Device Identification, Synchronization Can Boost Patient Safety Key Talking Points on Unique Device Identification Device Recall Survey Device Identification, Synchronization Can Boost Patient Safety By Joseph Pleasant Standardization in the supply chain can save time, money and most importantly, patients’ lives. Joseph Pleasant When peanut butter contaminated with salmonella was recalled last year, it was quickly and efficiently removed from grocery store shelves. Health care providers and suppliers, however, can’t reliably identify potentially life-threatening recalled or defective devices. Unlike virtually every other product in commerce, medical supplies and devices cannot be identified in a systematic and consistent manner. Hospitals spend an estimated $200 billion annually on supplies, the second largest expense after labor costs. Most experts agree that one of the primary reasons for increased supply costs and the inefficiency of the health care supply chain is the lack of an unique device identification (UDI) system. An effective UDI system includes a consistent numbering system for each product coupled with a process for all supply chain participants to populate and synchronize their information systems with that product information. Without such a system, it is difficult to track the recipient of a faulty product during a recall of implantable devices or to accurately and consistently track adverse events related to a specific product. The absence of a UDI system has resulted in “dirty,” or inaccurate, product item masters that create mismatches in accounts payable, wasted clinician time in finding correct products, and inaccurate pricing, rebates, returns and credits. According to a 2003 study by the Coalition for Healthcare eStandards and the Health Care eBusiness Collaborative, the health care supply chain wastes 24 percent to 30 percent of supply administration time on data cleaning and corrections at a cost of billions of dollars. A Better Way Other multibillion dollar industries—including grocery and retail—manage their product information and run their supply chains more effectively. What is their secret? Unique device identification: Most health care products do not have a unique identification number that is used by all supply chain participants. Other industries use a unique product code (UPC) or global trade identification number (GTIN) on products that can be read via bar code or radio frequency identification throughout the supply chain. In health care, each supply chain participant places its own number on the product. This inefficient practice makes it very difficult to identify the product among supply chain members, track and trace it for recalls, or interpret via an EHR the type of medical device provided to a patient on previous visits. An UDI system would greatly improve the efficiency and also enhance patient safety. Figure 1, below, illustrates potential efficiency gains. Data synchronization: Many other industries use a system for synchronizing product data. This type of system brings consistent product information to every member of the supply chain. Data synchronization is a two step-process. First, manufacturers collect data on their ordering and product management processes. Then they submit that data to a central repository, or product data utility (PDU), where it is synchronized, audited, verified and distributed to members of the supply chain. Aggregators may be used by the manufacturers to prepare the data for the PDU or by hospitals to receive and reformat the data. Figure 2, below, illustrates this process. Outside health care, industries use a global product data utility called the Global Data Synchronization Network, or GDSN, which is managed by GS1, a supply chain standards organization. This network serves as the mechanism to provide consistent synchronized product data to their supply chain. By adopting the use of a global trade identification number and the Global Data Synchronization Network, supply chain participants could synchronize and maintain accurate product information in near real time, increasing the efficiency of the entire supply chain. In addition, patient safety would be improved through automatic identification of the right product with the right patient, improved product recall ability, and the ability to track and trace products that are subject to counterfeiting. It would also allow the product number within the EHR to be interpreted by each institution that receives the record. Progressive Efforts Several other countries have adopted standards for the identification of health care products and in some cases have established or endorsed a PDU. While other U.S. industries engage in data synchronization through the Global Data Synchronization Network, health care has yet to adopt this logical, cost-effective and proven process. In a 2006 Premier Safety Institute survey, more than 80 percent of respondents stated that a national standard for identifying products, or UDI system, would enhance patient safety. However, every participant in the health care supply chain would need to support the UDI system for it to be effective. In the meantime, several efforts to promote a streamlined supply chain are underway: Legislation: In September, the Food and Drug Administration Amendments Act became law. It requires the FDA to adopt and require a UDI that will identify a medical device from manufacture through use. This law will help the industry move forward with the establishment of a UDI and process for synchronization of the data. Department of Defense pilot: The DoD authorized a pilot with the Global Data Synchronization Network to test