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The Worlds First Automatic Urine Sample Collector

What is it?

The Whiz Midstream is a midstream urine sample collection device, designed and clinically proven to make urine sample collection automatic, patient and staff independent, delivering a clinically proven, significantly superior and more accurate sample, which is collected more hygienically, more easily, cleanly, cheaply and faster than anything currently available.

The Midstream (as stated in Jackson et al) “is not simply a funnel, but incorporates a flow-sensitive channel and diverter that, using urodynamic principles, excludes the initial low-flow portion of the urinary stream, thus discarding the contaminated early stream volume, and automatically collects the midstream volume without interrupting the stream.”

The Midstream is a quantum-leap forward in technology and product design for woman and for men. Whilst the equipment for the analysis of urine has improved dramatically in the last 100 years, the method of collection has barely changed at all and sometimes has regressed with poor practice, due to the increased cost in time and difficulty of giving a sample and the use of cheap mass-produced, non regulatory, disposable, poor quality containers. Thus fast modern analytic machines or high quality microbiology departments are rendered useless if the quality of the sample is poor. In addition, urine samples currently have a high inherent contamination rate – a national average of 31% (Lifshitz et al 2000) but going to 56% amongst GP’s collected samples (Garcia et al 2004).

General introduction to Urine Sample Collection:

International and national governmental as well as professional health care standards throughout the world ensure that a patient receives the best health care possible. Errors in diagnosis or treatment; delays that could have been avoided; faulty procedures, or failing to follow correct procedures, faulty equipment, health and safety issues to name a few, are all governed by not only professional body standards but by these national and international regulatory standards.

Today too patient choice and patient knowledge of the risks, procedures and results are considered integral to the system of health care.

It is a simple fact that all patient health care is dependent on diagnosis, and 70% of all diagnostic health care is reliant on pathology (Carter Review on Pathology, 2006). Urine samples form a substantial percentage of these pathology tests and, unlike blood collection, involves non invasive collection as an accurate method of analysing many health conditions. In ante natal care for example accurate and clean urine sample is a critical factor for both the health of the mother and the unborn child.

The message put out by Health Authorities around the world is simple, Quality of sample = quality of Diagnosis = Quality of Patient Care. A contaminated urine sample is no sample at all and worse if it’s a false positive, since a false positive may well lead the patient to be given unnecessary medical treatment. This in turn can lead to antibiotic resistance and to issues of MRSA and C.difficile etc. If it’s a false negative, it could have very serious if not fatal consequences without treatment for example amongst ante-natal patients. There are many more regulations since urine is classified as a hazardous substance “that is for example clearly a sample of urine that is infected with Aids poses a health risk to both medical professionals and staff and patients and even visitors.”

Yet despite the importance for the need of a Midstream urine sample contamination rates as clinical trials have shown can be as high as 56% -at this level diagnosis becomes a lottery with 1 out of 2 specimens being possibly incorrectly diagnosed. A national average of contamination (in the UK) is 31%. A contaminated sample is one that is the sample is analysed by the pathology laboratory but the results show only that the specimen is contaminated (usually heavy mixed growth) and no pathology analysis can be made. It is absolutely incumbent on the medical practitioner to inform the patient of this and allow the patient to decide if they wish to give another sample (the preferred route) or have their medical condition diagnosed without the benefit of any pathological analysis. All too often it appears the patient is not informed and may be prescribed unnecessary antibiotics or a course of action that is inappropriate.

Although health care analysis has progressed enormously in recent years with many diagnostic and analytic machines becoming automated (saving time and money) yet the process of collection the fundamental data on which these machines ability to perform i.e. the actual specimen urine sample, has remained a process and method unchanged and static for 80 plus years and simply unable to match the need and sensitivity for analysis in a modern world. Collection methods can be gross, with samples collected in plastic bags, in containers for false teeth, in unsterilized cups etc. the USA regulatory slogan of trying to encourage good quality specimen samples i.e. Garbage in = garbage out is correct. A collected sample that is not clean and the best available for analysis will lead to a rubbish result.
But there are other reasons as well today for the high contamination rates: Inappropriate collection equipment or equipment that is not sterile. An inappropriate method of given the sample i.e. by stop and starting; or by touching or handling the sample; or by allowing foreign items in as a result of transferring the sample to another test tube (this can occur with no automatic diagnostic machines which can only read a sample that is in a 10 ml tube yet no samples are initially collected in a 10 ml tube.

