Global Reprocessed Medical Device Market - 2021-2028

Global Reprocessed Medical Device Market - 2021-2028

Market Overview

The global reprocessed medical device market size was valued US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).

Cleaning, remanufacturing, disinfection, testing, packing and naming, and sterilization are all phases in the process of reprocessing a used medical device so that it is used again. It provides financial benefits to the medical care facility, such as purchasing disposable tools or devices during a single patient procedure.

Market Dynamics

Innovation in next-generation reusable medical devices are expected to drive market growth.

Various stakeholders work together to reduce the risk of exposure to improperly recycled medical equipment. It includes the FDA, health care facilities in charge of cleaning, sterilizing, or disinfecting the devices, and manufacturers in charge of giving proper reprocessing instructions that are both user-friendly and effective. For instance, these design features include Non-interchangeable connectors for critical connections(tubes used with endoscopes for direct patient connection that cannot be interchanged with tubing used for waste drainage), smooth surfaces, including smooth inner surfaces of the long, narrow interior channels (lumens), Clear identification of connecting accessories, such as drainage tubing and designs that address how fluid flows through the device, and areas of debris build-up within devices. Moreover, the FDA collaborates with standard-setting organizations like the Association for Advancement of Medical Instrumentation and ASTM International to produce a set of best practices. Manufacturers will be given instructions for designing devices that are adequately reprocessed, as well as effective test techniques and criteria for verifying reprocessing methods for reusable medical devices. These are some of the factors the market is expected to drive in the forecast period.

Challenges of Reprocessing Medical Equipments are expected to hamper the market growth.

Enforcing a reprocessing technique within a healthcare facility may develop challenges. Ensuring that the facility adheres to governing bodies' standards and norms, such as the Association for the Advancement of Medical Instrumentation (AAMI), is critical to ensure patient and staff safety and compliance. More significantly, it raises the risk of infection in patients (Healthcare-Associated Infection). For instance, the U.S. Food and Drug Administration (FDA) found that patients who underwent endoscopic retrograde cholangiopancreatography had a high rate of postoperative infections (ECRP). The FDA found that the infections were caused by bacteria that remained in the devices even after reprocessing. They found that design flaws and complex reprocessing procedures contributed to the high infection rates. Therefore, the market is expected to get hampered in the forecast period from the above statements.

COVID-19 Impact Analysis

The COVID-19 pandemic has moderately impacted healthcare systems and the market. In a pandemic, many normally disposable products end up being reused because they are in short supply. To address acute shortages in traditionally single-use devices, such as respirators or face shields, the Centers for Disease Control and Prevention (CDC) issued guidance allowing for extended use, reprocessing, and reuse of PPE. Moreover, according to the FDA regulations, hospitals and third-party reprocessors are considered manufacturers of the reprocessed devices. They must comply with the same regulatory requirements as the original equipment manufacturers. This perspective provides a crisis-responsive framework for medical product design intended to avoid these risks. The framework is informed by traditional FDA guidance on product approval, implementation, and validation, but adapt that guidance to accommodate constraints in time, material resources, and human capital. Thus, the market will undergo impetus during the forecast period.

Segment Analysis

Endoscopy Instruments segment is expected to hold the largest market share in reprocessed medical device market.

The endoscopy instruments segment accounted for the largest market share in 2020. Flexible Gastrointestinal Endoscopy is a frequent procedure used as a diagnostic or therapeutic tool in treating GI disease all over the world. According to estimates, Over 20 million endoscopic treatments are conducted annually in the United States. Reprocessing is a detailed, multistep process to clean, disinfect, or sterilize reusable devices, including endoscopes. Bronchoscopes are identified as part of a subset of devices in FDA's March 2015 guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling that pose a greater likelihood of microbial transmission and pose a high risk of infection if they are not adequately reprocessed.

Moreover, there is also a risk of spreading microorganisms through the air through aerosolization or from the surfaces of the bronchoscope when using and reprocessing a bronchoscope. Therefore, the FDA evaluates reprocessing issues for bronchoscopes and other types of endoscopes, including information about documented and potential infections. Working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to mitigate them best has been a priority. Thus, from the above statements, the demand for the reprocessed medical device has increased, due to which the market is expected to boost in the forecast period.

Geographical Analysis

North America region holds the largest market share in the global reprocessed medical device market

In 2020, North America accounted for the highest revenue share. Increasing prevalence of Healthcare-Associated Infections (HAIs), rising market players for providing reprocessing support & services for the surgical instruments and increasing interest in the PDA guidelines, as well as the latest trends of using reprocessed medical devices are some of the factors due to which the market is expected to boost in the forecast period. For instance, many hospitals in Canada are currently using stained instruments. The use of stained or spotted instruments can raise critical issues during surgery, including dullness of scissors, breakage or misalignment of instruments, and interference with sterilization, leading to infections. The Centers for Disease Control (CDC) estimates that HAIs account for 1.7 million infections and 99,000 associated deaths each year in American hospitals alone. Of these infections: 32 percent of all healthcare-acquired infections are urinary tract infections. 22 percent are surgical site infections.

Moreover, SteriPro Canada, Inc., a Canada-based company that provides reprocessing services for the Surgical Instrument Treatment for Spotting, Staining & Corrosion. For instance, SteriClean is a unique method that uses the right chemicals at balanced concentrations to clean and repair the damage that occurred upon improper cleaning. The chemical process employs environmentally safe chemicals in a controlled environment. This process results in sustainable, stain-free and lustrous instruments, which are safe for use. Therefore, the North American region is expected to hold the largest market share in the forecast period from the above statements.

Competitive Landscape

Major key players in the reprocessed medical device market are Stryker Corporation, Medline Industries Inc., Sterilmed Inc. (Johnson & Johnson), Vanguard AG, Medtronic plc, SteriPro Canada, Inc., ReNu Medical, Inc., Block Imaging and AGITO Medical.

SteriPro Canada, Inc.:

Overview:

SteriPro Canada is an accredited and ISO 9001 and ISO 13485 certified company providing leading practice reprocessing and sterilization services from its facility in Mississauga, Ontario, and on-site at its partner hospitals. SteriPro has also invested in a Medical Advisory Committee, which comprises four physicians, Infection Control Representatives and Executive Leadership from non-customer hospitals. The function of this committee is to make recommendations to the Senior Leadership Team and Board of Directors at SteriPro Canada regarding the quality of reprocessing and sterilization services. The company has delivered successful reprocessing and perioperative supply chain improvement solutions at the local, regional and provincial levels in Canada.

Product Portfolio:

SteriPro Canada provides hospitals with a cost-effective solution for reprocessing and sterilizing reusable instrumentation and devices through on-site and off-site services.

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Target Audience

Service Providers/ Buyers

Industry Investors/Investment Bankers

Education & Research Institutes

Research Professionals

Emerging Companies

Manufacturers

Market Segmentation

Global Reprocessed Medical Device Market – By Product & Service

Reprocessing Support & Services

Reprocessed Medical Device

Global Reprocessed Medical Device Market – By Device type

Laparoscopy Instruments

Biopsy Instruments

Endoscopy Instruments

Catheters

Pulse Oximeter Sensors

Sequential Compression Sleeves

Others

Global Reprocessed Medical Device Market – By Application

Cardiology

Gastroenterology

Orthopedic Surgery

Urology

General Surgery

Others

Global Reprocessed Medical Device Market – By End user

Hospitals

Diagnostic Centers

Home-Healthcare

Others

Global Reprocessed Medical Device Market - By Region

North America

South America

Europe

Asia Pacific

Middle East & Africa