Automatic Tracking of Medical Devices, Tissues and Implants – How to Get It Right

The tracking of medical devices and other inventory used in surgery is a vital task for healthcare providers.

Setting the scene on the medical device, tissue and implant market

What are medical devices and implants?

Let’s start with a question – what is a medical implant? Medical implants are defined as tissues and devices that are used during surgery and placed on or in a patient. Implants can range from a tiny screw to prosthetics, which are used to replace missing body parts.

Medical implant devices are becoming ever-more sophisticated and represent some of the most expensive medical supplies in the healthcare setting. Implantable medical device examples include heart valves, stents, artificial hips, spine screws, rods, discs and more. They are used in a wide range of procedures and the market is continually developing smarter products.

Growth in demand for medical implants and devices

Demand for procedures that involve implanted medical devices is rising and the prediction is for this market to experience continued growth over the coming years.

At a time when both demand and costs are rising, many healthcare organizations are looking to tighten up their systems and workflows. Many have identified inefficiencies in their management of medical devices and implants and are keen to take action. Streamlining medical device inventory management, by addressing disjointed workflows and incorporating automation, is the route being taken by many. It’s a worthwhile investment, as getting it right will boost patient safety, improve cost control and ensure regulatory compliance.

Let’s start by taking a look at some of the industry predictions.

The continued growth of surgeries using consumable items

Medical devices and implants are expensive items, representing up to 30% of US healthcare organizations expenditure. Some large IDNs reportedly spend up to $300 million in this area.

The market for medical devices is experiencing year-on-year growth. According to a November 2021 report¹, the global implantable medical device market is expected to exceed $138 billion by 2025. Annual growth of 7.2% is predicted, leading to an estimated global market of $179 Billion by 2030².

Key drivers for market growth are:

• continuing technological advancements
• product development
• predicted increase in demand

With these factors fueling the medical implant device market, healthcare organizations will need to budget for higher supply levels and take steps to improve their management of this high value stock, in an area renowned for inefficiency and wastage.

The growing geriatric population fuels the rise in demand for implants, tissues and medical devices

One big factor in the projected growth of the medical device and implant sector, is the growing aging population.

The World Health Organization (WHO), reported that the 60+ age group across the world, will nearly double from 12% to 22% between the period 2015 to 2050. This is a clear indication that the medical implant market will grow over the same period.

• The rising geriatric population is an indicator for increased demand in neurological and cardiological disorders.
• The World Health Organization (WHO) reports that cardiovascular surgery is expected to increase to levels of more than 23 million by 2030.
• Demand for orthopedic implants such as knee and hip replacements, are also predicted to surge due to the aging population.
• Healthcare organizations will need to incorporate these areas of anticipated growth in their future planning, including the management and control of implantable medical devices.

We can see that the implantable medical device market is gearing up for continued growth in the coming years. At the same time, healthcare organizations are looking to improve efficiencies, so this area of inventory management is high up on the priority list.

So, let’s review the problems faced by many hospitals and surgery centers in their management of medical devices, tissues and implants. It is a tricky area for many, with known hot spots of inefficiency.

Problems managing the implant lifecycle

Many healthcare organizations struggle to keep tight control throughout the lifecycle of medical implants. Ineffective management of the medical device inventory causes gaps in the implant supply chain and these breaks in the chain can have serious consequences, such as higher levels of patient risk, inflated costs and lost income.

When looking to improve the management of medical devices and implants, a holistic view is needed of the whole supply chain, to ensure workflows are not task-based but take account of the bigger picture.

Tracking medical devices and implants

The tracking of medical devices is a key component of any implant management process.

Implant tracking is a regulatory requirement, with organizations requiring workflows that result in the electronic tracking of all implantable medical devices. The FDA’s UDI regulations are designed to facilitate the traceability of surgical implants and medical devices and were created to more effectively tackle implant recall.

