EASD Press Release March 14, 2013 Avoiding a medical device disaster in diabetes

The European Association of Diabetes (EASD) today announces its intention to lobby for an urgent overhaul of medical device regulation in Europe to make it fit for purpose.

 

“We want to avoid disasters similar to those that occurred with PIP breast implants and metal-on-metal hip replacements,” says Professor Andrew Boulton, President of EASD, Professor of Medicine at the Universities of Manchester (UK) and Miami (FL, USA), and Consultant Physician at Manchester Royal Infirmary, UK.

 

EASD wants the European Union to follow the example of some Scandinavian countries in setting standards for medical devices. SKUP—The Scandinavian Evaluation of Laboratory Equipment for Primary Care (which covers Norway, Sweden and Denmark)—conducts rigorous trials of devices to ensure that they are easy to use and do what they are supposed to do safely.

 

“As a consequence of the increasing incidence of type 1 diabetes and, driven by the obesity epidemic and ageing populations, an increase in type 2 diabetes, the number of diabetes diagnoses across Europe is soaring and this trend will likely continue for decades,” adds Professor Boulton. “As a result, the number of people requiring blood glucose monitoring devices, insulin pumps, and other equipment, will rise. Additionally, advances in technology mean we will soon have closed loop devices that both monitor blood glucose and infuse the appropriate dose of insulin. It is essential proper regulations are in place to monitor these devices. Without them, the potentially tragic consequences for diabetes patients are all too evident.”

 

Professor Boulton recently chaired a meeting of key stakeholders involved with diabetes devices, including academia, industry, learned societies, diabetes registry managers, and regulators across Europe, as well as guest speakers from both the American Diabetes Association (ADA) and the US National Institutes of Health (NIH) to outline the US perspective.

 

There was uniform agreement in the room that the current system of device approval in the EU was inadequate to deal with the surge of complex devices that have emerged in past 20- 30 years. To obtain approval for a medical device in Europe, manufacturers must be given the Conformité Européenne (CE) mark, awarded by so-called “Notified Bodies” (NB), which are generally independent organisations under the auspices of the competent authority of the European Union member state in which they are based. To register a new glucose monitoring device, a manufacturer can choose any notified body in any country, to which it will pay a fee. The NB then ensures the device meets the required specifications. Once the device has gone through this single process, it will receive the CE mark and can be marketed across Europe without any restriction or further scrutiny.

 

Critics of the system say that the wide variation in quality of NBs across Europe means that manufacturers could target the NB most likely to give rapid approval to their device. Since NBs are in effect competing with each other for device manufacturers’ business, the system could be open to abuse with NBs being less rigorous to secure this business. There are also substantial variations in the price NBs charge within and between EU member states. “These notified bodies also have little if any knowledge about diabetes care, diabetes treatment, or in fact how a device which is being inspected will be used by a member of the public. The disastrous events in relations to hip implants and PIP breast implants have demonstrated the inefficiency of the system.

 

”EASD urges the EU to follow the SKUP model, since SKUP conducts trials of devices by both healthcare practitioners and the end-users (patients) to ensure their ease of use. If a device does not meet SKUP standards, then it will not be approved for reimbursement in Norway, meaning it will likely be unviable for manufacturers to market in Norway even if it has obtained a CE mark through a notified body. If a device meets SKUP’s standards, all details of the evaluation are published once the device is marketed. “SKUP’s methodology and results are a perfect model of what might happen in the EU. EASD will work in close collaboration with SKUP to promote the results of their evaluations and bolster their claim that people with diabetes should be informed about the outcomes of these evaluations. Other health authorities should also base their reimbursement policies upon these outcomes.”

 

Another key change advocated by EASD regards post-marketing surveillance, which is says is currently below any proper medical standard. “No proper data on pumps are collected and therefore potential malfunction or flaws in pumps will rarely be discovered,” says Professor Boulton. EASD will work closely with registries in Europe to develop models on how to continuously evaluate insulin pumps. Our view is that only those pumps and other diabetes devices that undergo and pass such continuous evaluation and inspection should be approved for use and reimbursement by medical health insurance companies or health authorities.

Professor Boulton concludes: “Unfortunately, without substantial improvement to the present evaluation process established by the European Union disasters are likely to occur, a situation which the European Association for the Study of Diabetes will strive to prevent”.

EASD President Professor Andrew Boulton

Note:

 

Major European device manufacturers were represented at the meeting mentioned above, as well as industry bodies EUCOMED and EDMA. For their views on regulation of devices, please contact them directly.

____________________________________________________

 

The views in this press release at those of EASD only.

 

EASD’s full position statement is below:

 

Medical Devices in Diabetes Care: A statement on behalf of the European Association for the Study of Diabetes

 

The European Association for the Study of Diabetes is calling for an urgent overhaul of the current CE Marking procedure for the evaluation and approval of medical devices in Europe. As it currently stands, this system could result in situations that may seriously threaten the lives of people with diabetes because of its inadequacies.

 

Medical devices are an essential element of successful diabetes care. Blood glucose self- monitoring is an integral part of insulin treatment. Self monitoring enables patients to achieve appropriate metabolic control, avoiding hypoglycaemia and reducing the likelihood of developing long term complications of hyperglycaemia such as blindness or renal failure.