The sample that the health care practitioners prefer for routine use is the mid stream sample. This is best quality sample for analysis as it avoids contamination from the urethra and obtains the best or gold standard sample and a mid stream urine sample is defined by both regulatory and health care professionals as “The first part of voided urine is discarded and without interrupting the flow approximately 10ml is collected into a sterile container’ **.There are clear regulatory and professional guidelines on what is a sterile container.

But giving a urine sample can be a messy and embarrassing process especially if you are a woman or a child. And if you are a guy just think how difficult it is for women to produce a sample that can be collected without mess into a 30 ml bottle. Where larger bottles are used, these more often than not are not what is called Primary Collection containers but are secondary and the sample needs to be transferred to a smaller bottle that can then go to the lab or be used in the automatic machines.
Current methods and results are not only bad for you as a patient and for the community (infection control issues), but problematic to analyse in the lab. A rate of 56 percent of urine samples being contaminated and which signifies misdiagnosis or inappropriate antibiotics’ prescription is quite simply unacceptable in terms of patient care, use of resources and costs.

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The Whiz Midstream

The Whiz Midstream is a unique product, it has a revolutionary and patented automatic channelling feature and diverter and a unique patented shield and it automatically rejects the unwanted contaminated first urine stream and captures what doctors want: a sample. And thanks to an air lock, there is no overfilling the bottle. No need to stop and start, no need to keep checking whether you are getting the sample into the bottle. The collection process is automatic. Because other collection methods require messy insertion of collection container into the flow of urine, thousands of urine samples become contaminated by contact with fingers. The Whiz Midstream differs from these funnel devices.

The Whiz Midstream is simple and ingenious; all you have to do is to attach the provided sterilized collection bottle on the bottom of the device. Then, as it is not a funnel and possesses a patented shield which ensures total hygienic collection, as well as, comfort, hold it against the body and let nature and gravity do the rest. There are different instructions for men and women.

The Whiz Midstream is the only product available which automatically allows the early stream to flow off before collecting the sample. It is also the only product which conforms to all regulatory directives such as: standard operating procedures for the collection of an MSU; standard regulations against hazard substances (urine while sterile on leaving the body is a potentially a hazardous substance), standard regulations on patient and staff safety, standard regulations on appropriate equipment etc.

Because other collection methods require messy insertion of collection container into the flow of urine, thousands of midstream urine samples become contaminated by contact with fingers. The Whiz Midstream differs from these funnel devices. It is not a funnel and possesses a patented shield which is held against the groin and which ensures total hygienic collection, as well as, comfort.

Supplementary Instructions for Use, 2011 – Download Whiz Midstream Pdf

Although the Whiz Midstream is designed for use by women of all ages, from 3 upwards, it can also be used by boys and men. We are in the process of developing a device for babies and its use here must be left to the total discretion of patents who would need to hold the device in place.

When to use it

The mid stream sample is the preferred clinical method for all urine sample collection but is essential for all tests where microbiological analysis could be required and it is regulatory method for all antenatal patients.

It can be safely said that everyone will give a number of urine test in his or her lifetime.. Pregnant mothers give between 8-12 per pregnancy. Hospital admission requires a urine test. It is the single most used test for healthcare and preferred, if appropriate, to all invasive tests like blood sampling. There are four basic types of testing: routine, anatomic pathology, esoteric and substance abuse for employment. Routine testing is the single largest segment and is growing at approximately 1-2% p.a. This segment includes standard tests such as check up tests.

