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<SEC-DOCUMENT>0001096906-04-000326.txt : 20040810
<SEC-HEADER>0001096906-04-000326.hdr.sgml : 20040810
<ACCEPTANCE-DATETIME>20040810170057
ACCESSION NUMBER:		0001096906-04-000326
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20040810
ITEM INFORMATION:		Other events
FILED AS OF DATE:		20040810

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			UTAH MEDICAL PRODUCTS INC
		CENTRAL INDEX KEY:			0000706698
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				870342734
		STATE OF INCORPORATION:			UT
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12575
		FILM NUMBER:		04965014

	BUSINESS ADDRESS:	
		STREET 1:		7043 S 300 WEST
		CITY:			MIDVALE
		STATE:			UT
		ZIP:			84047
		BUSINESS PHONE:		8015661200
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>utahmed8k081004.txt
<TEXT>
                                  UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

                                    FORM 8-K

                       Pursuant to Section 13 or 15(d) of
                       The Securities Exchange Act of 1934



        Date of Report (date of earliest event reported): August 10, 2004


                           Commission File No. 0-11178
                                               -------


                           UTAH MEDICAL PRODUCTS, INC.
                           ---------------------------
             (Exact name of Registrant as specified in its charter)


                UTAH                                   87-0342734
   -------------------------------                ------------------
   (State or other jurisdiction of                (I.R.S. Employer
   incorporation or organization)                 Identification No.)


                               7043 South 300 West
                               Midvale, Utah 84047
                     Address of principal executive offices


Registrant's telephone number:      (801) 566-1200
                                    --------------


<PAGE>


- --------------------------------------------------------------------------------

                              ITEM 5. OTHER EVENTS

- --------------------------------------------------------------------------------


On August 10, 2004, Utah Medical Products, Inc. issued a press release
announcing its response to a Food and Drug Administration Complaint. A copy of
the press release is attached hereto as Exhibit 99.1

Consistent with UTMD's long-standing practice of repurchasing its own stock when
it believes it is undervalued, the Company also announces that it has been
buying and may continue to repurchase its shares in open market transactions.


- --------------------------------------------------------------------------------

                                   SIGNATURES

- --------------------------------------------------------------------------------

  Pursuant to the requirements of the Securities Exchanges Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.


                                                UTAH MEDICAL PRODUCTS, INC.
                                                ---------------------------
                                                REGISTRANT


Date:        8/10/2004                          By:   /s/ Kevin L.Cornwell
      ---------------------                          ---------------------
                                                     Kevin L. Cornwell
                                                     CEO




- --------------------------------------------------------------------------------

                                  EXHIBIT INDEX


Index
Number                   Description
- ------                   -----------

99.1                     Press release issued August 10, 2004: UTMD Responds to
                         Notice of FDA Complaint.

</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>utahmed8k081004ex99-1.txt
<TEXT>

                                  EXHIBIT 99.1

Salt Lake City, Utah - Utah Medical Products, Inc. (NASDAQ UTMD) has just
learned through a press release issued by the Food and Drug Administration (FDA)
that it seeks to enjoin UTMD from alleged deviations of the Quality System
Regulation (QSR).

The filing of this lawsuit does not affect the continued manufacture and
distribution of UTMD's devices. UTMD CEO Kevin Cornwell states, "We are innocent
until the government proves otherwise. There's never been an FDA allegation that
UTMD is not producing safe and effective products." In its twenty-five (25) year
history of inventing, manufacturing and marketing medical devices for critical
care applications, UTMD has never been prevented from distributing its devices
for domestic or foreign use.

This lawsuit follows a February-March five (5) week long comprehensive
inspection by three FDA inspectors intended to ascertain UTMD's current
compliance with the QSR, which ended with the issuance of a seven (7) item
FDA-483, and a March 16, 2004 six hundred (600) page written response by UTMD.
In addition to not receiving any FDA feedback to its detailed written
explanations, repeated requests by UTMD to discuss any unresolved issues with
FDA have been denied. In May, UTMD's request for mediation was rejected by Tim
Ulatowski, Director, Office of Compliance in the Center for Devices and
Radiological Health (CDRH), FDA.

Six months after the beginning of the last inspection, the filing of this
lawsuit follows UTMD's July 20 press release announcing 2Q 2004 results and its
belief "that this (FDA) abuse of process should not be tolerated because it
damages the public health by reducing continued prospects for innovation by, and
survival of, smaller companies which simply expect that FDA employees discharge
their obligation to communicate promptly with fairness and honesty."

