RFID in Hospitals

September 15th, 2008

Hospitals and G.P Surgeries are safe to use Radio Frequency Identification (RFID) in their facilities, according to a new study by U.S RFID Consulting Organisations BlueBean and Indiana University Purdue University Indianapolis (IUPUI). The study determined that passive RFID can be safely used in a hospital environment.

The study, which was completed in March 2008, tested 25 common medical devices resulting in 1600 performance assessments. In all cases, the devices performed as expected and no interference from the passive RFID devices was observed.

“This is great news for healthcare facilities. The results of this study make it clear that passive RFID is safe around common medical devices,” says BlueBean President Gregg Maggioli. “RFID systems to manage inventory, track items and assist in patient billing can now be used without any negative effects on equipment.”

Much has been said about the use of Radio Frequency Identification (RFID) technology in a hospital or primary setting; the issue has been discussed and debated since the technology has been piloted and evaluated and in some cases implemented into hospitals over the last few years.
The following technology opportunities are ones we at MWM have been made aware of over the last few years.
The wrong drugs being administered, wrong treatment being provided to patients or the right treatment but the wrong patient happens more than you may be aware. But thanks to RFID, error-free patient, treatment and drug identification and verification is now possible. RFID tags on patients allow electronic storage of information that allows healthcare practitioners to provide the right treatment and administer the right dose of medicine at the right times to the right patient.

RFID tags are being used to set off alarms for example in hospitals if patients or equipment is being moved inappropriately. In a community setting they are being used to issue warning signals when something untoward happens – like when Alzheimer’s patients wander outside the limits of their home or when wrong dosages of medicines are administered.
Some RFID tags are being used as sensors to warn clinicians of changes in temperature and humidity that control the storage of sensitive drugs.
Talking RFID tags are now being used to help visually-impaired patients with their medicine dosages – the tag reads out the name, dosage and time the medicine should be taken.
The introduction of RFID has been problematical due to the perceived risk of interference with other devices hopefully this recent American study will allay some of the fears of the clinical community.

Streets ahead of USA

September 1st, 2008

So you think the NHS has problems with its IT? Worried that the NPfIT / Connecting for Health program has messed up the health IT market and created even more problems? Well, maybe it’s not that bad. Reading a recent report by Health Data Management (HDM) about the state of the USA’s hospitals and GP networks, it looks to me like the UK is at least five years ahead.

For the full article, go to

http://www.healthdatamanagement.com/issues/2008_55/26710-1.html

As healthcare providers take matters into their own hands and develop hospital-centric networks, patients lose out, so the commercial need for adequate networking is increasingly pressing and urgent. If this is right, it paves the way for great opportunities for UK-based health IT organisations, which have had these systems in place for 15 years or more.

UK GPs have been exchanging data with the PCTs and hospitals as a matter of course for years, and while the NPfIT program has been criticised, it has stopped the ad hoc development of hospital IT and brought some sense of order with common data structures and protocols. The US hospitals that are developing their systems could at least learn our lessons by adopting our protocols and systems.

BT has created the UK NHS IT spine, which has been hailed as one of the ‘Connecting for Health’ successes. Surely this could provide the key for regional USA hospitals, with the potential of national USA linkage. I recently saw a demonstration of a system in an A&E unit, by a leading UK GP IT systems supplier. When a patient reported to A&E, the hospital could gain access to basic clinical data (based on information that the GP and patient wished to expose) to ensure they were aware of any significant issues or requirements. They could report back to the GP that the patient had presented themselves to the unit and arrange a follow up appointment.

Whilst the USA health system is bound to be set up differently, due to its funding, surely this is just a costing aspect. Why not beat the Americans at their own game? Go to the States, modify and develop your systems to meet their needs, using their money and then utilise and sell the tested product back here and elsewhere as they have been doing with us.

Darzi the Next Steps Review (NSR)

August 18th, 2008

The NHS is beginning to look at how it takes Lord Darzi’s vision forward through the next steps review process.

