Practical Guide for Selection of MVA Instruments

Publication date: 2004

Practical Guide forPractical Guide for Selection ofSelection of MVMVA InstrumentsA Instruments Chimco Ipas Single-Valve MedGyn Eve JMS Milex Laboratoire C.C.D. Pahsco Ipas Double-Valve MVA Instruments Evaluated Photos courtesy of PATH. Unsafe abortion is a major public health problem world- wide. The World Health Orga- nization estimates that each year about 70,000 women die from abortion compli- cations—complications that could easily be treated if women had access to appropriate and timely care. One of the most important approaches to preventing complications of unsafe abortion around the world is the introduction of manual vacuum aspiration (MVA) as a safe and effective alternative method of uterine evacuation. This technology offers many advantages to country health systems, including reduced cost of service delivery, expanded provision of postabortion care to lower-level health care facilities, and substan- tially reduced major medical complications. However, the instruments used for MVA vary in quality, cost, and local availability. In an effort to help buyers assess the various MVA instruments on the market, EngenderHealth and the Program for Appropriate Technology in Health (PATH) conducted the first-ever comparative evaluation of MVA instruments in 2001, testing the durability, qual- ity, safety, and usability of all instruments available at the time. In addition, for each product evaluated, information was compiled about the product, its dis- tribution, and the manufacturer’s contact information. In the field, MVA instruments (syringes and cannulae) are often used in ways that were neither intended nor tested by the manufacturer. For exam- ple, while the instruments typically are not designed for repeated use, they often are used many times before being discarded. In addition, improper cleaning or storage techniques, as well as combined use of syringes and cannulae from different manufacturers, are common, and generally are not addressed by prod- uct information or instructions tailored to ideal use. As no widely known standards existed for evaluating MVA instruments under field conditions, innovative laboratory tests were created for this evaluation to compare and contrast all instruments (see Table 1). The tests were designed to assess the instruments after repeated use, and did not necessarily reflect manufacturers’ internal quality assurance procedures or policies. In addition to providing useful information about the ways that the instruments evaluated endure real-life conditions, the procedures and standards created for all these tests may also serve as important future guides for assessing products that were not evaluated (e.g., new products and/or those that were not avail- able at the time of the evaluation). For this purpose, a description of test procedures and standards is pro- vided in Table 1. This guide does not make recommendations for any single instrument or instru- ments. Rather, it outlines sev- eral findings related to instru- ment handling, cleaning, and processing necessary for optimal instrument functioning (see Table 2). These findings, which may provide a useful context for choosing the right instrument for a particular health care setting, indicate that: ➴Both boiling and steam sterilization techniques seemed to cause moderate to significant change in quality and durability among all cannulae tested. Use of bleach and glutaraldehyde were the only methods of disinfection that did not cause signifi- cant cannula change (such as a decrease in cannu- la flexibility, and loss or alteration of depth or size markings) in any of the instruments tested. Practical Guide for Selection of MVA Instruments Introduction Tests and Standards Narrative Summary of Findings EngenderHealth Practical Guide for Selection of MVA Instruments 1 Figure and Tables Page 2 Figure 1. Basic Components of an MVA Kit Page 3 Table 1. Test Procedures and Standards Page 4 Table 2. Overall Comparison of MVA Instruments Page 7 Table 3. Cross-Compatibility of MVA Instruments Page 8 Table 4. Manufacturer and Product Information 2 Practical Guide for Selection of MVA Instruments EngenderHealth ➴Soft brushes were more appropriate for use in cleaning syringes and cannulae than were metal brushes or hard substances, which caused damage to some of the instruments and/or left grooves that can invite or lodge contaminants. ➴Some of the cannulae evaluated did not have uterine-depth markings (or