it as a platform for the health care PDU. From the pilot, DoD learned that synchronized item information netted considerable savings; item data collected from various DoD suppliers indicated significant data disconnects between supply chain partners; and requesting “one-off” data feeds from partners is a resource burden on all parties. GS1 and HL7: In June, HL7 and GS1 agreed to collaborate in developing global standards for improving patient care. GS1 will adapt its existing global supply chain standards to the specific needs of the health care sector. Medication errors can be avoided by automatically matching product data to patient data. These standards also enable effective traceability and reduce counterfeiting. GS1 Healthcare and GS1 Healthcare US: GS1 Healthcare is a voluntary global health care user group comprised of pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies and associations. GS1 Healthcare US, an industry-led group launched this year, was formed to support adoption and implementation of global GS1 standards to improve patient safety and increase supply chain efficiency. What Can Hospitals Do? The speed with which medical product identification and the corresponding synchronization of the product data through the Global Data Synchronization Network is implemented primarily depends on providers. Health care organizations should require their supply chain partners to provide products that have been assigned a GTIN and to support product synchronization through a certified Global Data Synchronization Network provider. This is how other industries became more efficient. Joseph Pleasant, FHIMSS, is CIO of Premier Inc., Charlotte, N.C. GIVE US YOUR COMMENTS! HHNMostWired welcomes your comment on this article. E-mail your comments to hhn@healthforum.com, fax them to Most Wired Magazine Editor at (312) 422-4500, or mail them to Editor, Most Wired Magazine, Health Forum, One North Franklin, Chicago, IL 60606.
Device Identification, Synchronization Can Boost Patient Safety
Key Talking Points on Unique Device Identification
Device Recall Survey
Device Identification, Synchronization Can Boost Patient Safety By Joseph Pleasant Standardization in the supply chain can save time, money and most importantly, patients’ lives. Joseph Pleasant When peanut butter contaminated with salmonella was recalled last year, it was quickly and efficiently removed from grocery store shelves. Health care providers and suppliers, however, can’t reliably identify potentially life-threatening recalled or defective devices. Unlike virtually every other product in commerce, medical supplies and devices cannot be identified in a systematic and consistent manner. Hospitals spend an estimated $200 billion annually on supplies, the second largest expense after labor costs. Most experts agree that one of the primary reasons for increased supply costs and the inefficiency of the health care supply chain is the lack of an unique device identification (UDI) system. An effective UDI system includes a consistent numbering system for each product coupled with a process for all supply chain participants to populate and synchronize their information systems with that product information. Without such a system, it is difficult to track the recipient of a faulty product during a recall of implantable devices or to accurately and consistently track adverse events related to a specific product. The absence of a UDI system has resulted in “dirty,” or inaccurate, product item masters that create mismatches in accounts payable, wasted clinician time in finding correct products, and inaccurate pricing, rebates, returns and credits. According to a 2003 study by the Coalition for Healthcare eStandards and the Health Care eBusiness Collaborative, the health care supply chain wastes 24 percent to 30 percent of supply administration time on data cleaning and corrections at a cost of billions of dollars. A Better Way Other multibillion dollar industries—including grocery and retail—manage their product information and run their supply chains more effectively. What is their secret? Unique device identification: Most health care products do not have a unique identification number that is used by all supply chain participants. Other industries use a unique product code (UPC) or global trade identification number (GTIN) on products that can be read via bar code or radio frequency identification throughout the supply chain. In health care, each supply chain participant places its own number on the product. This inefficient practice makes it very difficult to identify the product among supply chain members, track and trace it for recalls, or interpret via an EHR the type of medical device provided to a patient on previous visits. An UDI system would greatly improve the efficiency and also enhance patient safety. Figure 1, below, illustrates potential efficiency gains. Data synchronization: Many other industries use a system for synchronizing product data. This type of system brings consistent product information to every member of the supply chain. Data synchronization is a two step-process. First, manufacturers collect data on their ordering and product management processes. Then they submit that data to a central repository, or product data utility (PDU), where it is synchronized, audited, verified and distributed to members of the supply chain. Aggregators may be used by the manufacturers to prepare the data for the PDU or by hospitals to receive and reformat the data. Figure 2, below, illustrates this process. Outside health care, industries use a global product data utility called the Global Data Synchronization Network, or GDSN, which