Surgical Instrument Tracking Devices Market Size & Outlook, 2025-2033

Surgical Instrument Tracking Devices Market Size

The global surgical instrument tracking devices market size was valued at USD 458.88 million in 2024 and is projected to grow from USD 500.63 million in 2025 to USD 1004.89 million by 2033, growing at a CAGR of 9.1% during the forecast period (2025-2033).

Surgical sets typically contain up to 200 instruments and are assembled according to pre-defined instrument checklists. A technician is responsible for meticulously putting together sets, ensuring no missing or mismatched pieces. As a result, it is a difficult job requiring in-depth knowledge and experience from technicians. Time constraints are typical, and it is not uncommon for sets to deviate from pre-determined checklists. This task can be simplified by using a tracking system that provides technicians with pictorial guides for identifying instruments or, better yet, automatically identifying and matching instruments using radio frequency identification devices (RFID)/barcode reading.

Surgical instruments have their own shelf life, and manufacturers usually specify how many cycles they can be used for such as bipolar vessel-sealing surgical instruments. A surgical instrument tracking system shows users how many rotations an instrument has completed. In some cases, it can prevent further use once the maximum number of cycles has been reached. This eliminates user discretion, and manual cycle counts, resulting in a safer patient process. Additionally, the number of usage cycles completed by each instrument is critical information for staff when performing instrument maintenance or deciding whether or not to condemn or continue using these instruments.

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Surgical Instrument Tracking Devices Market Growth Factors

Increasing Need for Inventory Management and Implementation of Unique Device Identification (udi) Regulations by the Fda

The demand for surgical instrument tracking devices has grown dramatically after the FDA mandated using a unique device identification (UDI) system. The UDI requires surgical instrument labelers (manufacturers, re-processors, specification creators, re-packagers, and re-labelers) to use direct labeling at the individual instrument level. As a result, most systems have a specific user identifier that is human and machine-readable. The product labeler is expected to submit a certain level of detail about each device to the FDA's global unique device identification database (GUDID). The database is freely accessible, searchable, and downloadable by the public.

From the tray stage, hospitals and ambulatory centers have begun to mount the UDI on their instruments. The trackers are primarily used to track surgical instruments and equipment in the operating room. Some of the significant issues hospitals face are tracing medical equipment and inventory control across the work cycle, including treatment, post-surgery, storage, and sterilization procedures, leading to inventory management. Therefore, the need for inventory management in hospitals and ambulatory centers is creating an increased demand for surgical instrument-tracking devices in the global market.

The Rising Number of Surgical Procedures Globally

Another factor behind the use of surgical monitoring systems is the global increase in surgical procedures. As surgical procedures rise yearly due to improved and ground-breaking medical facilities worldwide, demand for tracking surgical instruments also increases. For instance, approximately 313 million surgeries are performed on average globally. Many complex surgical procedures are performed across the globe because of increased knowledge of medical disorders and early detection of chronic illnesses. The growth in operations and the government regulations to implement tracking devices on medical instruments led to the implementation of trackers in the devices, especially the ones used inside an operating theater (both disposable hand tools and reusable tools).

Market Restraining Factors

Technological Limitations

Although the market for surgical instruments is expanding, a few drawbacks could prevent it from doing so. For instance, extreme settings like autoclave temperatures, extensive sterilization with industrial chemicals, and interference from metals and liquids may be too much for metal tags, RFIDs, and barcodes. The use environment's other radio signals and electric and magnetic fields can also interfere. These reasons necessitate regular replacement of these trackers by hospital management. Only a few manufacturers on the market disclose information on the entire procedure, including the number of surgical operations in which the product has been used, the chemicals used to sterilize it, and the tissues involved. The limited data storage capacity of tracking devices must improve the seamless flow of inventory management and maintaining the data at hospitals and ambulatory centers. The investments and purchases of the widely used barcodes are predicted to suffer.

Market Opportunities

Availability of Technologically Advanced Products

The development of surgical equipment tracking devices is speeding up the completion of surgery and enhancing the accessibility and effectiveness of inventory control in healthcare institutions. Moreover, this system gathers and monitors real-time data on surgical tools used in the healthcare facility. Market players have attempted to create fresh goods and services catering to healthcare professionals' needs. The global market for surgical instrument tracking devices may change due to the development of devices with fast detection times and high data recording rates. For instance, Spa Track unveiled a new Auto-Scanner RFID surgical equipment in October 2018. It screens an entire instrument plate in about 12 seconds and is a hetero-directional, rotating processing device that can precisely track every single registration number of goods.

Another advancement in instrument tracking devices has come from web-based applications, operating room scheduling systems interfaces, and radio frequency recognition technologies. The segment's growth can be attributed to technological advances such as high durability, more data storage capacity, reusability, and the lack of a need for line-of-sight. The advancement in the technologies of surgical instrument tracking devices and the ease of operating them is anticipated to propel the demand for surgical instrument tracking devices in the market.

Regional Insights

North America is the most significant global surgical instrument tracking devices market shareholder and is anticipated to exhibit a CAGR of 8.5% during the forecast period. The majority of the market growth is contributed by the U.S. One of the critical drivers for the development of the market in the U.S. is the rising patient acceptance of advanced technologies, which can give more details and decrease examination time. Developing countries are expected to grow significantly in adopting surgical instrument tracking devices. In addition, the Canadian government is making significant investments to strengthen the healthcare system in response to the rising burden of chronic diseases. For instance, the governments of Canada and Quebec worked together to invest in 209 infrastructure projects to modernize, redevelop, and upgrade the health and social services institutions in Quebec, including hospitals and other care centers. This information was provided in a press release issued by the Canadian government in July 2021. The investment for these 209 infrastructure projects was USD 188.3 million, according to announcements from the federal ministers of infrastructure, communities, and health and social services. These investments require the availability of cutting-edge medical technology in hospitals.