the markings wore off easily during repeated processing), making them inappropriate for use by inexperienced providers, as working without such a guide may result in uterine perforation. ➴Assembly and disassembly of all single-valve instru- ments was difficult for most users. This is especially significant, as instruments that cannot be fully disas- sembled and reassembled are difficult to clean ade- quately, to sterilize properly, and to use effectively. ➴One single-valve and one no-valve instrument showed significant vacuum loss after 10 minutes. ➴None of the no-valve instruments tested created a vacuum until they were inserted in the uterus. This is significant, because creating a vacuum while inside the uterus can increase the risk of uterine perforation. ➴The no-valve instruments were incompatible for use with almost every other instrument. Using syringes and cannulae produced by different manu- facturers is a common prac- tice among MVA instrument users in the field. The Cross- Compatibility Test helps identify each syringe’s ability to provide a proper fit when used with cannulae from each of the other manufacturers evaluated (Table 3). The study affirms that no sin- gle brand of MVA instrument is perfectly suited to every set- ting, and no single element of the instruments unequivocally identifies one brand as superior to another. As such, findings from the tests were not used to develop overall rankings of the instruments evaluated. However, it is evident that certain instruments do not meet minimum safety, functionality, and durability standards. Moreover, the results suggest that while the lowest- cost MVA instruments may appear most appealing to procurers of equipment, these products may not necessarily be the safest or most cost-effective, due to their decreasing safety, functionality, or effectiveness over time. Accordingly, some products that cost more at the outset may in fact prove less expensive over the long term. Cross- Compatibility of MVA Instruments Conclusions Cannula Syringe Valve Barrel Plunger Valve liner O-ring Figure 1. Basic Components of an MVA Kit EngenderHealth Practical Guide for Selection of MVA Instruments 3 Evaluation parameter Test name Test procedures and standards Durability Disinfection/ Sterilization Test ■ Bleach ■ Boiling ■ Glutaraldehyde ■ Steam sterilization Cannula Tip Kink Test Evaluated each instrument’s ability to withstand various disinfection/sterilization methods. Following are the changes noted after each disinfection/sterilization process: ■ Each instrument was submerged in a 0.5% NaOCl (diluted bleach) solution continuously for 50 hours (rotated every 24 hours) and then was removed, rinsed, and dried. ■ Each instrument underwent five cycles of submersion in boiling water for 20 minutes, with a 20-minute cool-down period between cycles. ■ Each instrument was submerged in a 2.4% glutaraldehyde solution continuously for 50 hours (rotated every 24 hours) and then was removed, rinsed, and dried. ■ Each instrument underwent five steam sterilization cycles, at 121°C, in a conventional steam sterilizer. Each cycle lasted 20 minutes, with a 20-minute cool-down period between cycles. Using a computer-controlled tensile test machine, evaluated the force required to kink the tip of the cannula. Quality Finish, Fit, and Function Test Vacuum Test ■ Finish: Visually inspected the new cannulae and syringes for irregularities. ■ Fit: Tested the force required to remove a 5-mm cannula from a syringe (with vacuum, without vacuum, when wet, and after each disinfection/sterilization test); conducted a deflection test (to evaluate whether the cannula could be inadvertently knocked out of the instrument by a back-and-forth motion applied to the cannula). ■ Function: Measured the pull force required to establish vacuum (after 25, 50, 100, and 125 vacuum cycles). Measured the ability of the new syringe, the open and closed valves (in instruments with valves), and the entire instrument (including the cannula) to retain vacuum. The instrument and gauge were left in a horizontal position; presence of retained vacuum was recorded after 10 and 60 minutes. Safety Cannula Cleaning Test Instrument Marking Test The cannulae were immersed for 5 minutes in a solution of simulated blood and products of conception (POCs) and then removed and dried for 4 hours. They were then immersed in a 0.5% NaOCl (diluted bleach) solution for 10 minutes and cleaned with a toothbrush and soapy water for 2 minutes. After cleaning, the cannulae were