News

SELFCheck customer helpline

Friday 21st June 2019
JR Biomedical Ltd.

Medical self test kits have been helping ordinary people to get a quick diagnosis or monitor their health for decades. Diagnostic technology is evolving, moving out from the hospital laboratory, to the hospital ward, into GP practices and the patient's own home. Self test kits are easily accessed through pharmacies, supermarkets and online stores but not all retailers and distributors have the necessary scientific and technical background to answer all the questions that your customers may have. So, with a background in developing and manufacturing medical diagnostics, as well as an independently audited ISO9001 Quality Management System demonstrating our commitment to customer service, we are pleased to provide you with the support you may require to help you give the best customer service to your customers. Please feel free to include the following help line details on your website or provide these details to your pharmacy staff in store. SELFCheck help line - Freephone 0800 612 7531 (Monday to Friday 9am to 4pm). Online advice - www.selfchecktests.com Please note that although we are pleased to answer queries regarding the instructions for use or interpretation of test results, we cannot give any medical advice except to advise your customer to speak with their own doctor or pharmacist.…

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Pharmacy SELFCheck Starter Pack

Monday 17th June 2019
JR Biomedical Ltd

If you are an independent pharmacist or own an online pharmacy you may have considered offering self test kits and we would like to make things as easy as possible for you to get started. Product descriptionsHigh resolution images for your web siteRegulatory guidance You can now order the SELFCheck Starter Pack securely online from our B2B trade website and pay with credit card, debit card or Paypal. Order Now This website is strictly for trade orders only. Each starter pack contains 3 each of the 10 SELFCheck tests (30 packs in total). You will need to register on the site for a trade account to view pricing and place orders. For a full trade price list of the range please contact us.…

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New images for SELFCheck packaging

Friday 7th June 2019
SELFCheck

We are pleased to provide hi-res images of the SELFCheck self test packaging for our retailers to use online. Each product JPG file is 300dpi measuring approximately 2000x1860px and are available to download now from our Dropbox If you have any problems downloading the files or any questions please contact us.…

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Key information for UK retailers of self test kits

Saturday 1st June 2019
Dr John Rees FIBMS

Self tests are a class of medical devices that are tightly regulated in the UK, having to comply with the EU In Vitro Diagnostics Directive/Regulations (IVDD/98/79/EC) just like medical diagnostics used in hospital laboratories. Self test diagnostics such as blood glucose meters and pregnancy tests have been available for decades, allowing individuals to take more control over their health. Similar technology is now finding its way into tests for different diseases such as coeliac disease, bowel cancer and STIs. Used correctly and with good advice before and after purchase, self test kits can provide an accessible, low cost and reliable way to help identify a specific health issue. Whether the outcome of a self test is a positive or negative result, individuals can be encouraged to seek further advice from their doctor earlier than they otherwise might have. How you can keep on the right side of the law and provide the best service and products for your customers Customers should be advised whenever possible to speak with their pharmacist or GP if they are concerned about their symptomsAs with any medical test result, a self test result should not be used in isolation and must always be interpreted with consideration of the individuals clinical historyCheck whether your supplier of self test kits has a certified quality assurance system for medical devices ISO13485:2016 and undergoes annual on-site inspections by independent UKAS accredited auditorsEnsure that your products are correctly certified - the packaging of self test kits MUST display a CE mark AND the Notified Body number. Certified self test kits, such as SELFCheck, undergo independent review by scientific and clinical staff working for a Notified Body* (eg mdc, BSi, TUV) to show that the tests give reliable results and are easy to use by laypersons before they are allowed to be placed on the marketTests described as 'professional' means that they are only to be used by doctors, health care professionals and laboratories - it does not imply that they are superior in any way to other tests and if they only carry a CE mark without the 4 digit number, this means they are NOT approved for self test useTests described as FDA approved are not legal in the UK unless they also display the CE mark AND Notified Body number on the packagingThe instructions for use and packaging of regulated self tests have been independently reviewed and approved by a Notified Body. It is not possible to make changes to either without first gaining approval from the Notified BodyWhen preparing promotional materials or copy for your website do not make any claims outside those made in the instructions for use or on the packagingDo not place your own company details or branding on the packaging as this would constitute own labelling and you would need approval from the original manufacturer, approval from the Notified Body and a new CE certification processOnline retailers should make it clear on their website what the self test user should do once they have a result eg. 'Whether you have a positive or a negative result with your self test, you should always speak to your doctor if you are concerned about your symptoms.' *A Notified Body is an independent organisation such as mdc, BSi or TUV who, on behalf of a country's Competent Authority (in the UK this is MHRA), assess medical devices including self test diagnostic devices to ensure that they meet the legal requirements for use by the general public. If you have any questions, please feel free to contact our Quality Assurance and Regulatory Compliance Manager for advice.…

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New medical device regulations. Time is running out for distributors

Wednesday 29th May 2019
JR Biomedical Ltd.

