OPERATION BLUEBERRY CASTLE

CASE STUDY: TRACKING MEDICAL DEVICES AND HOSPITAL- STERILIZED IMPLANTS DURING SURGERY

Each year, hundreds of thousands of medical device reports of suspected device-associated deaths, serious injuries, and malfunctions are reported. New U.S. and E.U. laws require medical device companies to place Unique Device Identifiers (UDI) onto all medical device packaging, and permanent marks onto hospital-sterilized surgical implants. This medical device information must be collected at the point of care (during surgery), associated with a patient, and be electronically traced through the product’s lifecycle. Further, mandated UDI adoption is required in most developed countries. This Case Study will evaluate the effectiveness of identifying all medical devices during surgery, regardless of how the UDI is presented. This includes the placement of high speed, high-resolution scanner into the sterile field of the operating room that reads permanently annealed UDI data matrix codes on the surfaces of a hospital- sterilized implants, and identifies each device’s implanted anatomical location. Each implant may be identified through corresponding databases to verify that no active recall exists, with all case data transmitted to the hospital’s electronic health record. All other medical device information will be collected using a handheld scanner. 

Problem Patient Death and Injury Occur because of Untraceable Defective Surgical Implants. Pursuant to U.S. and European Parliament law, medical devices must bear a machine-readable mark known as the Unique Device Identifier (UDI). The UDI contains specific information regarding each device, including manufacturer, product, lot, serial and expiration. Healthcare providers are expected to collect and electronically maintain this information, and provide it to government payers. At present, there is not a single solution that is able to capture this information in a quick, easy and in a standardized method. 

As change management and UDI implementation strategies occur, there is a need for hardware and software solutions that are easy to adopt with minimal training required. Movement of sensitive patient information requires a secure platform to hold and transmit data (see GDPR laws). IT infrastructure systems that are antiquated must have a cloud based solution at an affordable cost to encourage adoption and value out of UDI compliance. 

Today, analog methods of recording medical device information cost billions while providing potentially inaccurate implant and utilization data. Hospitals and manufacturers need hardware and software solutions that will drive compliance, collect quality data to improve devices and procedures, and significantly reduce cost. 

Particularly challenging to track and identify are hospital-sterilized implants, which are removed from their packaging before placement into pre- configured trays. After which, they are assigned to manufacturer representatives or are consigned to hospitals. 

Once separated from their packaging, all UDI device identification is permanently lost. Prior to surgery, these trays are sterilized at the hospital. During surgical procedures, sterilized implants are placed into the sterile field, near the patient. 

Barcode scanners normally used to read data matrix code information may not be used for these devices because they must remain outside of the sterile field, and are incapable of reading small data matrix codes. 

From hospital-sterilized trays containing hundreds or thousands of unidentifiable implants, numerous devices may be implanted into a patient or discarded during surgery. The accurate match of every patient to their implanted devices is impossible, which is particularly concerning in the event of a recall. 

Financial losses due to industry’s inability to track and trace medical devices and drugs are significant. In October 2012 McKinsey & Company released a report highlighting the cost savings and patient safety benefits of adopting a single global supply chain standard in Healthcare. McKinsey interviewed more than 80 Healthcare leaders across the world and examined more than 25 cases of standards enabled improvement. 

The research has revealed “that implementing global standards across the entire healthcare supply chain could save 22,000-43,000 lives and avert 0.7 to 1.4 million patient disabilities.” 

Addressing counterfeit drugs, a major and ever-growing problem for public health and industry; the report concludes that “rolling-out standards based systems could prevent tens of billions of dollars’ worth of counterfeit drugs from entering the legitimate supply chain”. 

At the same time, it states that “global standards could enable substantial safety benefits and enable healthcare cost reduction of $40-100 billion”. Once adopted, global standards benefits will span over all supply chain stakeholders from manufacturers to patients. 

“The healthcare industry faces a potentially costly patchwork of requirements. Over the long term this patchwork could become unworkable. The adoption of a single set of global standards will cost significantly less than two and far less than three or more.” 

The report concludes that the potential benefits enabled by global standards in Healthcare supply chains “could be significantly larger than anticipated, as proven by the lessons learned from the CPG/retail industry, when GS1 standards were widely adopted”. End-to-end supply chain visibility could create new opportunities in mobile health, improve treatment compliance, avoid adverse drug interactions and more. 

