Wednesday, October 28, 2009

St. Alexius Medical Center's DuWayne Schlittenhard Appointed to HIBCC Board

PHOENIX, AZ (October 28, 2009)—DuWayne Schlittenhard, Vice President, Heart/Vascular & Professional Services for St. Alexius Medical Center, has been appointed to the Board of Directors of the Health Industry Business Communications Council (HIBCC). The announcement was made by HIBCC President, Robert Hankin.


Schlittenhard has been a Vice President at St. Alexius Medical Center since 1999. He oversees the following departments: the Heart & Vascular Center including the Cath Lab and Interventional Radiology, Respiratory Care, Radiology, Laboratory, Pharmacy, Rehabilitation Services, Anesthesia and the Heart and Lung Clinic, which includes Cardiology, Cardiothoracic Surgery, Allergy and Pulmonology.


Prior to his role at St. Alexius Medical Center, Schlittenhard was the Chief Operating Officer at PRACS Institute Ltd and the Director of Pharmacy at MeritCare Health System. Schlittenhard will represent the American Hospital Association (AHA) on the HIBCC Board.


Michael Guerin of AHA notified HIBCC that “the Board of Trustees of the American Hospital Association has appointed the following individual [DuWayne Schlittenhard] as AHA’s representative to the Health Industry Business Communications Council for a term effective immediately…”


HIBCC is an industry-sponsored, non-profit standards development organization (SDO) that maintains labeling standards for hospitals and their suppliers. It was founded in 1983 and has been accredited by the American National Standards Institute (ANSI).


HIBCC's bar code labeling standards are accredited by both ANSI and the European Committee for Standardization (CEN). The HIBCC mission is to facilitate electronic commerce by developing appropriate standards for information exchange among healthcare trading partners. This mission is extended globally via IHIBCC, a network of HIBCC offices located throughout the world.


Additional information regarding the HIBCC organization can be accessed from the HIBCC web site at: www.hibcc.org.



For additional information contact Katy Giglio, Director of Communications at 602-381-1091 ext 101.

Tuesday, October 27, 2009

Why UPNs Make Sense for Medical Devices

BAR CODE STANDARDS

Why UPNs Make Sense for Medical Devices

Mandating the UPN system would help manufacturers better track their products.

Kirk Kikirekov and Robert A. Hankin


In 2004, FDA published a final rule on bar code label requirements for drug and biological products. It subsequently began considering whether to expand that concept to medical device labeling. Over the past few years, FDA has held several meetings on unique device identification (UDI) to collect input from the device industry. It is expected that the agency will issue a draft guidance on the topic in the near future. The basis for these actions is FDA’s mandate to protect the consumer, in this case, patients. Evidence of significant medical errors related to product identification have made clear the need for regulatory initiatives.

Product identification, whether by traditional bar codes, newer two-dimensional symbols, or radio-frequency identification, is increasingly being used to locate and remove devices that are found to be the source of problems after they have entered the supply chain, or worse, have been used in medical procedures. The use of product identification as a resource in medical practice, as opposed to just a tool to manage inventory and warehouse logistics, is creating an entirely new paradigm. A UDI system based on universal product numbers (UPNs) would be a safe and efficient way to accommodate both hospital and warehouse needs.

The History of UPNs

Ironically, standards that uniquely identify medical products and meet FDA requirements have not only been in place for more than 25 years, but are already present on the vast majority of medical devices. Although widely used, UPNs have not been mandated by FDA, are often not placed on single-use packaging levels, and are frequently ignored in medical-delivery and hospital settings that lack the technology to capture the UPN information.

A primary component of the UPN is the health industry bar code (HIBC). It is maintained by the Health Industry Business Communications Council (HIBCC), which was created in 1983 by major healthcare associations at the behest of the American Hospital Association. HIBCC was specifically tasked with developing standards that met the unique needs of the healthcare supply chain. Traceability was a key concern for HIBCC; therefore, its standards permit manufacturers to directly encode product IDs in their labels, create consistency for packaging at all levels, and provide serialization and lot and batch information for track-and-trace purposes.

