July 12, 2002

Dockets Management Branch (HFA-305)

Food and Drug Administration

<fdadockets@oc.fda.gov>

SUBJECT: Docket No. 02N-0204

Department of Health and Human Services

Bar Code Label Requirements for Human Drug Products

Please consider this as our submission for your consideration regarding
the above hearing.

Let us first start by stating that we are not affiliated with any
healthcare organization, barcode equipment manufacturer, or risk
management firm. We are however experts on barcode technology and the
advantages gained by correct use of this important tool. AIS has been
specializing in barcode systems for 30 + years and has been involved
with retail barcode activity since the early 70\'s. We have broad
experience in this area. We are members of AIM, and have at one time or
another been involved with the UCC, AIAG, ISO TAG, HEDIC, Center for
Automatic Identification at Ohio University, etc. We have been around
the world and around the block on barcode. Our clientele includes
retailers such as Kmart, Dillard's, Limited and manufacturers such as
Kraft, Abbott Labs, Johnson and Johnson, Becton Dickinson, Honda, etc.

-   **The bad news is:**

    -   In information technology:

        -   Garbage in means garbage out -- no data integrity

        -   Garbage in means loss of control -- accidents

    -   Newer information systems may be designed to catch some key
        entry errors but 'garbage in' will always mean a greater chance
        of accidents.

> Legacy information systems can use barcode data entry at very low
> cost, but are very dependent on barcode quality and accuracy because
> they are much more susceptible to key entry errors not being caught.

-   Approximately 3% of retail products have barcodes that are difficult
    for even the best of scanners to read accurately, or cannot be read
    at all. An even higher percentage is below the acceptable minimum
    level. Projected onto healthcare applications, this data indicates
    that perhaps 1% of all barcode-based transactions could result in
    error. A typical hospital visit may result in 10's -100's of scans
    and this may be acceptable in retail but is clearly not the
    'quality' model to follow for healthcare.

-   An even higher percentage of barcode labels produced using 'on
    demand' printing, the type of printing found in hospitals and
    clinics, are difficult to read, can not be read or will be read
    inaccurately. Use and maintenance of this type of barcode printing
    is historically haphazard at best, making it even more imperative
    that, in healthcare, the job be done right from the start. Printing
    methods for 'on demand' printing should be scrutinized as well, i.e.
    thermal paper is temporary and cannot withstand exposure to
    moisture; laser printing leads to waste and increases the risk of
    misapplying barcodes. Laser labels may not stand up to the handling
    typically found in healthcare.

-   Healthcare applications are somewhat more difficult in that they
    will use barcodes that have multiple fields of data that can add
    complexity and probability of error. When specifying symbology
    preferences and fields of data, do so using historically proven
    symbologies with known value, readily available scanners and
    verifiers without leaping to 2D or RSS where devices for these
    technologies are still being refined.

-   In the history of barcode implementation in retail, there was a
    period of time that consumer confidence was driven low because of
    poor performance, pricing and scanning inaccuracies and suspicion
    that they were being cheated. In healthcare, if we make errors, we
    will quickly lose the consumers confidence, lose the opportunity
    this technology brings and, most importantly, put people at risk
    unnecessarily. We cannot afford to lose the confidence of the
    healthcare consumer and do not want to put anyone at risk
    unnecessarily.

-   We are years behind some countries with regard to how important it
    is to do it right -- from the beginning. Canada, Australia, New
    Zealand and others have had mandatory conformance certification in
    place and are clearly reaping the benefit.

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-   **The other (better) news is:**

    -   We are suffering from high costs and errors in healthcare.
        Barcode [is]{.underline} a very significant piece of the
        solution, a foundation for building a more efficient, more
        accurate, more flexible future for healthcare. There is no doubt
        that it has to be done and done right. Done right, we will be
        able to look back in coming years and mark this regulation as a
        milestone. Let's face it; it should have been done years ago.
        Does it make sense that we have better accountability for retail
        and automotive items than we do for those things we put in our
        body? Of course not. Mandating the use of barcode is the
        catalyst that will lead healthcare to the improvements we all
        seek.

    -   It is clearly possible to attain 'Six Sigma' levels of
        transactional accuracy by using barcode, but only if the barcode
        contains the right information, is encoded correctly and can be
        easily read by the barcode scanner. This means testing for data
        integrity, testing for labeling standards compliance and
        verification of barcode quality against barcode quality
        standards. It is not that hard to do but it will take the FDA to
        mandate it before manufacturers take the plunge.

    -   The FDA can take a 'GMP' approach that can be employed as a
        proactive means to the good use of this important technology.
        Good Manufacturing Practices recognize the importance of
        monitoring initial inspections, in-use inspections, and feed
        back systems to reinforce GMP philosophies. This will be
        especially true considering that it is possible to produce a
        good barcode and have it damaged or degraded in normal handling.

    -   Let's recognize that barcodes are, metaphorically speaking,
        black and white -- very little gray. It can be done right or
        wrong, and rules mandated by the FDA will directly impact the
        success of this implementation.

-   **What to do:**

    -   FDA should do a comprehensive audit of current barcode quality
        currently found in healthcare with the specific objectives of:

        -   Assisting the industry build a barcode based information
            infrastructure that supports these critical applications

        -   Protecting the public welfare

        -   Publishing current results so implementers are able to
            better assess risks and fix problems.