The part of this process that is of most interest to industry is the section covering innovation in medical devices and diagnostics. The following is a direct quote from the NSR…

The NSR statement on innovation and medical devices and diagnostics:

“Ensuring that clinically and cost effective innovation in [medicines and] medical technologies are adopted. For new medical technologies, we will simplify the pathway, by which they pass from development into wider use, and develop ways to benchmark and monitor uptake.”

The process to deliver this seems to break down into four main work streams, to be developed jointly between government and industry.

(i) Evaluation – a single pathway, fed by horizon scanning, via NICE & CEP, with outputs transmitted to the Evidence Centre [‘NHS Evidence’ in the NSR].

Government will need guidance from Industry to judge how far it needs to look ahead to spot new medical technology applications, as well as to find out which potential existing technologies in other global markets might benefit from evaluation or evidence gathering. But it’s clear that a streamlined evaluation pathway that could assist disruptive innovations would be welcomed by industry.

(ii) Create a “pull effect” within the system to help draw innovative technology into use - this is probably the most difficult strand as it goes to the core of the ‘culture’ of the NHS as an organisation. Potentially, this will challenge NHS organisations such as the Strategic Health Authorities to increase clinical engagement through periodic clinical conferences, designed specifically to diffuse knowledge of, or create an appetite for, innovative technologies.

Developing a focus through technology demonstrators, with organisations such as the Technology Strategy Board showcases healthcare innovations and develops stronger links between Industry and the research communities.

(iii) Make NHS Procurement more receptive to the value of innovative technologies - this is the bringing together of the recent review of the procurement hubs and the OGC review of NHS procurement along with the growth of emphasis on world class commissioning. Industry obviously has an interest in ensuring procurement functions make purchase decisions based on value and not cost.

(iv) Establish metrics to benchmark and monitor uptake and spread of innovative technologies - the intention is to develop an indicator using industry sales figures to the NHS in England. Industry will be supportive of this approach as long as there is adequate protection for commercially sensitive product data.

The first steps will be to agree which products should be captured and tracked under the “innovation” label, then to identify appropriate sources of data, for example, companies’ unit sales figures or NHS expenditure figures.

It is envisaged that there will be joint Industry and Government groups on each work stream, so watch this space if you want to get involved.

UK R&D is “world class”

August 11th, 2008

But the translation of research is still patchy
A report this week on academic research output has benchmarked the UK against the world’s 25 leading R&D economies, revealing that “the UK continues to punch above its weight in world class research”.
The report’s findings, which show that the UK is second only to the US in these terms, should act as an incentive to government to maximise this endeavour by investing in mechanisms to support the translation and application of current research.
According to the report by the Department for Innovation, Universities and Skills (DIUS), the UK has increased its share of published research in the world’s most influential scientific journals and “offers the best return globally for R&D investment”. The UK contributes 9% of papers and 12% of citations – second only to the US – according to an analysis of 17 million papers and 22.5 million citations in 8,000 scientific journals.
As an industry association, MedilinkWM has witnessed at first hand the amazing research capacity of our region; with many academic institutions undertaking ground breaking pieces of work in all the major healthcare and medical disciplines. The challenge remains for the region’s Science City and Innovation and Technology Council initiatives to buck the national trend of being good at “R” but no good at “D”.

We would then begin to see the West Midlands establish itself as a place where great science is undertaken and then translated into meaningful economic activity.

Over the next few years MedilinkWM will be working with all its colleagues in the knowledge economy to understand and articulate applied and academic research opportunities to the medical technologies industry in the West Midlands. The aim is to make sure that as much of the region’s intellectual property as possible is commercialised within its own industrial base.

Awaiting Feedback

August 1st, 2008

For those of you who read Tony’s post last week, titled “Is Government Listening?  It Appears So” we are anxiously awaiting your feedback, anecdotes or challenges.  Please forward these directly to Tony@MedilinkWM.co.uk or feel free to call if you’d prefer to not put the information in writing, 0121 452 5630.

Thank you!

Is Government Listening? It Appears So.

July 17th, 2008

Tony Davis, CEO, MedilinkWM

The recent Engineering Employers Federation survey stated that many manufacturing firms are out-performing the rest of the economy at present and are well placed to weather the current economic down turn.

