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<SEC-DOCUMENT>0001096906-04-000075.txt : 20040211
<SEC-HEADER>0001096906-04-000075.hdr.sgml : 20040211
<ACCEPTANCE-DATETIME>20040211150559
ACCESSION NUMBER:		0001096906-04-000075
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20040211
ITEM INFORMATION:		Regulation FD Disclosure
FILED AS OF DATE:		20040211

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:		04585962

	BUSINESS ADDRESS:	
		STREET 1:		7043 S 300 WEST
		CITY:			MIDVALE
		STATE:			UT
		ZIP:			84047
		BUSINESS PHONE:		8015661200
</SEC-HEADER>
<DOCUMENT>
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<SEQUENCE>1
<FILENAME>umed8kfeb1104.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): February 11, 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 9. REGULATION FD DISCLOSURE

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


On February 11, 2004, Utah Medical Products, Inc. issued a press release, a copy
of which is attached hereto as Exhibit 99.1


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

                                   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:     2/11/2004             By: /s/ Kevin L. Cornwell
               ------------------            ------------------
                                             Kevin L. Cornwell
                                             CEO



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

                                  EXHIBIT INDEX


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

99.1     Press release issued February 11, 2004: Utah Medical Products, Inc.
         Questions FDA Performance.





</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>3
<FILENAME>umed8kfeb1104ex.txt
<TEXT>



                                  EXHIBIT 99.1

Salt Lake City, Utah - On January 22 in its announcement of recent financial
results, Utah Medical Products, Inc. (NASDAQ: UTMD) publicly disclosed an
unresolved disagreement regarding the issuance of a Warning Letter by the U.S.
Food and Drug Administration (FDA) to UTMD in September 2001, and the lawsuit
UTMD has filed in U.S. Federal Court, District of Utah, in an effort to rectify
the FDA's withholding of export certificates.

On February 2, three FDA inspectors from Minneapolis, Dallas, and Denver arrived
at UTMD's Utah facility for another surprise inspection, the fourth
comprehensive inspection of the Company's Quality System in less than three
years. At the outset of the inspection, the inspectors agreed to notify UTMD
management as soon as they identified any condition that would rise to the level
of an observation of objectionable conditions. After eight full working days (24
inspector days), the inspectors have yet to report a single objectionable
condition. UTMD is pleased with this fact, but the inspection goes on without an
apparent end in sight.

UTMD advises that its devices are of state of the art quality preferred in
particular by sophisticated clinician users, and that its devices conform to the
quality and performance represented by UTMD. UTMD's quality systems have been
certified under ISO9001/ EN46001 quality standards since 1994, and
significantly, have recently been certified under the more stringent ISO13485
for medical devices. The ISO standards are quality system standards used by most
countries around the world including the U.S. The FDA's current Quality System
Regulation (QSR) was finalized, in part, during 1996 to be consistent with the
ISO standards; and, UTMD is secure in the belief that its manufacturing
procedures comply with any reasonable interpretation by qualified experts of the
FDA's QSR.

UTMD CEO Kevin Cornwell expressed his reaction to the FDA effort by stating:

         "On behalf of the 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. A normal FDA quality system inspection requires
         about five (5) total inspector days, according to FDA's own Website
         Data. In less than three years, UTMD has endured more than fifty-three
         (53) inspector days of inspection. Since an early 2002 inspection,
         there has been no attempt by the FDA to engage in constructive dialogue
         to resolve differences of opinion. The multiple inspections have not
         identified any health risk associated with our devices.




<PAGE>


         I am concerned that the FDA intends to further tarnish UTMD's good
         reputation through a motivation that has nothing to do with the safety
         or effectiveness of our devices. We recognize 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
         spurned. We are prepared to demonstrate our patient oriented "success"
         through law and principle, despite the FDA's June 2003 White Paper that
         defines its "success" by enforcement numbers. At a time when our
         President's top three economic priorities are jobs, jobs, and jobs,
         this example of FDA performance unfairly threatens this company and
         others who choose to manufacture their products in the U.S., and who
         contribute to improve life expectancy and economic well being for our
         residents.

         Because the FDA refused to engage in dialogue following the 2002 and
         2003 inspections, UTMD offered to make any reasonable changes in its
         quality system that FDA personnel requested, but they refused to
         identify any needed changes. Instead, they commenced this current
         extraordinary and wasteful inspection.

         Now, I believe it is 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 publicly disclosed. We invite our Congressional
         representatives who have a keen interest in the public welfare to use
         our experience in a formal investigation of FDA practices. To our
         clients throughout the world, I assure them that our continuing
         demonstration and commitment 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 a negligible
incidence of complaints by any objective standards of measurement. Mr. Cornwell
further expressed:

         "The confirmation of the success of UTMD manufacturing and quality
         procedures year after year is demonstrated by the excellent performance
         of our devices as used by skilled practitioners. UTMD builds its
         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 and cherished member
         of our family."

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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