Manual Vacuum Aspiration (MVA) - durbinglobal.com · Manual Vacuum Aspiration (MVA) for uterine...

Manual Vacuum Aspiration (MVA)

MVA for surgical management of miscarriage, fetal demise and T.O.P

Clinical Indications

· Treatment of incomplete abortion

· Endometrial biopsy

Safe and Effective

· 98% effective with low complication rates*

· Safe alternative to sharp curettage

Affordable and Versatile

· Reduces procedural costs by performing procedures in an outpatient setting

· Low initial investment and per-use cost

Discreet and Patient-Friendly

· Quiet procedure meets patients’ needs for privacy

· Enables faster recovery times compared to operating room procedures

· Individually wrapped and disposable

· Ready to use and sterilely packed

· 60 mL volume

· 610-660 mm (24-26 in) Hg vacuum

· Accepts 3, 4, 5, and 6 mm diameter cannulae

· Latex-free plastic

· FDA-listed, CE-marked, and ISO 13485 compliant

Single Valve Aspirator

MANUAL VACUUM ASPIRATION

Product Code: SVS-s10 (sterile pack of 10)

For uterine evacuation and endometrial biopsy

Effective · disposable · Affordable · Discreet

WomanCare Global Trading CIC is a UK Registered Community Interest Company (No.07231920).Email: [email protected]

©WomanCare Global, 2018A-CAT-NPS-501 Rev. 00

* In less than 2% of cases one or more of the following can occur during or after the procedure: uterine or cervical injury, pelvic infection, vaginal reaction, incomplete evacuation, or acute hematometra


UK HEAD OFFICE

Durbin House, Unit 5, Swallowfield Way, Hayes, Middlesex UB3 1DQT 020 8869 6500 F 020 8869 6592 W www.durbin.co.uk

Manual Vacuum Aspiration (MVA) for uterine evacuation under Local AnaesthesiaMVA for surgical management of miscarriage, fetal demise and T.O.P

98% effective. Suitable from 5 to 12 weeks gestation.

May be carried out in OPD setting (freeing theatres for other cases).

May be used with Local Anaesthesia.

Easier identification of gestational sac to confirm evacuation

Economical – theatre time estimated at £3,000+ per hour.

By definition: Improving data definitions and their use by the NHS. A briefing from the Payment by Results data assurance programme.

Day Case A day case is defined as: A patient admitted electively during the course of a day with the intention of receiving care, who does not require the use of a hospital bed overnight and who returns home as scheduled. If this original intention is not fulfilled and the patient stays overnight, such a patient should be counted as an ordinary admission.

For a patient to be a day case they must be admitted to hospital following a decision to admit, made by someone with the right of admission.

A decision to admit is defined as: A record of the event that a clinical decision to admit a patient to a particular healthcare provider has been made by, or on behalf of, someone who has the right of admission. This decision denotes that the patient is intended to be admitted to a hospital bed, either immediately or subsequently in the future.

The decision to admit is a decision on whether a patient requires admission to a hospital bed, under the care of a consultant.

A hospital bed is defined as: Any device that may be used to permit a patient to lie down when the need to do so is as a consequence of

the patient’s condition, rather than the need for active intervention such as examination, diagnostic investigation, manipulation/treatment, or transport.

Put simply, if a patient uses a bed (or trolley or chair) for treatment, and does not need to use the bed because of the medical condition being treated, because of some other medical condition, or to recover from the treatment itself, then this does not require a decision to admit. It follows that this activity would not routinely be classified as day case activity.

Where the activity should be classified as a day case, then it will flow in the APC CDS.

Use of a reclining chair as a bedThis was another area often debated. For some minor procedures patients require period of recovery on a reclining chair following the procedure before they are discharged home. Guidance states that a hospital bed includes any device that allows a patient to lie down as a result of the patient’s condition or treatment, rather than just during the investigation itself. According to the guidance, this should be classified as a day case (an admission).

