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Best HIT Manufacturing Practices


Not just commercial systems (VA, 'home-grown' ... Current Good Manufacturing Practice (CGMP) ... Vendor best manufacturing practices guide 'in progress' by CHIM ... – PowerPoint PPT presentation

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Title: Best HIT Manufacturing Practices

Best HIT Manufacturing Practices
  • Is Regulation Necessary?AHRQ Annual Meeting,
    Bethesda, MD, 9/14/09
  • Bob Elson, MD, MS (
  • President, Clinical Systems Design, LLC, Shaker
    Heights, OH
  • Affiliated Researcher, MetroHealth Center for
    Healthcare Research and Policy,
  • Cleveland, OH
  • Any opinions expressed herein reflect the
    personal opinions of Dr. Elson. They are not
    intended to represent the opinions or policy of
    the MetroHealth Center for Health Care Research
    and Policy.

(No Transcript)
Best Manufacturing Practices for HIT
  • State of the (quality control) market
  • Best practices (variation)
  • Opportunity lost
  • Emerging landscape

State of the Union (Quality Control)
  • Some (wide-scale) production examples
  • Auto stop orders, juxtaposition errors,
    inappropriately flagged abnormals
  • Not just commercial systems (VA, home-grown)
  • Lack of consistent surveillance, labeling, client
  • Industry response to Koppel findings is
  • Would we have seen the same thing if report had
    been about 22 ways that Goodyear tire design
    coupled with inflation pressure causes blowouts?
  • Industry is not immature, early lifecycle or
    teetering on the brink
  • Market cap of big 5 public (Cerner, McK, Siemens,
    GE, Eclipsys 283B)
  • 500 hospitals fully CPOE-adopted, many since
    mid-90s, some on 2nd
  • 500M CPOE orders / yr (SWAG Nobody knows)
  • 70M prescriptions / yr routed electronically
    doubling year over year

Koppel R, et al. Role of CPOE Systems in
Facilitating Medication Errors. JAMA.
20052931197-1203 Fictitious example
Best Practices (cGMPs)
  • Design and testing (especially human factors)
  • Defect handling (where safety rubber really hits
    the road)
  • Surveillance (nothing even remotely systematic)
  • Org structure (lack of necessary checks and
  • Structure ? process ? outcome
  • Unacceptable variation in HIT software quality
    can be directly attributed to manufacturing
    structural and process variations

FDA. Medical Devices Current Good Manufacturing
Practice (CGMP) Final Rule. Vol 21 CFR Parts 808,
812, and 820. Federal Register. 1996
61(195)52601-52662. http//
Window Closing on Self-Regulation?
  • 1986 The FDA states its HIT risk allocation
  • 1994 FDA moves blood bank IT systems to high
  • 1996 FDA feigns retreat from yet-to-be-codified
    86 position
  • 1997 AMIA, CHIM, AHIMA and others push back
  • 86 position should be written into doctrine
  • Local oversight committees
  • Voluntary product registration, adverse event
    reporting, labeling
  • Vendor best manufacturing practices guide in
    progress by CHIM
  • (2009 None of above happened, including
    codification by FDA, though unofficial doctrine
    still governs FDA risk-allocation policy for

Young FE. Validation of medical software
present policy of the FDA. Ann Intern Med. Apr
1987106(4)628-629 Miller, Gardner et. al.
Recommendations for responsible monitoring and
regulation of clinical software systems. JAMIA
19974442-457 See Section II of
Learned Intermediary Valid for HIT?
  • Basis for categorizing HIT as Class I device
    (lowest risk), but
  • Legal doctrine developed to protect
    pharmaceutical manufacturers from liability
    related to malprescribing, not to protect HIT
    vendors from liability related to adverse events
    due to user errors
  • Quite contrary to systems theory of human error
    implies that software cant systematically (and
    predictably) drive user error rates
  • Importantly, this FDA pseudo-doctrine as
    articulated by Young in 86 was developed for a
    very narrow set of HIT functions (specifically,
    A.I.-based diagnostic and treatment
    recommendations), not for the typically
    full-featured HIT of today (or of 97, for that
  • What was AMIA thinking in 97 when it commended
  • Did the end (no FDA reg of HIT!!) justify the
    means (learned intermediary), no matter how
    distasteful? Probably so, but a post hoc
    analysis is overdue.

Ironically, systems theory was heavily invoked
in the 1990s in order to justify why HIT was
necessary in the first place especially CPOE
(see Berwick DM. A primer on leading the
improvement of systems. BMJ. Mar 9
1996312619-622). e.g., info retrieval /
display, documentation, order communication,
other workflow CDS
Its The Users Fault
Intelligent Intervening Provider (aka learned
Evolving Regulatory Landscape
  • Lack of regulation indemnification no
  • By the way, CCHITs mission has little to do with
    ensuring public safety
  • Policy agenda tied up w/ MU, privacy/security,
  • Missed opportunity for resource allocation during
    ARRA ask period
  • Fear of spooking the funders (shame on us for not
    bringing up safety)
  • Legal and non-HIT engineering communities
    speaking out
  • Hoffman Podgurski. Harv Rev Law Tech. Feb 09
    and http//
  • Sweden and the EU
  • FDAs MDDS proposal, otoh, newly endorses past

Improving patient safety in the EU Many Medical
Information Systems should be classified as
Medical Devices. 2009. http//www.lakemedelsverket
ems-should-be-classified-as-Medical-Devices/ r/c
move MDDS from Class III to Class I
Whats Next?
  • AMIA Task Force (on vendor contracting not on
  • If stick with HIT-as-low-risk approach, need a
    new framework to justify it! (learned
    intermediary iswellembarrassing)
  • In parallel with addressing reg vs. no reg,
    should be thinking about ideal components of a
    workable reg program
  • Most impact on best practices with least resource
  • What can we learn from blood bank IT regulation?
  • Might forced compliance to cGMPs, with auditing,
    be enough?
  • Too late for voluntary adherence to best
  • Perhaps not, but usability which CCHIT and
    HIMSS have suddenly embraced (thats a good
    thing) is only one piece
  • Defect handling, surveillance, and org structure
    must also be addressed
  • 1/09 CCHIT rejected a proposed vendor best
    practices program