Routine testing is expected to remain an integral part of the delivery of health care services due to the following factors:

  • The aging in general of the population, resulting in increased utilization of testing services
  • An increase in the number of routine tests due to advances in technology and scientific knowledge
  • Increased automation in testing procedures due to the development of highly automated laboratory testing equipment leading to greater efficiencies
  • Increased awareness among physicians and the general public concerning the importance of preventive medicine and early detection.
  • Increased use of tests by physicians as protection against potential malpractice suits
  • Analysis tests by the ‘worried-well’ sector of the population – these will not necessarily involve path labs – as the worried well may prefer to use kit or self-testing systems at home – but the principles of a clean sample catch and convenience remain for this and all the above – in fact are more important due to the need for accurate home analysis.

Overall, the urine collection market is growing at approximately 2-4% per year due to population growth, a demographic shift to older patients and the discovery of new tests using urine.

Especially in the Healthcare Industry where a service and an analysis is being provided it is essential to use the clinically best and most effective method immediately. 70% of all health care is pathology based and Urine sample collection, on which the analysis will be based and in turn on which the healthcare will be based is no exception.

Because the urine sample is the basis of so much in healhcare (including MRSA) and even when not the importance of reducing spillage to spread diseases (eg with C.difficile) the Whiz Midstream offers multiple benefits to:

  • Patients
  • Staff
  • Clinicians
  • GPs
  • State Hospitals/NHS
  • Private hospitals
  • Pathology Labs
  • General Health care

First and foremost it is, we believe, the only current IVD (in vitro diagnostic) product that is fully regulatory compliant with all current health and safety regulations that ensure the health and safety of the patient, and the professional medical staff. Amongst others the Midstream also offers:

General savings and financial benefits of the Whiz Midstream

It should not be avoided that today costs are an issue. No one doubts that there is a substantial cost for every urine test, A figure of £28.50 is an accepted figure taking into account direct consumables and associated costs. Not included would be the costs of inappropriate anti-biotics or other health care associated costs, litigation or malpractise suits which could run to £100,000 let alone the loss to the patient. Also to be considered is the damage to the practioner involved in such a case of working or supplying equipment contrary to Regulations which could mean a loss of a job, wasted training etc etc.

Indeed in ante-natal, the human cost is far higher, as in the case of a fatality or major health implication as can so easily occurred in ante-natal cases where a UTI is not detected or the catching of issues of cross infection due to urine contamination
The reduction in the number of re-tests and associated costs create considerable financial benefits to the healthcare provider. The potential savings to the NHS on microbiological samples alone would be a minimum of £23 million**, with total savings of some £40-80 million. Individually, savings could be from a minimum of £1.28 to £8.00 per test (from areas where contamination is known to be as high as 56%) after deducting the cost of the device. Further financial benefits such as general hospital expenditure are not included.

Hospitals

Direct Benefits: Lower staff costs in collection centres. Lower cleaning costs in both time and materials. Lower contamination rates mean: less time spent on microscopy, fewer full cultures, fewer direct sensitivity tests, less time spent analysing results. Fewer false positives. Better detection of UTIs. Less coldroom and bench space required. Faster, more accurate service. Greater competitive edge.

Patient benefits

  • Significantly better results and therefore signifcantly better healthcare
  • Preference and convenience – Substantial majority of patients preferred Whiz Midstream to conventional techniques
  • Less messy, less hassle and less complicated
  • No need to stop/start
  • 70.39%* first time users rated Midstream improvement over conventional method, 100 % of second time users

General healthcare benefits

  • Standardisation of mid-stream urine collection
  • Improved working environment for staff
  • Adherence to BSOP41 and COSSH Guidelines
  • Removal of dependence on the patient to provide a good MSU
  • Represents best medical practice

General Practitioners

  • Cost Saving
  • Better Service
  • More Accurate Diagnosis

Comments by patients

  • “No uncomfortable pauses or wet hands”
  • “Clean and simple”
  • “Easy… very practical”
  • “No weeing on hands and down bottle”
  • “Why don’t doctor’s surgeries use these?”
  • “No mess, no spillages, no stop and start”

Use of the Whiz Midstream could not be simpler and more hygienic – it collects the sample automatically and independent of the patient allowing for a completely clinically accurate specimen. Being automatic it collects without interrupting the flow, which is the Standard Operating procedure – and an essential one – for the mid stream sample. And being automatic it standardises collection procedure – which is critical to ensure that diagnosis does not vary from place to place due to non standard manual decisions – i.e. a women may not collect a mid stream as she starts and stops or waits too long or begins to collect too quickly the mid stream.