reexamined, and areas of contamination were noted. Compared the initial clarity of the depth and size markings (if any) on the cannulae with that after the cannulae underwent disinfection/sterilization testing. Usability Ease-of-Use Test Ease-of-Learning Test Instructions and Packaging Test Cross-Compatibility Test Asked experienced users to compare their experience of assembling each instrument, using it on a pelvic model, and then disassembling it. Demonstrated the assembly and use of each instrument to new users, then asked the users to compare their experience of assembling each instrument, using it on a pelvic model, and then disassembling it. Evaluated the written and graphic content of each instrument’s instructions and packaging for clarity; appropriate layout, context, and perspective; and clear use of text and pictures. Measured the length of time that syringes and cannulae produced by different manufacturers maintained vacuum when used together. If vacuum was maintained for at least 30 seconds, the instruments were considered compatible. Table 1. Test Procedures and Standards 4 Practical Guide for Selection of MVA Instruments EngenderHealth Ta bl e 2. O ve ra ll Co m pa ris on o f M VA In st ru m en ts (N ote s f o llo w o n p ag e 6. ) Br an d Ki t i nf o rm at io n Du ra bi lit y Qu al ity Sa fe ty Us ab ili ty SI NG LE -V A LV E SY RI NG ES Ch im co Ki t p ric e: No in fo rm at io n Ca nn ula s ize s av ai la bl e: 4 to 1 2 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e; do es n ot w ith st an d st ea m st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :M an y irr eg ula rit ies Fi t: M od er at e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um : No lo ss a fte r 1 0 m in ut es ; s lig ht lo ss a fte r 60 m in ut es Cl ea ni ng :T ip re se rv oi r t ra ps co nt am in an ts ; r ou gh fi nis h; n o ad ap te r Ca nn ul a m ar kin gs :N on e ar e pr ov id ed Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :T ex t h ar d to re ad ; a de qu at e gr ap hic s Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Ev e Ki t p ric e: $3 0.7 5 Ca nn ula s ize s av ai la bl e: 4 to 8 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s glu ta ra lde hy de ; m od er at ely w ith st an ds b le ac h, b oi lin g, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Le ss s ec ur e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um :S lig ht lo ss a fte r 10 a nd 6 0 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r b oi lin g Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :T ex t e as ie st to re ad ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Ip as Si ng le - Va lv e Ki t p ric e: $2 0.2 5 t o $ 41 .50 Ca nn ula s ize s av ai la bl e: 4 to 7 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e, s te am ; m od er at el y wi th st an ds b oi lin g Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu la rit ie s Fi t: M od er at e Fu nc tio n: Lo we st p ul l f or ce n ee de d Va cu um :N o lo ss a fte r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r s te am st er iliz at io n Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :C om pr eh en siv e; co m pl ex d et ai l in s om e se ct io ns ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 4 of 2 7 ca nn ul ae JM S Ki t p ric e: $5 .50 Ca nn ula s ize s av ai la bl e: 4 to 8 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e; d oe s n ot w ith st an d bo ilin g or s te am st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ib ilit y un kn ow n. Fi ni sh :M od er at e nu m be r o f irr eg ula rit ies Fi t: Le ss s ec ur e Fu nc tio n: Lo we st p ul l f or ce n ee de d Va cu um :S ign ific an t l os s af te r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi nis h; n on re m ov ab le a da pt er Ca nn ul a m ar kin gs :N o de pt h m ar kin gs a re p ro vid ed Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :C le ar ly la id o ut ; sm al l t yp e; m in im al g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Pa hs co Ki t p ric e: $4 .00 to $5 .00 Ca nn ula s ize s av ai la bl e: Un kn ow n IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Le ss s ec ur e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um : Sl igh t l os s af te r 10 m in ut es ; s ign ific an t l os s af te r 6 0 m in ut es Cl ea ni ng :S m oo th fi nis h; n o ad ap te r Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r b oi lin g Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :L ar ge fo rm at ; or de r o f i nf or m at io n m ay b e co nf us in g; a de