is managed by GS1, a supply chain standards organization. This network serves as the mechanism to provide consistent synchronized product data to their supply chain. By adopting the use of a global trade identification number and the Global Data Synchronization Network, supply chain participants could synchronize and maintain accurate product information in near real time, increasing the efficiency of the entire supply chain. In addition, patient safety would be improved through automatic identification of the right product with the right patient, improved product recall ability, and the ability to track and trace products that are subject to counterfeiting. It would also allow the product number within the EHR to be interpreted by each institution that receives the record. Progressive Efforts Several other countries have adopted standards for the identification of health care products and in some cases have established or endorsed a PDU. While other U.S. industries engage in data synchronization through the Global Data Synchronization Network, health care has yet to adopt this logical, cost-effective and proven process. In a 2006 Premier Safety Institute survey, more than 80 percent of respondents stated that a national standard for identifying products, or UDI system, would enhance patient safety. However, every participant in the health care supply chain would need to support the UDI system for it to be effective. In the meantime, several efforts to promote a streamlined supply chain are underway: Legislation: In September, the Food and Drug Administration Amendments Act became law. It requires the FDA to adopt and require a UDI that will identify a medical device from manufacture through use. This law will help the industry move forward with the establishment of a UDI and process for synchronization of the data. Department of Defense pilot: The DoD authorized a pilot with the Global Data Synchronization Network to test it as a platform for the health care PDU. From the pilot, DoD learned that synchronized item information netted considerable savings; item data collected from various DoD suppliers indicated significant data disconnects between supply chain partners; and requesting “one-off” data feeds from partners is a resource burden on all parties. GS1 and HL7: In June, HL7 and GS1 agreed to collaborate in developing global standards for improving patient care. GS1 will adapt its existing global supply chain standards to the specific needs of the health care sector. Medication errors can be avoided by automatically matching product data to patient data. These standards also enable effective traceability and reduce counterfeiting. GS1 Healthcare and GS1 Healthcare US: GS1 Healthcare is a voluntary global health care user group comprised of pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies and associations. GS1 Healthcare US, an industry-led group launched this year, was formed to support adoption and implementation of global GS1 standards to improve patient safety and increase supply chain efficiency. What Can Hospitals Do? The speed with which medical product identification and the corresponding synchronization of the product data through the Global Data Synchronization Network is implemented primarily depends on providers. Health care organizations should require their supply chain partners to provide products that have been assigned a GTIN and to support product synchronization through a certified Global Data Synchronization Network provider. This is how other industries became more efficient. Joseph Pleasant, FHIMSS, is CIO of Premier Inc., Charlotte, N.C. GIVE US YOUR COMMENTS! HHNMostWired welcomes your comment on this article. E-mail your comments to hhn@healthforum.com, fax them to Most Wired Magazine Editor at (312) 422-4500, or mail them to Editor, Most Wired Magazine, Health Forum, One North Franklin, Chicago, IL 60606.
By Joseph Pleasant
Standardization in the supply chain can save time, money and most importantly, patients’ lives.
Joseph Pleasant
When peanut butter contaminated with salmonella was recalled last year, it was quickly and efficiently removed from grocery store shelves. Health care providers and suppliers, however, can’t reliably identify potentially life-threatening recalled or defective devices. Unlike virtually every other product in commerce, medical supplies and devices cannot be identified in a systematic and consistent manner.
Hospitals spend an estimated $200 billion annually on supplies, the second largest expense after labor costs. Most experts agree that one of the primary reasons for increased supply costs and the inefficiency of the health care supply chain is the lack of an unique device identification (UDI) system. An effective UDI system includes a consistent numbering system for each product coupled with a process for all supply chain participants to populate and synchronize their information systems with that product information. Without such a system, it is difficult to track the recipient of a faulty product during a recall of implantable devices or to accurately and consistently track adverse events related to a specific product.
The absence of a UDI system has resulted in “dirty,” or inaccurate, product item masters that create mismatches in accounts payable, wasted clinician time in finding correct products, and inaccurate pricing, rebates, returns and credits. According to a 2003 study by the Coalition for Healthcare eStandards and the Health Care eBusiness Collaborative, the health care supply chain wastes 24 percent to 30 percent of supply administration time on data cleaning and corrections at a cost of billions of dollars.