There are simple instructions are on the packaging of each product. All you do is attach the sample bottle, hold the Midstream comfortably against the body, and wee normally. Nature and gravity and the Midstream do the rest.

Female Usage:

Male Usage:

As the experts wrote: “The urine collection device employed is not simply a funnel, but incorporates a flow-sensitive sampling channel and diverter which, using urodynamic principles, excludes the initial low-flow portion of the urine stream, thus discarding the contaminated early stream volume and automatically collects the volume without interruption of the stream.” * Jackson et al, BJU Int., Aug, 2005.

As there is no spillage or over-fill, neither the patient nor the staff member handling the sample experience wet hands, wet clothes or soiled bottles. It is the most efficient MSU collector available and the only one that complies with many regulations regarding the correct collection procedure for mid stream urine ie to collect without interrupting the flow, the correct worldwide regulations on the ‘Control of Substances Hazardous to Health (COSSH) regulations and many other standard regulations around the world regarding patient safety, staff safety including that of the correct devices.

Download Whiz Midstream Instruction Pdf – For Female Use

Download Whiz Midstream Instruction Pdf – For Male Use

Technical Specification Sheet – Available on Request

We are frequently asked to provide data for the adoption of the Whiz Midstream by nurses, health specialists, procurement officers, GP’s, financial managers, clinicians etc. With their input we have developed a pro forma procurement checklist and set out their comments and evaluations in separate sections. There are certain pre-requisities for the evaluation and or adoption of any IVD device by health care authorities – that is:

  • Regulatory approval
  • Clinical efficacy – does the product do what it is supposed to do
  • Patient and clinicians acceptance
  • Value for money – although some authorities still cling to the belief
  • Patient, staff and clinician safety including medico legal issues

We have divided Patient, staff and clinician safety into the following categories:

1. Regulatory approval EU: CE Mark; USA: FDA approval:
2. Regulatory and/or Mandatory Compliance Factors
3. Professional regulatory and National Guidelines regarding Professional Codes of Conduct
4. User (clinician and Patient) Evaluation, Input and Preference:
5. Efficiency
6. Pricing
7. Value and Economic Arguments
8. Risk Assessment
9. Use and methodology of use

Pro-forma documentation available on request.

The Whiz Midstream is a midstream urine sample collection device, designed and clinically proven to make urine sample collection automatic, patient and staff independent, delivering a clinically proven, significantly superior and more accurate sample, which is collected more hygienically, easier, cleaner, faster and cheaper than anything currently available.

It is “not simply a funnel, but incorporates a flow-sensitive channel and diverter that, using urodynamic principles, excludes the initial low-flow portion of the urinary stream, thus discarding the contaminated early stream volume, and automatically collects the midstream volume without interrupting the stream.”

The Whiz Midstream is a leap forward in technology and product design. While the equipment for the analysis of urine has improved dramtically the last 100 years, the method of collection has not changed. A fast modern machine is rendered useless if the quality of the sample is poor. And currently urine samples have a high inherent contamination rate as high as 56% amongst GP’s collected samples (Garcia et al). In large scale trials the Cleancatch has reduced this to 3­4%.