Audit Commission1st Floor, Millbank Tower, Millbank London SW1P 4HQTelephone 0844 798 3131 | Fax 0844 798 2945 | Textphone (minicom) 0844 798 2946| Online www.audit-commission.gov.uk

UK HEAD OFFICE


UK HEAD OFFICE


Manual Vacuum Aspiration (MVA) in the management of missed and incomplete miscarriage up to 12 weeks under local anaesthesia

References:1. Gazvani, R, et al, EJOGRB, 112 (2004), 197 – 2002. Lara, R, R et al, ginecol Obstet Mex, 65 (1997), 101 – 1063. Blumenthal, P, D & Remsburg, R, E, Int J Gynecol Obstet, 45, (1994), 261 – 674. Dalton, V, K, et al, Obstet & Gynecol, 108, (2006), 103 – 110

Backed by 40 years of global market use and IPAS’ long-standing quality reputation

FDA-listed, CE-marked, and ISO 13485 compliant

Small, inexpensive, portable, quiet, and safe 2,3,4

Ideal for performing procedures in the outpatient setting

Ideal for settings with no electricity or with space constraints

Limited investment required

Easy to use

The IPAS Aspirator Product LineA cost effective solution for uterine evacuation

Demonstrated clinical benefits in uterine evacuation.

IPAS EVA SHARP ASPIRATORS CURETTAGE

Safe ● ●

Lower Incidence of Side Effects/ ● ● Complications

Cost Effective ● ●*

Portable ● ●

Quiet ● ●

Single Use ● ●

Reusable ● ● ●

Outpatient/ ● ● No Anaesthesia

Quick Recovery ● ● Time

No Electricity ● ● Required

Requires Limited ● ● Space

Requires Limited ● ● Investment

*When used without anaesthesia

References:1. Veruyl DAA, Crowther CA. (1993). Suction v. Conventional curettage in complete abortion: a randomized clinical trial. S Afr Med J,83:13-15.2. Blumenthal, Paul D and R.E. Remsburg. 1994. A time and cost analysis of the management of incomplete abortion with manual vacuum aspiration.

Int J Gynecol Obstet, 1994, 45: 261-267. 3. De Jonge ETM, Pattinson, RC, Makin JD et al. (1994). Is ward evacuation for uncomplicated incomplete abortion under systematic analgesia safe and effective:

a randomized clinical trial. S Afr Med J, 84:481-483. 4. Fawcus S, McIntye J, Jewkes RK et al. (1997). Management of incomplete abortions at South African public hospitals. S Afr Med J, 87:438-442. 5. World Health Organization, Department of Reproductive Health and Research. Safe Abortion: Technical and policy guidance for health systems. Second edition. 2012. Annex 5,

Recommendation 1, page 113. 6. Hale RW, Kobara TY, Sharma SD, Tsuei JJ, Gramlich EP, Nakayama RT. Office termination

PRODUCT PORTFOLIOASPIRATORS

● Ipas Plus® Aspirator

●Single Valve Aspirator

●Double Valve Aspirator

CANNULAE

● Ipas EasyGrip® Cannulae

●Flexible Karman Cannulae

DILATORS & ACCESSORIES

●Adapter sets, dilators and aspirator accessories also available

KITS

●Miscarriage Management Kit

TRAINING TOOLS

●Pelvic Model

First trimester pregnancy loss occurs in 14 – 19% of registered pregnancies.1

There is evidence of increasing reluctance amongst women to accept general anaesthesia or expectant management.1

MVA has a success rate in missed and incomplete miscarriage of 98 – 99%.1, 2

After MVA, a high proportion of women are happy to recommend the method to a friend or relative (in one study 57 out of 57 1).

MVA does not require the use of an operating theatre, offering significant cost saving and freeing theatre time for other cases. 3, 4

MVA is associated with a reduction in post-procedure hospital stay, again reducing costs. 3

Total procedure time can be less with MVA than with electric suction 3, 4 (up to 42%, less 3%)

Perceived Clinician preference influences patient choice of method. 4

Ipas MVA Plus® Aspirator

MANUAL VACUUM ASPIRATIONIpas MVA Plus® Aspirator

Product Code: PLUS

For uterine evacuation

EFFECTIVE · SAFE · AFFORDABLE · DISCREET


· Treatment of incomplete abortion for uterine sizes up to 12 weeks since the woman’s last menstrual period

Safe and Effective









· Reusable

· Steam autoclavable at 121° C (250° F)