Operation Blueberry Castle Given the clinical and financial importance of UDI, a coalition was formed to observe and report on the results of a unifying Universal AIDC platform to collect implant, instrument and supplies to realize “Scan4Safety” goals in the operating room. 

The Blueberry Castle coalition includes some of the world’s top UDI stakeholders who have demonstrated a commitment to ensure the success of a global UDI rollout. The objective of the alliance is to collect UDI information from 2D data matrix codes permanently annealed onto hospital sterilized surgical implants configured into trays, which are available for surgeon selection in the sterile field of the operating room. 

Specific observations include: (1) contribute to the ability to quickly alert patients with defective devices, thus reducing patient injury, infection and death, (2) identify potential financial returns in eliminating duplicative and/or inaccurate manual input, (3) accurately identify inventory and utilization, (4) optimize outcomes through post-market surveillance efforts, (5) accurate charge capture and billing from manufacturers and healthcare providers, and (6) transmit case data to Google Cloud Platform, where it will be securely maintained as development occurs with payers. 

Labels containing the device UDI from RFID, Barcodes, Data Matrix codes, and human readable sources of pre-sterilized packaged devices outside of the sterile field of the operating room will be collected. Study goals include:

1. Accurate documentation of medical implants via AIDC¹ scanning technology in the operative theatre. 

2. Creation of an exportable “best practice” that can be adopted by countries seeking a solution for UDI compliance. 

3. Creation of an IHI²/UDI interface for use by the government. 

4. Demonstration of a cloud based system to hold de-identified information that is GDPR compliant³. 

5. Demonstration of scanning technology and the ability to capture small⁴ dpm⁵ data matrix codes. 

6. Demonstration of time savings 

7. Enhance human factors of proposed solution to increase the likely adoption of technology in the operative theatre. 

8. Integration and automated output of UDI⁶ data into a hospital EHR⁷. 

9. Real time analysis of completed procedures for immediate notification of potentially recalled items. 

10. Sharing of data to key stakeholders in meaningful formats. 

11. Successful integration of hardware and software systems for agnostic data capture and sharing. 

12. Demonstrate the benefits of having a single, unified standards system. 

Surgery

Theatre Sites and Equipment Selection Multiple host sites have been identified to perform surgeries. Facilities will initiate scheduled spine and other surgeries, resulting in the documentation of data flow of the UDI for each implant and supply in the surgery, as well as provide case information, including anatomical placement of each device to the hospital EHR. 

Matrix IT Medical Tracking System’s “Tractus” Implant Tracking System, was selected to determine the ability to demonstrate pre-and post-data transfer, track both hospital-sterilized direct part marked (DPM) and pre-sterilized packaged implants labeled with GS1 data matrix codes. 

Tractus scanners collect UDI information on all surgery utilization, including both packaged pre- sterilized and hospital sterilized devices. Tractus integrates with hospital EHR systems, allowing seamless data transfer to occur. Equipment is comprised of the following items: 

1 _{Automatic Information and Data Capture.} 2 _{Individual Health Identifier.} 3 _{General Data Protection Regulation} 4 _{As defined as 0.5mm^2 in size.} 5 _{Direct part marked.} 6 _{Unique Device Identifier.} 7 _{Electronic Health Record.}

• Tractus Sterile-Field Scanner, is a battery-operated, Bluetooth enabled scanner and illumination system that captures hospital-sterilized medical implant UDI information at the point of care, inside of the operating room sterile field. 

• Tractus Drape is a sterile equipment cover, encompassing the Tractus Scanner so that it may be used in the sterile field. The Tractus Drape contains a clear polycarbonate cap that is locked into place over the camera’s view port, allowing the Tractus Scanner to capture the implant’s UDI information that has been encoded into data matrix codes with a direct part mark on each device. 

• Tractus Handheld Scanner, is a hand-held battery-operated, Bluetooth enabled camera and lighting system which collects pre-sterilized packaged medical implant and supply UDI information inside of the operating room, but outside of the sterile field. Capable of collecting UDI data from linear barcodes, data matrix codes and RFID tags. 

