Whiz Midstream
These are a sample of the most frequently asked questions; do not hesitate to ask if you have others. Our replies are given to the best of our ability and are given without warranty. If in doubt consult your medical practitioner.
Yes. It is ideal in fact for anyone who has any impairment issue as it can be held with one hand and used in a sitting, hovering or standing position.
The Midstream is designed to be used by men and women of all ages. Due to the difference in anatomy there are different set of instructions for use men or women. Each person can decide which set suits them best. Mobility impaired women or men who have had penile amputation or retraction will know what the best method is for them.
With children who are aware when they are going to wee the Midstream is perfectly safe. Parents have safely used the Midstream with babies and holding the device in place all the time or ready the moment there is a wee. It is essential that the parent is satisfied prior to use that the baby is comfortable with the fit. We are looking into making a baby version that can be held in a nappy. If you are interested to participate in a trial of this or contribute your comments do let us know.
Both sets of instructions for use are downloadable; go to media and downloads; there are also other interesting and relevant items that can be downloadable giving you more information on the product.
There are no earlier models of the Midstream
although we have been approached to develop a model that can take the
30 ml and the 10 ml sample bottles/containers. We were asked that as
some of the new machines for urine analysis only use a 10 ml bottle,
there is spillage and contamination and a difficulty of giving the sample.
Furthermore the medical preference is always to have the sample that
is tested, tested from the sterile sample bottle in which it was given
(called primary collection bottle) and not a test on a sample that has
been transferred, which runs the risk not only of increased contamination
but also. the risk of patient mix-up of samples.
Yes it is ideal for use as a home test as it delivers the best possible quality sample without the need for the intervention of a health care professional. It can be used in conjunction with any home test self test device such as pregnancy to obtain the most uncontaminated sample. We sell Whiz Midstreams for the home self test in packs of 1 and 10 and they are sold without boric acid only. The reason is that boric acid is a preservative for use when the sample will take some time to get to the laboratory; clearly not the case for the home environment.
The Midstream can give you the opportunity to have the best possible medical care since the determination of the treatment for you is dependent on the pathology laboratory analysis. For the Health Care professional, it not only minimizes the risk of exposure to the urine sample, but also gives them the possibility to exercise their expertise to the best of their ability; and not find that they are taking a stab in the dark as they have no pathology report to go on.
It is also the best and safest way to do tests in the Home environment without the intervention of a healthcare professional protecting not only you but your immediate family.
It can even when a sample is required by the GP be used in the GP surgery; consult your GP for timing of the sample and if you can drop it off without an appointment.
A contaminated urine sample is where the urine sample cannot be analysed due to it being mixed or contaminated with bacteria other than from the bladder (e.g. from the urethra, unsterile sample containers etc). Contamination is not the same but can lead to what is called a false positive or a false negative sample. The reason for this is that if the sample is contaminated the doctor cannot tell what is wrong and will make a judgement call believing that there is an infection (i.e. a positive) and prescribe medication or treatment when in fact there is no infection hence a false positive diagnosis. A false negative is when the doctor decides not to treat when in fact there was an infection and should have been treated. If it's a false negative it could have very serious if not fatal consequences without treatment for example amongst ante-natal patients.
Yes, under COSHH regulations it is so classified as it can contain dangerous pathogens such as HIV. But in itself urine is actually sterile in the body and on leaving the body. It only becomes non sterile on contact with outside pathogens.
The Midstream can be used in any situation where
a urine sample needs to be given. It can be used in any environment
i.e. hospitals, homes, GP's offices, law enforcement, or public corporate
testing etc.
The Midstream is very easy to use. We have tested the device on children, students, pregnant mothers to be, and men and women including 80 year olds and they were all complimentary. It has been trialled in 2003-4 in 4 NHS hospitals and used by tens of thousands since. The results were published in the British Journal of Urology August 2005, (Jackson et al, 2005) and showed significant clinical benefits. Further large scale clinical trials again in four different NHS hospitals and GP practices showed even better results due to familiarity with the new process. The Midstream is not a funnel but a hygienic shield and a diverter and these were published as Dryden et al 2007 (both available from downloads under media).