The present dispute developed as a result of a September 2001 Warning Letter
that was issued to UTMD after an inspection by the FDA of its facilities in
Midvale, Utah. In the 2001 Warning Letter, without discussion with the Company
of its written response to the 2001 FDA-483, Regina Barrell of the FDA Denver
District Office demanded that UTMD hire an outside consultant to certify its
quality system. Exercising its rights and confidence in its quality system, the
Company respectfully declined. Four inspections of UTMD's Midvale facility
ensued. Unable to reach closure without the benefit of any dialogue with agency
personnel, in 2003 UTMD engaged a former District Director; Director, Division
of Compliance Programs, CDRH; principal in the development and applications of
regulations including the 1978 GMP Regulation and FDA Guidelines on the
Principles of Process Validation; and 28-year veteran of the FDA; to review the
documentation of the prior FDA inspections as well as conduct an independent
investigation of UTMD's quality system. The resulting opinion states "that the
investigators who conducted the inspection of the Utah Medical facility in
February and March of 2003 engaged in inspectional practices in disregard of
explicit instructions and policy stated in FDA's Investigations Operations
Manual and prepared an Establishment Inspection Report (EIR) that contains
numerous misrepresentations of the actual facts, bias, and material omissions.
These deficiencies create an impression about the company's compliance status
that is at odds with the facts. If I had received such a report as the District


<PAGE>


Director of FDA's New England District, and, upon review, became aware of the
extent of material omissions and misrepresentations, I would have disregarded
the report in its entirety, and reprimanded the investigators for failure to
follow FDA inspection policy. I believe the number and significance of
deficiencies found in the EIR suggests the real possibility of agency misconduct
and bias against Utah Medical Products, Inc."

The Midvale inspection in 1998 immediately prior to the 2001 inspection and
warning letter was "clean" - classified as NAI (no enforcement action indicated)
and no FDA FORM 483 was issued. This comprehensive inspection, conducted after
FDA implementation of the current QSR, covered the same issues as the 2001
inspection. UTMD's manufacturing operations, documentation system and products
have not significantly changed since the 1998 inspection. UTMD's Oregon facility
specializing in injection molding operations, operating under the same quality
system, was inspected in 1998 and again in 2004 without the issuance of a
FDA-483.

UTMD's facilities have previously been certified under ISO 9001/EN 46001 quality
standards since 1994. During 2003 UTMD was certified to compliance with the more
stringent ISO 13485 standard applicable specifically to medical devices. The ISO
standards are recognized throughout the world to reflect current quality system
performance. These standards are issued by the most widely recognized
international quality manufacturing standards organization and represent
requirements applicable to approval in countries such as those of the European
Union as part of the CE marking process.

UTMD is surprised that the FDA would issue a press release prior to any service
of a Complaint on UTMD. UTMD advises that its devices are of state of the art
quality preferred in particular by sophisticated clinician users, and that the
FDA has never questioned the safety or effectiveness of its devices.

UTMD Chairman & CEO Kevin Cornwell expressed his reaction to the FDA effort by
stating:
         "On behalf of the Directors, management, and employees of
         UTMD who have been and are dedicated to development and release of the
         safest and most effective devices possible, I am disappointed and
         bewildered by the performance of the FDA. We advise that the FDA has
         the burden to prove its allegations in the Courts of law, and regret
         that efforts by UTMD to engage in meaningful dialogue since 2001 have
         been repeatedly spurned. UTMD has offered to make any reasonable
         changes in our quality system that the FDA could identify, but they
         have refused to identify any changes or engage in any dialogue. Now, I
         believe it in the best interests of the company, the industry and the
         American public that the details of our dispute and the FDA's
         performance be fully discovered and publicly disclosed. To our clients
         throughout the world, I assure you that our continuing demonstration to
         satisfy their needs for our line of quality devices will not be
         affected."

UTMD devices have been used hundreds of thousands of times annually for many
years in high risk birth and neonatal critical care situations with an extremely
low frequency of complaints by any objective standards of measurement. Mr.
Cornwell further expressed:
         "The confirmation of the success of manufacturing and quality
         procedures year after year is demonstrated by the excellent performance
         of our devices as used by skilled practitioners. UTMD builds its


<PAGE>


         quality into its devices by carefully managing its activities through
         the performance of dedicated employees whose mission is not just to
         make devices but to make the best possible devices for mothers and
         babies as if each member of the public is a loved member of our family.
         We cannot concede to or tolerate conduct by the FDA that harms the
         public health through a misguided desire to cover up its mistakes and
         misuses public funds, abusing those who seek dialogue. UTMD requests
         that concerned industry members join us in our effort to assure that
         the FDA discharges its broad mandate fairly and objectively."

Utah Medical Products, Inc., with particular interest in health care for women
and their babies, develops, manufactures, assembles and markets a broad range of
disposable and reusable specialty medical devices designed for better health
outcomes for patients and their care-providers. For more information about Utah
Medical Products, Inc., visit UTMD's website at www.utahmed.com.
                                                ---------------




</TEXT>
</DOCUMENT>
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