Packaging for terminally sterilized medical devices, challenges of sterile barrier systems use and storage in hospitals.

1. Medical Packaging Conference "Sterile Packaging's important stake in
patient safety“ Helsinki, Finland on the 23rd and 24th of April.
Challenges of SBS in hospitals
Kaisa Hirvonen RN, MSc

2. 22.5.2015
2
Use
Transport
Cleaning
and
desinfection
Inspection
Packing
Sterilization
Sterile
storage

3. 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.

4. 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.

5. 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.

6. Packaging should be suitable for sterilizing
the goods it contains.

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

8.  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.

9.  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.

10. 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.

11. Wraps
 The grade of the
sterilization wrap
should be chosen
according to the size,
shape and weight of
the medical devices.

12. 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.

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

14.  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%.

15. Packaging workstation
 Packaging is a job,
which requires careful
attention.
 Instruments, trays, and
packaging materials
need to be handled
carefully.

16.  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.

19. 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.

20. 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.

21.  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.

22. 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.

23. 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.

24. Challenges: Lack of space!

25.  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.

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

27.  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.