This confirms what many of us in the manufacturing sector have known for a long time: UK manufacturing in the 21^st century is lean, dynamic, and above all innovative - delivering high value to the economy.

In a recent Business Enterprise and Regulatory Reform (BERR) department meeting in London, the Medilink UK networks and other healthcare trade associations were requested by senior civil servants at the department to canvas their members for feedback on how medical technology SMEs are coping with the current economic climate and the credit crunch.

Has there been a reduction in orders?

Have expansion or relocation plans been shelved?

Has R&D activity been suspended?

Concurrent with asking UK medical technology companies for their feedback on trading conditions, BERR have been engaging with industry as a result of the previous industry taskforce on how best to organize and reform the existing support / funding available, and to best advantage a sector which government has identified as being a significant contributor to the nation’s GDP. 

With the split up of the old DTI, many industry pundits predicted there would be a long hiatus in any sort of intelligent response from government in assisting the MedTech industry’s growth. In reality though, many of us have been surprised by a willingness from BERR (and DIUS) to look at many of the old DTI mechanisms and consult with industry on how to make them fit for purpose for the coming economic challenges.

So please email (Tony@MedilinkWM.co.uk) any comments or answers to the above questions or general comments you think the government should hear. Also keep a look out for an event later in the year where you can give your feedback directly to BERR.

High Quality Care for All

July 3rd, 2008

Most of us in industry have lived through many “New Dawns” for the NHS with many a government expert delivering their diagnosis on what ails the NHS and how government should react to provide potential solutions. Previous reports have majored on how the NHS had suffered from underinvestment and the current government reacted accordingly and increased the investment considerably. But were these investments made wisely? And did the NHS leadership along with the politicians have a robust strategy which informed the investment decisions?

 

In the same week as the report was published, the Confederation of British Industry (CBI) has urged the government to increase the pace of reform by embracing the independent sector. It advocates maximising competition and patient choice as the basis for tackling “failing provision and poor standards” in the NHS. “One thing recent years have shown us is that extra money alone has a limited effect on service outcomes,” said CBI Director-General Richard Lambert, in reference to the NHS’ £111bn budget. Richard Lambert is not alone in his assessment of the lack of impact the extra investment has had, many industry pundits are already talking in terms of the “Missed Opportunity” in truly reforming the 60 year old NHS post the Wanless review.

 

Many of those who participated in Lord Darzis’ review would share my view that he showed thoroughness and openness to all views and opinions, and perhaps for the first time we in the medical technology industry detected a true interest in innovation and technology and a willingness to include industry in the agenda of reform.

 

In the report and many of his recent statements I believe he understands the potential of new technologies to deliver part of the solution in creating a 21^st century healthcare system. However I am not convinced that his political masters or the leadership in the DOH &NHS share his vision or have the desire to carry it out.

 

The Secretary of State’s announcement to the house articulated the vision presented within the document, however the measures he proposed in my opinion stopped well short of being radical, it seemed to be a mixture of announcements of increased layers of bureaucracy at both regional and national levels, more panels, more boards etc and re-announcements of measures that the government introduced when they came to power, for example speeding up NICE.

 

On a more positive note we see the announcement from the Secretary of State on relationships with industry to be a positive move “We will create an environment in which excellence and innovation can flourish. That is why the report heralds new partnerships between the NHS, universities and industry to achieve the very best care for patients” Also in the report there is mention of “Innovation Clusters” where the NHS, Academia and Industry collaborate.

 

So do we believe Lord Darzi is sincere in his reform of the NHS? Largely yes!

Do we believe Government and the Civil Servants will carry it through? The jury’s out on that one I’m afraid!

 

 

 

The growing importance of overseas markets

June 23rd, 2008

The increasing emphasis on driving down price in the NHS potentially means that the procurement and adoption climate in the UK has never been more hostile.

That’s why new product entries and the adoption of disruptive technologies are becoming much harder, causing many UK companies to choose to supply a larger percentage of their products to export markets year on year. It’s therefore crucial that the UK Government provides a world-class export service to industry that will be fit for purpose.