qu at e gr ap hic s Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 9 of 2 8 ca nn ul ae Ta bl e 2. O ve ra ll Co m pa ris on o f M VA In st ru m en ts (N ote s f o llo w o n p ag e 6. ) Br an d Ki t i nf o rm at io n Du ra bi lit y Qu al ity Sa fe ty Us ab ili ty SI NG LE -V A LV E SY RI NG ES Ch im co Ki t p ric e: No in fo rm at io n Ca nn ula s ize s av ai la bl e: 4 to 1 2 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e; do es n ot w ith st an d st ea m st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :M an y irr eg ula rit ies Fi t: M od er at e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um : No lo ss a fte r 1 0 m in ut es ; s lig ht lo ss a fte r 60 m in ut es Cl ea ni ng :T ip re se rv oi r t ra ps co nt am in an ts ; r ou gh fi nis h; n o ad ap te r Ca nn ul a m ar kin gs :N on e ar e pr ov id ed Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :T ex t h ar d to re ad ; a de qu at e gr ap hic s Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Ev e Ki t p ric e: $3 0.7 5 Ca nn ula s ize s av ai la bl e: 4 to 8 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s glu ta ra lde hy de ; m od er at ely w ith st an ds b le ac h, b oi lin g, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Le ss s ec ur e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um :S lig ht lo ss a fte r 10 a nd 6 0 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r b oi lin g Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :T ex t e as ie st to re ad ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Ip as Si ng le - Va lv e Ki t p ric e: $2 0.2 5 t o $ 41 .50 Ca nn ula s ize s av ai la bl e: 4 to 7 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e, s te am ; m od er at el y wi th st an ds b oi lin g Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu la rit ie s Fi t: M od er at e Fu nc tio n: Lo we st p ul l f or ce n ee de d Va cu um :N o lo ss a fte r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r s te am st er iliz at io n Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :C om pr eh en siv e; co m pl ex d et ai l in s om e se ct io ns ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 4 of 2 7 ca nn ul ae JM S Ki t p ric e: $5 .50 Ca nn ula s ize s av ai la bl e: 4 to 8 m m IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e; d oe s n ot w ith st an d bo ilin g or s te am st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ib ilit y un kn ow n. Fi ni sh :M od er at e nu m be r o f irr eg ula rit ies Fi t: Le ss s ec ur e Fu nc tio n: Lo we st p ul l f or ce n ee de d Va cu um :S ign ific an t l os s af te r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi nis h; n on re m ov ab le a da pt er Ca nn ul a m ar kin gs :N o de pt h m ar kin gs a re p ro vid ed Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :C le ar ly la id o ut ; sm al l t yp e; m in im al g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 8 of 2 7 ca nn ul ae Pa hs co Ki t p ric e: $4 .00 to $5 .00 Ca nn ula s ize s av ai la bl e: Un kn ow n IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Le ss s ec ur e Fu nc tio n: Lo we r p ul l f or ce n ee de d Va cu um : Sl igh t l os s af te r 10 m in ut es ; s ign ific an t l os s af te r 6 0 m in ut es Cl ea ni ng :S m oo th fi nis h; n o ad ap te r Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r b oi lin g Us e an d le ar n in g: Di ffic ul t as se m bl y an d di sa ss em bl y In st ru ct io ns :L ar ge fo rm at ; or de r o f i nf or m at io n m ay b e co nf us in g; a de qu at e gr ap hic s Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 9 of 2 8 ca nn ul ae EngenderHealth Practical Guide for Selection of MVA Instruments 5 Fl ex ibl e. 10 m in ut es ; s ign ific an t l os s af te r 6 0 m in ut es Cr os s co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 9 of 2 8 ca nn ul ae DO UB LE -V A LV E SY RI NG ES Ip as D ou bl e- Va lv e Ki t p ric e: $2 7.2 5 t o $ 66 .25 Ca nn ula s ize s av ai la bl e: 4 to 1 0 m m a nd 1 2 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e; d oe s n ot w ith st an d bo ilin g or s te am st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Ve ry s ec ur e Fu nc tio n: G re at es t p ull fo rc e n ee de d Va cu um : No lo ss a fte r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r s te am st er iliz at io n Us e an d le ar n in g: Di ffic ul t di sa ss em bl y In st ru ct io ns :C om pr eh en siv e; co m pl ex d et ai l in s om e se ct io ns ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 4 of 2 7 ca nn ul