HIBC standards were also designed to coexist with generic retail and pharmaceutical standards known as GS1 codes. The codes work well in cash-register and warehouse environments, but are less suitable for medical applications in which safety and error minimization are crucial. Because HIBC standards are alphanumeric and GS1 codes are limited to numbers only, the two can coexist without being confused.

Adoption of UPN Standards

It is logical for FDA to adopt the UPN standards for UDI because they are based on existing, internationally recognized standards and leverage the significant progress that has already been made by the medical device industry in product identification. These standards meet the requirements for track and trace and, if fully implemented, can help reduce medical errors.

The most important aspect of HIBC UPNs, in terms of patient safety, is that they enable device manufacturers to directly encode their existing alphanumeric product identifiers into their labels. This avoids the unsafe practice of changing or cross-referencing them to meet arbitrary new or numbers-only requirements. In short, it would be counterproductive for FDA to add new risk by imposing new standards.

Additionally, a deviation by FDA from existing labeling standards and practices would burden manufacturers with significant costs at a time when reducing healthcare inflation is a critical national priority. Manufacturers that currently use HIBC formats would be required to redesign their labeling systems and implement changes to software in their warehouse and distribution centers.

The HIBC Data Structure

The HIBC supplier labeling standard ANSI/HIBC 2.3 is an alphanumeric standard that encodes key information necessary for track and trace of medical devices. The encoded information includes the following:


• The unique product identifier (the primary bar code).
• Track-and-trace information and expiration information (the secondary bar code).

Figure 1. (click to enlarge) An example of a primary HIBC label (top) and a secondary bar code label (bottom).
A typical HIBC-compliant primary and secondary label appear in Figure 1. The primary label begins with the HIBC supplier labeling flag—the + character that represents the red or white cross that universally symbolizes medical care. In the case of HIBC, the + indicates that an item is a medical product and is followed in sequence by the labeler identification code (LIC), which is assigned by HIBCC and uniquely identifies each manufacturer. Next comes the product number that has been assigned by the manufacturer, a unit of measure ID indicating the packaged quantity, and a check sum that is calculated from the previous data in the label. There are two significant aspects to this structure that are designed to minimize error. Manufacturers can use their original product identifiers in the label, thereby avoiding the inherent risks of changing or cross-referencing them. The HIBC structure also includes an additional check character that is not present in other standards to ensure correct scanner reads.

The secondary label (see Figure 1) includes the information that is essential for track-and-trace capability, beginning with the HIBC supplier labeling flag character, followed by expiry date format information and the appropriate date, as well as lot or serial number. For added security, a link character is included in the secondary bar code, which matches the check sum in the primary bar code, and a separate check character is calculated thereafter.

If desired by the manufacturer, the primary and secondary bar codes can be made into a concatenated version. The overriding goal of the various requirements in the standard is to minimize coding or scanning errors and to maximize the ease of traceability of the product.

Manufacturers that adopt the HIBC supplier labeling standard register with HIBCC, which assigns them their unique LIC. As a consequence of the unique LIC and the alphanumeric structure of the HIBC standard, a single LIC per manufacturer provides for a virtually infinite number of identifiers. This is particularly important for manufacturers of medical devices because there are often hundreds of thousands of unique parts to be identified. The forms and appropriate steps for obtaining an LIC from HIBCC are available on the HIBCC Web site at www.hibcc.org.

Point-of-Use Data Capture

It is important for device manufacturers to understand how their product identifiers are used once a product leaves its facility. Point-of-use data capture is the process required to accurately capture information about consumables and other products used in patient procedures. For the most part, this process is performed manually by hospitals using paperwork to record the details. Written notes are placed in a paper-based patient file. Some of the data are entered manually into patient administration systems, but often key information is left out. Consequently, a disproportionate amount of a caregiver’s time is consumed by recording medical devices used, ordering and replenishing, and tracking (in the case of recalls).

