The global Medical
Device Reprocessing market is foreseen to grow by 15.1%, from USD 1.99 Billion
in 2022 to USD 6.13 Billion in 2030. Increasing level of supply chain cost
savings in healthcare facilities, growing adoption of strategies for
sustainability and environmental safety, rising geriatric population is to
drive the market for the upcoming forecast period. However, Increasing risk of
hospital-acquired infections among patients, increasing number of medical
device surface alterations due to reprocessing remains one factor hindering the
market growth over the anticipated period.
What Is Medical Device
Medical device reprocessing is the process of cleaning,
disinfecting, and sterilizing medical devices that are intended for reuse. The
aim of this process is to ensure that the devices are safe for use in
subsequent Process Types, as well as to reduce costs and waste associated with
the purchase and disposal of single-use devices.
reprocessing process typically involves several steps, including cleaning and
decontamination, functional testing, disinfection or sterilization, and
repackaging for reuse. Reprocessed devices may include items such as surgical
instruments, endoscopes, and other medical equipment.
One of the main
benefits of medical device reprocessing is cost savings. Reprocessing can
reduce the need for single-use devices, which can be expensive and generate significant
amounts of medical waste. By reprocessing and reusing devices, healthcare
facilities can save money while still maintaining high levels of safety and
medical device reprocessing must be conducted with care and attention to detail.
Reprocessed devices must be thoroughly cleaned and disinfected to ensure that
they are safe for use in subsequent Process Types. In addition, the
reprocessing process must adhere to strict regulatory guidelines to ensure that
devices are properly labeled, tracked, and tested.
medical device reprocessing can also play a role in promoting sustainability
and reducing environmental impact. By reducing the amount of medical waste
generated by single-use devices, reprocessing can help healthcare facilities to
reduce their carbon footprint and contribute to more sustainable practices.
medical device reprocessing is an important process that can help healthcare
facilities to save money, promote sustainability, and maintain high levels of
safety and quality in medical Process Types. However, it is important that the
process is conducted with care and attention to detail, and that regulatory
guidelines are strictly followed to ensure that reprocessed devices are safe
and effective for use in subsequent Process Types.
Reprocessing Market Dynamics
dynamics of medical device reprocessing are driven by several factors. One of
the primary drivers is the increasing level of supply chain cost savings in
healthcare facilities. Reprocessing of medical devices and equipment has become
a popular strategy for cost reduction among hospitals, surgical centers, and
other healthcare facilities. This is because reprocessed medical devices are
significantly cheaper than new ones, with an average cost reduction of 30% to
50%, according to the Association of the Medical Devices Reprocessors (AMDR,
US). By adopting reprocessing strategies, healthcare facilities can save
millions of dollars annually. This allows them to invest in other improvements
such as hiring additional staff, upgrading technologies, and enhancing healthcare
quality, among others. Manufacturers are also recognizing the potential
competitive advantage of offering reprocessed devices and equipment.
are also several restraints to the growth of the medical device reprocessing
market. One of the major concerns is the increasing risk of hospital-acquired
infections (HAIs). HAIs are nosocomial infections that occur during a patient's
stay at hospitals and related facilities. Inadequate reprocessing of medical
devices contributes to a significant proportion of HAIs. According to research,
22% of all surgical site infections (SSIs), one of the most common types of
HAIs, are related to equipment reprocessing. Despite advances in device
reprocessing methods and the existence of reprocessing guidelines, the risk of
HAIs remains a concern.
in Medical Device Reprocessing Market
Regulatory Changes Encouraging Adoption of Medical Device Reprocessing
device reprocessing market is expected to witness significant growth opportunities
in several countries, including France, Japan, and the Middle East & Africa
due to changing dynamics. As per the AMDR, Japan has recently taken measures to
provide hospitals with access to commercially reprocessed single-use medical
devices. This move is considered a crucial development for the global
remanufacturing medical device industry, as Japan joins other countries in
adopting regulatory pathways for remanufactured single-use devices.
Consequently, the emergence of regulatory guidelines for reprocessing medical
devices in these countries presents lucrative opportunities for market players
to expand their geographical footprint and gain a larger market share in the
Medical Device Reprocessing Market
Regulatory Process Types for Reprocessed Medical Devices
medical devices must comply with all the standards applicable to a new medical
device. The guidelines for reprocessing medical devices do not differentiate
between single-use and multi-use medical devices and require the same high
standards for both. Therefore, the reprocessed device must meet the regulatory
standards for medical devices as stated in the FDA and EU regulations to
receive 510K approval or ISO/CE certifications for marketing in North America
and Europe. The stringent regulations for reprocessing medical devices impose
significant pressure on market players to ensure compliance, thereby posing a
significant challenge to the growth of the medical device reprocessing market.
forecast period, the reprocessed support and services segment is projected to
have the highest compound annual growth rate (CAGR) in the medical device
reprocessing market. This segment includes reprocessing support and services,
and it is expected to register the highest growth due to the increasing
adoption of third-party reprocessing services by healthcare facilities. These
services are utilized to reduce the in-house reprocessing costs, leading to
cost savings for the healthcare facilities.
In 2021, the
critical devices segment dominated the medical device reprocessing market. The
market is segmented into critical devices, semi-critical devices, and
non-critical devices based on the device type. The growth in the critical
devices segment can be attributed to the rising number of cardiac diseases
globally and the adoption of reprocessed catheters. Reprocessing critical
devices is becoming an increasingly popular means to reduce hospital and Process
Type costs, driving the market growth.
In 2021, the
cardiology segment held the largest share in the medical device reprocessing
market based on application. The market is segmented into cardiology,
gastroenterology, gynecology, arthroscopy and orthopedic surgery, general
surgery & anesthesia, and other applications (urology, non-invasive
surgeries, and patient monitoring). The increasing prevalence of cardiac
diseases is leading to higher demand for diagnostic and cardiac Process Types,
driving the growth of the cardiology segment. The adoption of reprocessed medical
devices is also increasing in this segment as a means to reduce the costs
associated with purchasing new devices for every Process Type.
market forecasts, the medical device reprocessing market in the Asia Pacific
region is expected to experience the highest Compound Annual Growth Rate (CAGR)
during the forecast period. Although North America currently holds the largest
share of the market in 2021, the Asia Pacific region is expected to grow
significantly due to various factors.
growing economy, increasing prevalence of chronic diseases, and the need to
reduce hospital costs are among the primary reasons for this growth. As
healthcare costs continue to rise, there is an increasing demand for
cost-effective medical device reprocessing solutions. This demand is
particularly high in developing countries in the Asia Pacific region.
For the purpose
of this report, the global Medical Device Reprocessing market segmented on the
basis of product type, device type, process type, application, end user, and region:
Product Type Outlook:
On the basis of
product type, the market is segmented into reprocessing support & services,
reprocessed medical devices.
Device Type Outlook:
On the basis of
device type, the market is segmented into critical devices, semi- critical
devices, non- critical devices.
Process Type Outlook:
On the basis of
process type, the market is segmented into automatic cleaning, disinfection,
manual cleaning, presoak.
Figure 1 Medical Device Reprocessing Market
By Process Type (Market Size And Forecast By Value - USD Million, 2022 & 2030)