In Part I of this two-part series we looked at how a number of surgical instrument companies introduced ”modular” instruments that could be disassembled for internal cleaning during processing. The concept was intended to reduce the risk of a surgical infection caused by an instrument that remains contaminated with bioburden and debris after processing.
The manufacturers of modular instruments claim that once you’ve disassembled an instrument, you can visualize the bioburden inside of the instrument and manually remove it during processing. As was explored in Part I, the human eye is NOT capable of seeing microscopic bacteria and biofilm on the surface of a surgical instrument. Both AAMI and the Healthcare Sterile Processing Association (HSPA and formerly IAHCSMM) have long been aware of the limitations and dangers of relying on ”visual” inspection to insure the removal of bioburden and debris from instruments during processing.
AAMI’s ST 79 on cleaning IFUs clearly states, “Visual inspection alone may not be sufficient for assessing the efficacy of cleaning processes.” ST79 goes on to state, “The use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.”1
HSPA points out in its CRCST Self-Study Lesson Plan, “Understanding Biofilm,” “Even with the use of most visual enhancing tools, microorganisms will still not be seen. To help solve this problem, tests have been developed to help verify that cleaning quality standards have been attained. These tests include protein tests and adenosine triphosphate (ATP) bioluminescence tests, both of which test for residual soils, and which might also be suggestive of biofilm formation.”2
As followers of #IFUcan have learned, the only way to ensure clean, sterile, moisture-free surgical instruments on every processing cycle is only to use instruments whose cleaning and sterilization IFUs have been validated using AAMI and FDA testing protocols. Presently, there is no brand, make or style of modular instruments available whose cleaning and sterilization IFUs have been validated using AAMI and FDA validation testing protocols.
The personnel at The Joint Commission (TJC) have also been very concerned about the problems associated with reprocessing modular instruments. Their concerns start in the O.R. where pre-treating at point-of-use prior to transport is often lacking, or simply non-existent. TJC was so concerned that in January 2011 the organization revised the guidelines for its inspection teams in the operating rooms.
Specifically, the revised TJC guidelines read as follows:
“Some typical point-of-use shortcuts that have been observed in operating rooms are: Not unlocking instruments; not disassembling instruments; not wiping off gross material and body fluids during procedures; not moistening or pre-treating instruments before transporting them for sterile processing; and not returning instruments to their proper containers.”3
Based on TJC’s January 2011 inspection guidelines, it is obvious that the failure of O.R. personnel to disassemble and manually prepare modular instruments for transport is a major concern/problem. An even greater concern/problem exists once modular instruments arrive in CS/SPD for decontamination, cleaning and sterilization if they are not properly disassembled, cleaned and properly reassembled.
One of the many problems with modular instruments is that most are not labeled as ”modular,” and as such O.R., CS and SPD personnel don’t disassemble them for processing. In fairness to O.R., CS and SPD personnel, most modular instruments look just like conventional, non-modular instruments. When modular instruments are not disassembled during processing, bioburden and debris quickly accumulates within the instrument. This accumulation of bioburden and debris can increase the risk of a surgical infection caused by the contamination that remains trapped inside of the instrument.
Another significant problem with modular instruments that are re-assembled prior to sterilization is that residual moisture can remain trapped inside of the instrument after the sterilization cycle. This greatly increases the risk of an instrument contaminated with waterborne pathogens being returned to surgery. To avoid this problem, you should only use instruments whose sterilization IFUs have been validated to return moisture-free instruments after the sterilization cycle. This significantly reduces the risk of a surgical infection caused by water-borne pathogens and it also reduces the potential for rust to form within the instrument.
Next to infecting a patient with a contaminated instrument, the second most important concern for the surgeon is the tactile feel and response of the instrument coupled with the bite force that can be applied to the jaw. To be easily disassembled and re-assembled, modular instruments are not built with the same tight tolerances that conventional, non-modular instruments are built to. That is why no modular design will ever be able to match the tactile feel, response and bite force of a conventional, non-modular surgical instrument.
In summary, there are no studies that document lower infection rates with the use of modular instruments. Additionally, there are no brands, makes or styles of modular instruments whose cleaning and sterilization IFUs have ever been validated using AAMI and FDA validation testing protocols.
Given the time and effort required to manually decontaminate and clean a non-validated modular instrument (several minutes) vs. a simple flush with a conventional, flushable instrument (several seconds) whose IFUs have been validated, you have to question why a facility would continue to purchase and use non-validated modular instruments. If your facility isn’t using instruments whose cleaning and sterilization IFUs have been validated using AAMI and FDA validation testing protocols, you have no way of insuring clean, sterile, moisture-free instruments for every patient, every time!