Europe Surgical Instrument Tracking Devices Market Trends

Europe is estimated to exhibit a CAGR of 10.1% during the forecast period. Europe is the second-largest adopter of these advanced technologies. Some of the companies in the market are headquartered in this region and maintain a strong presence in the domestic market. The large base of early adopters of such systems is in Europe. Europe is expected to remain the second epicenter of innovations in the global market over the forecast period. Furthermore, doctors' demand for advanced surgical instrument-tracking devices is expected to play a crucial role in propelling the growth of the surgical instrument-tracking devices market. In 2019, ASANUS Medizintechnik GmbH developed a new type of insertion of micro-RFID chips into surgical instruments. Moreover, in July 2019, Key Surgical LLC, a global provider of sterile processing and operating theater supplies, announced its agreement to acquire Hamburg, Germany-based Insitumed GmbH. The strategic acquisition will broaden Key Surgical's portfolio of endoscopy products and further extend its global footprint.

Asia Pacific Surgical Instrument Tracking Devices Market Trends

Asia-Pacific is the third largest region. Due to increasing per capita income and the rapid progress of surgical techniques, the Asia-Pacific region is a developing market for surgical instrument tracking devices. In addition, China and India make up 67.0% of the population in the Asia-Pacific area and account for 36.0% of the global population, creating a flourishing emergent market. 

Technology Insights

The market is segmented into barcodes, RFIDs, and IoT. The RFID segment accounted for the largest market share and is estimated to exhibit a CAGR of 9.6% during the forecast period. To have enough surgical instruments on hand for the surgeries, hospitals must keep track of the surgical instruments' ever-changing and expanding availability. It takes time for staff to do manual counts and barcodes, which are standard inventory management systems (as they are in many sectors). By reducing counting time, radio frequency identification devices (RFID) will enable pharmaceuticals to be tallied more frequently while ensuring accurate data and the suitable types and quantities of drugs on hand. During inventory checks, RFID tags can be read using portable readers, fixed readers, and shelf antennas.

The software segment is the second largest. The medium-high growth in this segment can be attributed to increased government focus on reducing healthcare costs with enhanced patient outcomes. This has significantly shifted patient care from inpatient settings to outpatient settings.

Product Type Insights

The market has been segmented into hardware, software, and services. The hardware segment owns the largest market share and is estimated to exhibit a CAGR of 8.4% during the forecast period. The growth in the hospital segment is primarily driven by the rising number of surgeries and various regulations associated with device identification. However, only the high-end multispecialty private hospitals and clinics use these tracking systems equipped with instruments because public healthcare centers usually need financial help. Once installed, the tag's bi-directional nature lets it receive firmware and configuration updates from MobileView. This eliminates the need for field workers to manually collect, update, and re-deploy tags. The T12s Tag can be attached to infusion pumps, defibrillators, and portable X-Ray machines, among other medical devices. Inventory control, rental management, and effective preventative maintenance are all made more accessible with real-time asset tracking.

End Users Insights

The market has been segmented into hospitals, ambulatory surgical centers (ASCs), and others. The hospital segment accounted for the largest market share and is estimated to exhibit a CAGR of 9.3% during the forecast period. The growth in the hospital segment is primarily driven by the rising number of surgeries and various regulations associated with device identification. Tags are attached to hospital items, such as inventories and durable assets. Single-use products (gloves, plastic vials, gauze), linen, bottles, and boxes containing medication, medical tools, and equipment (surgical tools, pumps, monitors) may be included in this list. Assets can have tags applied to them or embedded in them (e.g., in surgical tools). Labels are also used for packaging containing prescriptions and single-use products. Many hospitals in developed nations already have policies requiring patients to wear an identifying bracelet throughout their stay. With the addition of barcode technology, more hospitals are redesigning these bracelets. When a healthcare expert scans the wristband, he can be sure he is treating the right patient properly. A mobile point-of-care solution boosts efficiency and patient safety while lowering expenses. Nurses and staff can collect data from a patient's identification bracelet, which includes the capacity to access their medical records electronically.

The ambulatory surgical centers (ASCS) segment is the second largest. The medium-high growth in this segment can be attributed to increased government focus on reducing healthcare costs with enhanced patient outcomes. This has significantly shifted patient care from inpatient settings to outpatient settings. However, with a reduction in elective surgeries, the use of these instruments at the ASCs also gets impacted substantially.

List of key players in Surgical Instrument Tracking Devices Market

1. Asanus Medizintechnik GmbH
2. Braun Melsungen AG
3. Becton Dickinson and Company
4. Fortive Corporation
5. FingerPrint Medical Limited
6. Getinge AB
7. Haldor Advanced Technologies
8. Integra Lifesciences Holding Corporation
9. Murata Manufacturing Co.Ltd
10. NuTrace
11. Scanlan International.

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Recent Developments

• February 2023- BD, a leading global medical technology company, announced the outcomes of a peer-reviewed study that showed BD technology could be used to significantly reduce hazardous drug surface contamination and provide pharmacies and healthcare facilities with real-time measures to more effectively monitor and improve the safety of health care workers and patients.
• March 2023- WiMi Hologram Cloud Inc., a leading global Hologram Augmented Reality ("AR") Technology provider, announced that it is developing a collaborative eye-tracking data visualization system.