CLINICAL BENEFITS OF THE WHIZ MIDSTREAM:

SIGNIFICANTLY REDUCES:

  • General contamination in GP’s surgeries by 73%****
  • Heavy mixed growth by 60%*
  • General contamination by 31%*
  • Urine spillage by 41%*
  • Re–test rates by 28%*

IMPROVES:

  • Identification of UTIs by 6%*
  • Number of clinically non-significant cultures by 5%*
  • Quality of sample
  • Accuracy of diagnosis
  • Staff working conditions and practices

SATISFIED CLINICAL PROFESSIONALS

  • It greatly reduces contact with urine
  • No time consuming instruction need to be given
  • Confidence in urine sample, whether given at home or in presence of doctor/nurse
  • Standardises urine collection practice

PUBLIC & PRIVATE FINANCIAL BENEFITS OF THE MIDSTREAM:

The reduction in the number of re-tests and associated costs create considerable financial benefits to the healthcare provider. The potential savings to the NHS on microbiological samples alone would be a minimum of £23 million**, with total savings of some £40-60 million p.a. Whiting et al 2006 – a major NHS cost study gives (p.116) the cost of a urine test at £25.00 in GP environment and £100 plus in a hospital environment. At national average contamination rates of 31% and at a clinically proven 4% Whiz rate, this is a minimum saving of £15.84 per test from GP’s and £93.84 per test in the hospital environment when paying £1.12 per unit for the Midstream and only 7p for the non-sterile universal. *****

The Midstream results in lower staff costs in collection centres. Lower cleaning costs in both time and materials. Lower contamination rates mean: less time spent on microscopy, fewer full cultures, fewer direct sensitivity tests, less time spent analysing results. Fewer false positives. Better detection of UTIs. Less coldroom and bench space required. Faster, more accurate services.

REFERENCES:

* “A novel midstream urine collection device reduces contamination rates in urine cultures amongst women” Jackson et al – BJU Int. August 2005, 96 pp 360-364

** University of Oxford, Said Business School Health Economic Model – MBA Programme

*** Failure to comply could lead to medico/legal action. In 2003 the NHS paid £450M in claims and currently holds a provision of £8B for future claims. Professor Sir Ara Darzi – Synaptiq

**** “Improving the quality of mid-stream urine samples with a collection device” Dryden et al – Poster (ICAAC Program Committee Award), ICAAC Sept 2007, Chicago.

***** “Department of Health, Centre for Evidence based Purchasing Report #07004”, January 2008

In April 2005 the Whiz Midstream was jointly awarded NHS contract for supply of MSU devices:

100 units per carton

Whiz Midstream with Sample Bottle (without Boric Acid)

Whiz Midstream with Sample Bottle (with Boric Acid)

NHS Order Codes

Ref: JUCD Ref: FSW243

Ref: JUCDB Ref: FSW244

Women can use the Whiz Midstream at home. This is particularly useful for pregnant women and/or women who need or would prefer to take samples at home rather than in a clinic.

10 Whiz Midstream with Sample Bottle (without Boric Acid)

1 Whiz Midstream with Sample Bottle (without Boric Acid)*

Ref: CC10

Ref: CC1

* Only available when ordered with a Whiz Freedom (www.whizaway.com)

Our Customer Testimonials

100 percent of all medical staff who have used the Midstream recommend it. Below some written comments from formal trials:

“Use of the device represents best medical practice and the significant benefits resulting there from, cannot be ignored.”

Senior Consultant Microbiology

“The Whiz Midstream is highly attractive to clinician and patient alike; it significantly lowered contamination rates and hence the need to repeat urinalysis. My patients were pleased to use this simple and hygienic device.”

Head of Obstetrics and Gynaecology

“My patients benefited from using the Whiz, it was easier to use than our current methods and for the staff it was an effective way of saving time.”

Outpatients Manager, Woman's Centre

“As a physiotherapy physican I have found that many women cannot use their pelvic floor muscles and would therefore be unable to do an efficient mid-stream sample of urine, this new device will be greeted with great glee by them – no more wet hands, no more wadding through puddles. Have I tried it? I most certainly have and as a person who is known to have frustrations with a a great many devices I found it a cinch – isnt it great to have good news to share?”

ACA Continence Advisor