Hospitals need to digitally capture each medical device’s UDI reference code and then track the item through to surgery. They are therefore looking for the most effective way to capture device data from supply to usage, providing full device visibility. This should result in digital records showing the details of each medical device used in surgery and link this to the patient, as well as to the procedure and physician.

UDI capture and the resulting implant traceability, has a direct impact on patient safety, preventing the usage of recalled implants. In addition, in the event of a recall after the surgery has taken place, the electronic records will facilitate quick patient contact.

So, UDI capture is a regulatory requirement and there are systems out there designed to record this information in the healthcare setting. However, it has become evident that healthcare organizations have multiple issues trying to capture UDI data at all stages of the supply chain.

Problems capturing UDI of medical devices, tissues and implants

Many hospitals and surgery centers have found that although there are many UDI capture tools on the market, many of them are not the instant fix they claim to be.

The vast number of UDI capture solutions are barcode scanning devices, which are known to have issues capturing the full UDI data required by the FDA. Product packs can contain 5 or 6 bar codes so it not immediately clear which barcode to scan. This can necessitate rescanning successive barcodes in search of the UDI information.

Even if the barcode does capture the UDI, there are other issues which can elongate the data capture process. Every scanned barcode is verified against the hospital’s master item list. This list is incredibly hard to keep up to date, due to the sheer number of suppliers, changing product choices, updated batch numbers etc. If a barcode is scanned, an out-of-date item list may mean that the data is not recognized, creating cumbersome and manual corrective workflows.

The time spent trying to capture UDI details from products is a big frustration for busy clinical staff. Implant tracking is a regulatory requirement so finding a quick, workable solution is paramount.

Tracking inventory is crucial for robust expiry and recall management and healthcare organizations are searching for an easier way to do this.

Expiry, Recall and Warranty management of implants and medical devices

The tracking of medical devices used in surgery helps healthcare organizations to manage their stock and enhance patient safety relating to:

• recall management
• expiry management

Recall management is completely dependent on the product being accurately logged in the MMIS, EHR and ERP systems.

Hospitals have two areas of responsibility:

• to prevent the usage of any recalled stock
• to undertake swift patient contact for those fitted with a recalled medical device or consumable.

Failing to prevent the use of a recalled product during surgery or being unable to quickly provide a list of patients who have had the item implanted – are major patient safety and compliance issues.

Recall management requires full item capture and tracking, and failure to have an effective system in place to trace recalled products puts patient at risk, as well as compromises regulatory compliance.

Expiry management is patient-critical so hospitals need to:

• know if there are any expired items in their supplies
• be able to prioritize the usage of soonest-to-expire items
• have a system in place at the point of use that prevents the accidental implanting of an expired item.

To effectively manage expiration dates on medical implants and devices, automated inventory management systems are the best solution. Manual systems that involve the visual checking of stock are time consuming, inefficient and heavy on staff resources.

Common Medical Device System Fails

Hospitals and surgery centers may have a manual or automated system in place to manage their medical devices and implants. However, as technology advances, the functionality and protection offered by modern systems is improving and it’s certainly worth reviewing current developments in industry software systems.

Many existing systems involve repetitive data entry or ineffective barcode scanning. Adding enhanced automation and interoperability will improve workflow efficiency and reduce the time spent on materials management.

Those using a manual system, or an automated system that falls short, may experience problems in areas:

• Implant Storage: Medical devices need to be effectively controlled while in storage:

• • Systems lack real-time visibility of the stock at hand – it’s the basic requirement of any medical device management process but many fail to show real-time data.
  • expiry and recall management are not adequately controlled. System data should flag up the soonest-to-expire items to prevent wastage as well as reduce patient risk.

