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At least 37 records · Page 2Linked to original sources
PubMed2026

An impact assessment of the European medical device regulations implementation - the current status quo.

BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.

Equipment and Supplies↗
PubMed1978

The monoblock appliance.

While the use of this appliance would appear to require relatively litlle operative time, it must be clearly understood that the function of this appliance is not as predictable as that of other types of removable devices. Under such circumstances, it is of great importance to ensure that a correct diagnosis and evaluation of the original condition has been made relative to the listed criteria; all factors must be considered and no diagnosis should be made purely and simply on the basis of an obvious increase in overjet and a class II malocclusion. In addition, the personality and nature of the patient is of paramount importance, since it is his cooperation and interest that in the end will lead to successful therapy.

Acrylic Resins↗
PubMed1977

Psychological timing of orthodontic treatment.

A questionnaire type of study was undertaken to test the hypothesis that prepubescent patients are more cooperative than adolescents. Older children were held to be psychologically resistant to the demands of orthodontic treatment because of their involvement in Oedipal conflicts, a normal but distracting aspect of "growing up". Our observers found that patients under 12 were more cooperative than other age groups in the wearing of headgear and other removable devices. They were less cooperative in keeping appointments or in protecting appliances from breakage. The differences were significant at the 5 per cent level of confidence. If responders' observations are an accurate index of true performance, the study suggests that, from a psychological standpoint, activator and headgear treatment should be begun sometime after age 6 and soon enough to be completed before the onset of puberty.

Adolescent↗
PubMedDate not supplied

Publicity and the public health: the elimination of IUD-related abortion deaths.

Widespread publicity in the mass media about the dangers of leaving an IUD in place in a pregnant uterus was apparently more effective than traditional scientific publication and drug package inserts in getting doctors to remove devices from pregnant patients. This suggests that such publicity could be effective in improving clinical practice and the public health in other instances, such as getting doctors to prescribe and women to request birth control pills with lower doses of estrogen, and persuading women to obtain early rather than the riskier midtrimester abortions.

Abortion, Septic↗
PubMed1977

[The diagnosis and removal of obscure intrauterine devices (author's transl)].

When the thread of an intrauterine device cannot be seen in the cervical canal a diagnostic procedure to insure continued contraceptive effectiveness is mandatory. Hysteroscopy is the method of choice for localization of an intrauterine device even during pregnancy. Hysteroscopic removal is possible even during pregnancy. With this method we removed 16 obscure intrauterine devices and 7 devices during pregnancy. The advantages and disadvantages of other diagnostic and therapeutic methods are discussed.

Adult↗
PubMed2026

Assessment of Surgical Salvage Outcomes for Exposed Cranial Neuromodulating Devices.

OBJECTIVES: Implanted neuromodulating devices (NMDs) such as cochlear implants (CIs) and deep brain stimulators (DBSs) are commonly used in modern medicine. Rarely, complications arise post-operatively, including hardware exposure. Traditional teaching suggests that these devices require removal if exposed; however, surgical salvage is a high risk, high reward alternative. We review our single institution experience managing NMD exposure with surgical salvage. METHODS: Retrospective chart review was performed on individuals who had a NMD implanted and underwent an attempt at surgical salvage for exposure during the study period (January 01, 2021 through December 31, 2023). Study outcome success was defined as maintaining a functional NMD 1 year after salvage was attempted. Surgical techniques associated with successful salvage were compared. RESULTS: Nine of 729 patients (1.2%) implanted with NMDs experienced hardware exposure during this 2-year study period. Nine subjects were referred for NMD salvage; however, only 6 of 9 subjects (66.7%, CI = 3; DBS = 3) underwent NMD salvage attempts. Four of the subjects had successful salvage demonstrated successful salvage with a functioning NMD and without wound healing concerns 1 year after their salvage procedure. CONCLUSIONS: Classic teaching states that exposed NMDs require explantation. However, this approach necessarily imposes time without benefit from the NMD between explantation and reimplantation. Our experience demonstrates that surgical salvage can be a successful alternative for the majority (66.7%) of individuals.

Humans↗
PubMed1977

[Ability to conceive after intentional interruption of intrauterine contraception].

Out of 3415 first insertions, the intrauterine contraceptive device was removed in 152 women (4.45%) owing to planned pregnancy. Nineteen cases dropped out of evidence, so that 133 remained for further analysis. Out of these 133 women, 120 (90.23%) became pregnant, the reamining 13 (9.77%) did not. In the first three months following the removal of the intrauterine contraceptive device, 77 women 57.89% conceived, 3--6 months after the removal 22 (16.54%), 6--12 months 18 (13.53%), and after one year 3 women (2.26%) were recorded pregnant. The ability to conceive is analysed according to the age of the women surveyed, the length of the use of intrauterine contraceptive devices, and the number of previous births and abortions. It is concluded that the use of intrauterine contraception has no influence on the later ability and speed of conception and that, for this reason, this contraception method could be considered fully reversible.

Abortion, Induced↗
PubMed1979

Review of methods for removing cast gold restorations.

Most techniques and devices described for crown removal, in one way or another, destroy the integrity of today's precision cast crowns. There were only three techniques described that do not require drilling a hole, cutting a notch or slot, clamping with claws or jaws, prying with instruments, or grasping with forceps and pliers. These are the copper band filled with cement, the coping of cold-curing acrylic resin, and the Richwil crown remover. The safest and least traumatic of all crown removal devices and techniques is to cut a slot and pry the crown loose. Although the crown is destroyed, damage to the tooth is avoided.

Acrylic Resins↗
PubMed1976

Surgical treatment of acromioclavicular dislocation.

The results of surgical treatment of 17 patients with complete acrominoclavicular dislocation are presented. The operative procedure described is technically easy, gives good results, has few complications which often follow operations using metallic fixation devices. A second operation to remove fixation devices is avoided.

Acromioclavicular Joint↗
PubMed1975

Hysteroscopic removal of occult intrauterine contraceptive device.

Dilatation and curettage or hooking an occult intrauterine contraceptive device (IUD) may fail to recover the device on occasion. Theoretically, endoscopic observation should enable the controlled removal of this type of device. Of 200 patients who underwent hysteroscopic examination, 10 had an occult IUD. In 8 cases, the device was visible through the hysteroscope, and in 6 patients a successful removal was accomplished with this endoscopic technic. Failures and problems are discussed, and the importance of adequate preoperative study is stressed. Hysteroscopy is an effective procedure in the recovery of the occult intrauterine contraceptive device in selected nonpregnant patients.

Adult↗