· Processable by cold methods such as Cidex® and Sporox® II

· Easy disassembly and reassembly

· 60 cc volume

· 610-660 mm (24-26 in) Hg vacuum









Safe and Effective









Double Valve Aspirator


Product Code: DVS


Effective · disposable · Affordable · Versatile





· 60 mL volume

· 610-660 mm (24-26 in) Hg vacuum




DOUBLE VALVE Aspirator

Ipas MVA Plus® Aspirator

MANUAL VACUUM ASPIRATIONIpas MVA Plus® Aspirator

Product Code: PLUS


EFFECTIVE · SAFE · AFFORDABLE · DISCREET



Safe and Effective









· Reusable



· Easy disassembly and reassembly

· 60 cc volume

· 610-660 mm (24-26 in) Hg vacuum









Safe and Effective











Product Code: DVS


Effective · disposable · Affordable · Versatile





· 60 mL volume

· 610-660 mm (24-26 in) Hg vacuum




DOUBLE VALVE Aspirator

UK HEAD OFFICE


UK HEAD OFFICE


IPAS MVA Plus® Aspirator


EFFECTIVE SAFE AFFORDABLE DISCREET



Treatment of incomplete abortion for uterine sizes up to 12 weeks since the woman’s last menstrual period


Quiet procedure meets patients’ needs for privacy

Enables faster recovery times compared to operating room procedures

Safe and Effective

98% effective with low complication rates*

Safe alternative to sharp curettage


Reduces procedural costs by performing procedures in an outpatient setting

Low initial investment and per-use cost


IPAS MVA PLUS® ASPIRATOR●Steam auto-clavable at

121° C (250° F)

●Processable by cold methods such as Cidex® and Sporox® II

●Easy disassembly and reassembly

●60cc volume

●610 – 660 mm (24 – 26 in) Hg vacuum

●Latex-free plastic

●FDA-listed, CE-marked, and ISO 13485 compliant



EFFECTIVE DISPOSABLE AFFORDABLE VERSATILE



Treatment of incomplete abortion for uterine sizes up to 12 weeks since the woman’s last menstrual period

Endometrial biopsy




Safe and Effective






DOUBLE VALVE ASPIRATOR● Individually wrapped

and disposable

●Ready to use and sterilely packed

●60 mL volume

●610 – 660 mm (24 – 26 in) Hg vacuum


●FDA-listed, CE marked, and ISO 13485 compliant


DISP0023060

£10.70

DISP0021060

£11.44




Safe and Effective











· 60 mL volume

· 610-660 mm (24-26 in) Hg vacuum















Ipas EasyGrip® Cannulae

Ipas EasyGrip CannulaeALSO AVAILABLE FROMWOMANCARE GLOBAL

Product Code: SR4-SR12 (No 11 mm)

The tactile response of a rigid curette with the gentle probe of a flexible cannulae

EFFECTIVE · DISPOSABLE · AFFORDABLE · VERSATILE

· Semi-rigid


· Permanently-integrated winged base, color-coded by size

· Printed insertion guides

· Two opposing apertures (4-8 mm)

· Large, single scoop aperture (9, 10, 12 mm)

· Approximately 24 cm (9.5 in) in length

· Available in eight diameters: 4, 5, 6, 7, 8, 9, 10, and 12 mm


· FDA-listed and compliant with ISO 13485 and CE-marked

Denniston DilatorsFor cervical dilation associatedwith uterine evacuationProduct Code: DD5-S

Ipas MVA Plus® AspiratorFor uterine evacuationProduct Code: PLUS

Size 4 mm 5 mm 6 mm 7 mm 8 mm 9 mm 10 mm 12 mmCode SR4 SR5 SR6 SR7 SR8 SR9 SR10 SR12

product code/diameter chart

®








· Semi-rigid














®

DISP0022060

£6.56

DISP0291001

£21.26




Safe and Effective











· 60 mL volume

· 610-660 mm (24-26 in) Hg vacuum













UK HEAD OFFICE


UK HEAD OFFICE




EFFECTIVE DISPOSABLE AFFORDABLE DISCREET



Treatment of incomplete abortion

Endometrial biopsy




Safe and Effective







Single Valve Aspirator● Individually wrapped and

disposable

●Ready to use and sterilely packed

●60 mL volume

●610 – 660 mm (24 – 26 in) Hg vacuum

●Accepts 3, 4, 5, and 6 mm diameter cannulae


●FDA-listed, CE-marked, and ISO 13485 compliant

IPAS EasyGrip® Cannulae


EFFECTIVE DISPOSABLE AFFORDABLE VERSATILE

IPAS EASYGRIP® CANNULAE

Semi-rigid

Ready to use and sterilely packed

Permanently-integrated winged base, color coded by size

Printed insertion guides

Two opposing apertures (4 – 8mm)

