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Regulatory path of the medical device. The safety of medical devices (MD) is recognized by the CE marking allowing their free circulation on the European market. The new European regulation will reinforce the application and the survey of MD. For implantable MD, clinical data will be required, and the traceability will be facilitated by the implementation of a unique identifier. The safety of MD is under the European governance responsibility, while the circulation, the reimbursement and the survey of MD is under the responsibility of each country. In France, the evaluation of the clinical benefit and conditions of use of MD reimbursed is under the responsibility of a specific commission of the HAS, while their surveillance is under the responsibility of the ANSM."Parcours réglementaire du dispositif médical. Le marquage CE médical garantit la sécurité des dispositifs médicaux et permet sa libre circulation sur le marché européen. Les exigences de ce marquage CE vont se renforcer grâce à la mise en application du nouveau règlement européen tant à l’obtention que dans son suivi. Les investigations cliniques pour les dispositifs médicaux implantables deviennent une règle. La mise en place de l’identifiant unique du dispositif médical va faciliter sa traçabilité. Si la sécurité du dispositif médical relève d’une gouvernance européenne, la prise en charge et la surveillance relève de la compétence de chaque pays. En France l’évaluation du bénéfice clinique et des conditions d’utilisation des dispositifs médicaux relève de la HAS alors que leur surveillance est sous la responsabilité de l’ANSM."

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.

All contact lenses with replacement schedules longer than daily must be maintained. At each step of their use, the lenses may be contaminated. Contact lens solutions perform the essential functions of cleaning, decontaminating and preserving the lenses to prevent infectious problems and improve wearing comfort. Contact lens contamination essentially comes from hands, cleaning solutions, cases, water and the environment. The pathogenic microorganisms are mainly Gram-negative bacteria, fungi and amoebae. Contact lens deposits may or may not have an organic origin. Their presence increases the risk of infection because they serve as a nutrient matrix for microbes, and they are responsible for wearing discomfort. Contact lens solutions differ in their composition, their mechanism of action and the concentration of the various agents. To prescribe the best lens care system to each wearer and for each material, it is necessary to be very familiar with them. Maintenance is the main cause of discomfort with contact lenses, either through improper use, solution-material incompatibility, or a reaction of the wearer to the components.

In order to answer statutory requirements and to anticipate the future needs and standards, the EFS is committed, since a few years, in a process of harmonization of its metrology function. In particular, the institution has opted for the skills development by internalizing the metrological traceability of the main critical quantities (temperature, volumetric) measurements. The development of metrology so resulted in a significant increase in calibration and testing activities. Methods are homogenized and improved through accreditations. The investment strategies are based on more and more demanding specifications. The performance of the equipments is better known and mastered. Technical expertise and maturity of the national metrology function today are assets to review in more informed ways the appropriateness of the applied periodicities. Analysis of numerous information and data in the calibration and testing reports could be pooled and operated on behalf of the unique establishment. The objective of this article is to illustrate these reflections with a few examples from of a feedback of the EFS Pyrénées Méditerranée. The analysis of some methods of qualification, the exploitation of the historical metrology in order to quantify the risk of non-compliance, and to adapt the control strategy, analysis of the criticality of an instrument in a measurement process, risk analyses are tools that deserve to be more widely exploited for that discipline wins in efficiency at the national level.

Health care vigilance committees appeared with time in France. Some vigilance entities are present at a regional level, but all are found at the National Drugs and Health Care Products Safety Agency. Along with health care centers' certification, vigilance committees' coordination has evolved: whereas its presence was optional in the first version of certification, it has now imposed itself within health care centers with the more recent versions of certification, detailing the actions it must undertake. In parallel, a lot of attention is put on health care-related risk management with a health care center. Vigilances' coordination can thus take advantage of this in sharing an incident declaration system common with that of health care-related risks management. This collaboration will enable the generation of a priori risks' maps, help analyze adverse events and use the notion of criticality within a global safe care policy in each health care facility.

Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials.We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted.In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked.For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

Recently new models of cardiac pacemakers have been commercialised. Some of these models have the particularity to be compatible with MRI (they are called MRI safe). The safety of the MRI for the patients implanted depends on the device it self and the lead(s). These review article focuses on the benefits and limits of these new devices. A practical guideline is proposed for patients implanted by a pacemaker or ICD and undergoing MRI.

