Medical Packaging Conference "Sterile Packaging's important stake in patient safety“ Helsinki, Finland on the 23rd and 24th of April.

Challenges of SBS in hospitalsKaisa Hirvonen RN, MSc

01.05.20232

UseTransportCleaning and desinfectionInspectionPackingSterilizationSterile storage

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 This technical report provides guidelines for

evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems.

It also provides guidance on validation requirements for forming, sealing and assembly processes.

Practices varies but the challenges seems to be quite similar How to choose best barrier systems to many

kinds of different items? Varies from small microscopic instruments to

large instrumentations.

What is the optimal amount of different sterile barrier systems?

Choice Consider sealable pouches

and reels; the continuous roll or

reel type that is sealed along both edges.

pre-cut to a specific size and sealed on three sides,

sterilization wraps; reusable containers

Sterilization method, size and shape of

items, demands for

endurance : transportation, storage,

economic efficiency.

Packaging should be suitable for sterilizing the goods it contains.

All packaging should be validated in combination with the actual load and the sterilization process used.

The size of the pouch and the strength of the packaging materials should be based on the medical device which is going to be packaged.

Pouch should be filled up to a maximum of ¾ of space.

Many small items in the sterile barrier system may cause the items to move around, rupture the seal and penetrate the package materials.

Autoclaving is a hard process Thin or fragile

materials can be damaged during handling, transport, and distribution

Items either too large for a package or with sharp edges will put extra pressure on the seals and the materials.

This may cause rupture.

Wraps The grade of the

sterilization wrap should be chosen according to the size, shape and weight of the medical devices.

Wrapping technique

When choosing sheets of sterilization wrap the wrapper should be large enough to cover

the medical device, not so big that it has

to be wrapped several times around the medical device.

It is good to have many SBS options but the more you choose, the more space you need.

Challenge: Where to storage packing materials before use?

Many CSSD’s are small and it is very difficult to store materials in proper way. shelter from UV- light

and dust, temperature 18-22 C, humidity 40- 60%.

Packaging workstation Packaging is a job,

which requires careful attention.

Instruments, trays, and packaging materials need to be handled carefully.

Packaging workstation should be designed in such a way that the work can be done efficiently and that physical problems of the workers are prevented.

Control of the transport A transport package

is used for external transporting of sterile goods in their primary and secondary packaging.

Usually it is a strong cardboard box, cradle, closed trolley or other type of container.

Challenges: Exposure of the packaging

systems to the uncontrolled environment may increase the risk of contamination of the package.

Increasing amount of handling,

shaking of trolleys, how to control automation

and decontamination of

transport packages.

The more the sterile barrier system is handled the greater is probability that there occurs cracks, lid deformation, gasket damage, tears, holes or material separation.

Loss of sterile barrier system integrity is regarded as event related rather than time related

It is dependent on the quality of the sterile

barrier materials, possible interaction

between the medical device,

selected sterile barrier system,

storage conditions and

amount of handling.

Appropriate storage environment preventing any

damage, maintaining

temperature and humidity stability,

limit exposure to dust and sunlight,

keep protective packaging in place,

minimizing handling, physical separation

of clean and contaminated items.

Challenges: Lack of space!

Before any packaging system is used in a facility for the first time, its performance should be tested and be evaluated through all the intended processes of sterilization, handling, distribution and storage, up to the point of use.

You have to make sure that the packaging material that you choose to use fits every step of the process.

Hospital made or industry made – challenges are same when it comes to handling packaging. Hospital made is on CSSD responsibility, Industry made is on the logistic

departments responsibility.