ae NO -V AL VE S YR IN G ES La bo ra to ire C. C. D. Ki t p ric e: No in fo rm at io n Ca nn ula s ize s av ai la bl e: Un kn ow n IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e, s te am ; m od er at el y wi th st an ds b oi lin g Ca nn ula e: St ro ng ly wi th sta nd bl ea ch ; m od er at el y wi th - st an d glu ta ra lde hy de ; d o no t w ith st an d bo ilin g. F lex ibi lity un kn ow n. Fi ni sh :M an y irr eg ula rit ies Fi t: Ve ry s ec ur e Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Si gn ific an t l os s af te r 1 0 an d 60 m in ut es Cl ea ni ng :F ro st ed c an nu la an d op aq ue , n on re m ov ab le ad ap te r i m pa ir vis ua liz at io n Ca nn ul a m ar kin gs :N o de pt h m ar kin gs a re p ro vid ed Us e an d le ar n in g: Di ffic ul t an d in co m pl et e di sa ss em bl y. Pl un ge r c an no t b e pu lle d ba ck u nt il t he a ss em bl ed M VA in st ru m en t i s in sid e th e ut er us . In st ru ct io ns :N on e in clu de d Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t ca nn ul ae M ed G yn Ki t p ric e: $5 .50 Ca nn ula s ize s av ai la bl e: 4 to 6 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ib ilit y va rie s; s om e ar e rig id. Fi ni sh :F ew ir re gu lar itie s Fi t: No t t es te d Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Ne w eq ui pm en t n ot te st ed (p oo r fi t w ith so m e of m an uf ac tu re rʼs ow n ca nn ul ae ) Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :N on e ar e pr ov id ed Us e an d le ar n in g: Pl un ge r ca nn ot b e pu lle d ba ck u nt il th e as se m bl ed M VA in st ru - m en t i s in sid e th e ut er us . In st ru ct io ns :B as ic te xt ; m in im al g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t c an - n u la e (so me tim es ev en w ith m an uf ac tu re rʼs ow n ca nn ul ae ) M ile x Ki t p ric e: $1 0.2 5 t o $ 15 .00 Ca nn ula s ize s av ai la bl e: 3 to 7 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ula e: Th e 5- m m c an nu la st ro ng ly wi th sta nd s ble ac h, glu ta ra lde hy de , s te am st er iliz at io n; m od er at el y w ith st an ds b oi lin g. T he 8 -m m ca nn ul a wi th st an ds b le ac h an d glu ta ra lde hy de o nly . Fl ex ib ilit y va rie s; s om e ar e rig id. Fi ni sh :M an y irr eg ula rit ies Fi t: Ve ry s ec ur e Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Sl igh t l os s af te r 10 a nd 6 0 m in ut es Cl ea ni ng :R ou gh fi nis h; ad ap te r i s no t d et ac ha bl e an d ha s in te rn al ri dg es (di ffic ul t t o cle an ); c on tam i- n an ts c an a lso g et tr ap pe d in th e gr oo ve u nd er th e ru bb er rin g on th e ad ap te r i f t he ru bb er ri ng is n ot re m ov ed Ca nn ul a m ar kin gs :A re pr ov id ed ; b ec am e di st or te d af te r b oi lin g Us e an d le ar n in g: Pl un ge r ca nn ot b e pu lle d ba ck u nt il th e as se m bl ed M VA in st ru - m en t i s in sid e th e ut er us . Pl un ge r a rm c an no t b e re m ov ed fr om th e sy rin ge , s o lu br ica tio n ca nn ot b e ad de d. In st ru ct io ns :B as ic te xt ; ex ce lle nt g ra ph ic of o pe ra tio n of p lu ng er Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t ca nn ul ae Fl ex ibl e. 10 m in ut es ; s ign ific an t l os s af te r 6 0 m in ut es DO UB LE -V A LV E SY RI NG ES Ip as D ou bl e- Va lv e Ki t p ric e: $2 7.2 5 t o $ 66 .25 Ca nn ula s ize s av ai la bl e: 4 to 1 0 m m a nd 1 2 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e; d oe s n ot w ith st an d bo ilin g or s te am st er iliz at io n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ibl e. Fi ni sh :F ew ir re gu lar itie s Fi t: Ve ry s ec ur e Fu nc tio n: G re at es t p ull fo rc e n ee de d Va cu um : No lo ss a fte r 1 0 an d 60 m in ut es Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :A re pr ov id ed ; s pa cin g be ca m e al te re d af te r s te am st er iliz at io n Us e an d le ar n in g: Di ffic ul t di sa ss em bl y In st ru ct io ns :C om pr eh en siv e; co m pl ex d et ai l in s om e se ct io ns ; e xc el le nt g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge co m pa tib le w ith 1 4 of 2 7 ca nn ul ae NO -V AL VE S YR IN G ES La bo ra to ire C. C. D. Ki t p ric e: No in fo rm at io n Ca nn ula s ize s av ai la bl e: Un kn ow n IS O o r C E ce rti fie d: Un kn ow n FD A re gis te re d: Un kn ow n Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , g lut ar ald eh yd e, s te am ; m od er at el y wi th st an ds b oi lin g Ca nn ula e: St ro ng ly wi th sta nd bl ea ch ; m od er at el y wi th - st an d glu ta ra