• Tractus Software, synchronizes with medical device registration and recall databases, and GS1’s Global Data Synchronization Network (GDSN), which exchanges standardized and synchronized supply chain data, the hospital’s master inventory record and electronic health record (EHR) system, allowing for the confirmation of all EudaMed and FDA registered products and population of limited patient information. Post-surgery, all collected data is forwarded to the hospital’s EHR system, including the anatomical location of each implanted device as well as a list of discarded supplies and implants, with the reason for discard. 

Procedure

The circulating nurse logs into the Software system and prepares for a “New Case,” where the following identifiers are obtained. 

1. Operating theatre Scheduling Options from dropdown menu, scan information OR key input 

a. Patient Name b. Patient YOB c. Patient MR # d. Surgeon Name e. Surgeon I.D. # f. Diagnosis (optional) g. Patient Gender h. Record keeper (circulating nurse) 

2. Master Device Record – all devices uploaded to hospital’s item master 

3. Medical Device and Recall synchronizations are previously uploaded 

The sterile field scanner is placed onto a Mayo Stand and covered with a Sterile Drape attached to a clear polycarbonate cap above the scanner viewing port. The cap is affixed to the scanner. 

Once draped, the scanner is positioned near the scrub tech for scanning of implants prior to handing to surgeon for implantation. 

During the procedure, the surgeon calls out for hospital-sterilized implants. The scrub technician pulls the requested device, passing it over the scanner’s viewing port of the Sterile Field Scanner. The device UDI is collected and wirelessly transmitted to the circulator’s software system and placed into the Software’s “Unassigned” Bin. 

After implantation, the surgeon identifies the anatomical location of the implanted device. Using the Software, the circulating nurse transfers the implanted device from the “Unassigned” Bin into the correct anatomical location. Each subsequent device uses the same procedure. The circulator may relocate several “unused” devices into the software system’s “Discarded” Bin and provide a reason for discard, which included: Defective, Fitment, and Non-Sterile. 

For supplies and implants that were sterilized inside of packages, the Handheld Scanner is used to document utilization from the UDI formatted label via identification through RFID, Bar or Data Matrix Code. 

Post-Operative Data Flow 

Appropriate utilization may be sent to: 

• Company (ex. Manufacturer, distributor, GPO) 

• Departments (ex. medical records, EMR, EHR, central supply, SPD, revenue cycle management, surgery, etc.) 

• Individuals (ex. rep, agent, physician, patient) 

• Implant Registries 

• Replenishment order generated 

Supplies During Surgery 

• Sterile Processing Department for notification of completed case 

• Payers 

Expected Data Collection 

• Anatomical placement of each device 

• Case Time 

• Case Utilization 

• Data Synchronization 

• Discarded items by reason for discard 

• Full device UDI 

• Patient Statistics 

• Post-Case Utilization 

• Pre-Case Inventory Tracking 

• Process Control Metrics Validation Report 

• Reports, including Pricing, Time Between Implantations, and Case Time, sorted by: Device, Surgeon, Diagnosis, Patient Gender and Patient Age 

• Surgeon Information 

Goals 

• Upon case completion, all surgical implant, supply and instrument data should be forwarded to the hospital’s electronic health record, with data flowing from the Tractus Software to the facility’s EHR system, including: Revenue Cycle Management, Medical Records and Supply Chain. If the hospital has no EHR documentation capability, a Case Report is uploaded to the server or emailed to medical records. 

• A reduction of case times is expected because of electronic data capture via Tractus vs manual systems. 

• The potential for human error from manual call out of device identifiers is expected to be eliminated. 

• The potential for inaccurate labeling, loss of stickers, or inaccurate identification of implanted vs discarded devices is expected to be removed. 

• The anatomical location for each device should be identified. 

• Maintenance of easily indexed records matching patients to the implant and their anatomical placement. 

Once trained, staff should report the following: 

➢ Draping of the Tractus Sterile Field Scanner should be easy, and may be performed several ways. 

➢ Each Scanned device UDI should be quickly collected with no negative effects to the case flow or surgical times. 

➢ The circulator should easily manage the software and anatomical device placement. 

➢ Each device should be successfully scanned in a reasonable of time. 

➢  Successfully collect the full UDI from devices containing data matrix codes as small as 0.5mm². 