Since 1985, a Council Resolution defines a new approach to technical harmonization and standards. The directives resulting from this new approach establish the essential safety requirements with which products put on the market must conform, and which should therefore enjoy free movement throughout the European Union, owing to a presumption of conformity. However, if the manufacturer is responsible for the conformity of its product in terms of safety, it is the end-user who must make sure that its requirements for a specific use or a considered application are satisfied and that the product meets its needs. It is the objective of the procedure of validation, which calls upon protocols of qualification intended to show the aptitude of a material, a system, a device, of an installation, to meet the requirements of specified quality and safety. This concept of qualification applies to the data-processing software of the hospital blood banks. Only the stage of operational qualification will be developed here. It involves scenarios made up of test files which make it possible to check the electronic data interchanges between the hospital blood bank and the blood establishment (transmission of the results of analysis, transmission of the data of traceability), as well as the functions of assistance to the issuing of the labile blood products.

Medical devices are known to carry risks from design to scrap. Accident reports in ICU show that medical device account for only 20% of accidents. Formation of users and providing a postmarketing incident reporting are thus essential in health institutions. Clinical and engineering departments should cooperate to produce and secure procedures which should be applied during the lifetime of each clinical device. Several points should be especially fulfilled: close cooperation between clinical departments and biomedical engineering departments with available technicians, computer-based inventory of all devices, evaluation of specifications required before purchasing a new device, education of users on utilisation and maintenance, technical follow-up of devices and keeping maintenance and repair logs, ability to provide users with replacement devices, provision of check-lists before use, forging criteria to decide when device should be discarded. These principles are simple and should be considered as mandatory in order to improve medical device related security.

Invasive or endotracheal mechanical ventilation can lead to numerous complications likely to burden morbidity and mortality of patients in the intensive care unit. Various safety practices for mechanical ventilation may involve intubation, the mechanical ventilation period, weaning and extubation, the use of tracheostomy as well as non-invasive ventilation. The main objective of safety practices described in this chapter is to prevent or avoid the main risks due to invasive mechanical ventilation.

The presence of a pacemaker or an implantable cardioverter-defibrillator was historically considered a contraindication to magnetic resonance imaging (MRI), due to the risks for both patient and device: reed-switch closure responsible for asynchronous pacing, inhibition of pacing, rapid ventricular pacing, heating on the lead tip or even device displacement... However, many recent studies demonstrate that if MRI is crucial for the management of the patient, it can be performed under specific monitoring and scanning conditions and after device reprogramming. The growing implication of device constructors in constructing a MRI safety device will perhaps extend in the future the indications of this imaging modality in implanted patients.

Radiotherapy accidents are exceedingly rare. However, they may have major negative consequences: for health (and sometimes life) of victims as well as for the trust that patients put in radiotherapy and radiation oncologists. Each accident must be pointed out, analysed and reported, in order to allow preventive actions, avoiding repetitive accidents. Through examples of majors accidents occurred all over the world in the last decades, affecting professionals, public or patients themselves, the necessity of transparency is demonstrated. The International Commission of Radiobiological Protection has drawn positive lessons from such accidents and insists on following recommendations: necessity of sufficient number and competent professionals, importance of continuous and initial education, information of professionals and, in general, a strict Quality Assurance program. It is clear that each radiotherapy center remains at risk for errors. It is essential to develop preventive procedures to avoid transformation of errors into accidents. In that context, complete and detailed description and reports of each anomaly or incident must be encouraged as it is done for sectors of aviation or nuclear industry. Radiation oncology must develop such a culture of transparency and of systematic report of all incidents.

Brachytherapy consists of sealed radioactive source implantation. The diversity in the nature of radioelements, in their energy and activity requires strict implantation and utilization rules. These rules include radioactive source physical parameters check, after-loading machine and treatment planning system quality assurance and safe and reproducible dosimetric systems. Patient and medical workers information guarantee radioprotection and prevention of accidental exposures.

One of the missions of the Agence Française due Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whole blood chain from blood collection to receivers' follow-up. This system is now operational and contributes with efficacy to the safety of blood transfusions (see: A quoi sert l'hémovigilance? Transfus Clin Biol 1998; 5: 415-21.). The French law No. 98-535 dated July 1st 1998, whose enforcement orders were published in March 1999, is the legal foundation of the system. In this article the national and regional structures of the national system of sanitary safety are described, and the main guidelines of material vigilance, the last element of this system, is presented.