This manual process of data capture is prone to errors. Transcribing the lot and serial number(s) of a medical device and then entering them into a computer system carries a much higher risk of mistakes than if the information was directly scanned from a bar code and automatically entered into a database. Errors made in the recording process could lead to a hospital using a recalled or expired device. Additionally, when hospitals incorrectly enter product information, medical device manufacturers can’t accurately manage their inventory.

Like groceries, every medical device should be scanned before it is used. However, there is a vast difference in the healthcare supply chain that makes scanning at the bedside far more challenging than scanning groceries in a supermarket. Unlike a grocery store where the primary reason for scanning an item is a price check, the scanning of medical devices for a patient procedure requires a deeper understanding of the interconnected processes and dependencies that exist to ensure patient safety. These processes include the following:


• Purchasing arrangements. There are numerous variations that exist for medical devices such as consignment stock, loan stock, and purchased stock. Each variation requires a different set of rules for the purchasing and invoicing.
• Billing and rebates. Many medical devices are billed to the patient and the rebates that may apply depend on the health insurance coverage for the patient.
• Tracking devices to the patient. For many hospitals, it is not sufficient
to simply capture the product type used in a procedure. For example, for implants it is necessary to capture the lot or serial number. This ensures that devices can be tracked to a patient and, in the case of a recall, the affected lot can be traced to all patients. It also identifies consignment and loan stock devices used so that the hospital can fulfill its contractual arrangements with the supplier for supplying consignment or loan stock items. The bar code standard used, therefore, must contain a field for lot and/or serial numbers.
• Units of sale. These are more controlled in supermarkets. In hospitals, medical devices and consumables must be issued at the patient’s bedside. Patients might be charged for an entire package of syringes that is brought into their room, even though only one syringe was used. Or the patient might not be charged if the package isn’t labeled because it is part of a larger package that was labeled.
• Expiration dates. To reduce the risk of infections, it is important that medical devices provided in sterile packaging have not reached their expiration date. The bar code standard used must contain a field designated for the expiration date to alert the caregiver that a device has expired when the bar code is scanned.

The following technology issues must also be considered before introducing a point-of-use data capture system:


• What kind of hardware is required to easily capture the medical devices used in a procedure? Caregivers are highly mobile, which should be factored into the design of the system.
• How will medical device product data be stored, maintained, and accessed—i.e., how will all the bar codes, product descriptions, units of issue, etc., be databased in the first place and then maintained on an ongoing basis? The bar code for product identification is, after all, just a string, and the system needs to reference the product attributes when the bar code is scanned.
• What data are required for the system and how will this information be stored and structured?

A Data Capture System that Works

In Australia, a data capture system that relies on UPNs to manage medical devices is already being employed in many hospitals. The system captures all medical devices used in operating rooms by scanning a manufacturer’s bar code and then creating a bill of materials against a patient procedure or episode of care. The system is a software-as-a-service application that consists of handheld computer software and a back-end server. The handheld computer is a mobile device with a built-in bar code scanner. Before the start of a surgical procedure, the caregiver scans the medical record number and episode number for the patient either from a bar code on the patient’s wristband or from the patient’s file.

Figure 2. (click to enlarge) A handheld computer scans the primary bar code on the pictured label (a). A lot number is required, so the computer prompts the operator to scan the secondary bar code (b). Image courtesy of hTRAK PTY LTD. (Victoria, Australia)
As medical devices are used in a patient procedure, a user scans the HIBC-compliant UPN labels and automatically captures the devices (see Figure 2). When the procedure is completed, the user synchronizes the handheld device and the data captured is uploaded to the back-end server. Purchase orders for used devices are automatically created in the system. In many cases, this function is interfaced with hospital enterprise resource planning systems.

We have observed a very high compliance rate in hospitals that use this method of data capture. Clinicians find it easier to capture information by scanning bar codes rather than by keeping paper records. Additionally, the system is intrinsically linked to purchasing and patient accounting, which means that clinical staff has a distinct interest in ensuring that all data is captured.