➢ Compilation of utilization data, with the ability to manage inventory and send case utilization reports to manufacturers. 

➢ Device and case information should seamlessly transfer data to the EHR, if available. 

Project Requirements 

1. Manufacturers should include UDI validation of direct marks into their manufacturing process to ensure readability in the sterile field by the end user. 

2. Manufacturers should verify that hospital has input all product codes into the Master Item List with corresponding UDI information. 

3. Hospital should allocate appropriate resources to ensure implementation success. 

4. During UDI implementation, hospital should have effective supply chain systems that cross-reference all product numbers to a specific product (ex. GTIN, Hospital generated barcode, Vendor product code (UPC)). This information needs to be accessible to third party programs. 

5. In lieu of supply chain system, a Master Inventory List should cross-reference bar code(s) to products. As transition to FDA UDI standards agencies occur, cross referencing products will be crucial in accurate product identification. 

6. Hospital surgery scheduling system should be accessible to provide case information (including patient and physician). 

7. Hospital EHR system should be able to accept all identified case information, including anatomical location of implants. 

8. EHR systems must accept and forward case data to other systems, including medical records, inventory management, billing and collections, manufacturer, GPO, etc. 

9. Hospitals should assign a “project champion” to ensure that each requirement is met from each department on a timely basis. 

10. Ensure utilization accuracy, including implanted vs discarded. 

11. Document anatomical location in the event an implant is removed / replaced. 

12. Document accuracy and speed of different UDI collection methods. 

13. Collect all device information, including lot and serial number, negating the need to reconcile “bill only purchase orders.” 

Device UDI Permanent Marking Requirements 

1. Adjust laser marking systems to maximize DM location and readability. 

2. Optimize power requirements needed to maximize device integrity. 

3. Validate that hospital-sterilized implant data matrix codes may be read during surgery. 

Inventory Consignment and Tracking 

1. Scanning each tray that will be configured with implant tools and devices. 

2. Scanning each device’s data matrix code before placing them into pre-identified trays. 

3. Assigning pre-filled trays to manufacturer representatives and/or hospitals. 

4. Replenishing trays after completed surgeries. 

Anticipated Beneficiaries 

• Commercial stakeholder groups and companies require reliable connected data resources to help mitigate risk and manage extended health care regimes for implantable and other medical device products. 

• Device Labelers 

• Healthcare providers 

• Hospital connected strategic commercial, integration and technology partners. 

• Manufacturers 

• Patients and patient groups and associations. 

• Public and private payer groups 

• Regulators 

• Research organizations 

• Stakeholder representative associations —–Stakeholder models are becoming more and more important in shaping demand and regulatory requirements globally across all aspects of Life Sciences. 

• Supply Chain Organizations 

• Surgical Facilities 

Next Steps 

Blueberry Castle will be organized into two phases, which include simulated surgeries and live surgeries. Before each phase, participants will be selected, with responsibilities assigned to each. The system will be installed, with appropriate staff training performed. Once completed, the studies will be started. Data flow and analytics will be identified, with a process and data flow diagram created. Final report collaboration will occur to publish the study findings. 

Conclusion

The global UDI initiative’s primary purpose is to improve patient safety by creating a mechanism to quickly identify expired or dangerous devices, as well as collect comprehensive data to trend device performance. UDI has the added benefit of reducing the overall cost of healthcare through numerous means, which must be fully exploited as healthcare costs continue to rise. 

Hospital-sterilised implants containing data matrix codes as small as 0.5mm² are expected to be easily read at the point of use in the operating room sterile field. UDI data for all other implants and supplies that have been packaged and sterilized is expected to be collected via the handheld scanner. 

The Tractus UDI data collection system is expected to synchronize with the US and EU device and recall databases, identifying all approved medical devices as well as hospital-specific inventory. Further, case-specific utilization reporting that may be documented in other departments and organizations, include; Sterile Processing, Medical Records, EMR/EHR, Surgery Scheduling, Surgery Management, Revenue Cycle Management, Inventory Management, Manufacturers and Group Purchasing Organizations (containing de-identified patient information). 

This study is designed to identify opportunities and recommendations for a global best practice in support of multi-stakeholder UDI adoption and data collection and analytical methodologies. 