• Implant Tracking: Practical barriers to tracking implants include:

• • barcode issues – multiple barcodes, inconsistency of barcode placement, incomplete barcode data. The training video may show you one quick swipe and job done, but the reality is very different.
  • item list errors – even when the data is captured it may not be plain sailing. Out of date item lists lead to elongated admin processes to get the products ‘in the system’.
  • nursing time – convoluted workflows place a burden on nursing staff, taking them away from patient care.
  • systems that work in silos – stand-alone systems necessitate manual processes that compensate for the lack of data integration with the ERM, EHR and MMIS. Staff need a single-input system and managers need the full picture, and not a fragmented view.
  • non documentation of implant usage:
    • POU capture – the most challenging places for hospitals to track implantable items are operating and procedural room suites. In this setting there is simply no time for convoluted processes at the point of care.
    • trunk stock, newly delivered and not in hospital systems, presents a particularly high risk.
    • safety checks – nurses and physicians are the last line of defense in the use of expired or recalled products – they need system safeguards to flag up any safety issues with medical devices prior to them being implanted.

Medical device, tissue and implant inventory costs

As already mentioned, medical devices and surgical implants are the most expensive hospital stock items. Because many healthcare organizations do not have real-time visibility of their surgical implant inventory there are many opportunities for wastage.

• overordering due to lack of accurate stock visibility and an unclear picture of usage – this leads to wasted expenditure on products that are not needed or used.
• expiry issues – excess inventory and poor stock rotation lead to expired products sitting on the shelves, ending up as wastage.
• financial waste – can include inflated costs on last minute trunk stock – some of which could have been anticipated and be available as a stock item, rather than being rushed in by the sales rep as a pricey emergency item. Expired products due to unnecessary surplus stock also leaks dollars.
• expensive physician preference items can hamper organizational efforts to make economic choices in the supply chain. Individual physicians may have preferred items from a range of suppliers when better economies of scale could be achieved by streamlining orders for the same product type. Average costs per surgeon can vary greatly for the same procedure and reviewing this issue and ordering from a selected supplier base will help hospitals to make significant savings.
• lack of item capture at POU is directly responsible for reduced revenue reimbursement.
• lack of commercial choice with vendors who require joint and accurate inventory visibility before they can discuss better commercial arrangements, such as consignment.

Because surgical implants are expensive, it is crucial to have an effective inventory management system in place that promotes cost efficiencies and reduces wastage.

Better control of medical devices, tissue and implants by storage in RFID Cabinets

The proven way to improve stock visibility is to use technology to automate inventory management. There are a range of RFID cabinets that have inbuilt sensors, providing real-time vision of the inventory at hand as well as support expiry and recall management.

Radio Frequency Identification uses coded item tags and cabinet sensors to track products.

Using RFID cabinets is an efficient method to ensure perpetually accurate stock visibility by providing real-time inventory counts.

IDENTI’s Total Sense cabinet uses RFID technology to provide stock control and tracking for surgical implant supplies. IDENTI’s provides added flexibility, the advanced sensing technology enables items to be stored at any angle, giving multiple options for storage.

The cabinets can be provided in a number of different configurations to suit different product sizes.

Due to the accuracy of the RFID sensors, cabinet data provides real time inventory visibility.

Having an RFID cabinet is a great solution for improving inventory management and this technology is driven by a management system.

Total Sense cabinet

Combining hardware and software for maximum control

In today’s world the effective management of surgical implants and medical devices involves both hardware and software. Hardware such as RFID cabinets provide a comprehensive solution that is powered by a management system. This technology collects and analyses cabinet data.  It is the combination of both the hardware and implant tracking software that leads to optimum management and control of implantable medical devices.

System reports flag up soon to expire items and ensure that stock is used in date order, preventing the storage and usage of expired products and reducing patient risk.

Automated inventory management ensures the data capture of all stock items removed from the implant storage cabinet. This information can be analyzed and produce data insights that can be used to identify usage patterns and inform restocking, so that orders are only placed for items that are required.

Data-driven restocking prevents wasted expenditure and product surpluses.

IT silos and disconnected data both result in operational blind spots that prevent managers from being table to control costs and improve workflows. The IDENTI Platform managing system seamlessly integrates with all hospital systems and can also link to vendor systems too.

Data insights made visible at the enterprise-level are key to creating implant inventory strategies that drive supply chain optimization.

