Hospital Pharmacy - September 2017 - 556

556

Hospital Pharmacy 52(8)

Table 2. Contamination Levels for 5 Commercial Closed System Transfer Devices at 3 Different Steps During the Hazardous Drug
Handling Procedure.
Products

Condition

Total pixels

Onguard

Pharmacy
Nursing
IV set
Pharmacy
Nursing
IV set
Pharmacy
Nursing
IV set
Pharmacy
Nursing
IV set
Pharmacy
Nursing
IV set

1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800
1 228 800

PhaSeal

Safety Enclosed Vial
Adapter (SEVA)
Spiros/Genie

Texium

moderate effect on the HD contamination level. The exception was the BD PhaSeal CSTD, which was reported by the
technicians as the most difficult product to use of the 5 CSTD
systems.
The Allison Medical CSTD system, however, required an
additional step of using the SEVA sleeve to pick up the vial
and deposit it into the SEVA bag. Although the alcohol prep
was already accessible in the bag providing some labor savings, the additional step of placing the vial in the bag added
another manipulation when using the SEVA system, particularly when compared with the CareFusion Texium CSTD
and the ICU Medical Spiros/Genie CSTD. If increasing the
number of product manipulation steps was a primary factor
in HD cross-contamination, the act of picking up the vial
using the SEVA sleeve and SEVA bag should have increased
HD contamination rather than reduced it (Table 2). The
Allison Medical SEVA added minimal additional time when
compared with the other CSTDs. PhaSeal requires the use of
a proprietary lever, which aids in attaching the vial adapter
to the vial. Other products require about the same amount of
time as conventional vial adapters, as Spiros (ICU Medical)
is often used with a conventional vial adapter. SEVA,
depending on the user, added an additional 5 to 10 seconds
per use; most of that time is taken up when placing the SEVA
bag over the vial, sliding the vial into the bag, and sealing
the bag.
Also noted, Texium and Smartsite are used as components
in both the Allison Medical SEVA and the CareFusion CSTD
systems. Protocol for the SEVA system is identical to the
CareFusion CSTD system, except that the steps taken to prevent contamination are performed in the SEVA bag, which is
an important difference when comparing these two CSTD
systems. In Table 1, it is shown that multiple components
are used in each CSTD and that when the Texium and/or

Pixels indicating test medium
76 469
10 808
52 062
63 514
7816
20 714
0
0
0
51 227
10 443
24 939
66 393
7891
27 562

Percent indicating test medium
6.22
0.88
4.24
5.17
0.64
1.69
0.00
0.00
0.00
4.17
0.85
2.03
5.40
0.64
2.24

Smartsite are used with the SEVA, there is no contamination,
but when they are used alone, there is significant contamination. More importantly, use of the SEVA sleeve and isolation
bag significantly decreases the spread of HD contamination,
despite the additional steps required when using this system.
Furthermore, results demonstrate the act of providing a contamination barrier that fully encloses the HD contamination
source is effective in the prevention of HD contaminants.
The 4 CSTD devices exhibiting HD contamination spread
were designed to focus primarily on preventing the spread
of HD contamination at their connection sites. Note that
Equashield was not included in this study as it was relatively
new at the time and had little market share. Although it has
demonstrated a somewhat improved market position since
then, it still has exhibited the same deficiencies of the other
products tested in that HDs on the exterior of vials can still
be transferred via touch contamination.15 All products currently on the market have the same deficiency in that none of
them address HD contamination on vials. This suggests that
any product system tested would likely have the same or
similar results as found when compared with the Allison
Medical SEVA product.
Other studies, especially those reported on the PhaSeal
website,16 focus on comparing relative HD contamination on
the small surface areas of competitive product connection
site septas and release of vapors from vents (eg, B. Braun
Onguard Vial Adapter17). In contrast, HD vial contamination
focuses less on the comparatively large surface area on the
vial exterior where HD may transfer to gloves and other PPE
posing a previously unacknowledged risk to those who use
such products on a frequent basis. The PhaSeal is also not a
closed system in terms of providing an enclosure around a
vial, neglecting to prevent HD contamination as a result of
handling vials with HDs on the exterior of a vial. Despite use

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