Increase in Number of Hospital-acquired Infections to Augment Market

Within the healthcare sector, reprocessing of ‘single-use’ devices has become mainstream across hospitals and clinics as a measure to reduce costs. However, while reprocessing enables healthcare providers to reduce costs, there is a downside to it– the risk of cross-contamination and pathogen infection. The number of hospital-acquired infections (HAI) has increased at a steady pace across the global healthcare sector and thus, medical device cleaning processes have garnered significant attention from regulatory bodies. At present, medical device manufacturers are increasingly focusing on providing robust guidelines and manuals that offer insights regarding sterilization, disinfection, and cleaning of ‘single-use’ medical devices. Thus, medical device cleaning validations have become an integral part of the reprocessing validation cycle. Moreover, it also assures that medical devices can be cleaned and sterilized by adhering to the medical device manufacturer’s instruction for use (IFU).

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While the prevalence of hospital acquired infections continues to grow across ambulatory clinics, surgical centers, hospitals, etc., the medical device cleaning market has also gained notable momentum. In the current scenario, in the U.S., guidelines provided by The American Society of Testing and Materials (ASTM) related to medical device cleaning are applicable, which predominantly focus on equipment design, documentation, sampling, analytical techniques, procedures, etc. Owing to these developments in the healthcare sector concerning medical device cleaning, the medical device cleaning market is projected to reach a value of ~US$ 3.2 Bn by the end of 2020.

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Automatic Cleaning Process Gains Popularity

Scientific advancements in therapeutic and diagnostic medicine have triggered the production of cutting-edge reusable medical devices. However, due to the risk of cross-contamination and a range of other infections, medical device manufacturers have the responsibility to validate their product label claims as far as reusability is concerned. Label guidelines require approval from the Food and Drug Association (FDA) to ensure the overall efficacy and safety of the provided guidelines. The efficacy of the guidelines primarily depends on the markers utilized to soil the devices prior to cleaning. Some of the most commonly used markers include hemoglobin and protein.

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Medical device cleaning techniques have evolved over the years and are one of the most critical stages in the reprocessing of reusable medical devices. Cleaning techniques are primarily segregated into manual and automatic processes. Manual medical device cleaning processes are largely deployed to clean highly complex and delicate medical devices, such as lensed instruments, microsurgical devices, and flexible endoscopes among others. Automated cleaning techniques are predominantly used when other cleaning techniques prove to be ineffective, to prevent soiling of crevices, joints, lumens, and other parts of a medical device. Within the medical device cleaning market, the automatic cleaning process segment is estimated to reach a value of ~US$ 2 Bn and account for ~63% share of the medical device cleaning market by the end of 2020. The automatic cleaning process segment is also projected to expand at a higher CAGR than manual cleaning process segment during the forecast period (2019-2027).

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Focus on Guide Approvals and Product Launches Gain Momentum in Medical Device Cleaning Market

The American Society of Testing and Material is an important regulatory body that is responsible for the approval of new standards for medical device cleaning. Testing laboratories, regulatory agencies, and medical device manufacturers are required to comply with these standards. In the medical device cleaning market, attaining approval from the ASTM for new standards has gained significant momentum in recent times. For instance, in November 2019, the ASTM approved a list of new standards wherein the effectiveness of new medical device cleaning procedures is thoroughly evaluated. Additionally, the newly curated guide will largely focus on the extraction process of test soils to verify new cleaning methods. According to a member of the ATSM, approval of new standards is a crucial step in the overall process of validating cleaning instructions.

Stakeholders in the medical device cleaning market are also focusing their efforts on the launch of new medical device cleaning products. For instance, in April 2019, DuPont launched a medical device cleaning bio-based enzyme – OPTIMASE. The product, which is part of the company’s new product range is primarily developed to provide optimum cleaning efficiency in medical devices.

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