North America Single-Use Medical Device Reprocessing Market - Growth, Trends, and Forecasts (2020 - 2025)

The North America Single-Use Medical Device Reprocessing Market is segmented by Device (Class I Devices, Class II Devices) and Geography.

Market Snapshot

Study Period:

2017-2025

Base Year:

2019

CAGR:

5.5 %

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Market Overview

The North America Single-Use Medical Device (SUD) reprocessing market is anticipated to grow at a CAGR of 5.5% over the forecast period. Rising clinical urgency to minimize the generation of medical waste in healthcare settings and hospitals is among the key factors driving market growth. Growth of the single-use medical devices is also expected to be spurred by the increase in FDA-approved critical and non-critical cardiovascular reprocessed devices, which hold a large share of the single-use devices used in healthcare.

A single hospital can divert over a ton of devices from the waste stream each year. According to the Association of Medical Device Reprocessors (AMDR), as of 2017, more than 3,000 US hospitals were purchasing reprocessed SUDs, and saving more than USD 600,000 annually, through their recycling and redistribution initiatives.​

Along with cost reduction, it also results in environmental sustainability. SUD reprocessing is one of the top healthcare supply chain strategies used to reduce costs and optimize resources. The aforementioned factors are anticipated to contribute towards the development of industry in the immediate future. However, the lack of dedicated SUD reprocessing facilities in emerging markets is currently a huge opportunity for this market, while the unauthorized overuse of reprocessed SUDs in emerging markets is currently the major challenge faced by this market.

Scope of the report

Single-use device (SUD) reprocessing includes cleaning, disinfection, and sterilization, as well as testing and restoration of the technical and functional safety of the used device. Reprocessing of SUDs makes it possible for hospitals to maintain patient care quality while saving substantial amounts of money.

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Key Market Trends

Sequential Compression Sleeves by Class II Device Segment is Poised to Register Robust Growth

  • Sequential compression sleeves are designed to increase venous blood flow in patients with deep vein thrombosis and pulmonary embolism. Compression sleeves are considered reusable, as they can withstand the necessary cleaning and sterilization process.​
  • The quality of the device and physical characteristics are not likely to be affected by reprocessing and the device remains safe and effective for its intended use. Hospitals are believed to save USD 300,000 by reprocessing compression sleeves. FDA reported that in 25% of all hospitals in the United States that use SUDs, sequential compression devices constitute about 15.8% of the reprocessed items. Compression sleeves account for the greatest volume of the overall business of SUDs reprocessing. ​
  • Stryker is the leading provider of reprocessed compression sleeve devices and has FDA clearance for the product offering. The company’s reprocessed compression devices are intended for use in preventing deep vein thrombosis, reducing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.​
  • The annual savings estimate of Stryker for DVT compressor sleeves is USD 27,950. Currie Medical Specialties Inc. and Covidien (Medtronic) have also received 510K FDA clearances to reprocess compression sleeves. ​
  • Reprocessed Kendall SCD express compression sleeves and reprocessed Kendall SCD comfort compression sleeves from Covidien (Medtronic) received FDA clearance on January 19, 2017. Medline also offers reprocessed compression sleeves.

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Competitive Landscape

The North America Single-use Medical Device Reprocessing Market is moderately competitive and consists of several major players. In terms of market share, a few of the major players currently dominate the market. The major market players include Hygia, Medline ReNewal, NEScientific, ReNu Medical, SterilMed among others. In a bid to achieve greater market penetration, the major players are resorting to various strategies such as mergers and acquisitions. For instance, in April 2020, Yale New Haven Health formed a strategic partnership with Medline.

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Table Of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Cost Savings Through Reprocessing Single-use Devices

      2. 4.2.2 Regulatory Pressure to Reduce Volume of Medical Waste

    3. 4.3 Market Restraints

      1. 4.3.1 Potential of Material Alteration and Cross Infection with Reprocessed Device

      2. 4.3.2 Preconceived Notions Regarding the Quality of Reprocessed Single-use Medical Devices (SUDs)

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Bargaining Power of Suppliers

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Device Type

      1. 5.1.1 Class I Devices

        1. 5.1.1.1 Laparoscopic Graspers

        2. 5.1.1.2 Scalpels

        3. 5.1.1.3 Tourniquet Cuffs

        4. 5.1.1.4 Other Class I Devices

      2. 5.1.2 Class II Devices

        1. 5.1.2.1 Pulse Oximeter Sensors

        2. 5.1.2.2 Sequential Compression Sleeves

        3. 5.1.2.3 Catheters and Guidewires

        4. 5.1.2.4 Other Class II Devices

    2. 5.2 Geography

      1. 5.2.1 North America

        1. 5.2.1.1 United States

        2. 5.2.1.2 Canada

        3. 5.2.1.3 Mexico

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Hygia

      2. 6.1.2 Medline Industries Inc.

      3. 6.1.3 NEScientific

      4. 6.1.4 ReNu Medical (Arjo)

      5. 6.1.5 Sterilmed Inc. (Johnson & Johnson)

      6. 6.1.6 Stryker Corporation

      7. 6.1.7 SureTek Medical

      8. 6.1.8 Vanguard

  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

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