Large, single scoop aperture (9, 10, 12mm)

Approximately 24cm (9.5 inches) in length

Available in eight diameters: 4, 5, 6, 7, 8, 9, 10, and 12mm

Latex-free plastic

FDA-listed and compliant with ISO 13485 and CE-marked

Product Code / Diameter Chart

Size 4mm 5mm 6mm 7mm

Code DISP0022004 DISP0022005 DISP0022006 DISP0022007



£1.39 each

DISP0022___








· Semi-rigid














®

Endometrial Biopsy Kit

Contains one Single Valve Aspirator and 15 x 3mm Cannulae, all sterile



Flexible Karman Cannulae

Flexible Karman CannulaeALSO AVAILABLE FROMWOMANCARE GLOBAL

Product Code: FC4-FC12 (no 11 mm)

The original flexible cannulae

Effective · disposable · Affordable

· Flexible

· Disposable and sterilely packed

· Available in eight diameters

· Color-coded by size (adaptor kit required)

· Depth markings in cm printed on cannulae

· Two opposing apertures for cannulae with diameters of 4-8 mm

· Large, single scoop aperture for cannulae with diameters of 9, 10, and 12 mm






Cannulae Adaptor SetsFor use in conjunction with applicablecannulae and MVA AspiratorsProduct Codes: ADPSET (sizes 6-10 MM) ADP6MM offered as a set of 5

Size 4 mm 5 mm 6 mm 7 mm 8 mm 9 mm 10 mm 12 mmCode FC4 FC5 FC6 FC7 FC8 FC9 FC10 FC12


Denniston Dilators


Denniston Dilators

ALSO AVAILABLE FROMWOMANCARE GLOBAL

Product Code: DD5-S

For cervical dilation

· For cervical dilation prior to uterine evacuation

REUSABLE · GRADUATED · LIGHTWEIGHT



· Reusable

· Tapered - requires half the force of a non-tapered dilator



· Set of five double-ended, tapered dilators: 5/6 mm, 7/8 mm, 9/10 mm, 11/12 mm, 13/14 mm diameters





Ipas EasyGrip® CannulaeFor use with the Ipas MVA Plus®AspiratorProduct Codes: SR4-SR12 (no 11 mm)




Flexible Karman CannulaeALSO AVAILABLE FROMWOMANCARE GLOBAL

Product Code: FC4-FC12 (no 11 mm)


Effective · disposable · Affordable

· Flexible

· Disposable and sterilely packed

· Available in eight diameters

· Color-coded by size (adaptor kit required)

· Depth markings in cm printed on cannulae

· Two opposing apertures for cannulae with diameters of 4-8 mm

· Large, single scoop aperture for cannulae with diameters of 9, 10, and 12 mm







Size 4 mm 5 mm 6 mm 7 mm 8 mm 9 mm 10 mm 12 mmCode FC4 FC5 FC6 FC7 FC8 FC9 FC10 FC12


DISP0022060

UK HEAD OFFICE


UK HEAD OFFICE




EFFECTIVE DISPOSABLE AFFORDABLE

FLEXIBLE KARMAN CANNULAE

Flexible

Disposable and sterilely packed

Available in eight diameters

Colour coded by size (adaptor kit required)

Depth markings in centimetres printed on cannulae

Two opposing apertures for cannulae with diameters of 4 – 8 mm

Large, single scoop aperture for cannulae with diameters of 9, 10, and 12 mm

Approximately 24 cm (9.5 inches) in length

Latex-free plastic

FDA-listed and compliant with ISO 13485 and CE-marked

Product Code / Diameter Chart





£0.86 each

Denniston Dilators

For cervical dilation

REUSABLE GRADUATED LIGHTWEIGHT

DENNISTON DILATORS

Reusable

Tapered - requires half the force of a non-tapered dilator

Steam auto-clavable at 121° C (250° F)

