisms and to reduce infection. I am not stating that all postoperative or cross-infections will disappear, if you use single-use packaging materials, but it will help to reduce them. We should not forget that a chain is (only) as strong as the weakest link. Single use packaging systems offer maximum safety, sterility and efficiency. Single use packaging materials consist of non-wovens, papers and plastics and are used in various combinations.
Many hospitals re-use sterilization wrap to save money. What do you think of this practice?
TIM Strictly unacceptable, and a dangerous practice, not only for the above mentioned reasons but also because hospitals would no longer have insurance covering and open themselves up to litigation. Secondly, as a patient I would never accept the re-use of single use devices, or if it was not I, it could be somebody of my family who is in the operating room. What guarantee of quality can be given?
It should be remembered that every material, which is sterilised, is physically and chemically charged () and some of the typical properties will change during the sterilization process. Properties like tensile strength or burst can only be checked by analysing the product after use, to determine any changes in the product, which occurred during the sterilization process. The manufacturers of single-use sterile packaging systems test their products to demonstrate that they can withstand the claimed sterilization processes and still form a sterile barrier. They do not subject them to repeated cycle testing because they are not manufactured as re-usable products.
Some of the risks associated with re-use are:
Damage during transport or storage that is not detected.
Has the packaging been in contact with blood, virus particles, human tissue, or any other dirt?
What chemical reaction has the medical device had on the packaging material?
How stable is the medical device?
What kinds of sterilization processes are, and how reproducible are they?
There are no documented records of the number of times the packaging is re-used.
In part of EN 868-2 it is noted that:
Raw materials used for the manufacture of packaging materials may be virgin or reclaimed materials, provided the source, history and traceability of all raw materials, especially recycled materials, are known and controlled to ensure that the finished product will meet the requirements of this standard.
NOTE: With current commercial technologies it is unlikely that reclaimed material other than manufacturing waste will be sufficiently controlled to allow its safe use for medical device packaging. If a manufacturer does not consider it a safe practice to recycle packaging material out of its control, you can imagine the risks a hospital would take in this regard.
Another problem is that bacteria are becoming more resistant to antibiotics and we now have to contend with new viruses like SARS and illnesses like Creutzfeld Jacobs, Hepatitis. MRSA (Multi Resistant Staphylococcus Areas) and AIDS.
Hospitals owe it to their patients and staff to protect them as much as possible from such threats. Single Use Sterile Barrier Systems should only be sterilized once. In some European countries it is strictly forbidden to re-use single use products, for example France, due to the scandal with contaminated blood. The same applies in the UK as a result of the CJD problem.
You mentioned in your presentations during your South African visit that "Sterility is not Time related, but Event related". What do you mean by this?
TIM The loss of sterile package integrity is usually regarded as event related, rather than time related. What we really mean is that the sterility will probably not be lost over a period of time, e.g. 1 month or 6 months, when stored in optimal conditions. Loss of sterility is rather due to something that happens. Let me give you some examples.
A sterile medical device is dropped on the floor, which damages the Sterile Barrier System.
The Sterile Barrier System gets wet.
The peel pack pouch has been lifted several times when being forced back into a cupboard etc.
Shelf life is a complex matter and depends on many different factors, which have to be taken into consideration like;
How stable is the medical device, which has been packed?
How stable are the raw materials from which the packaging material is manufactured?
The chance of penetration of microorganisms during transport / storage.
How and by whom has it been packed?
The method of sterilization.
Method of transport.
How easy is it to open the packaging aseptically and how has it been opened in the theatre?
Can you tell us more of how and why the "Points" system to determine sterile shelf life was developed in the Netherlands?
TIM The German standard DIN 58953-9 ; 1998 advises on shelf life as follows:
Sterile Barrier System (Packaging)
Way of packing
Shelf life Storage on open shelves
Shelf life Storage in a closed cupboard
According to DIN EN 868-1
According to EN 868
In the Netherlands we have a different philosophy. We have always been convinced that the logistics of (disinfecting / cleaning, packaging, sterilization, transport and storage, vary in the majority of hospitals. It was Jack van Asten who wanted it to do it in a different way.