Proposed Blueberry Castle Study Participants 

1. SteriTrack Limited, a Matrix IT Company. 

a. www.steritrack.com. 

b. Owner of all patents of sterile field data collection and scanning. Developer of the world’s first and only sterile field scanner and universal operating theatre UDI data collection system. Capable of scanning data matrix codes with a full UDI as small as 0.5mm^2 with an x-dimension of 30 microns. 

c. SteriTrack is to provide scanning software, hardware, and drapes for the study to drive the capture of medical implant data. 

2. Aesculap AG, a B.Braun Company. 

a. www.aesculap.com. 

b. A well-established medical device manufacturer with a full line of medical implants and instruments that are UDI compliant and hold data matrix codes that have been laser annealed. c. Aesculap is to provide medical device instruments and implants. 

3. Google Cloud Platform, a Google Company. 

a. cloud.google.com. 

b. A market leader in offering cloud and analytical based data storage and user driven analytics. 

c. GCP⁸ is to provide access to cloud based storage and analytical tools. 

4. GS1 Ireland and Germany 

a. www.gs1ie.org. 

b. www.gs1-germany.de.

 c. The standards company that is predominately associated with barcoding and automation standards. 

d. GS1 is to provide insight, observations, and ideas towards the effective utilization of current standards. 

5. Cork Institute of Technology 

a. www.cit.ie. 

b. A top Irish academic institute of technology that focuses on industry driven education and services. 

c. CIT⁹ is to provide assets to analyze current device capture methods, user flow analysis of proposed technology, and design of new systems to enhance and the user experience. 

6. Sibley Memorial Hospital, Johns Hopkins Medicine 

a. www.hopkinsmedicine.org/sibley-memorial-hospital 

b. A world renown medical and healthcare research institution based out of Washington D.C. 

c. Sibley is to provide a clinical assessment of proposed capture techniques and technology in order to solve documentation and compliance challenges. 

7. University Hospital Carl Gustav Carus Dresden 

a. www.uniklinikum-dresden.de. 

b. A well-established German hospital, the University Hospital in Dresden is an established medical academy founded in 1815 by Friedrich August I. 

c. University Hospital Dresden is to provide clinician feedback on the efficacy of the software and hardware systems that are in place and being proposed for the study. 

8. RCSI

a. www.rcsi.ie. 

b. The foremost experts of surgery and surgical instruction in Ireland, the college is a leader in helping with the adoption and implementation of new and exciting technologies to better patient outcomes and care. 

9. Gartner 

a. www.gartner.com. 

b. The world’s most well connected and knowledgeable research firm, Gartner is a leader in industry knowledge, research, information, and strategy. 

c. Gartner is to provide an analysis of the opportunity, challenges, and suggested enhancements to what is found and discovered by the study. 

10. The Association for Healthcare Resource & Materials Management (AHRMM) 

a. www.ahrmm.org 

b. The premier membership group for healthcare supply chain professionals.

c. AHRMM is expected to observe study results, hospital challenges and lessons learned in the collection of UDI during surgery and the flow of post case data. Interview hospital personnel and develop white paper(s) on study findings to aide in the formulation of a recommended strategy for participating AHRMM member hospitals. 

Compliance Requirements

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL “Placing of the UDI on the label of the device or on its packaging;” “Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.” “Its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;” “Establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.” “UDI carriers shall be placed on the label of the device and on all higher levels of packaging… The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.” “For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.” 

FDA UDI Final Rule The UDI Rule is intended to create a standardized identification system for medical devices used in the United States. As stated in the preamble, this system makes it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use (78 FR 58786). The UDI Rule specifies that the labeler, as defined under 21 CFR 801.3, is responsible for complying with the UDI labeling (21 CFR 801 Subpart B) and GUDID submission (21 CFR 830 Subpart E) requirements. The UDI Rule also requires UDIs to be issued under a system operated by an FDA-accredited issuing agency (21 CFR 830.20(a)). Each labeler, therefore, must work with one or more FDA-accredited issuing agencies to develop UDIs for devices that are required to bear a UDI. For there to be an effective identification system, it is essential that the FDA-accredited issuing agencies develop and operate systems for the assignment of UDIs that allow labelers using these systems to be in compliance with UDI labeling requirements.