Processable by cold methods such as Cidex® and Sporox® II

Set of five double-ended, tapered dilators: 5/6 mm, 7/8 mm, 9/10 mm, 11/12 mm, 13/14 mm diameters

Approximately 29 cm (11.5 inches) in length

Latex-free plastic


For cervical dilation prior to uterine evacuation

DISP0240015

£19.18

Cannulae Adaptor Sets

For use in conjunction with applicable cannulae and MVA Aspirators

ADPSET (sizes 6 – 10mm)

DISP0240001

£0.79

DISP023_ _ _ _

£6.56

DISP0260102

£43.75

UK HEAD OFFICE


UK HEAD OFFICE


Uterine Pelvic Model

For effective training

EASY TO USE OPEN DESIGN REALISTIC

UTERINE PELVIC MODEL

Open design for ease of training for intrauterine procedure including uterine evacuation

Simulation of both smooth and gritty tactile sensations during uterine evacuation

Plexiglass base with suction cups to ensure stability

Lightweight and portable

Measures 25 x 25 x 18 cm (10 x 10 x 10 in) approximately

DEMO0061001

£294.98

Uterine Evacuation Kit

Contains 1 x Double Valve Aspirator, 4 x EasyGrip® sterile cannulae in sizes 6mm, 7mm, 8mm and 9mm.

DISP0016019

£25.74

Single use Sterile MVA Kit 54

Contains 1 x sterile Double Valve Aspirator, 1 x plastic Speculum broad, 1 x Luer Tenaculum, 1 x Dental Syringe, 1 x Rampley Sponge-holder 24cm, 1 x Hegar Dilator 3/4, 1 x Hegar Dilator 5/6, 1 x Hegar Dilator 7/8, 1 x kidney dish, 1 x 60ml Gallipot, 1 x pair nitrile gloves (medium), 5 x large cotton wool balls, 1 x crepe paper 30 x 50cm, 1 x yellow waste bag and tie.

1) Don’t patients prefer to be asleep during these procedures?

It is easy to assume that, but remember many women choose medical management purely because they wish to avoid a general anaesthetic.

There is also no doubt that patients can sense any reservations you yourself may have about using MVA under local anaesthesia. We recommend that you watch the video of the procedure on this website featuring real patients undergoing MVA under local anaesthesia. We can also put you in touch with units currently using who will let you “sit-in” and witness for yourself how well tolerated MVA under local anaesthetic really is.

Many studies report that most women state they are happy to undergo MVA again under local anaesthesia and would recommend it to family or friends.

Pain scores of 2 – 3 are common. There are reports that medical management is far more

painful than MVA. Undeniably, how you offer the choice of local anaesthesia

will influence its take-up. Assuming the patient has chosen Surgical Management,

we recommend something like: “OK, there are two ways we can handle this: For the first, under a general anaesthetic, you’ll have to go

home, starve yourself overnight, get someone to drive you in the morning and collect you after the procedure. You may feel groggy for a couple of days and every general anaesthetic does carry a small risk. Unfortunately, we cannot guarantee that we’ll be able to get you into theatre tomorrow, so you may have to go through this starvation routine two, three or even more times until we can find a theatre slot.

Alternatively, we can do the procedure under local anaesthetic within the next hour and you’ll be fine to drive yourself home.“

Both the RCOG and NICE have recommended MVA under Local Anaesthesia recently. Abortion charities have been using MVA under local anaesthesia for over 15 years and increasing numbers of NHS hospitals are using it for miscarriage management.

We know of at least three units where midwives carry out the procedure under local anaesthesia.

2) Surely MVA under local anaesthesia is painful?

Please see answer “one” on the left. We recommend a NSAID about 60 – 90 minutes before the

procedure and “vocal-local” during it – i.e. a chatty nurse distracting the patient.

Pain scores of two to three are commonly reported.

Another critical factor is technique – a gentle rotating action with the cannula within the uterus without the tip bouncing off the fundus is crucial!

