BUSINESS STANDARDS
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Business Standards > Articles

A healthy business

28 Jan 2008
Topics: Healthcare, Quality management, ISO 9001, Medical devices, CE mark, Information security, ISO/IEC 27001

Healthcare in the UK is under the microscope as never before. Standards of equipment, cleanliness and quality of care are under much more rigorous scrutiny as politicians, patients and healthcare professionals look for improvements in the service. The popular view is that whether through under funding, poor management or too much interference by politicians, standards have slipped in this crucial public service.

When Lord Ara Darzi unveiled his interim report into the National Health Service (NHS) in 2007, he acknowledged the problems and talked about the need to create a clinically driven and locally led NHS fit for the 21st century.

The report came at a time of concern over the cleanliness of hospitals and the high incidence of infections in the UK compared with countries such as Holland, where the MRSA and clostridium difficile bacteria are much less of a problem. Some argue that improvement can only come from a radical overhaul of the way hospital trusts are managed.

"Some chief executives are evidently not in control of their hospitals: that is the problem," says Dr Dennis Green, international consultant and principal auditor on ISO 9001, and author of Quality Patient Care in Hospitals. "Hospitals need a system of management that enables chief executives to be in control of their hospitals and encourages all employees, including medical staff and other professional staff to work together, not only for their own satisfaction, but most importantly, for the benefit of patients."

Dr Green knows hospitals: he was the assistant regional physicist with the Greater Glasgow Health Board for many years, and established an international reputation in connection with implantable cardiac pacemakers. He was involved clinically with over 1,000 pacemaker patients at operations in several Glasgow hospitals, at pacemaker clinics.

Dr Green argues that management standards such as ISO 9001, which has been a staple of quality management systems in commercial organizations for 20 years, would greatly improve the performance of hospitals.

"ISO 9001 helps staff to get themselves organized with the full support of top management and encourages - indeed demands - that internal auditing takes place to ensure that what is being done is in accord with agreed procedures," he points out.

"In one case, inspectors went to a radiology department and found 2,700 unopened letters from GPs about their patients," he adds. "ISO 9001 specifies requirements which must be addressed in order to comply with the standard - failure to do so would mean that a hospital will not be awarded an ISO 9001 certificate. It could have prevented such a lapse from occurring."

Managers at Northgate Hospital in Northumberland, which caters for people with learning disabilities, have been certified to ISO 9001 for years. Shirley Wakefield is one of the service managers at the hospital who are responsible for managing the standard. She chairs a monthly committee that considers reports from managers and auditors.

"The process of constantly reflecting on your practice gives you an opportunity to improve it," Wakefield explains. "It was quite a challenge to get healthcare to work in this way because it is less tangible than a product you can count and measure. However, we can learn lessons and make improvements that are based on real evidence."

Training is critical to making sure that care is consistent, according to Simon Alcock, sector content manager for healthcare at BSI British Standards. This is especially important when decision-making is being devolved to primary care trusts and can result in varying practices. For example, there is some concern about the extent to which practitioners reuse medical instruments that are only meant to be used once.

"These single use instruments are clearly marked," says Alcock. "However, they are being reused and that raises questions about how people are being trained in the use of the symbols that appear on them. There are some 50 standards for single-use at primary care trust level."

Changing for the better

Efforts to improve the performance of the NHS have been underway for some time. For the past 10 years, the Department of Health has used national service frameworks (NSFs) to set standards and to measure progress towards achieving them. One chief aim of NSFs is to reduce the variations in treating specific diseases in different parts of the country.

In addition, there are over 2,000 health standards administered by bodies outside the NHS covering everything from medical devices and patient records to hospital management and business continuity. These standards are crucial to the quality of care.

"Why have them?" asks Alastair Trivett, managing director of BSI Product Services. "Simple. If you were getting an artificial hip, for example, you would want to be sure it would last 15 years - you would be pretty upset if it broke after two."

Standards not only improve the quality of equipment and services, but they also reduce costs by providing benchmarks against which managers can measure value for money. In the mid-nineties the European Union introduced the Medical Devices Directive, which lays down standards of design, manufacturing and quality management for medical device manufacturers.

It is a system that defines the processes that should result in a good quality product rather than defining the product itself.

"It provides a road for you to follow, but how fast you drive on it is up to you," explains Romana Stefek, director of quality and environmental assurance at Nobel Biocare, a Swedish dental medical device company.

The Directive, which has been incorporated into the local laws of member states, not only protects patients from harm, but also provides medical device manufacturers around the world with a much bigger market than would be possible if they had to meet different requirements for each country.

"It has made the market much more homogenous," says Stefek. "Before the standards, you had to have your own test plans. Now if something goes wrong, you can validate yourself out of the problem. You don't have to be afraid that there is something wrong with your device."

Despite efforts at greater standardization within individual countries, and even within the EU, however, there is a big variation in healthcare standards around the world.

"Governments tend to drive standards in this area and different countries have standards at different stages," says Trivett. "In developed regions such as Europe and the US, standards will be more complex. In parts of the world where a hospital might be lucky to have glass in its windows, things are different."

