Medical Device Packaging : End
Medical device packaging must be
simple enough for a child to open. Devices should be easy to remove from their
packages. Both inner and outer packaging could be sturdier. Color coding and
consistent expiration date formats among different products would be beneficial.
End users of devices should be consulted in the development of the device
package. Packages should create less waste and/or be recyclable. These
"suggestions" were among the most dominant responses from operating room (OR)
nurses responding to a recent Institute of Packaging Professionals' Medical
Device Packaging Technical Committee /Assn. of periOperative Registered Nurses (AORN)
Custom Research Survey.
"The purpose of the survey was to
gain a better understanding of what nurses go through, to get feedback, and to
make packaging better and easier for end users," said Neid. More than 200 people
responded to the survey, with a high percentage of them aged 51 or more, with
21+ years of experience.
Nearly 60% of respondents
identified themselves as Registered Nurses, 37% as having a Bachelor of Science
in Nursing, and about 2% as Licensed Practical Nurses. About 90% of the survey
respondents indicated that they work in hospitals. The remaining 10% work in
outpatient centers. With more outpatient procedures being done, this was seen as
an area of growth for medical treatment and personnel. Three of four respondents
indicated they worked in urban environments.
One of the survey's findings was that nurses are not always clear on terms used
frequently in packaging, indicating a need for education and clarification from
the packaging community.
Asked what form of packaging OR
nurses prefer, 60% of respondents selected formed rigid trays with lids, while
19% said flexible pouches, 14% indicated header bags (clear film bags with a
white Tyvek opening strip on one end), while 6% said formed flexible packaging
with lids (syringe type).
Another question asked
respondents to rank eight different medical device package considerations on a
scale of one to eight, with one being the most important. For those responding
with a one (most important), here is respondents listed the package
1. Easily read text/font labeling
2. Speed of opening package
3. Manufacturer's instructions for use provided via Web
4. Manufacturer's instructions for use in every package
5. Smallest possible package
6. Color-coded labeling
7. Consistent package sizes
8. Least amount of packaging waste
Among the other survey
findings were the following:
Double sterile barrier pouches (a
tray within a tray or a pouch within a pouch) were preferred nine to one
compared with single sterile barrier packs for long-term implantable devices.
Neid mentioned that such added barrier characteristics also add to the package's
expense. "During a procedure, a single sterile barrier package is acceptable as
long as it maintains device sterility," she said.
For medical device products where
the package size or style is selected during a surgical procedure, 84% preferred
a double barrier package, with 16% choosing a single-barrier pack.
Double pouches and double trays
were the most preferred sterile package for sterile medical products/implants.
"Dumping" or "flipping" a product
from its package onto the sterile field was seen as an acceptable technique or
practice by 57% of respondents.
Among the recurring packaging
issues expressed by respondents: Trays with snaps become more difficult to open
as they age. Header bags are hard to open. Chevron-style pouches are not
understood by some nurses. Ease of opening needs to be focused on even more.
The most likely reasons to
question the sterility of a product and/or package, were holes,
dirt/hair/foreign materials, dents, fold/crease marks, and scuff/scrape marks.
Sterility indicators and
expiration dates were ranked as very important in labeling medical devices.
In responding to how packaging
material is disposed of at their facility, about four of five respondents said
it went into the trash, while only 5% said it was red bag waste, which was seen
as a surprisingly low figure. About 12% said that used packaging was separated
or stored for recycling.
Survey respondents offered the
following packaging suggestions:
add slip grips on the bottom of
trays, provide a color change on the seal upon opening the package to indicate a
breach, and "to stop using cheap material on the outer packaging. Most of the
products arriving on the dock today are falling apart before they begin to reach
the end user."