Conclusion

For more than 25 years, the standards created by HIBCC have provided the platform for applications that capture medical device information. These systems offer manufacturers accurate information on devices used in patient procedures, timely receipt of purchase orders, and improved traceability. Forcing the medical device industry to switch to a new format would introduce increased costs and risks.

Kirk Kikirekov is president of HIBCC AU (New South Wales, Australia). Robert A. Hankin, PhD, is president and CEO of HIBCC (Phoenix).

Copyright ©2009 Medical Device & Diagnostic Industry

"The State of Healthcare Logistics"

"The State of Healthcare Logistics"
Posted by Dirk Rodgers at 9:34 PM

Earlier this year The Association for Healthcare Resource & Materials Management (AHRMM) and the Center for Innovation in Healthcare Logistics (CIHL) at the University of Arkansas published the results of a survey they conducted in 2008 titled "The State of Healthcare Logistics". The survey polled 1381 healthcare supply chain professionals regarding their “perceptions of cost and quality efficiencies and improvement opportunities within their organization”. I’m always a little skeptical (alright, I’m a lot skeptical) of “perception surveys”, but since this one was focused on the specific supply chain that I’m a member of, I took some interest. This survey included a series of questions about the respondent’s perception of Data Standards, which really caught my eye.

In fact, I’ve been doing a little investigating myself into the competing standards that are related to supply chain master data. My career experience in this area has almost solely dealt with GS1 standards, but that may be because the healthcare part of my career has centered on the pharmaceutical distribution corner of the full healthcare supply chain. If it had been centered on the distribution of medical devices, I would have been much more familiar with HIBCC (Healthcare Industry Business Communications Council) supply chain data standards. I’ve been trying to figure out if the industry needs multiple competing data standards and, if not, which one is a better set: GS1 or HIBCC? And should I consider some other set of standards that I just don’t know about? Are there good reasons to continue the use of either or both sets of standards in our supply chain?

In this light, I turned my attention to the AHRMM/CIHL survey results, hoping to gain some valuable insight. I quickly got stuck on their very first survey question in the Data Standards section (on page 15 of their report):

A. Is your organization moving towards the adoption of a data standards system (such as GS1) in the next five years?

Now this is an amazingly bad survey question that wouldn’t even pass a “survey questions 101” class. It is a classic example of a leading question. One where the desired answer is provided directly in the question itself. But look at the choice of answers!

1. Yes – GS1
2. Yes – Other
3. No
4. Don’t Know

Wow. Clearly this survey is trying to lead the respondents to indicate support for only GS1 data standards, and it worked. Over 50% of the respondents chose answer “1”, over 30% chose answer “4”, and about 20% chose answer “3”. What about answer “2”, indicating support for “other” data standards systems? Only about 3%.

But the authors go further. Here is part of the analysis provided in the report for this survey question:

“The majority of those that indicate that they are moving towards a data standards system other than GS1 do not know which system their organization is moving towards.”

Maybe that’s because they didn’t tell the respondent which “other” systems are out there. I'm assuming that the authors were just a little sloppy and failed to include in the report the additional question(s) that provided them with this extra information.

I wonder what they would have found if they had asked the question this way:

B. Is your organization moving towards the adoption of a data standards system (such as HIBCC) in the next five years?

1. Yes – HIBCC
2. Yes – Other
3. No
4. Don’t Know

My bet is that the results would be nearly the same.

In general, perception surveys don’t deserve much weight. This one provides a perfect example of why, and this one question destroys any remaining credibility this survey could have had. For this reason, this survey contributed absolutely nothing to my own investigation into systems of standards and it answered none of my questions. That’s sad, because I’m sure there are many other people in the supply chain who are having the same thoughts right now, and we could use some solid, unbiased information about the pros and cons of each choice.

This report has inspired me to construct my own perception survey:

C. Which standards organization (such as GS1) is most likely to have directly or indirectly funded the survey that generated Question A.?

1. GS1
2. Other
3. No
4. Don’t Know

D. Which public university (such as the University of Arkansas) should be most embarrassed by the construction of Question A. and the conclusions drawn from it?

1. The University of Arkansas
2. Other
3. No
4. Don’t Know