lde hy de ; d o no t w ith st an d bo ilin g. F lex ibi lity un kn ow n. Fi ni sh :M an y irr eg ula rit ies Fi t: Ve ry s ec ur e Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Si gn ific an t l os s af te r 1 0 an d 60 m in ut es Cl ea ni ng :F ro st ed c an nu la an d op aq ue , n on re m ov ab le ad ap te r i m pa ir vis ua liz at io n Ca nn ul a m ar kin gs :N o de pt h m ar kin gs a re p ro vid ed Us e an d le ar n in g: Di ffic ul t an d in co m pl et e di sa ss em bl y. Pl un ge r c an no t b e pu lle d ba ck u nt il t he a ss em bl ed M VA in st ru m en t i s in sid e th e ut er us . In st ru ct io ns :N on e in clu de d Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t ca nn ul ae M ed G yn Ki t p ric e: $5 .50 Ca nn ula s ize s av ai la bl e: 4 to 6 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ula e: St ro ng ly wi th sta nd bl ea ch , g lut ar ald eh yd e; m od er at el y wi th st an d bo ilin g. Fl ex ib ilit y va rie s; s om e ar e rig id. Fi ni sh :F ew ir re gu lar itie s Fi t: No t t es te d Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Ne w eq ui pm en t n ot te st ed (p oo r fi t w ith so m e of m an uf ac tu re rʼs ow n ca nn ul ae ) Cl ea ni ng :S m oo th fi ni sh ; re m ov ab le a da pt er Ca nn ul a m ar kin gs :N on e ar e pr ov id ed Us e an d le ar n in g: Pl un ge r ca nn ot b e pu lle d ba ck u nt il th e as se m bl ed M VA in st ru - m en t i s in sid e th e ut er us . In st ru ct io ns :B as ic te xt ; m in im al g ra ph ics Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t c an - n u la e (so me tim es ev en w ith m an uf ac tu re rʼs ow n ca nn ul ae ) M ile x Ki t p ric e: $1 0.2 5 t o $ 15 .00 Ca nn ula s ize s av ai la bl e: 3 to 7 m m IS O o r C E ce rti fie d: Ye s FD A re gis te re d: Ye s Sy rin ge :S tro ng ly wi th sta nd s bl ea ch , b oi lin g, g lut ar ald eh yd e, st ea m s te ril iza tio n Ca nn ul ae :T he 5 -m m c an nu la st ro ng ly wi th sta nd s ble ac h, glu ta ra lde hy de , s te am st er iliz at io n; m od er at el y w ith st an ds b oi lin g. T he 8 -m m ca nn ul a wi th st an ds b le ac h an d glu ta ra lde hy de o nly . Fl ex ib ilit y va rie s; s om e ar e rig id. Fi ni sh :M an y irr eg ula rit ies Fi t: Ve ry s ec ur e Fu nc tio n: M od er at e pu ll fo rc e ne ed ed Va cu um : Sl igh t l os s af te r 10 a nd 6 0 m in ut es Cl ea ni ng :R ou gh fi nis h; ad ap te r i s no t d et ac ha bl e an d ha s in te rn al ri dg es (di ffic ul t t o cle an ); c on tam i- n an ts c an a lso g et tr ap pe d in th e gr oo ve u nd er th e ru bb er rin g on th e ad ap te r i f t he ru bb er ri ng is n ot re m ov ed Ca nn ul a m ar kin gs :A re pr ov id ed ; b ec am e di st or te d af te r b oi lin g Us e an d le ar n in g: Pl un ge r ca nn ot b e pu lle d ba ck u nt il th e as se m bl ed M VA in st ru - m en t i s in sid e th e ut er us . Pl un ge r a rm c an no t b e re m ov ed fr om th e sy rin ge , s o lu br ica tio n ca nn ot b e ad de d. In st ru ct io ns :B as ic te xt ; ex ce lle nt g ra ph ic of o pe ra tio n of p lu ng er Cr os s- co m pa tib ilit y: Sy rin ge in co m pa tib le w ith m os t ca nn ul ae 6 Practical Guide for Selection of MVA Instruments EngenderHealth Kit information ■ All prices are in U.S. dollars. Prices are as of 2001; current prices may vary. Special pricing for large orders may be available from any manufacturer. Price ranges generally depend on such factors as the number of cannulae included in the kit and the extra items required for the kit (e.g., lubricant, valves, O-rings). ■ Kit contents are as of 2001; current contents may vary. Kit contents vary considerably among brands. See Table 4 for detailed product and distribution information. ■ The cannula sizes listed are those provided in the standard kit. Some of the manufacturers produce other cannulae, which can be purchased separately. ■ The International Organization for Standardization (ISO) is composed of representatives from standards organizations in each of its member countries, and establishes standards for industry, research, and government. The CE marking is a mandatory product mark for the European market, indicating that the product has been designed and manufactured in conformity with European requirements and standards. ■ The U.S. Food and Drug Administration (FDA) regulates food, cosmetics, medical devices, biologics, and blood products in the United States. Durability ■ None of the cannulae withstood steam sterilization. Quality ■ Function assessments reflect the average pull force of