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<SEC-DOCUMENT>0001096906-05-000133.txt : 20050407
<SEC-HEADER>0001096906-05-000133.hdr.sgml : 20050407
<ACCEPTANCE-DATETIME>20050407120132
ACCESSION NUMBER:		0001096906-05-000133
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20050407
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20050407
DATE AS OF CHANGE:		20050407

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:		05738561

	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>utahmedical8k040705.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): April 7, 2005


                           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 8.01 OTHER EVENTS
- --------------------------------------------------------------------------------


On April 7, 2005, Utah Medical Products, Inc. issued a press release providing
an update on the status of FDA litigation. A copy of the press release 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:          4/7/05                     By:   /s/ Kevin L. Cornwell
     --------------------------           ---------------------------
                                                    Kevin L. Cornwell
                                                    CEO




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

                                  EXHIBIT INDEX


Index
Number          Description
- ------          -----------
99.1            Press release issued April 7, 2005: UTMD Updates Status of FDA
                Lawsuit






</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>utahmedical8k04070599-1.txt
<TEXT>
                                  EXHIBIT 99.1

Salt Lake City, Utah - Utah Medical Products,  Inc. (Nasdaq:UTMD)  continues its
efforts to discover  the basis for a lawsuit  filed eight months ago by the Food
and Drug  Administration (FDA or Agency) in the U.S. District Court in Salt Lake
City,  alleging failure to comply with the FDA Quality System  Regulation (QSR).
The discovery of documents and deposition testimony of responsible FDA personnel
provides   considerable   doubt  about  FDA  management  of  its  resources  and
procedures, and interpretation of the QSR.

UTMD,  consistent  with the stated  intent of the QSR "to ensure  that  finished
devices will be safe and  effective..."  implemented  and  maintains  procedures
since the QSR became  effective in 1997.  On November 16, 2004,  UTMD  announced
that a FDA designated  enforcement  official admitted under oath that the FDA is
not claiming that UTMD's devices are unsafe, ineffective,  defective, or causing
any patient  harm.  UTMD  welcomed  these  admissions  and assures users that it
continues to manufacture safe and effective devices without interruption.

CEO Kevin Cornwell states,
         "We remain  disappointed  and  surprised  by the  conduct of  personnel
         within the FDA who are  responsible for this aggressive and unnecessary
         lawsuit  against UTMD and its employees.  Our desire has always been to
         manufacture and distribute  devices of the highest  quality.  I believe
         our  procedures  meet those  directed by the QSR,  conform to ISO 13485
         certification,  and  result in  release of high  quality  devices  that
         perform as intended. As the discovery process continues, I am confident
         that there is credible evidence to support responsible criticism of FDA
         performance."

During the last four months,  scores of FDA  documents  that would not otherwise
have seen the light of day have been produced  through the fairness  required by
the litigation process. Additionally,  testimony under oath has been provided by
numerous FDA personnel  including FDA device  specialists and national  experts.
One of the  national  device  experts was Monica  Wilkins,  a FDA  official  who
formerly reviewed  inspection reports,  and made  recommendations for regulatory
actions  including  injunctions.  As part of her testimony  under oath about her
five weeks'  duration  inspection  of UTMD during 2004 along with two FDA device
specialists,  Ms.  Wilkins  made a number  of  statements  that  support  UTMD's
position.

The questions  (denoted "Q") are being asked by UTMD legal counsel.  The answers
(denoted "A") are provided by Ms. Wilkins under oath.

     Q. So you found no evidence during the 2004 inspection that there were
        procedures required by the regulations that did not exist; is that true?
           A. What I recall, I don't remember citing anything specific to that,
              so that would be correct.

                                      ****

     Q. All I can ask you about is what you've  reviewed,  and based on what you
        reviewed  during  the 2004  inspection,  you found no  evidence  of Utah
        Medical failing to follow its own procedures; is that true?



<PAGE>


           A. That is true.
                                      ****

     Q. And through  looking at all of those records,  you didn't come up with a
        single  example in which you  believed a corrective  action  should have
        been open[ed] but wasn't; is that correct?
           A. ....no, I did not find any instance where they did not take
              corrective action.

                                      ****

     Q. That's the words I'm using.  There was no observation from the 2004
        inspection that a corrective action should have been open[ed] but
        wasn't; is that true?
           A. Yes, correct.
                                      ****

     Q. For the corrective actions that had been fully pursued and completed,
        you did not see any example of a corrective action that was undertaken
        but undertaken improperly; is that correct?
           A. Correct, for the sample of records I reviewed.

                                      ****

     Q. We've gone through a number of observations today in which you reached a
        different conclusion than the prior investigator.
           A. That is correct.
                                      ****

     Q. Do you ever  remember  another  inspection  in which  there were so many
        observations  that you  reached a  different  conclusion  than the prior
        inspector?
           A. That I wouldn't recall without looking at specific information.

                                      ****

CEO Kevin Cornwell states,
         "The  Federal  Court  will  interpret  the  evidence  presented  by the
         government and UTMD to decide whether or not UTMD is in compliance with
         the QSR.

          We sincerely  regret that the FDA selected  this avenue to discuss our
          disagreement  with observations and opinions made by FDA investigators
          and  reviewers  who never  have had the  training,  responsibility  or
          experience to manufacture medical devices. Our efforts to exercise our
          option to "disagree  with any agency  decision,  action,  or operation
          without fear of retaliation" as expressed in a required  attachment to
          the FDA 482  announcement of inspection was rejected and ignored.  Our
          repeated  requests  for feedback  regarding  UTMD's  detailed  written
          responses to FDA-483  observations were ignored.  Our multiple appeals
          to supervisory personnel were ignored. Our request to mediate prior to
          filing of the  lawsuit  was  ignored.  This was not the  reception  we
          expected when we sought to exercise our option to disagree in the year
          2001.




<PAGE>



          The facts do not  support  the FDA's  characterization  of UTMD in its
          lawsuit. UTMD has dedicated, well-trained personnel who understand the
          importance  of  accuracy  and  following  procedures  in the course of
          manufacturing  millions of specially  hand-assembled  devices. As UTMD
          proceeds to discover the truth,  the whole truth,  and nothing but the
          truth,  we hope that the new  representatives  of this  Administration
          will recognize that this lawsuit was neither  justified nor necessary.
          Moreover,  we truly believe that the right thing for the government to
          do is to  acknowledge  the  great  performance  of UTMD  during a long
          history  of  providing  safe and  effective  medical  devices  for the
          benefit of health care providers and their patients."

For the benefit of shareholders,  UTMD affirms its belief in previous statements
in press releases about its  conscientious  compliance  with the QSR, as well as
significant deficiencies in the FDA's performance,  which have been increasingly
supported by the evidence in  discovery to date.  For the benefit of  customers,
UTMD  continues to  manufacture  and  distribute  all of its safe and  effective
products worldwide without any regulatory restriction.

Utah Medical Products,  Inc., with particular  interest in health care for women
and their babies, develops, manufactures, assembles and markets a broad range of
well-established,  proven safe and effective,  disposable and reusable specialty
medical devices.


</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
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