Aside from its intended purpose which is to collect a MSU the Whiz Midstream kit has three key features:
First, the Midstream device is ‘sterile’ rather than merely “aseptic manufactured” which is basically unsterile
Second, the Midstream device has a patented diverter inside it which automatically collects and captures a MSU sample, where other devices rely on the dexterity of the user and, it would seem, a certain amount of chance in seeking to ensure that what is sampled is mid-stream urine.
Third, the design of the device with what is called the “lily shield patented design” and its material renders it (unlike the use of other devices) significantly less likely that there will be spillage and therefore decreases (unlike other devices which increase) the risk of the spread of any infections carried by the user as a result to third parties. In turn this decreases the risk of infection to the user.
For women we recommend Midstream is simply held against the body with the broad area of the opening uppermost and then you begin to wee. Nature and gravity do the rest with the diverter simply allowing the first stream to flow away and the mid stream to be collected. No need to stop and start, to position, to get hands or container wet, no need to judge when it is a mid stream. The Midstream does it all automatically. For men it is important not to place the penis over the opening as this can cause air blockage. For men place the penis above the shield and aim for the target hole.
There are two elements of regulatory approvals. The first is that the device can be lawfully sold and meets these regulatory requirements. The second is if it is fit for purpose and meets the regulations regarding its claims for use.
As an IVD Device (Directive 98/79/EC), the Midstream has stringent regulatory requirements to meet in order to obtain its CE mark or FDA approval. The Midstream is registered with the Competent Authority of the Republic of Ireland since 2004 as an IVD device and is CE marked and FDA approved and it is sold throughout the world subject to the local registration laws of selling a medical product and any local language requirements for the instructions for use.
In regard to fit for purpose it is entirely fit for purpose to collect a midstream urine sample and does so based on published wide scale clinical trials better than any other known device for collection midstream urine samples. The results of the wide scale clinical trials above mentioned have indicated this; there is also the Centre for Evidence Based purchasing results (all downloadable) showing its significant cost benefits and cost saving per test.
Our Technical Specification Sheet gives a full specification of the device and the purchaser can make an objective decision. Please contact us to obtain a copy of the Technical Specification sheet for the Midstream.
Mentally and physically it caters for all patient comfort. As a sterile CE marked product, it meets the highest specifications to give a quality sample. The material is recyclable.
No, it is not necessary for women to undress to use the Midstream.
If you are wearing trousers then you can undo your zip or buttons, push your underwear to one-side and use the Whiz quite discreetly. (All trousers have different zip lengths so they need to have enough length for you to use the Whiz. Check that yours is sufficient. If you use buttons you may only need to unbutton the top two or three and lower your trousers a few centimetres).
Skirts and dresses are even easier.
You can also use the Midstream in a sitting, or hovering or standing position.
The first stream will go into a toilet wherever you point the Midstream.
The mid stream will be automatically collected in the provided sterile
sample container, the remaining or last stream will go into a toilet
wherever you point the Midstream.
First do not attach the collection bottle if you have placed the home test strip in flowing urine then depending on the test requirements; if it is first stream: place the strip in the flow coming out of the front of the device e.g. for Chlamydia, if its midstream place the strip in the flow coming out of the diverter, and if its last stream wait until you are about to stop voiding and then place it in the flow coming out at the front of the device.
If there is no requirement to place the strip in flowing urine you can attach the collection bottle and then if the test requires a midstream sample simply dip the test strip into the sample container which will contain the midstream.
No it's for single use only and if the sterilisation
packaging seal is broken do not use it.
Completely. It is Sterilised and comes in sterilisation packing that ensures the sterility is maintained to a level of the legal requirement for sterile products of 10(-6) and which has the instructions printed on the verso. The legal requirements on the level of sterility are set out in the EU Harmonised standards 556-1 and 556-2. In a nutshell any claim for a sterility assurance level (SAL) must follow these procedures. Aseptically manufactured or clean room manufactured is not a claim for sterility assurance level and is considered unsterile. All claims for a SAL must be in protective packaging in order to maintain the SAL level claimed. This is why the Midstream is individually packed and then sterilisation occurs of the entire kit after the product has been packed.
If your hospital or GP is using the Midstream they will simply hand you a pack which contains the sterile Midstream and sample bottle. If you are purchasing it over the web the Whiz Midstream is posted in a plain envelope or in a box of 100 which contains the name and address of Jbol Ltd and the product on the outside. Where the person ordering is clearly identified as male, the male instructions for use are included as well.
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The World's First Automatic Urine Sample Collector.