A Better Way
Other multibillion dollar industries—including grocery and retail—manage their product information and run their supply chains more effectively. What is their secret?
Unique device identification: Most health care products do not have a unique identification number that is used by all supply chain participants. Other industries use a unique product code (UPC) or global trade identification number (GTIN) on products that can be read via bar code or radio frequency identification throughout the supply chain.
In health care, each supply chain participant places its own number on the product. This inefficient practice makes it very difficult to identify the product among supply chain members, track and trace it for recalls, or interpret via an EHR the type of medical device provided to a patient on previous visits. An UDI system would greatly improve the efficiency and also enhance patient safety. Figure 1, below, illustrates potential efficiency gains.
Data synchronization: Many other industries use a system for synchronizing product data. This type of system brings consistent product information to every member of the supply chain.
Data synchronization is a two step-process. First, manufacturers collect data on their ordering and product management processes. Then they submit that data to a central repository, or product data utility (PDU), where it is synchronized, audited, verified and distributed to members of the supply chain. Aggregators may be used by the manufacturers to prepare the data for the PDU or by hospitals to receive and reformat the data. Figure 2, below, illustrates this process.
Outside health care, industries use a global product data utility called the Global Data Synchronization Network, or GDSN, which is managed by GS1, a supply chain standards organization. This network serves as the mechanism to provide consistent synchronized product data to their supply chain. By adopting the use of a global trade identification number and the Global Data Synchronization Network, supply chain participants could synchronize and maintain accurate product information in near real time, increasing the efficiency of the entire supply chain. In addition, patient safety would be improved through automatic identification of the right product with the right patient, improved product recall ability, and the ability to track and trace products that are subject to counterfeiting. It would also allow the product number within the EHR to be interpreted by each institution that receives the record.
Progressive Efforts
Several other countries have adopted standards for the identification of health care products and in some cases have established or endorsed a PDU. While other U.S. industries engage in data synchronization through the Global Data Synchronization Network, health care has yet to adopt this logical, cost-effective and proven process. In a 2006 Premier Safety Institute survey, more than 80 percent of respondents stated that a national standard for identifying products, or UDI system, would enhance patient safety. However, every participant in the health care supply chain would need to support the UDI system for it to be effective.
In the meantime, several efforts to promote a streamlined supply chain are underway:
Legislation: In September, the Food and Drug Administration Amendments Act became law. It requires the FDA to adopt and require a UDI that will identify a medical device from manufacture through use. This law will help the industry move forward with the establishment of a UDI and process for synchronization of the data.
Department of Defense pilot: The DoD authorized a pilot with the Global Data Synchronization Network to test it as a platform for the health care PDU. From the pilot, DoD learned that synchronized item information netted considerable savings; item data collected from various DoD suppliers indicated significant data disconnects between supply chain partners; and requesting “one-off” data feeds from partners is a resource burden on all parties.
GS1 and HL7: In June, HL7 and GS1 agreed to collaborate in developing global standards for improving patient care. GS1 will adapt its existing global supply chain standards to the specific needs of the health care sector. Medication errors can be avoided by automatically matching product data to patient data. These standards also enable effective traceability and reduce counterfeiting.
GS1 Healthcare and GS1 Healthcare US: GS1 Healthcare is a voluntary global health care user group comprised of pharmaceutical and medical device manufacturers, wholesalers and distributors, group purchasing organizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies and associations. GS1 Healthcare US, an industry-led group launched this year, was formed to support adoption and implementation of global GS1 standards to improve patient safety and increase supply chain efficiency.
What Can Hospitals Do?
The speed with which medical product identification and the corresponding synchronization of the product data through the Global Data Synchronization Network is implemented primarily depends on providers. Health care organizations should require their supply chain partners to provide products that have been assigned a GTIN and to support product synchronization through a certified Global Data Synchronization Network provider. This is how other industries became more efficient.
Joseph Pleasant, FHIMSS, is CIO of Premier Inc., Charlotte, N.C.
HHNMostWired welcomes your comment on this article. E-mail your comments to hhn@healthforum.com, fax them to Most Wired Magazine Editor at (312) 422-4500, or mail them to Editor, Most Wired Magazine, Health Forum, One North Franklin, Chicago, IL 60606.