3) We don’t have a suitable room for MVA. To use MVA under local anaesthesia, all you really need is

a couch with leg-supports (preferably, but stirrups will do) and a decent light source.

Many units use the colposcopy or hysteroscopy room or an outpatient clinic room.

In addition we recommend that there is somewhere the patients can sit quietly after the procedure for 20 to 30 minutes just to check there is no excessive bleeding before they go home.

4) Do we need to give antibiotics? Whatever your antibiotic protocol for electric suction

evacuation is, it should be the same for MVA. For example, many units routinely administer azithromycin prior to evacuation.

MVA per-se does not increase the need for antibiotics.

5) What about Anti-D? The indications for administering Anti-D following MVA are

identical to those for any other method of evacuation.

MVA Frequently Asked Questions:

6) How safe and effective is MVA ? Over the last 40 years MVA has been shown to be 96 – 98%

effective – almost exactly the same as Electric Vacuum Aspiration (EVA).

Likewise, the incidence of adverse events is virtually identical to those with EVA. In fact some clinicians think uterine perforation is less likely with MVA under local anaesthetic, precisely because the patient is awake.

7) How much does MVA cost? MVA under local anaesthesia in a non-theatre setting is

staggeringly good value for money! The Department of Health has estimated that theatre time (including all staff costs, etc.) can be up to £3,000 per hour. An MVA aspirator cost no more than £12, the cannulae less than £1.50 and local anaesthetic is literally pence, so the business case for MVA is overwhelming.

PLUS whilst MVA is being used, theatre could be used for other cases actually increasing revenue for the Trust, and remember no bed is required – another cost saving.

8) Should we check evacuation with ultrasound after MVA?

It certainly is not a requirement for MVA, but if you have easy access to ultrasound scanners, then why not use them?

Carriage is only free only if your total invoice value BEFORE VAT is over £120.

Smaller orders are subject to a carriage charge of £10.00 per order.

UK HEAD OFFICE


IPAS Double-Valve Aspirator (Non-Sterile) DISP00210601 to19 £11.44 each|20 to 29 £10.97 each|30+ £10.60 each

IPAS Double-Valve Aspirator (Sterile) DISP00250601 to19 £12.51 each|20 to 29 £12.07 each|30+ £11.65 each

IPAS Single- Valve Aspirator (Non-Sterile) DISP00220601 to 19 £6.56 each|20 to 29 £6.40 each|30+ £6.08 each

IPAS Single-Valve Aspirator (Sterile) DISP0025600 (Karman cannulae only sizes 4 to 6mm)1 to 19 £7.83 each|20 to 29 £7.65 each|30+ £7.19 each

For all EasyGrip Cannulae prices are: For all Karman Cannulae prices are:1 to 19 £1.39 each 1 to 19 £0.86 each20 to 29 £1.36 each 20 to 29 £0.84 each30+ £1.24 each 30+ £0.81 eachEasyGrip Cannula size 4mm DISP002204 Karman Cannula size 4mm DISP0230004EasyGrip Cannula size 5mm DISP002205 Karman Cannula size 5mm DISP0230005EasyGrip Cannula size 6mm DISP002206 Karman Cannula size 6mm DISP0230006EasyGrip Cannula size 7mm DISP002207 Karman Cannula size 7mm DISP0230007EasyGrip Cannula size 8mm DISP002208 Karman Cannula size 8mm DISP0230008EasyGrip Cannula size 9mm DISP002209 Karman Cannula size 9mm DISP0230009EasyGrip Cannula size 10mm DISP002210 Karman Cannula size 10mm DISP0230010EasyGrip Cannula size 12mm DISP002212 Karman Cannula size 12mm DISP0230012 When using Karman Cannulae with the Double-Valve Aspirators, the Adapter Kit is required.

Set of 5 different Adapters (DISP0240001)1 to 19 £0.79 each|20 to 29 £0.77 each|30+ £0.74 each

For the Cannulae the volume discounts refer to each size; 10 each of 2 different sizes would NOT generate the discount.

All prices quoted exclude VAT.

To send your order by fax - please use the number below: To email your order - please use the address below:020 8869 6592 [email protected]

Manual Vacuum Aspiration (MVA) Discounts:

FREE CARRIAGEON ALL ORDERS OVER £120

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