Single-use
medical device reprocessing is the concept of sterilizing,
repackaging, testing, and manufacturing a used product. There is no
clear definition for the term single-use device and it is entirely
based upon the end user perception. Reprocessing of single-use device
is acceptable, if the device is properly sterilized while keeping its
physical and technological functionalities intact. Single-use medical
device reprocessing is done in two ways: third party processing and
in-hospital processing. Third party processing is considered to be a
better option, as regulatory authorities are able to impose strict
regulations for validation and quality assurance purpose.
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Single-use
medical device reprocessing is gaining popularity as it helps to
reduce hospital waste and allows for major cost savings. For
instance, Kaiser Permanente, which is an integrated delivery network
based in U.S., saved US$ 11 million on an annual basis by
reprocessing of single-use devices. Reprocessing enables the
hospitals to purchase the same device at a lower price in comparison
to the cost of original equipment, which eventually leads to cost
savings. Practice Green Health, an NGO providing environmental
solutions to the healthcare sector, quoted that single-use medical
device reprocessing prevented the entry of 10,000 tons of medical
waste during 1997–2007, by processing an estimated 50 million
devices. Single-use medical device reprocessing market is poised to
grow significantly, as hospitals realize potential cost savings and
its ability to reduce environmental hazards.
Cost
constraints for Hospitals and positive environmental impact will
drive growth of the single-use medical device reprocessing market
Hospitals
across the globe are facing cost pressures due to rise in price of
original medical equipment. In the U.S., Obamacare and its associated
guidelines might get repealed with the change in government. This
could lead to low third-party reimbursement for hospitals, in turn
influencing them to adopt cost saving initiatives such as single-use
medical device reprocessing. The biggest advantage is that hospitals
can reduce the cost associated with medical device to 50%, which
becomes a crucial factor when dealing with expensive devices such as
catheter and cardiac ablation devices. At present, 250 medical
devices are already being processed with 10% of medical devices
eligible for single-use medical device reprocessing. In terms of
environmental protection, hospitals are able to reduce the medical
waste to an estimated 50% by the use of single-use medical device
reprocessing. Medical waste treatment not only puts enormous cost
pressure on hospitals, but in countries such as U.S., China and
Japan, it has become a full-fledged industry.
North
America is estimated to be the growth pocket for single-use medical
device reprocessing market
U.S.
has the biggest healthcare system in the world with government
spending an estimated 30% of annual budget on healthcare. U.S. is
also home to large-sized hospitals such as Cleveland Clinic, Mount
Sinai Hospital, Beth Israel Deaconess Medical Centre and Johns
Hopkins Hospital. These hospitals are subject to meeting
sustainability goals and contain costs at the back of recession. For
instance, in 2007, 45% of U.S. hospitals entered into an agreement
with third-party processing companies and this number increased to
70% in 2008 due to severe economic crisis. Single-use medical device
reprocessing is subject to FDA and required third-party processing
companies to maintain quality standards in accordance with the
original equipment. FDA formulated stringent regulation to create
standardization and avoid infections related to the reuse of
single-use devices. FDA has set up a grievance mechanism for
reporting of adverse events related to use of single-use device which
in turn reinforces accountability.
Single-use
medical device reprocessing market is in nascent stage with few
players dominating the market
The
key players in the single-use medical device reprocessing market are
Stryker Corporation, Medline ReNewal, Centurion Medical Products
Corporation, Midwest Reprocessing Center, SterilMed Inc., Vanguard AG
and Hygia Health Services Inc, among others. These players have
successfully demonstrated the impact of single-use medical device
reprocessing on cost savings and environmental protection. These
companies will benefit in a large manner as the regulatory scenario
becomes established in Europe and Asia Pacific.
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