both disinfected and new instruments. The lowest initial pull forces are approximately 6 kg and the highest are approximately 12 kg. Categories of “lower” and “higher” reflect the amount of force that was generally required. ■ Vacuum assessments reflect vacuum quality of new instruments only. Safety ■ Cannula markings were assessed for clarity (e.g., markings for size of the cannula; markings for uterine depth on the cannula). Some of the cannulae do not have markings, or may have markings only for size and not depth, or vice versa. Those that do have markings may have them written in ink (which are easily worn off after repeated disinfection/sterilization cycles), or they may be engraved or cut into the material of the cannula. Notes: Table 2. Overall Comparison of MVA Instruments (continued) EngenderHealth Practical Guide for Selection of MVA Instruments 7 Cannula Syringe Brand Size (mm) Chimco Eve Ipas Single-Valve Ipas Double-Valve JMS Laboratoire C.C.D. MedGyn Milex Pahsco Chimco 5 N Y N N N N N N 6 Y Y Y Y N N N Y 7 Y Y Y Y N N N Y Largest (8) Y N Y Y N Y N Y Eve 5 Y Y Y Y N N N Y 6 Y Y Y Y N N N Y 7 Y Y N Y N N N Y Largest (8) N N N N N N N N Ipas 5 Y Y Y N N N Y 6 Y Y Y N N N Y 7 Y Y Y N N N Y Largest (8) Y Y Y N N N Y JMS 5 N N N Y N N N N 6 Y Y Y N N N N Y 7 Y Y Y Y N N N Y Largest (8) Y Y N Y N Y N Y Laboratoire C.C.D. 5 Y N N Y Y N N Y 6 Y Y N N Y N N Y 7 Y Y N N Y N N Y Largest (12) N N N N N N N N MedGyn 5 N Y Y N N N N Y 6 Y Y Y Y Y N N Y 7 Y Y Y Y Y Y N Y Largest (13) N N N N N N N N Milex 5 N N N N N N N N 6 N N N N N N N N 7 N N N N N Y Y N Largest (12) N N N N N N N N Pahsco 5 Y Y Y Y Y N N N 6 Y Y Y Y Y N N N 7 — — — — — — — — Largest (6) Y Y Y Y Y N N N Legend: Y = Cannula fits N = Cannula does not fit — = Cannula does not exist or was not procured Notes: 1. In the Cross-Compatibility Test, 5-, 6-, and 7-mm cannulae, as well as the largest cannula provided by each manufacturer, were tested. (The size of the largest cannula provided by each manufacturer for this test is shown in parentheses.) Note that some of the manufacturers offer larger cannulae than those provided for this test. 2. When testing cannulae with the Ipas double-valve, the following adapters were used: ■ Laboratoire C.C.D., Milex: Did not use any adapter ■ MedGyn: Removed the MedGyn adapter and used an Ipas adapter ■ All others: Used the attached adapters with Ipas adapters Table 3. Cross-Compatibility of MVA Instruments 8 Practical Guide for Selection of MVA Instruments EngenderHealth Table 4. Manufacturer and Product Information Brand Contact information Product and distribution information Chimco Manufacturer: Sigma International 4/14A Asaf ali Road New Delhi, 110 002 India Phone: 011-91-11-3274361, -3276130, -3282284 Fax: 011-9111-3284391 e-mail: surgex@nda.vsnl.net.in Countries sold to: Worldwide Distributor system: None; contact Chimco directly Order requirements: NA Warranty/return policy: NA In-country product support: In India only Training material: Print material available Kit: Contains one syringe, lubricant, and an instruction manual; cannulae sold separately. Piece count: 100 syringes per case. Minimum order: NA Eve Manufacturer: Liam Health Care Pvt. Ltd. Distributor: Harleys Ltd. P.O. Box 42718 00100 GPO Nairobi, Kenya Phone: (254-20) 229400, -226748, -227989 Fax: (254-20) 337107, 219092 e-mail: info@harleysltd.com www.harleysltd.com Countries sold to: African continent only Distributor system: Harleys Ltd. Order requirements: Prepayment via wire Warranty/return policy: NA In-country product support: NA Training material: Print material available in English. No audio/video training materials. Kit: Contains one 60-cc syringe, a syringe valve, flexible cannulae of varying sizes with adapters, silicone oil, an extra O-ring, an extra collar stop, and a manual Minimum order: No minimum order required Ipas Manufacturer: Ipas 300 Market Street, Suite 200 Chapel Hill, NC 27516 U.S.A. Phone: 1-800-334-8446 (toll-free in U.S.); 919-967-7052, 919-918-2085 Fax: 919-918-2094, 919-929-0258 e-mail: ipas@ipas.org www.ipas.org Countries sold to: Worldwide Distributor system: 60+ worldwide; contact Ipas for nearest location Order requirements: Payment in advance Warranty: Syringe guaranteed for up to 50 uses Return policy: Ipas will replace or repair any item found to be faulty. This guarantee does not cover defects arising from accident, neglect, or misuse. In-country product support: Varies with distributor Training material: Print material available through all