For some years there have been efforts to close the gap. The Global Harmonization Task Force, a voluntary group of representatives from regulatory authorities and industry, has been working to harmonize standards relating to the safety, effectiveness and quality of medical devices. Although it has published 26 guidance documents, they have yet to be implemented by members. This year, the group announced efforts to make a larger impact on regulators.

One of the problems of any standards setter is the fact that medical practice is constantly changing as technology develops. Laws in the UK are currently being updated to comply with the latest Medical Devices Directive, which puts greater emphasis on the clinical evaluation of devices to prove they will not harm patients.

However, technology is a moving target especially as previously separate areas of development such as pharmaceuticals and biosensors start to merge. For example, stents - the small springs that are used to keep the blood vessels open in patients with heart disease - are now being coated with aspirin to help reduce the possibility of a heart attack.

Some areas of research also throw up complex ethical issues. Nanotechnology and cell-based therapy have been the subject of intense scrutiny from science watchdogs. Here BSI has been involved in drawing up guidelines for organizations operating in the field, intending to reassure the public and enable the commercial development of these technologies in the UK.

One thing is certain: clear and consistent standards are crucial to delivering the service improvements so desired by healthcare consumers and to meeting the commercial ambitions of the UK medical industry.

>CASE STUDY: Securing patient data

When a Prime Minister reads passages from an international standard in the House of Commons, security is front-page news. That is what Gordon Brown did recently after discs containing personal information on 25 million people who claim Child Benefit went missing; he quoted from the information security standard ISO/IEC 27001 in a bid to reassure the public that the government was making efforts to safeguard the personal data that it holds.

Data security is a sensitive issue for those responsible for public sector information processing, especially in healthcare where patient record confidentiality has always been a key objective. Security is the sine qua non of the £12bn NHS "Connecting for Health" IT modernization programme, which aims to make it easier to access health records electronically.

Patients have the right under the Data Protection Act to insist that their data is removed from the NHS network - maintaining a high level of confidence in privacy precautions is vital to its effectiveness. Access to the database called the Spine, which holds electronic patient records uploaded from local files, is restricted to authorized staff who need a smartcard and PIN number issued by their local NHS trust to request or add information to the system.

Full patient records are held in the GP's surgery or hospital where a patient is treated. The Spine contains a summary of the data including name, address and medical details such as allergies, the medicines a patient is using and test results. The database also hosts the Choose and Book service, which allows patients and their GPs to make appointments with hospitals and other health services, and the Electronic Prescription Service.

NHS organizations already have to conform to ISO/IEC 27001 and must satisfy the Information Governance Unit based in Leeds that they do so correctly. In addition, suppliers working on the Connecting for Health project have also had to adopt the security standard because their employees have ready access to personal medical data.

Recently, a third group - private hospitals and clinics doing work for the NHS - has also come under the ISO/IEC 27001 umbrella. The Horder Centre in East Sussex is an independent orthopaedics hospital that won an extended choice network contract in 2006, which opened up its 59-bed hospital to NHS patients from all over the country. Ninety per cent of the Horder Centre's work is already with the NHS through local trusts. Since joining the network, the hospital has treated patients from as far afield as Devon and Lancashire. But before it could access the patient choice facilities, the Horder Centre had to invest some £1m in new IT systems and adopt improved security procedures.

"The hard work has made us a better organization," says Karen Planterose, director of operations and deputy chief executive. "We have had to look at our systems. Although it is mainly about IT, getting ISO/IEC 27001 certification has affected the whole organization - everything from making sure we wear a name badge to shutting down our PC and clearing our desks at the end of the day."

For more information, visit:www.bsigroup.com/jan08infosec

>CASE STUDY: CE marking: an essential ingredient

For manufacturers of medical devices in the US and Asia-Pacific, entry into the European market can mean significant business, but breaking into the market can also be a significant challenge if a business is not prepared.

"CE Marking is important for US manufacturers because the EU is the biggest and most valuable export market for US medical device manufacturers," explains Paul Brooks, vice-president and country manager of BSI Product Services US, Healthcare. "Medical devices are a sector where the US has a significant trade surplus with EU, so it's simply very attractive.

"The biggest challenges include: understanding the EU regulatory framework and how medical device manufacturers are empowered under the EU Medical Device Directive; and having access to a Notified Body that supports them in terms of understanding the EU regulatory environment and their responsibilities," he adds. "We need to get the approach as efficient and effective as possible to ensure timely access to the EU Market with robust supporting regulatory/patient safety data and quality assurance systems that address EU expectations."

To help American manufacturers of medical equipment achieve faster access to the European market, BSI Product Services, Healthcare launched CE-90, a 90-day CE marking programme. The CE-programme is designed for products needing design dossier reviews, detailed reviews of the technical file of a specific product. This includes Class III, highest risk devices, such as those in contact with the heart, brain, central circulatory system or central nervous system, and often implantable, such as cardiovascular stents.

For more information, visit:www.bsigroup.com/jan08medicaldevice

Business Standards © 2010. Editorial produced by Caspian Publishing in association with The British Standards Institution. Editorial opinions expressed on are not necessarily those of BSI Group or Caspian Publishing. Neither Caspian Publishing nor BSI Group accept responsibility for advertising or editorial content, nor for that appearing on linked third-party websites. Reproduction in whole or in part is forbidden without written permission from BSI Group or Caspian Publishing.

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