The new European Regulation on IVD's (diagnostic tests) EU-MDR/2017/746 came into force 25th May 2017 with a 5 year transition period. This means that all laboratory and self test diagnostic tests sold in the UK will have to be compliant with these regulations by May 2022. These new obligations may impact current supply and distribution agreements. An important point related to the distribution chain for medical device manufacturers means that each economic operator (manufacturer, importer, and distributor) must verify that a previous economic operator has complied with the EU MDR requirements. Thus, importers and distributors must ensure independently that, prior to placing a medical device on the market, the manufacturer, importer and the device itself meet the stipulated EU MDR regulatory requirements. Distributors must verify that all of the following requirements are met: the device has been CE marked and that the EU declaration of conformity of the device has been drawn upthe device is accompanied by the information (on the packaging and IFU) to be supplied by the manufacturer in legible and easily understandable Englishfor imported devices, the importer has complied with the requirements and included the importer's contact details So, an important question to consider when purchasing diagnostic tests is does your distributor have a Quality Management System (QMS)? Does this include procedures for traceability, and recall in the event that this should become necessary? Do they keep a register of complaints, non-conforming devices, recalls and withdrawals? Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available must immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative (for devices manufactured outside the EU) and the importer. Forward traceability of a medical device throughout the distribution chain is another crucial feature of the EU MDR as all economic operators will have to track devices. Manufacturers, importers and distributors will have to identify at any given time from whom - and to whom - the medical device was supplied along the supply chain, including devices provided to health institutions and/or healthcare professionals. Eventually all devices will have to carry a UDI (Unique Device Identifier) assigned by the manufacturer. This information will be registered in EUDAMED, a publicly accessible database currently being set up. Is your distributor aware of their obligation to register with EUDAMED once this database is up and running? And are they aware of the obligation to engage in post market surveillance activities and report complaints to the manufacturer? Can you also be confident that products you buy are stored appropriately in a clean environment before dispatch? ISO 13485:2016 certificated by a UKAS accredited certification body is the "gold standard" QMS that ensures compliance with the regulatory requirements for medical devices. ISO 9001:2015 certification, while demonstrating that a supplier has quality systems and procedures in place, does not ensure compliance with these regulatory requirements. Investment in certification is expensive and time consuming and while not currently mandatory for distributors, an organisation that has been successfully audited to ISO 13485:2016 has shown that they have a robust QMS that does comply with all these requirements. Annual re audits are required to maintain certification giving you confidence that a distributor holding ISO 13485:2016 will supply you with products that consistently meet regulatory and quality requirements. For further information please contact our Quality Assurance and Regulatory Compliance Manager.…

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The importance of knowing your PSA levels

Tuesday 28th May 2019
Professor Christopher Eden, The Royal Surrey County Hospital, Guildford

