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 to be gained by correct use of this important tool. AIS has
specialized 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
> immediately.

-   Approximately 3% of retail products have barcodes that are difficult
    for even the best of scanners to read, or cannot be read at all. An
    even higher percentage is below the acceptable minimum level.
    Quality control of retail barcodes has historically been on an 'as
    needed' basis, a reaction to a problem rather than a pro-active
    approach to insure accuracy and quality. This is understandable
    considering that the initial cost justification for barcode in
    retail was labor savings rather than data related. In recent years,
    as data has become more important to retailers, ongoing education
    programs that cover barcode quality and formatting have been
    established. My opinion is that retail is still on an 'as needed'
    basis for barcode quality issues.\
    Projecting the retail experience onto healthcare applications may
    indicate that perhaps 1% of all barcode-based healthcare
    transactions could result in error. This error level may be
    acceptable in retail, but since a typical hospital visit may result
    in 10's -100's of scans, and we could be affecting a person's
    health, it 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 have the
    possibility of being 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 materials and methods for 'on demand'
    printing should be scrutinized as well, i.e. thermal paper is
    temporary and cannot withstand exposure to certain liquids and gels
    found in hospitals; laser printing can be wasteful, have a higher
    risk of being misapplied, do not stick as well and 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 in each barcode.
    This adds some complexity and increases the probability of format
    errors. 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 of promoting a quality
    mentality.

-   Even with the very limited use of barcode in healthcare, the FDA has
    already had to recall products because of unreadable or incorrectly
    encoded barcodes to protect consumers.

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

    -   We are suffering from high costs and too many unnecessary errors
        in healthcare. *[Barcode is a very significant piece of the
        solution.]{.underline}* Barcode can provide 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 everything from Barbie Dolls to wheel
        bearing than we do for life saving drugs and devices? 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]{.underline}*, 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 traditional 'GMP' approach and be
        effectively proactive to help healthcare make good use of this
        important technology.]{.underline}* Good Manufacturing Practices
        recognize the importance of initial inspections, in-use
        inspections, and having feedback systems to reinforce GMP. Most
        importantly, GMP implies record keeping as a management tool to
        insure the checks are completed as required, help identify best
        practices and to limit damage due to recall action. This will be
        especially important considering that it is possible to produce
        a good barcode at the point of printing and have it subsequently
        damaged or degraded in normal handling, finally resulting in a
        barcode that can not be read at point of delivery.

    -   Let's recognize that healthcare 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 inventories 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.

    -   FDA should support mandatory testing and verification of
        barcodes. 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, start getting tighter control and build this into their
        core competencies. By doing it now, they may be able to avoid
        the expense, risk and chaos of relabeling inventory. 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. Follow a GMP mentality and insist that
        manufacturers keep good records.

**Scope of Discussion Points --**(follows your document outline)

*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 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. Note
    that the UCC's RSS code has a composite format that has both linear
    and 2D components that can cover the broad range of printing and
    scanner capabilities while providing extended data carrying
    capability to those users who need and can justify the added costs.

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 or possibly 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\. Probably not for linear codes -- note that we are not a manufacturer

> 2\. Many have been producing HIBCC Code 39 or UCC UPC and Code128--
> note that we are not a manufacturer
>
> 3\. Some will use on line verification of barcodes just as they now
> verify data codes and lot numbers on line with machine vision systems.
> Others will use proven SPC techniques for barcode quality just as they
> now use that technique for determining the quality of the product
> itself-- note that we are not a manufacturer
>
> 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 apologize in advance for any chaos you may detect in our comments as
we tried to get the important points out and also follow the outline in
your request for input. We certainly welcome any questions; please
contact us via email or the phone numbers provided. We will support your
effort and wish you good luck 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