We describe an original device developed by the biomedical technicians of the University Hospital of Nancy for checking tightness and measuring the capacity of medical gas pipeline network. A leak can be assessed either as a loss of pressure or as a loss of volume per unit of time (cmH2O.min-1 and mL.min-1 respectively). To assess the latter, the capacity of the explored pipeline must have been measured when it still was gas-tight. With the device, a leak can be assessed within a few minutes whereas the official procedure requires a delay between 1 and 24 hours. The device still has to undergo bench evaluation and validation.

When a gas cylinder valve is opened slowly, as required, the associated pressure reducing valve works properly and gas expansion decreases the temperature of the device proportionally to the delivered gas flow. Conversely, when the valve is opened rapidly, the pressure in the high pressure chamber grows suddenly from 0 to 200 bars in the case of a full O2-cylinder, if no flow is required at the valve outlet. This adiabatic compression in a small space generates a peak of high temperature. In the presence of combustible foreign debris and O2, ignition can occur. When the melting point of the metallic component is reached the device bursts and those in the vicinity are at risk of burns or death from inhalation of melten metallic debris. As several of such critical incidents occurred with O2-pressure-reducing valves whose high pressure chambers were made of aluminium, the French medical devices agency has enacted a regulation prohibiting their use.

Maintenance of medical devices is either curative, in case of a failure of the device, or preventive. Preventive maintenance (PM) is undertaken either at constant time intervals or when a given parameter crosses a specified limit. The aim of PM is to amend wear from intensive use as well as from ageing. Normally, the modalities of PM are defined by the manufacturer who must anticipate the possible deficiencies of the device. Some manufacturers tend to recommend exaggerated maintenance procedures. Obsolescence of a medical device is defined by one of the following criteria: a) loss of its initial performances; b) development of medical techniques requiring a wider spectrum of performances; c) presence of new devices with improved securities.

In France the manufacturer, the user of a medical device and all those informed of an event or a risk for an event caused by the device and resulting in death or the deterioration of the health status of a patient must declare the event without delay to the appropriate administrative authority. The witness of the event informs either the local correspondent for materiovigilance, when available, or the ministry directly. A major objective of the local correspondent is to act as a filter and to select among the declarations of events those to be transmitted without delay or quarterly to the ministry, and those to be registered only locally. Within 48 hours the ministry: a) returns an acknowledgement with instructions how to proceed with the involved device; b) communicates the declaration to the chairman of the ad hoc subcommission; c) informs the manufacturer of the device. The chairman decides on the degree severity (major event requiring an immediate investigation, event requiring an investigation, event to be entered in a follow-up programme). In the first two cases an investigation is undertaken by one or several members of the subcommission in co-operation with the manufacturer and the declarant of the event. Conservative measures can be undertaken to prevent the re-occurrence of an event either with the involved and/or with similar devices and to facilitate the investigation.

The atrial defibrillator is a new non-pharmacological treatment of atrial fibrillation (AF) for restoration of sinus rhythm. This device has two programmable modes: automatic or activated by the physician or patient. In the automatic mode, the device delivers a shock synchronous with the R wave to restore sinus rhythm when AF is detected. Two patients with paroxysmal AF resistant to pharmacological therapy were included in a study to assess the efficacy and safety of the atrial defibrillator in the mode activated by the physician. The device implanted in the pectoral region is connected to 3 electrodes, two for atrial defibrillation and sensing positioned in the coronary sinus and right atrium respectively and a sensing and pacing electrode in the right ventricle. The right ventricle is paced if a post-shock pause is detected. It is possible to interrogate the device with a programmer using its Holter function and so determine the number of episodes of AF sensed and treated. The number, intensity and energy of the shocks and the parameters of ventricular stimulation are programmable. In these two patients, the atrial defibrillator effectively reduced prolonged episodes of AF with a follow-up of 12 and 7 months. No pro-arrhythmic effects were observed. Further clinical evaluation is under way to assess this new mode of treatment, including the mode activated by the patient, safety and tolerance of the shocks. In our two patients, the treatment of prolonged episodes of AF was followed by reduction of many short or asymptomatic episodes.