The government organisation responsible for overseas trade is UK Trade and Investment (UKTI) and the section responsible for Medical and Healthcare markets is the Life Science Unit. This consists of two market disciplines – Biotechnology & Pharmaceuticals and Healthcare & Medical.

UKTI is driven by many factors, but not necessarily by what’s best for the SME industry base. As international trade promoters, MedilinkWM and My M-link are mindful that priority markets are often chosen because they are eye catching and politically significant. However, many of these large emerging global markets, including China and India, simply represent too much of a challenge for SMEs. The cost, time and commitment required to break such markets are investments that only the largest of Medtech companies can afford.

Many of the SMEs we talk to about international trade have told us that they are interested in markets closer to home, such as Germany, France and Scandinavia. Many of these smaller companies are seeking low-cost, well-targeted approaches to European markets.

So is UKTI missing the mark for SMEs? And what does it hope to achieve? Well, the recent UK Life Science Marketing Strategy focuses on large global markets and seems to be somewhat overly emphasised on the UK’s biotechnology sector – which is strange, because as the export strategy itself identifies in 2006, pharmaceutical exports were £12 billion, healthcare exports were over £14 billion, while UKTI forgot to include the export figure for biotechnology!

With the exception of Roy Johnson, the medical device and healthcare entrepreneur and Chris Francis, director of the UK India Business Council Chair of the UKTI Healthcare Sector Advisory Group, the recently formed UK Life Science Marketing Board is extremely light on members representing or even understanding the needs of SME’s in the medical and healthcare technology sector.

But be assured that as ambassadors for the sector, MedilinkWM and My M-link are working closely with colleagues from UKTI in the region to promote trade in the most effective way and to make sure that all our export efforts are industry-led and driven by the needs of West Midlands’ SMEs.

The Medical Devices Directive – Commission Consultation May 2008

June 15th, 2008

Posted by Tony Davis, CEO, MedilinkWM

In general it’s agreed that the system of regulating medical devices in Europe works well. The legislation was recently reviewed and improvements proposed. These improvements are in the process of being implemented, but the Commission has now embarked on a consultation containing proposals which would undermine the current system. This will stifle innovation and increase product costs without any consequent improvement in patient care or safety.

The three Medical Devices Directives and six modifying or implementing Directives form the framework for the regulation of medical devices. These directives come under the umbrella of the New Approach and classify devices into four categories according to risk. They were developed and implemented in the early to mid nineteen nineties. The main Directive (93/43 EC which covers the widest number of products) was reviewed in 2001 resulting in a report published in 2002. This report concluded that the regulatory regime created by the directive generally worked well but that various improvements could be made. Work on these improvements has been carried out by the Commission, Member State Competent Authorities and industry over the last several years. These changes were extensively scrutinised by the European Parliament and the process was completed with the publication of Directive 2007/47 /EC which comes into force in September 2010. It was indicated at this time that there would be a need for some further review because of the on-going review of the New Approach. It was also suggested that a process of ‘simplification’ (merging all the existing directives in to a single legislative instrument) might bring further improvement and this would be considered at the same time.

The Commission recently (May 2008) issued a consultation to a wide range of stakeholders, one of the most important being the medical technology industry. However the consultation, while covering the aspects described above, goes a great deal further in that it also proposes moving the regulation of higher risk devices into a regime similar to that of medicines using EMEA. Industry has serious concerns about these proposals. Were they to be implemented, there would be a significant increase in the cost of medical technology (the difference between notified body fees and those of EMEA is a factor of ten) and a decline in the number of innovative technologies coming to market with a consequent adverse effect on patient care. Many of these innovative technologies are coming from SMEs, which will be disproportionately affected by a more costly regulatory regime. On the other hand, if special fees are created for SMEs, then bigger Companies will see their competitiveness seriously eroded. Furthermore, the burden has to be spread over a few thousand units compared to several millions in the case of medicinal products

The document itself is flawed, is highly inconsistent, and makes claims not supported by any evidence:

· There is a clear statement at the outset that medical devices should remain under the New Approach. However the proposal to use EMEA would in itself move a large number of devices away from the New Approach
· The suggestion, both stated in the consultative document and implicit in the proposal to use EMEA, that there is a need for a new radical approach to device regulation is totally at odds with the recent Commission report that the current system requires only minor modification.
· The switching from NB to EMEA in terms of evaluation of the products will for the first time require the direct involvement of Competent Authorities officials, who have never had experience in evaluating medical devices: does this match with improving patient safety?
· There is a constantly repeated claim that the system does not work well. This is not only in contradiction of the earlier report but is completely unsupported by any evidence. In addition, this fails to acknowledge that the recent revision of the MDD will enter into force in 2010. We believe that the modified MDD should be allowed to demonstrate its effectiveness before embarking in a new revision of this kind.
· A claim is made that there is underreporting of device incidents in the EU. Again this is not supported with any evidence.
· The efforts made by the Global Harmonisation Task Force to harmonise device regulation globally is supported in the document but it is clear that the proposals concerning high risk devices would be incompatible with GHTF.

Industry is happy to engage in the debate prompted by many of the proposals in the consultation. However we are of the opinion that further improvements in the regulation of devices can be made without recourse to a costly and prescriptive regulatory model which will only increase cost and stifle innovation.

The Trials and Tribulations of the NHS Rapid Review Panel

June 9th, 2008

By Tony Davis, CEO, MedilinkWM

That the history of the NHS Rapid Review Panel is somewhat chequered is a great example of how even when politicians, clinicians and the public want something to happen quickly in the NHS, it’s still almost impossible to achieve.

The Rapid Review Panel was established in 2004 by the then secretary of state for health, John Reid, as a reaction to the rising ground-swell of public outrage at the increase in MRSA and other “Super Bugs” seemingly spreading throughout the whole of the NHS (primarily acute trusts) in the UK.

John Reid made the following observations at the time:

“Cleanliness remains a major patient concern and MRSA is a growing problem. The NHS is open about this. A clean environment provides the right setting for good patient care practice and good infection control. It is important for efficient and effective healthcare”.

“Patients rightly expect hospitals to be clean. Just like a clean hotel, a clean hospital gives a good first impression and can make a difference to how patients feel about the NHS and how they feel they have been treated. It is a physical manifestation of the health of the NHS”.

“Our new approach is to empower patients with more knowledge and encourage them to demand the highest standards of hygiene.  It is to give matrons and nurses at ward level the practical advice and power to ensure high standards are maintained. It puts cleanliness and the control of infection at the heart of inspection regimes, and it is to learn from the best at home and abroad to tackle the increasing problem of infection.”

His information came from a number of reports published by the DoH at the time, such as:
Winning Ways: working together to reduce healthcare associated infection in England. Report from the Chief Medical Officer <http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4064682&chk=Vqjhyn>

New technologies, products and services were seen as potential solutions to the situation the NHS found itself in. However, when the politicians wished to push through “Silver Bullet” solutions such as alcohol gels and deep cleaning bombs, they discovered what we in the medtech industry had known for years. The time it would take to get such products evaluated, tested and trialed in a clinical setting, then procured, would equate to a full term in office of constant lambasting by the media – hence the Rapid Review Panel for Hospital Acquired Infection Products was born.

As is the way with knee jerk, short term political solutions, the Panel was given an almost impossible task: a colossal work load due to the amount of profile it received in the press and hardly any resources. The members of the Panel were exactly the right mix of experience and expertise, however it is largely done on a voluntary basis with a small secretariat resource. This means it can only be reactive not proactive in its relationships with industry, resulting in a trail of bad experiences and dashed expectations, and an undeserved reputation as a blocker rather than an enabler of technology.

We are now seeing, at long last, an increased investment by the Department of Health in the process aligning its activity with the Centre for Evidence-based Procurement (CEP) and the NHS National Innovation Centre which should result in a better quality of interaction with industry and potentially increased take-up of product.

So, for the time being the jury’s out on whether the RRP will make the difference that is required in using new technologies to reduce infections; but we all have an interest as companies and as patients in their endeavors.