    -   Mandatory testing and verification of barcodes should be
        supported by FDA. This is no different than other mandatory
        marking legislation/regulation where font size, contrast,
        location, etc. are specified with the objective of providing
        accurate, understandable data to the users reading labels. Now
        we need accurate, understandable data for barcode scanners
        reading labels. Data validation, a check of the accuracy of the
        data in the barcode, must also be part of the verification
        process to avoid accidental or intentional mis-marking of
        products.

    -   Manufacturers should start immediately to assess their current
        status and start getting tighter control. By doing it now, they
        will be able to avoid expensive relabeling of existing
        inventories to meet requirements. By doing it now they will
        start building this into their core competencies. Note that
        healthcare inventory supply chains can take 2 years plus to
        clear.

    -   Again - ensure a strong foundation by requiring barcode
        verification and data validation as close to point of printing
        as possible.

**Scope of Discussion Points --**

*A. General Questions Related to Drugs and Biologics:*

1.  All medical products, prescriptions, over-the-counter drugs,
    devices, etc. should be barcoded. The objective should be to provide
    healthcare with a pervasive foundation for efficient and accurate
    data entry.

2.  Walk before you run. Take conservative, cautious steps to insure
    that you are able to build on success. That is to say that linear
    barcodes and linear barcode scanners are proven right now, are
    readily available and inexpensive right now, and will work with
    existing systems now. Their maximum capability should define the FDA
    specified minimums required now. The 2D higher data carrying
    symbologies and their related scanners should be identified as
    optional. This is in line with the current trend in the retail
    industry, which will gradually move to use both linear and 2D. FDA
    specs should identify both the mandatory and optional fields using
    the currently available application identifier (UCC) approach.

3.  We recommend that conventional linear symbologies be utilized, at
    least initially. Scanners, verifiers, and conformance tools are
    already in use throughout healthcare today and are readily
    available. Until such a time exists where proven measures are
    available for testing quality and data content of RSS and 2D
    symbologies, ensure error free transactions by sticking with
    commonly used specifications. We must continue to refine verifier
    and scanner performance for RSS and 2D, before accelerating use of
    them.... especially within healthcare. Many manufacturers are
    already marking items, let's measure their accuracy and allow them
    to continue with investments made thus far

4.  Just make it easier for people to scan in the information than it
    would be for them to key it in and you will have a 'check' in place.
    If the outer container is shed in distribution, then it is important
    that the inner container have the appropriate barcode on it so it
    may be read as the transaction takes place.

5.  There are a lot of barcodes already in the healthcare environment.
    Many are bad and should not be used. They may not have been reported
    through the supply chain channels because they are not being scanned
    yet and also because the length of the healthcare chain is so long.
    This is why it is imperative that the FDA do a comprehensive audit
    of current barcode quality found in healthcare with the specific
    objectives of:

    a.  Assisting the industry build a barcode based information
        infrastructure that supports these critical applications

    b.  Protecting the public welfare

    c.  Publishing current results so implementers are able to better
        assess risks and current problems.

6.  A proposal submitted by the Center for Automatic Identification at
    Ohio University to the Patient Safely Foundation that fell just
    short of a grant award, recommended many of the points that we are
    suggesting. A copy of the extensive proposal is available for review
    and reconsideration.

# *B. Medical Device Questions:*

# All medical devices and healthcare products should carry a barcode. Automated transactions will streamline the healthcare supply chain, records management, inventory levels, billing accuracy, etc.

1.  All medical devices should be identified with barcodes to allow for
    easy means of identification.

2.  Yes - Keep a GMP mentality, whether for original or re-packed items,
    should lead to success.

3.  Clear, concise patient records can be maintained and medical
    billings will be accurate. When a tongue suppressor is used in the
    ER and scanned just prior to the point of delivery, inventory levels
    can be adjusted, while patient billing reflects accurate charges.

# *C. General questions and economic impact questions*

1\. We are not a manufacturer, but probably not for linear codes

> 2\. We are not a manufacturer, but many have been producing HIBCC Code
> 39 or UCC UPC and Code128
>
> 3\. We are not a manufacturer, but some will use on line verification
> of barcodes just as they now verify data codes and lot numbers on
> line. Others will use proven SPC techniques for barcode quality just
> as they now use that technique for determining the quality of the
> product itself.
>
> 5.With mandatory barcode quality verification and data validation
> guidelines in place, even less aggressive scanners can be used. This
> will alleviate the need to replace existing equipment until such a
> time when advancements in these technologies make it necessary.
>
> 7\. Effective shortly after actionable audit reports are released...
> perhaps year's end. Follow up audits must be conducted to report
> on-going quality levels and ensure continuous improvement.

We welcome any questions; please contact us via email or the phone
numbers provided, and good luck to you on this critical mission.

Sincerely,

Mike Nolan

Patty Davis

CC: Dr. James Fales, Ohio University Center of Automatic Identification

Tom Brady UCC Vice President of AIDC

John Roberts --UCC Director of Healthcare

Mark Frye --UCC Director, AIDC