Biocompatibility can be interpreted as the optimal combination of a series of interactions occurring at the material-tissue interface as soon as these two systems are in contact. It is a multifactorial interface property which integrates all of the phenomena involved in a biological environment i.e. absence of toxicity of the material for the body and absence of degradation of the material by the body. Biocompatibility can be evaluated in a normative context by using in vivo techniques in animals or in vitro techniques using cell cultures allowing the study of cytotoxicity (related to a concept of safety) and cytocompatibility (related to biological acceptability) of a material. Because of their intimate contact with the urothelium throughout implantation, the biocompatibility of catheters and stents constitutes a major requirement. This review presents the current data reported in the literature concerning the evaluation of the biocompatibility of materials used in urology. The main problems encountered are alterations of the urothelium, such as erosions or, on the contrary, mucosal hyperplasia, and the existence of incrustations developing on these materials.

Administrative texts published in 1995, 1996 and 1997, have reinforced materiovigilance and impose disinfection precautions for endoscopes. The steps of disinfection of non-sterilizable endoscopes are: preliminary treatment, rinsing, actual disinfection, final rinsing, storage (see: Progrès en Urologie, 1997, 7, 505-507). Each procedure from collection of the endoscope until storage must be defined by written standard operating procedures validated by CLIN. The risk of transmission of Creutzfeld-Jakob disease requires autoclaving, which is only possible, at the present time, with the most recent rigid endoscopes. Until disinfection has become generalized, the traceability of endoscopes (labelling, utilization files) must be established on the model recommended for haemovigilance (circular of 02/04/96).

To evaluate the efficacy and morbidity of treatment of localized prostatic cancer using transrectal high-intensity focused ultrasound.44 patients (mean age: 72 years) with clinical stage T1 (20) or T2 (24) prostatic cancer, not eligible for radical prostatectomy, were treated by two different prototypes of the Ablatherm (Technomed Medical System). The second prototype includes several safety devices designed to reduce morbidity. 99 sessions were performed, i.e. an average of 2.25 sessions per patient: the prostate was treated in one session (5 patients), 2 sessions (26 patients), 3 sessions (10 patients), or 4 sessions (3 patients), usually under spinal anaesthesia. The mean PSA was 9.92 ng/ml and the mean prostatic weight was 37 g.Complications occurred in 10 (50%) of the first 20 patients treated (1993-1995): 2 recto-urethral fistulas, 2 asymptomatic rectal burns, 2 cases of stable urinary retention, 1 case of severe incontinence, 3 cases of bladder neck sclerosis, and 1 febrile urinary tract infection. In the 24 patients treated subsequently (1995-1997), complications occurred in only 4 patients (16%): 1 case of stable urinary retention, 1 febrile urinary tract infection, 1 case of bladder neck sclerosis, 1 case of stress incontinence. A complete response (repeated negative follow-up biopsies) was obtained in 27 patients (61%). The mean post-treatment PSA level in patients of this group was 1.09 +/- 1.06 and remained stable (mean follow-up: 346 days; range: 60-1250). A residual cancer was detected in 17 patients (39%). 8 patients were considered to be failures (mean post-treatment PSA: 4.8 ng/ml) and received adjuvant treatment (hormonal: 3; external radiotherapy: 5). Complementary treatment by focused ultrasound will be performed in another 9 patients, if their PSA rises above 3 ng/ml (patients of this group are symptomatic with a mean post-treatment PSA of 1.6 ng/ml).The morbidity of treatment by transrectal focused ultrasound has now been reduced. These results suggest that this new treatment can constitute a useful option for certain patients with localized cancer, not suitable for radical prostatectomy.

The feasibility of left heart catheterisation and coronary angiography using small calibre 4 French catheters was assessed in a prospective register of 355 consecutive patients. The average age was 64 +/- 10 years: 21% were women. The indications were: evaluation of coronary artery disease (279 patients), control of bypass graft patency (38 patients including 34 internal mammary artery grafts), 26 valvular lesions (including 15 aortic stenoses) and 12 cardiomyopathies. In 20.5% of cases, the catheterisation was performed on an out-patient basis. The catheters used for coronary opacification were Cordis Pigtail and Amplatz; mammary, multipurpose and right Judkins were used occasionally. The operators used on average 2.14 catheters, without difficulty in 13% of cases. A larger catheter was not required in any of the cases. There were no complications. The angiograms were estimated to be of good quality in 96% of cases. With the exception of patients undergoing immediate angioplasty and 9 patients with severe hypertension or anticoagulant therapy, the patients did not require compressive dressings on the puncture site and could be mobilised early. There were no local complications at the puncture site. The results of this study suggest that 4 F catheters can be used systematically for left heart catheterisation with safety. A short period of training is required after which good quality angiograms can be obtained without technical problems. Compressive dressings are not necessary after this type of investigation.