distributors. Audio/video training materials available through some distributors. Kit: Available with silicone lubricant and a variety of cannulae Minimum order: No minimum order required JMS Manufacturer: Jan Mangal Sanstha Unit 111, Vasan Udyog Bhavan Bombay 400013 India Phone: (9122) 5662-3190, 5662-3191, 2498-9003, 2498-9041 Fax: (9122) 5662-3195 e-mail: Janmangal@vsnl.net Countries sold to: NA Distributor system: None; contact the manufacturer directly Order requirements: Prepayment Warranty/return policy: NA In-country product support: NA Training material: NA Kit: Contains one single-valve syringe; one 4-, 5-, and 6-mm cannula; and one 10-cc bottle of lubricant Minimum order: NA continued EngenderHealth Practical Guide for Selection of MVA Instruments 9 Brand Contact information Product and distribution information Laboratoire C.C.D. Manufacturer: Laboratoire C.C.D. 60, rue Pierre Charron 75008 Paris France Phone: 33-1-4495-1495 Fax: 33-1-4495-1490 e-mail: contact@ccdlab.com www.ccdlab.com Countries sold to: France only Distributor system: NA Order requirements: NA Warranty/return policy: NA In-country product support: NA Training material: NA Kit: NA Minimum order: NA MedGyn Manufacturer: MedGyn 328 North Eisenhower Lane Lombard, IL 60148 U.S.A. Phone: 1-800-451-9667 (toll-free in U.S.); 630-627-4105 Fax: 630-627-0127 e-mail (international): intlsales@medgyn.com e-mail (U.S.): ussales@medgyn.com www.medgyn.com Countries sold to: Worldwide Distributor system: Contact MedGyn for distribution information Order requirements: Prepayment may be required for international purchases Warranty: 1 to 5 years (depending on item) Return policy: Defective material may be returned for full refund or replacement In-country product support: Only in countries with distributor Training material: Spanish print materials are currently in production Kit: Contains one 60-cc syringe and one 4-, 5-, or 6-mm cannula Minimum order: $50 (U.S.) Milex Manufacturer: Milex Products, Inc. 4311 North Normandy Chicago, IL 60634 U.S.A. Phone: 1-800-621-1278 Fax: 1-800-972-0696 www.milexproducts.com Countries sold to: Worldwide Distributor system: Contact Milex for distributor information Order requirements: NA Warranty: 2 years Return policy: Material may be returned if shipment is made without customer’s authorization of order, if incorrect items were shipped, if nonconforming items were shipped, or if nonconforming items are covered by the standard warranty. Shipping procedures: Will prepare shipment, but international customs must arrange shipping logistics In-country product support: Only in countries with distributor Training material: Print training materials available in English only Kit: Contains one 60-cc syringe and one cannula Minimum order: $50 (U.S.) Pahsco Manufacturer: Pahsco 4F, No. 160, Daye Road Beitou, Taipei Taiwan Phone: 886-2-2895-5050 Fax: 886-2-2891-7873 (exports division) e-mail: pahsco@pahsco.com.tw; pahsco@ms9.hinet.net Countries sold to: Worldwide, except the United States Distributor system: None; contact the manufacturer directly Order requirements: Prepayment via wire transfer Warranty: Syringes guaranteed for up to 50 uses Return policy: Will replace or repair products found to be faulty by reason of poor craftsmanship or materials In-country product support: None Training material: Print material available Kit: Contains one syringe; one 4-, 5-, and 6-mm cannula; and one 5-cc bottle of lubricant Minimum order: No minimum order required Table 4. Manufacturer and Product Information (continued) Note: NA = Information was not provided by the manufacturer at the time of the evaluation. © 2004 EngenderHealth. All rights reserved. 440 Ninth Avenue New York, NY 10001 U.S.A. Telephone: 212-561-8000 Fax: 212-561-8067 e-mail: info@engenderhealth.org www.engenderhealth.org This guide draws on the findings of an evaluation of manual vacuum aspiration (MVA) instruments conducted in 2001 by EngenderHealth and PATH. Selected findings from this evaluation were published in 2003 (Girvin, S., and Ruminjo, J. 2003. An evaluation of manual vacuum aspiration instruments. International Journal of Gynecology and Obstetrics 83[2]:219–232.). The evaluation was supported by the Open Society Institute. EngenderHealth staff members Lauren Pesso, Joseph Ruminjo, and Karen Landovitz developed, reviewed, and edit- ed the guide, and Anna Kurica designed it. Preparation of this guide was supported by funding from two anonymous donors.

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