Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.

United States. Congress. Senate. Committee on Governmental Affairs

Date:: 2003

Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.

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$GH he ananamon oe SISOS cee ce LYKINS VS. -CRYOLIFE, ET AL: 7 RESULTER If A £98,000 SAVING. WITHOUT ANY INCREASED RISK. Q AND SDE 1997 HAVE YOU REINITIATER PRE- PROCESSING TEST WG? 4 CUSTOMERS REQUESTED WE DO THAT. Q eHo? : RESPOND TO THE REQUESTS CF CUSTONERS. CUSTOMERS IF Was NOT = AYES. Q WHAT YAS TRE RESPONSE? A THEY WERE CONCERNED THAT THEY WANTED To AVOID ANY APPEARANCE -- THEY DID NOT UNDERSTAND THE ISSUES, IN MY OPINION, IN’ HAY CASES.” IN OTHER CASES TO NO THAT. IN ADOITTON I BELIEVE TH SEVERAL JHSTANCES 79 Q AD SO THEH THE BASIC REASON THAT You STARTED PRE-PROCESSING TESTING YAS — WAS TO ENSURE THE GND CUSTOMER -- OR SCRATCH THAT. YOU RESTARTED PRE-PROCESSING TESTING ; BECAUSE YOUR CUSTOMER -- THE END CUSTOMER, THE HOSPITALS AND THE DOCTORS GUT THERE -~ UANTER IO SEE IT DONE. © A THERE WERE REQUESTS FROM PEOPLE SUPPLYING ALLOGRAFTS AQ THERE VERE REQUESTS FROM PEOPLE YHO VERE 8E 00 THAT AKO VE MUST MEET CUSTONER NEEDS AND Q AHD THAT'S THE ONLY REASOH WHY YOU STARTED PRE-PROCESSING TESTING. nN THAT 3S THE ONLY AEASON YE RESTARTED THAT PRE-PROCESSING CULTURE. Q AND BEFORE I LEAVE THAT MEHO, THE -- EXHIBIT 4, YOU -- YOU FEEL IN.1997 THAT THE SAVINGS oF $90,080 VAS \ HINOR CONSTDERATIGN IN STOPPING PRE- TESTING -- PROCESSING TESTING? A IT WAS CERTAINLY WOT THE DRIVING FORCE oR ANY PRIME — PRIKE REASOM IT WAS IMPLEMERTED. THE VAST AMOUNT OF THS MEMO GOES INTO HOU, IF WE PUT ik AK ADOED TEST AT THE ENO, VE ¥OULO MAKE UP FOR AND PROVIDE COMPLETE EQUIVALENT ASSURANCE ON THE ELIMINATION. It SUST WASN'T EL THEHATED. THERE BAG AEOOMHODAT FOR FOR BoOarnraunaA wm = BGORFRBeananea one 78 WHAT VE WANT TO DO AND HAVE, REGARDLESS OF THE sCTENCE OF Jf. If IS BENEFICIAL TO THE HOSPITAL FROM JUST ne) JUST THE SEXSE OF DOING IT, SO UE REINSTITUTED IT FoR THAT REASON, BECAUSE WE HAD NO CHANGE OF THOUGHT PROCESS] THAT IT MAKES & DIFFERENCE. a SO THE PRE PROCESSING (ESTING THAT WAS DOKE IN JUNE OF 2882 WAS DONE BECAUSE IT -~ OF MARKETING PURPOSES. NR. MAJOR: OBJECT 10 THE FORK OF THE QUESTION. IT HISCHARACTERIZES His TESTIMONY. TRE DEPONENT: WE HAD PEOPLE TO WHOM UE*RE SUPPLYING ALLOGRAFTS AND YE RAD PEOPLE wio WERE SUPPLYING TISSUE THAT WOULD GENERATE ALLOGRAFTS HO REQUESTED THAT WE IMPLENENT THAT, FoR WHATEVER REASONS, AND THERE VERE A VARIETY OF REASOS -- AS I UNDERSTAID It, *CAUSE I RAD RO DIRECT ‘CONTACT. I'M GIVING YOU MY URDERSTANDING OF THE SITUATION, BUT IT CERTADILY SASH‘T pox BECAUSE JE HAD DISCOVERED SOME DATA OR SCIENCE THAT SAID THAT UE HAD SEEN YRONG BEFORE. BY WR. ALLER: Q SO THE BOTTOM LINE, YOU DIDN'T RESTART THE! PRE-PROCESSING TESTING BECAUSE OF SOME SCIENTIFIC DATA THAT WAS PUT FORWARD TO You. WHAT VE VERE USING THE TESTING FOR AND Ov TO ACCOMMODATE THAT MORE E-FICIENTLY. Q I JUST WANT TO FINISH REARING THE REST OF THAT — THAT FIRST PARAGRAPH. ABDITIONAL CONSTDERATIONS INCLUDE AVOIDING THE NEED To AND TNCUBATOR AND LAB FLOOR SPACE, kS WELL AS A SECOND FTE — UHICK IS, STANDS FOR? a FULL TIME EQUIVALENT. “a UHICH IS PERSONNEL? a PERSONNEL. € OKAY. ~~ FOR THE EXPANDING PRE-TREATHENT jf WORKLOAD NOT PROVIDED FOR IM CURRENT LAB DESIGH, PERTOD.| APPROXIMATELY 1.5 PERCENT OF THE POST-TREATMENT CIRTURES| WOULD REQUIRE A RETEST WHICH Is NOT CURRENTLY PERFORMED DUE TO MATCH BETWEEM PRS- ANO POST-TREATMENT ORGANISMS. } OID I READ THAT RIGHT? A CORRECT. a SO IN YOUR ESTIMATION, 1.5 PERCENT OF -- OF TISSUES THAT CAME OUT OF PROCESSING YOULD -- WOULD WEED AN ADDITIONAL TEST, IS THAT ECORRECT? rN Di -~ IN OUR REVIEV OF TT AND THE CIRCUMSTANCES OF HOU VE VERE USING THE BESULTS, UE OETERNIMED THAT YE OULD REED TO ADD TESTING, UHICH UE DIO, TO GIVE EQUIVALENT RESULTS, OM 1.5 PERCENT OF IRE PRODUCT.$