The Sterile Barrier Association designed and validated new symbols for Sterile Barrier System configurations respective packaging systems for sterile medical devices for incorporation into ISO 15223-1.
Reasons for incorporating such symbols are to control specific risks with an aseptic display, comply with new legal provisions deriving from the EU-MDR 2017/745, and give additional user benefits.
Why do we need symbols for the description of SBS configurations?
• Sterile medical products are produced and processed by Medical Device Manufacturers (MDM’s) and in healthcare or reprocessing facilities.
• Sterile packaging systems restrict the ingress of microorganisms and provide an aseptic presentation.
• Sterile packaging systems formed of at least one sterile barrier system which keeps sterility and provides for aseptic presentation
• A Protective Packaging (PP) layer is usually added to physically preserve the SBS and its contents continuously at the point of use. Protective packaging can be outside and also inside the SBS.
• In many cases, there is no problem differentiating the two. A corrugated exterior dispenser box is not a sterile barrier system but may still be created to be used as protective packaging for transportation and storage. A single sterile barrier system, e.g., a pouch containing a sterile medical product, may be classified as a sterile barrier system.
• There are events where it is difficult to distinguish between a validated sterile barrier system and protective packaging that seems like a sterile barrier system. In these cases, risks could occur during the aseptic presentation: chances of contaminating the device and the sterile field and sterile gowns of operating room personnel.
Symbols help to recognize and distinguish between SBS and PP to mitigate that risk:
The new symbols are made of ovals, which are created either from:
– a solid line which symbolizes a Sterile Barrier System layer (maintaining sterility) or
– a dashed line, which indicates a Protective Packaging layer that is not a validated microbial barrier.
The symbols shall be marked on the label that identifies the medical device, adjacent to or in combination with the symbol ‘sterile.’
A typical packaging system form for sterile medical products could be made from a header bag, including sterile products are wrapped in protective packaging. The protective packaging does not give validated barrier properties but is used to produce an aseptic presentation tool.
In the diagram shown below:
– The outside solid line oval denotes the header bag, which is the Sterile Barrier System.
– The dashed line oval means that the medical product is wrapped in a protective packaging layer for aseptic performance.
– The protective packaging layer does not give validated barrier features.
– Operating room staff can immediately identify this particular packaging configuration, meaning they should place only the inner pack on the sterile field for aseptic presentation.
Which layers of packaging should be labeled?
The MDR needs the packaging which keeps the sterile condition of a device (‘sterile packaging’) to have evidence permitting the sterile packaging to be recognized as such. The MDR does not specify which layers of the packaging must be labeled.
ISO 11607-1: 2019 needs in subclause 6.1.8: “If the packaging system to be opened at the point of the application consists of more than one packaging layer, the sterile barrier system(s) shall indicate to be recognized as such.”
According to ISO 11607, there is no necessity to label anything other than the SBS. However, the MDR also needs annex 1 – GSPR 11.1. The design enables easy and safe handling and inhibits microbial contamination from eliminating, or decreasing as far as possible, the risk of infection to the patient.
The decisiveness to label protective packaging should be an issue of the risk evaluation and packaging system design method to do good usability for aseptic presentation. If protective packaging seems like an SBS, then the validated symbols should control the chance of unintentional contamination of the sterile field. In the state of paper board protective packaging, the risk is moderate that healthcare professionals consider this an SBS so that no labeling would be needed. Depending on the user conditions and the intended use, the manufacturer can determine the need to label the protective packaging if it is considered useful for healthcare professionals.
The objective of the usability evaluation for aseptic presentation, a new provision of ISO 11607-1: 2019, is to show evidence that the design including the respective labels provides for easy and safe handling.