Thirty-five years following the discovery of prostate specific antigen or PSA (a molecule in the blood) we now have scientific evidence of the highest quality (a randomized controlled trial) that screening men for prostate cancer using PSA saves lives. PSA has come in for a lot of criticism, as it is not completely sensitive or specific for detecting prostate cancer. It is elevated by a number of non-cancerous conditions (increased age, increased size of prostate, urinary infection, urinary obstruction, prostate trauma and ejaculation) as well as being normal in a fifth of men with prostate cancer. However, urologists know this and never diagnose prostate cancer on the basis of a raised PSA level alone. We use it to identify men in whom we should take a greater interest to investigate the possibility of prostate cancer. Over the past decades there has been considerable uncertainty about the value of screening for prostate cancer but the following points constitute real game-changers in this debate and should prompt all middle-aged men to get their PSA checked. The European Randomised study of Screening for Prostate Cancer (ERSPC) This trial recruited 182,000 men and randomised (allocated to either group randomly) them to be screened for prostate cancer or not. Screened men had PSA tests every 2-4 years and a prostate biopsy (sampling prostate tissue using a thin, hollow needle) if their PSA exceeded 3 ng/ml. In these patients, who have now been followed up for an average of 11 years, there was a 29% lower death rate due to prostate cancer than in non-screened patients. However, in the 20,000 Swedish patients in this study who had an average follow-up of 14 years, the reduction in the prostate cancer specific death rate was 42% with a 42% reduction of rate of metastasis (distant spread). The number of patients necessary to treat (NNT) to save one life from prostate cancer in this group was 12, which compares very favorably to the NNT for cancers that we already screen for: breast cancer (18); bowel cancer (29) and cervical cancer (10). The Prostate Lung Colorectal & Ovarian cancer screening (PLCO) study has been discredited. This smaller American study, whose results are routinely used to counter the evidence from the ERSPC, found 17% more cancers in screened men but no survival advantage. However, the study has since been discredited and it was heavily contaminated (44% of men in it had already had their PSA checked, so many prostate cancers had already been removed from this population) and there was poor adherence to randomised groups: 15% of men allocated to have their PSA checked didn't attend for the test, 52% of men allocated to no PSA testing continued to have their PSA checked and only 31% of patients with a PSA over 4 ng/ml had a prostate biopsy. Active surveillance (AS) is now the default option for men with low-risk prostate cancer. Evidence from several studies on both sides of the Atlantic now confirm that low-risk prostate cancers (PSA less than 10 ng/ml, Gleason grade of 6 and cancer limited to only one side of the prostate) usually grow slowly and are safe to monitor, only intervening if surveillance tests show progression of the cancer. For instance, a study of 450 men with low-risk prostate cancer on AS that .was published in 2010 showed that the men in the study were almost 19x more likely to die of a cause unrelated to prostate cancer, which was the cause of death of only 2.8% of men seven years after starting AS. Prostate biopsy is no longer the first investigation for men with a raised PSA in many units. Many urologists will now arrange a special type (multiparametric) type of MRI (magnetic resonance imaging) scan as the first investigation of a man with a raised PSA. This allows men with a normal scan to be monitored, if other tests concur that this is a sensible plan, knowing that MRI scanning will detect most prostate cancers. Men with an abnormal scan can have the abnormality specifically targeted, increasing the accuracy of prostate biopsy. Prostate biopsy has been improved The traditional method of biopsying the prostate through the rectum (back passage) has given way to targeted (using information from the MRI scan that preceded it) transperineal (the area of skin behind the scrotum and in front of the anus) template (using a grid to increase the accuracy of the biopsy needle placement) biopsy under a general anaesthetic, usually as a day case, in many forward-thinking Urology units. A PSA level before the age of 50 accurately predicts the future risk of prostate cancer. Several studies have shown that a baseline PSA test before the age of 50 is a stronger predictor of prostate cancer risk than race (prostate cancer is much commoner in Afro-Caribbean and less common in Asian men) or family history. This information could be used to guide the frequency of future PSA testing: 'adaptive' screening. For instance, a man aged 45 with a PSA level of less than 1 ng/ml would be advised that his next PSA test should be done in 8 years' time, whereas a similar man with a PSA of 1.5 ng/ml would be advised to have it re-checked in a year. Key pointsScreening for prostate cancer using the PSA blood test saves livesNot all prostate cancers need treatmentNot all men with a raised PSA need a prostate biopsy thanks to MRI scanningProstate biopsy is now more accurate and more comfortable for patientsHaving your PSA checked before the age of 50 accurately predicts your future risk of developing prostate cancer …

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Bowel cancer

Tuesday 28th May 2019
Patrick Kirby, Medical Scientist

Bowel cancer is the UK's second biggest cancer killer and the fourth most common cancer. Just under 16,000 (15,708) people die each year in the UK - that's a life every 32 minutes. Over 40,000 (40,695) people are diagnosed with bowel cancer each year - that's one every 13 minutesOne in 14 men and one in 19 women have a lifetime risk of developing bowel cancerOver 93% of people diagnosed with bowel cancer at an early stage survive for at least five years compared to less than 7% of those diagnosed at a late stageFive-year survival rates for bowel cancer have doubled over the last 40 yearsMore than 8 in 10 cases of bowel cancer occur in people aged 60 or over, but bowel cancer can affect people of all ages Statistics from Cancer Research UK…

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A case for home testing

Tuesday 28th May 2019
Patrick Kirby, Medical Scientist

I have recently read several articles about home testing and, in an ideal world home screening tests would not be necessary but early diagnosis and prompt medical intervention is always beneficial, and figures announced by Diabetes UK indicate that there may be one million undiagnosed Type II diabetics in the UK, which the current NHS systems are just not picking up. So, how do you identify early signs of an abnormality? You implement a screening programme aimed at "high risk groups". At least the Government has introduced national bowel cancer screening for people in England & Wales between 60 and 69 (to be extended to age 74). But in 2017 nearly 1,800 people under 60 died from bowel cancer (about 11% of the total) and 8,800 (56% of the total) people over 75 died of the illness. Thus, the current screening arrangements do not pick up over half of all bowel cancer sufferers. The SELFCheck self-test kits all have regulatory approval and offer a quick, low cost method of establishing if you should visit your GP for more detailed examination. What is interesting is that women know how reluctant their men folk are to visit their doctor, so we sell more prostate tests to women than to men, as they know that men will not take the initiative themselves!…

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