Automated implant management look in practice

So, let’s put the whole picture together and see what the automated and streamlined lifecycle management of medical devices and implants looks like in practice.

We can see from this image that the best automated healthcare inventory management systems record all stock items on to MMIS systems – this is the foundation of good inventory tracking. Full item visibility ensures stock rotation and expiry/recall management.

Automated cabinets result in item tracking, as each item is removed from storage and used in surgery.  Tracking at the POU should then update all hospital systems, ensuring that the supply chain is closed by patient charting, full charge capture and billing reconciliation.

It’s a smooth data flow from delivery, storage, usage to billing.

Inventory analysis and data insights

Efficient tissue and implantable device management is supported by using technology with built-in data analytics that deliver robust data collection for improved inventory control and supply chain visibility.

Management system reports that collate and analyze data from the cabinets provide managers with useful information that help then manage their medical device and implant inventory. Data insights are also available, to help with forecasting and future planning.

Once this level of clarity is achieved, inventory managers will be making data-driven decisions and achieve a balanced inventory, that tackles head on the issues of stock-outs, surplus stock, expiry and recall issues.

This diagram shows that when effective implant inventory management is achieved, there are six big wins; streamlined supply chain, interoperability, embedded safety and compliance, prevention of ‘never events’, use of data insights and full revenue capture.

All that actionable information travels through the workflow to ensure all the boxes are ticked for each consumed item.

Simplifying ease of implant capture at the point of care

RFID cabinets are an excellent tool to manage implant and medical consumables, but once an item is removed it still needs to be accounted for. Despite all the improvements provided by automated RFID cabinets, there is one area that creates a weak link in the supply chain – and that is in the surgery setting.

Problems recording implant usage at the POC are common. Tools available tend to rely on barcode scanning and entering a sticker into the ‘big book’ – which needs to be followed up with electronic recording to ensure UDI compliance and complete the revenue cycle.

Added to this, is the fact that a high level of implants and surgical consumables arrive as trunk stock – and are therefore not preloaded on to hospital systems. These items, delivered directly by vendors into procedural spaces, and which may not even be on the hospital’s item list, provide a whole new level of administration in order to accurately log item usage.

Feedback suggests that as much as 52% of items are not captured in OR,

resulting in no charge on the medical billing and no revenue capture.

For high value medical implants this is a real and unnecessary loss. Added to this, are the patient safety risks of not having any electronic association between the product and the patient.

That’s why IDENTI Medical has filled a gap in the market by providing the only data capture tool, designed for surgery settings that makes capturing the data of any product a breeze.

Solution for medical device, tissue and implant capture at POC

Snap & Go is an innovative data capture tool that works in the surgery setting.

It uses patented image recognition and AI technologies to take a ‘snap’ of item packaging at the point of use. It takes just five seconds to capture full product information, including UDI.

Our newest product feature ensures even the smallest implants can be traced – procedure room Count Sheets, filled out manually – can now be digitally captured in seconds, ensuring full data capture at POU of all consumables.

Product features include:

• Real-time expiry and recall flags, providing a safety net for the surgical team, who are the last line of defense.
• Taps in to IDENTI’s global item master, so can handle trunk stock items with ease.
• Interoperable with ERM, EHR and MMIS.
• Revenue-enabler – 100% charge capture

Having an easy-to-use system that provides full item utilization and checks product validation at the point of use, is the best safety net and income-booster for hospitals and surgery centers.

This article has discussed the growth and rising costs of medical devices and implants – reinforcing the need to improve systems and procedures to better track and manage this high value stock.

Snap & Go is the ideal partner for the IDENTI Total Sense RFID Cabinet. Together these two tools provide hospitals with full control of their medical device and implant inventory and result in both cost savings and increased revenue capture.

Data Sources:

1    MarketWatch Report: Implantable Medical Devices Market importunity Size, Analysis, Competitive Strategies and Forecasts to 2025 – MarketWatch

2    Allied Market Research: Implantable Medical Devices Market | Global Forecast 2030 (alliedmarketresearch.com