1 AAMI’s ST 79; 2017 “Comprehensive Guide to Steam Sterilization”
2 HSPA’s CRCST Self-Study Lesson Plan, “Understanding Biofilm”
3 The Joint Commission inspection guidelines for “Point-of-use preparation,” (www.jointcommission.org)
Prior to his retirement in December 2018, James Schneiter had been the founder, owner and president of America’s MedSource Inc., which designed, developed, licensed and marketed a variety of implantable vascular devices, laparoscopic devices and neurosurgical instruments. Schneiter has nearly five decades of experience in medical device design and production, is a recognized expert in instructions for use (IFU) and independent laboratory IFU validation studies and is a co-founder of #IFUcan, an online community that examines and explores the world of manufacturer IFUs. Schneiter can be reached at [email protected].
Katika sehemu ya kwanza ya mfululizo huu wa sehemu mbili tulitazama jinsi makampuni kadhaa ya vyombo vya upasuaji yalivyoanzisha vyombo vya "modular" ambavyo vinaweza kutenganishwa kwa ajili ya kusafisha ndani wakati wa usindikaji. Dhana hiyo ilikusudiwa kupunguza hatari ya maambukizo ya upasuaji yanayosababishwa na chombo ambacho kinabaki kuchafuliwa na mzigo wa kibiolojia na mabaki baada ya usindikaji. Watengenezaji wa vyombo modular kudai kwamba mara moja umekuwa disassembled chombo, unaweza kuona bioburden ndani ya chombo na manually kuondoa wakati wa usindikaji. Kama ilivyoelezwa katika sehemu ya kwanza, jicho la binadamu haliwezi kuona bakteria ndogo na biofilm kwenye uso wa kifaa cha upasuaji. AAMI na Shirika la Utaratibu wa Utoaji wa Sterili wa Huduma za Afya (HSPA) wamekuwa wakijua kwa muda mrefu juu ya mapungufu na hatari za kutegemea ukaguzi wa "kuona" kuhakikisha kuondolewa kwa mzigo wa kibiolojia na mabaki kutoka kwa vyombo wakati wa usindikaji. "Kama ilivyoelezwa katika AIMI ST 79 juu ya kusafisha IFU, ""Uchunguzi wa kuona peke yake hauwezi kuwa wa kutosha kwa kutathmini ufanisi wa michakato ya kusafisha."" ST79 inaendelea kusema, ""Matumizi ya mbinu ambazo zinaweza kupima mabaki ya kikaboni ambayo hayawezi kugunduliwa kwa kutumia ukaguzi wa kuona yanapaswa kuzingatiwa katika sera ya kusafisha kituo na taratibu za kusafisha.""" Ili kusaidia kutatua tatizo hili, vipimo vimeundwa kusaidia kuthibitisha kwamba viwango vya ubora wa kusafisha vimepatikana. "Mchunguzi wa ""Adenosine triphosphate (ATP) bioluminescence"" unaonyesha kwamba kuna uwezekano wa kuunda biofilm, na kwa hivyo, ni muhimu kuhakikisha kuwa vifaa vya upasuaji ni safi, visivyo na unyevu, na vya kutosha kwa kila mzunguko wa usindikaji." Kwa sasa, hakuna chapa, mtindo au mtindo wa vifaa vya modular vinavyopatikana ambavyo kusafisha na sterilization IFUs zimethibitishwa kwa kutumia AAMI na FDA itifaki za upimaji wa uthibitisho. Wafanyakazi katika Tume ya Pamoja (TJC) pia wamekuwa na wasiwasi sana kuhusu matatizo yanayohusiana na usindikaji wa vyombo modular. Mahangaiko yao huanza katika chumba cha upasuaji. Kwa hivyo, matibabu ya awali katika mahali pa matumizi kabla ya usafirishaji mara nyingi hayapo, au hayapo kabisa. TJC ilihisi wasiwasi sana hivi kwamba mnamo Januari 2011, shirika hilo lilirekebisha miongozo kwa timu zake za ukaguzi katika vyumba vya upasuaji. "Miongozo ya TJC ilisema: ""Mambo ya kawaida ya njia za mkato ambazo zimegunduliwa katika vyumba vya uendeshaji ni: kutofungua vyombo, kutofungua vyombo, kutofuta vifaa vya mwili wakati wa taratibu, kutoingiza au kutunza vyombo kabla ya kuvihamisha kwa usindikaji wa sterili, na kutorudisha vyombo kwenye vyombo vyao sahihi.""" Utaratibu wa kuunganisha na kuunganisha vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa vya vifaa. Matatizo makubwa zaidi yanatokea mara tu vyombo vya modular vinapofika katika CSP kwa ajili ya kuondoa uchafuzi, kusafisha na sterilization ikiwa hazijakatwa vizuri, kusafishwa na kuunganishwa tena. Moja ya matatizo mengi na vyombo modular ni kwamba wengi si labelled kama "modular", na kama vile O.R., CS na SPD wafanyakazi si disassemble yao kwa ajili ya usindikaji. Kwa mujibu wa O.R.C.S.P.D. na S.P.D.P.D.S.P.D., vifaa vya kawaida vya kuagiza vinaonekana kama vifaa vya kawaida. Wakati vyombo modular si disassembled wakati wa usindikaji, bioburden na takwimu haraka hukusanyika ndani ya chombo. Kujipanga kwa bio-uzito na mabaki kunaweza kuongeza hatari ya maambukizo ya upasuaji yanayotokana na uchafuzi ambao unabaki ndani ya chombo. Tatizo jingine kubwa na vyombo modular kwamba ni reassembled kabla ya sterilization ni kwamba unyevu mabaki inaweza kubaki kukamatwa ndani ya chombo baada ya mzunguko sterilization. Hilo huongeza sana hatari ya chombo kilichochafuliwa na vimelea vinavyosababisha magonjwa vinavyosambazwa na maji kurudishwa kwenye upasuaji. Ili kuepuka tatizo hili, unapaswa tu kutumia vyombo ambayo sterilization IFUs wamekuwa kuthibitishwa kurudi vyombo unyevu-free baada ya mzunguko sterilization. Hii hupunguza hatari ya maambukizi ya upasuaji yanayotokana na vimelea vinavyosababishwa na maji na pia hupunguza uwezekano wa kutu kufanyizwa ndani ya chombo. Baada ya kuambukiza mgonjwa na kifaa cha kuambukiza, wasiwasi wa pili muhimu kwa daktari wa upasuaji ni hisia ya kugusa na majibu ya kifaa pamoja na nguvu ya kuumwa ambayo inaweza kutumika kwa taya. Kwa kuwa ni rahisi kutenganishwa na kuunganishwa tena, vyombo vya modular havijengwa kwa uvumilivu sawa na vyombo vya kawaida, visivyo vya modular. Kwa hiyo hakuna muundo wa moduli utaweza kulinganisha hisia ya kugusa, majibu na nguvu ya kuumwa ya kawaida, vifaa vya upasuaji visivyo vya moduli. Kwa muhtasari, hakuna masomo ambayo yanaonyesha viwango vya chini vya maambukizi kwa kutumia vyombo vya modular. Kwa kuongezea, hakuna bidhaa, bidhaa au mitindo ya vifaa vya modular ambavyo kusafisha na sterilization IFUs zimewahi kuthibitishwa kwa kutumia AAMI na FDA itifaki za upimaji wa uthibitisho. Kwa kuzingatia muda na juhudi zinazohitajika kwa kuondoa uchafuzi na kusafisha kifaa cha modular kisicho na uthibitisho (duka la dakika) dhidi ya kusafisha rahisi na kifaa cha kawaida, kinachoweza kusafishwa (sekunde kadhaa) ambacho IFU imethibitishwa, lazima uulize kwa nini kituo kitaendelea kununua na kutumia vifaa vya modular visivyo na uthibitisho. Ikiwa kituo chako hakitumii vyombo ambavyo kusafisha na sterilization IFUs zimethibitishwa kwa kutumia AAMI na FDA itifaki za kupima uthibitisho, huna njia ya kuhakikisha safi, sterile, unyevu-free vyombo kwa kila mgonjwa, kila wakati! "AKA ""Mwongozo wa kina wa sterilization ya mvuke"" (AAMI ST 79), ""Mwongozo wa kina wa sterilization ya mvuke"" (HSPA CRCST Self-Study Lesson Plan) na ""Mwongozo wa ukaguzi wa Tume ya Pamoja kwa ajili ya utayarishaji wa hatua ya matumizi"" (JCC) kabla ya kustaafu kwake mnamo Desemba 2018, James Schneider alikuwa mwanzilishi, mmiliki na rais wa MedSource Inc., ambayo ilibuni, kuendeleza, leseni na kuuza vifaa mbalimbali vya mishipa ya mishipa, vifaa vya laparoscopic." Schneider ana karibu miongo mitano ya uzoefu katika kubuni na uzalishaji wa vifaa vya matibabu, ni mtaalam anayetambuliwa katika maagizo ya matumizi (IFU) na majaribio ya uthibitisho wa maabara ya kujitegemea ya IFU, na ni mwanzilishi mwenza wa #IFUcan, jamii ya mtandaoni ambayo inachunguza na kuchunguza ulimwengu wa IFU ya mtengenezaji. Schneiter anaweza kupatikana katika [email protected].