The Dutch guideline for shelf-Life should really be seen as a tool to determine an appropriate expiry date. See table 1. The individual values (points) should not be used to compare values or situations. The total amount of points calculated is based on the logistics of the hospital. I am not in the position to state which system is more scientific. The Dutch point system is certainly realistic.
Guidelines for Sterile Shelf life (Table 1)
Direct Wrapping Material
Sheet of wrapping material (paper)
Sheet of special wrapping material (non-woven)
Pouch (paper / plastic film)
Blister - Covered with paper - Covered with Tyvek
Container including inner packaging, a sheet of non-woven
2nd layer of packaging Not of influence when the second layer is seen as part of the sterile product
24 hours 1 week
400 Points: expiration 6 months 1: Paper sheet
2: Nonwoven wrapper (Tray wrap)
3: No extra's (eg. Dust cover)
4: Stored in open shelf
5: OR sterile store
120 points: expiration 2 months 1: Non-woven
3: No extra's
4: Stored in open cupboard
180 points: expiration 2 months 1: Pouch
3: No extra's
4: Stored in open cupboard
Why does a non-woven wrapping material score more points than paper wrapping material?
TIM Experts were of the opinion that non-woven wrap has certain superior properties to crêpe paper; it therefore got a higher score. Such properties include being virtually lint free, softness, memory free, conformability (forms well to it's contents), strength characteristics, superior fluid repellency for low-tension liquids, blood and water.
Why do you think that linen is still widely used as a sterile packaging material in South Africa?
TIM There could be several reasons for this:
Is it well known in South Africa that conventional textiles are not considered a bacterial barrier?
Are the real costs of using conventional textile fully understood?
Are all users aware of the single use Sterile Barrier Systems (Non-woven or Crêpe)?
Over the years, several costings have been done which proved that non-wovens or crepe are not more expensive than textiles. The introduction of single use products into hospitals in the early 1960s lead to a large reduction in post-operative infections. A significant factor in this improvement was the replacement of textiles by single use materials. Single use material costs are limited to the initial purchase price and disposal costs. Costs associated with re-usable products include their initial purchase price, storage, capital costs, component replacement costs, labour, energy, inspection, repairs (material and equipment), losses, rejection rates, chemicals, maintenance, water treatment, and eventually replacement costs. The cost of the various systems will vary from user to user and from application to application. The SBA (Sterile Barrier Association previously ESPA) is working very hard to develop a consumer friendly document to be able to make a fast cost comparison between single use and reusable packaging materials.
Many people will argue that single use products cause an environmental problem with waste disposal. How do you respond to this?
TIM The SBA Sterile Barrier Association (previous ESPA) has published a position paper covering environmental considerations. The total volume of waste produced currently stands at almost 2.5 billion metric tonnes a year. Only 5% of this waste comes from domestic sources. Waste from medical barrier systems represents a very small part of the total volume of waste produced.
Recovery is the general term for the process where raw materials with inherent recoverable value are used for material or energy recovery. Medical barrier systems waste can in principle be recovered but with obvious limitations. For patient and product health and safety reasons, used hospital medical materials, which could be contaminated, should not be used for production of primary medical barrier systems. Therefore, recycling of medical waste including medical barrier systems should preferably be directed into incineration with energy recovery or, when applicable, into lesser end-user applications.
Calculating the environmental burden of different types of materials is difficult. Whether comparing the impact of energy required to produce aluminium, or the fossil fuel to produce plastics, or a managed renewable resource, such as trees for paper, the analysis is not straightforward. Re-usable containers may appear to offer a more environmentally acceptable option. However, these systems require replacement of the inner wraps, filters, indicators, labels and closures.
In addition, containers and textiles need large quantities of water, detergents, disinfectants and energy on a daily basis. Single use materials, on the other hand, may be difficult to recycle because infectious materials have contaminated them, or they are made of composite materials. They may however be incinerated, using approved combustion techniques. The energy recovered from that process makes them an environmentally acceptable option. To provide a complete answer to these questions a life cycle assessment for each system is required. This is an extremely complex and costly study, which may be subject to interpretation.