 

Insulin pumps enable numerous patients to achieve excellent metabolic control and together with other devices such as subcutaneous glucose sensors, and, in the future, closed loop systems, facilitate diabetes care in such a way as to maximize patient care whilst minimizing patient discomfort. However, the proper functioning of these devices is absolutely essential for people with diabetes; malfunctions can have serious consequences and in some cases could result in death.

Insufficient CE Marking evaluation protocol

At present, there is a low level of regulation and control of medical devices in the European Union. This is a continuous threat to the health of people with diabetes. Medical devices in the EU must have a CE Marking; however, obtaining this CE Marking for medical devices and the lack of post-marketing surveillance can in no way be compared to the rigorous processes required to gain approval for pharmaceutical products, and thereafter the post- marketing surveillance. Drugs are reviewed prior to admission onto the open market by the European Medicines Agency, the EU’s counterpart to the Food and Drug Administration in the United States of America. The EASD has previously called for an improvement of the current European system for device registration, which, to date, has failed to be realised [1].

 

The CE Marking claims to guarantee the safety of the device being sold. However, it does not, in any respect, represent an independent confirmation of its quality. In addition, so called “notified bodies”, located all over Europe, which are involved in the CE Marking process have little if any knowledge about diabetes care, diabetes treatment or in fact how a device which is being inspected will be used by a member of the public. The disastrous events in relation to hip implants and PIP breast implants [2], [3], [4] which have been detected in recent years have demonstrated the inefficiency of the current system.

 

The notified bodies do not control the fulfilment of the current ISO standard for blood glucose test systems (DIN EN ISO 15197:2003, currently under review). Furthermore, the new proposals from the European Commission for the improvement of the current system will, essentially, not change this unsatisfactory and insecure system of control which is criticized by leading scientists [5].

EASD calls for urgent action

It is the position of the EASD that in order to protect people with diabetes, the following actions are essential:

 

• Firstly, since the procedure for obtaining a CE Marking and the role of notified bodies have proven to be ineffective, medical devices in diabetes care should be evaluated by independent research institutions. The standard of this evaluation should be the respective ISO-norm.

 

• Not only in vitro standards will have to be evaluated but also, and more importantly, real-life settings and situations will need to be evaluated.

 

• A continuous post-marketing surveillance of random samples should be a pre-requisite. When trying to improve the quality management of medical devices in diabetology, the European Union can look to specific examples in certain European countries which could serve as a model for change.

 

The Scandinavian evaluation of laboratory equipment for primary health care, SKUP, (http://www.skup.nu), for example, which is based in Norway, has, in collaboration with Denmark and Sweden, set up an excellent system for the control of blood glucose monitoring devices.

 

Their methodology of evaluation and the subsequent open-publishing of study results, which are carried out by independent research institutions, are a perfect model of what might happen in the European Union. The European Association for the Study of Diabetes will work in close collaboration with SKUP to promote the results of their evaluations and bolster their

claim that people with diabetes should be informed about the outcomes of these evaluations. Health authorities should also base their reimbursement policies upon these outcomes.

Post-marketing evaluation of insulin pumps jeopardizes patient safety

In Europe the level of quality control for insulin pumps is as ineffective as it is for blood glucose monitoring. Here again the control is based upon the same form of CE Marking procedure by notified bodies which have no knowledge with respect to the clinical problems of insulin pumps.

 

The current post-marketing surveillance is below any proper medical standard. No proper data on pumps are collected and therefore potential malfunction or flaws in pumps will rarely be discovered. It is absolutely essential to continuously evaluate insulin pump treatment using registries of people with diabetes. The European Association for the Study of Diabetes will work closely with the registries in Europe to develop models on how to continuously evaluate insulin pumps. Only those insulin pumps which undergo and pass such continuous evaluation and inspection should be approved for use and reimbursement by medical health insurance companies. In future, the evaluation of glucose sensors and closed-loop systems for the treatment of diabetes will require intense collaboration between specialists involved in diabetes care and in technology. EASD will further promote research in this area.

 

Unfortunately, without substantial improvement to the present evaluation process established by the European Union disasters are likely to occur, a situation which the European Association for the Study of Diabetes will strive to prevent.

Professor Andrew J. M. Boulton MB, BS (Hons), MD, DSc (hon), FRCP

President, European Association for the Study of Diabetes Professor of Medicine, Universities of Manchester, UK, and Miami, Florida, USA, and Consultant Physician, Manchester Royal Infirmary, UK.

 

References: 1. A J M Boulton & S Del Prato (2012) Regulation of medical devices used in diabetology in Europe: Time for reform? Diabetologia 55:2295–2297 2. Berry M G, Stanek JJ (2012) The PIP mammary prosthesis: a product recall study. J Plast Reconstr Aesthet Surg 65(6):697-704 3. Cohen D (2012) Hip implants: how safe is metal on metal? BMJ 344:e3410 4. Torjesen I (2012) NHS should replace PIP implants even if they have been privately fitted. BMJ 344:e2379 5. M Wilcox (2013) Assuring the quality of diagnostic tests: BMJ 346:f836

 

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