Biomedical engineering enables today’s remarkable developments in medical knowledge to be applied in practice. DNV is involved in the CE labelling of medical equipment – a matter of life or death, and fully consistent with DNV’s objective of safeguarding life, property and the environment.
71-year-old Johan Dybdahl from Kristiansand in southern Norway lay reading a book as he was wheeled into the operating theatre. The arteries to his cardiac muscles had become blocked. He had been through this before he had had a cardiac operation a few years ago, at which time his whole chest had to be opened up. This time its easier. He does not even need a general anaesthetic, and can watch the entire operation.
The doctor, Arne Johannes Tofte, and radiographer Inger Johanne Saastad have entered a catheter via the groin. They can watch the catheter searching for the cardiac muscles blocked arteries on large X-ray screens. Dr Karleif Vatne is watching the operation in the next room and explaining to me just what is happening. We can see the two doctors conferring.
The atmosphere is very calm. When the operation is over, three metal stents tubes to keep the arteries open have been left in Johan Dybdahls cardiac muscle artery.
Vital inspections
Dr Karleif Vatne was the first doctor in Norway to use stents in cardiac operations. He cannot overemphasise the importance of properly inspecting the technical equipment used. After all, were talking about human lives. Theres no use having inferior inspections. Nor must we go to some certification company in order to get away with a simpler, and maybe cheaper, inspection.
Eugenie Husebye, who heads DNVs work on medical equipment, points out that CE labelling by DNV is in accordance with all the latest rules and provisions. The equipment used in this kind of surgery is classified as a Class 3 product, so no errors are tolerated, she explains. Theres always a risk that something can go wrong a calculated risk with all medical equipment but that risk must be evaluated.
Ms Husebye explains that all the equipment used in the operation we have just seen is CE labelled. We look at the technical documentation on each product and then inspect the entire process. The plastic used in the catheter balloon used to unblock the artery is assessed by risk analysis. The same is true of the stainless steel used in the stent that will keep the artery open and of everything else involved.
ISO certified, CE labelled
The Saint Côme Chirurgie facilities in Marseille and European Catheter Technology (E.C.T.) facilities in Toulouse are both ISO certified and CE labelled by DNV. The CE standards are very strict. Our products are in the maximum-risk class Class 3. DNV has carried out a complete audit of our work, states Ms Christiane Fouere, who started Saint Côme Chirurgie together with her husband in 1993. He invented and patented the metal stents of their company.
We have specialised in stents and balloon catheters. In future, well also make narrow radiology products for use in brain surgery. In the same way as balloon catheters are used to open cardiac arteries and stents are left in to keep arteries open, new methods will also make brain operations easier and less risky than they are today.
Says Christiane Fouere, New technology is changing the face of medicine. In future, doctors will avoid surgery as much as possible. Surgical procedures will only be necessary in critical situations. For example, a bypass operation needs at least 3-4 weeks of convalescence and involves a risk of serious problems. Now the doctors put in stents straight away so the market keeps on growing.
All safety aspects considered
Philippe Periphanos at DNV in Marseille works with Sterling Kwartz to certify Saint Côme Chirurgie's quality system, and to CEMark its Class 3 products. Kwartz is Dutch, living in France, and has considerable experience of working on medical hazards. Together, the two have conducted the audit, with Periphanos responsible for following up the directive itself, and the medical expert, Kwartz, responsible for the technical side of the product.
Its particularly important to take all the safety aspects into consideration, states Periphanos. A stent has to be inserted into the body. The risk analysis must be checked. Added to this, we have to follow a checklist of essential safety requirements. When dealing with a Class 3 product, we must also carry out qualitative surveys and evaluate if the risk analysis covers all the relevant risks. This is where we apply DNVs skills and experience of systematics, certification, medical knowledge and risk assessment for the benefit of the manufacturer and most importantly of the patient.
CE labelled for life
More and more products will be CE labelled. It is important that people who come into contact with these products know what CE labelling involves, and that they can trust the label.
The CE standards are very strict, and they have to be, states Ms Fouere. Without CE labelling, a product is worthless. Once it is CE labelled, the product can carry out its function and both save and prolong life.
In Kristiansand, Johan Dybdahl is hopefully still enjoying life. Maybe hes sitting reading? At least he is not bothered about the three stents he had inserted into his cardiac muscle. They have given him a new, better life and, hopefully, many good years ahead of him. CE labelling has undoubtedly helped.
The Medical Devices Directive (MDD)
Directive 93/42/EEC (MDD) was adopted on 14 June 1993, as part of the process of removing barriers to free movement as well as of securing the safety aspects of medical devices within the EU/EFTA member states. Until the implementation of the MDD, medical devices were covered by local laws and regulations in each individual country. The directive became mandatory on 14 June 1998.
DNV Region Norge AS (DNV RN) has been appointed the Notified Body for all medical devices under the directive, with the identification number 0434. Its main task is to verify all assessments and take a uniform approach to the MDD. This is done by supporting the local DNV units, which carry out the CE assessments at clients premises.
In total, DNV has issued 600 certificates. Today, DNV is involved in the CE assessment of medical devices in Europe, America, Australia and Asia. Its success is due to it having highly qualified personnel in the local DNV units, and to good co-operation between them and DNV RN. DNV Italy has been especially active. Taiwan is catching up, and new countries to come are China, India and Brazil.