To assess the learning curve of a new lighwand device, Trachlight (Laerdal), for blind orotracheal intubation in patients without foreseen difficulty in airway management.Open, prospective, clinical study. USERS: Twelve persons practicing anaesthesia (specialists, trainees, nurses) underwent videotape learning and manikin training with ten successful intubation manoeuvres required with the device.Each person had to carry out a tracheal intubation in ten consecutive patients undergoing scheduled surgery and without history or clinical sign of difficults airway management.One hundred and twenty patients were included. The overall success rate with the Trachlight was 87%. An easy learning curve was obtained as demonstrated by the low failure rate in the first three patients, and by the success rate on the first or second attempt in the last four patients. There was no significant difference in failure rate with or without muscle relaxation (10 vs 20%, NS). Finally, all failures with the Trachlight were followed by successful intubation using direct laryngoscopy, and no traumatic complications were recorded with the device.Trachlight is a new lightwand device enabling blind tracheal intubation with a easy learning curve in patients without difficulty in airway management, even for non-selected operators.

With monochromatic infrared gas spectrometers (MIS), the displayed concentration is computed from measured IR absorption and a gain factor specific for the selected volatile agent (VA). As MIS cannot detect which VA is actually present, the displayed concentration can be very different from the actual one. As bottles and vaporizers are very specific for desflurane, it is impossible to misfill a vaporizer; however an erroneous selection of VA on MIS remains possible. The aim of this study was to assess the displayed concentrations after erroneous vapour selection on the monitor. When either desflurane, or isoflurane or enflurane were delivered at constant concentrations, all VA measured by the MIS, namely desflurane, sevoflurane, isoflurane, enflurane and halothane were successively selected and the displayed concentrations compared with the actual vapour concentration using a Capnomac Ultima (Datex) monitor. Consequences of erroneous selection can be included in three categories: 1) dangerous error, when a displayed concentration is much lower than the actual one, e.g. desflurane or sevoflurane erroneously selected; 2) evident error, when displayed concentration is much higher than 10 vol%; 3) uncomfortable situation, when displayed and actual concentrations are similar, e.g. isoflurane erroneously selected instead of desflurane. This error can only be detected by a careful checking of the device.

To assess the value of quality control tests after routine maintenance procedures of anaesthesia machines.Prospective laboratory study.Over a 4-year-period, anaesthesia machines were checked after regular maintenance procedures, in order to detect unrecognized dysfunctions before clinical use.Overall 106 tests were performed on 14 machines and five dysfunctions were identified. Three of them concerned gas proportioning devices, which delivered a hypoxic gas mixture (FO215%). This defect was recognized by gas analysis at their outlet, whereas mechanical controls were satisfactory. The last two concerned pressure relief valve linearity and gas leak at PEEP valve.This study underlines the necessity of both postmaintenance controls and gas analysis at the outlet of the gas proportioning device. These controls should be performed by hospital technicians, independent from those involved in regular maintenance procedures.

To describe and to assess the use of a checklist for anaesthetic equipment, the effects on the quality of care, as well as the difficulty to obtain a complete and permanent compliance of anaesthesia staff to the use of the checklist, in comparison with the practice patterns in other countries and of the recommendations by the French society of anaesthesia and intensive care for the anaesthetic machine checking.Prospective quality assurance study with two subsequent phases.Both a detailed and a simplified checklist were initially tested over a 57-day-period to evaluate the incidence and severity of recognized abnormalities and to assess the compliance of the staff with this new procedure. Four months later, the same evaluation was performed again. The detailed checklist was used before the first anaesthetic in the morning and called "Theater opening form". The simplified list was used before the subsequent anaesthetics and called "Checking before induction form".During phase I, the detailed and simplified forms of the checklist were only used in 54% and 32% of cases respectively. They were more often completed in scheduled (93%) than in emergency cases (31%). The detailed checklist detected 5/165 potentially severe abnormalities in the breathing system that could be amended before use. After formal discussion with all members of the department, the simplified checklist was abandoned, as it did not detect any significant abnormality and was considered too time-consuming. During the phase II of the study, as the staff checked the anaesthetic machine more often in emergency cases (52%), the overall compliance increased (73%) but remained insufficient. However, no critical incident could be detected during the second evaluation period.This study demonstrated the safety benefits associated with the procedure of checking anaesthetic equipment, but also pointed out the difficulty to obtain a full participation of the staff in quality-assurance programmes.