Healthcare Hygiene magazine December 2019 | Page 29

number of life-saving and life-enhancing devices, primarily
those made of plastics or containing electronics, that cannot
tolerate exposure to the extreme temperatures, radiation and
moisture present in other sterilization methods. The effect of
steam and radiation on anti-microbial coatings on single-use
plastic devices makes them an unacceptable alternative.
Material integrity and degradation and damage to sensitive,
sophisticated electronic devices and their components are
also major concerns. Given the sensitive nature of the devices
and the sterilization involved, the entire process is regulated
by the FDA -- where the use of EtO has been validated as
a vital sterilization process. As a low-temperature sterilizer,
ethylene oxide gas won’t damage the types of medical
devices discussed. Ethylene oxide also is used to sterilize
other healthcare products such as bandages and ointments,
reducing potential damage to the product that may occur
from other means of sterilization.”
Rouse O’Neill adds, “Our manufacturing partners conduct
exhaustive studies to validate that the required sterility
assurance levels are achieved by the process and to confirm
that exposure to the sterilization process does not adversely
affect the device’s performance, safety or effectiveness.
HIDA is profoundly concerned about a host of unintended
consequences – such as product shortages and the inability to
sterilize critical healthcare products. These would likely arise
for the healthcare supply chain and the patients they serve
as a result of any swift change in policy regarding the use
of currently approved sterilization techniques. Most devices
sterilized with EtO have no acceptable alternative, putting
the supply chain at significant risk without this vital mode
of sterilization. Banning or heavily restricting the use of EtO
would require the identification and validation of an alternative
method, which currently does not exist. Additionally, it may
require the redesign of many medical devices, and many
products would require major changes to product design,
material selection, manufacture and distribution. The redesign
process could take several years and require lengthy regulatory
approval. The direct impact of any elimination or severe
restriction would potentially threaten the entire health care
system, as low product inventories and severe backorders of
sterile single-use devices could result, putting patients at risk.”
In addition to shortage-mitigation efforts, the FDA has
addressed the broader need for innovation and improvements
to medical device sterilization techniques by announcing
two new-innovation challenges to encourage ideas from
stakeholders, academics, industry and others about novel
solutions for improving sterilization processes, including
alternatives to using EtO.
It is important to note that the Advisory Committee
meeting convened by the FDA focused on industrial sterilizers
and industrial sterilization processes, not hospital sterilizers,
including those using EtO. However, during the hearings it
was proposed that hospitals consider taking on a share of the
industrial sterilization effort. Experts from the hospital sterile
processing arena asserted the already-considerable burden of
existing in-house medical device disinfection and sterilization
services that sterile processing departments provide.
Susan Klacik, a clinical educator with the International As-
sociation Of Healthcare Central Service Materiel Management
(IAHCSMM), pointed out the significant differences between
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industrial sterilization, in that pre-conditions loads for days in
environmentally controlled rooms, while healthcare facilities
do not. Other differences exist between sterilization cycles,
loading patterns and aeration. Additionally, manufacturers
sterilize items using a standard load configuration and in-
dustrial loads are scheduled, and healthcare facilities require
a manufacturer’s Iinstructions for use (IFUs) to process items.
Klacik also pointed out at the FDA hearings that for
hospitals to even consider such an undertaking, additional
space would be needed for the sterilizers, for preparation,
inventory holding, and load quarantine – a luxury many
healthcare facilities do not have or can afford.
Additionally, Klacik confirmed that many older facilities
would be unable to accommodate this additional needed
space and transformations. As well, the healthcare EtO
infrastructure needs – including dedicated exhaust, monitoring
and documentation of ventilation rates, vent system alarms,
a dedicated, separate room, environmental monitoring, and
engineering controls to reduce emissions, per ANSI/AAMI
ST41:2008 – could be problematic for healthcare institutions.
“We simply don’t have the space; the logistics in the
hospital are very difficult; we don’t have the personnel (to
perform additional EtO sterilization).”
At the November hearings, Klacik explained that EtO is
effective but not available in most healthcare facilities and
pointed out that EtO use is burdensome in parts of the country,
in that some states require abatement. She added that the
total sterilization cycle time is 15.5 hour or greater, making
EtO a challenging option. Furthermore, implementation of
EtO can be costly for healthcare institutions, including the cost
of sterilizer and supporting infrastructure expenses.
Klacik reviewed for hearing attendees the solutions for
the present-day challenges, including:
• Disposable scopes
• Disposable end caps/tips
• Include the clearly defined processing time in
IFU/marketing
• Mandate that adequate processing time be allotted
for sterile processing personnel
• Increase use of quality-control monitoring tools
(inspection, cleaning verification)
• Addition of new types of low-temperature modalities
specifying the exact scope model for the specific
sterilization cycle
• If sterilization is mandated, time will be needed for
implementation
• Routine scheduled-service inspections
Regarding new innovations, Klacik recommended:
• Development of new products less complex to process
• Development of scopes that can be disassembled
• Use materials that can be thoroughly cleaned
• Use materials and designs that can undergo steam
sterilization
• Use materials that can readily identify debris and defects
• Provide IFU that are less complex and comprehensible
• Provide education and training on new products,
especially new technology
• Recommend sterilization for duodenoscopes
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