Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

BACKGROUND: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events. METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of ‘patient use’. The phases of ‘patient use’ are divided into: 1) inspecting, 2) preparing, and 3) applying medical device. RESULTS: As for the question on the beginning point of ‘patient use,’ 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups. CONCLUSION: From training courses using virtual cases, we found that there was no consensus on ‘patient use’ point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.

Long-term outcomes of progestin plus metformin as a fertility-sparing treatment for atypical endometrial hyperplasia and endometrial cancer patients / 부인종양

OBJECTIVE: The present study investigated long-term outcomes of medroxyprogesterone acetate (MPA) plus metformin therapy in terms of control of atypical endometrial hyperplasia (AEH) and endometrial cancer (EC), and post-treatment conception. METHODS: We retrospectively analyzed 63 patients (42 with EC; 21 with AEH) who underwent fertility-sparing management using MPA plus metformin. MPA (400 mg/day) and metformin (750–2,250 mg/day) were administered to achieve complete response (CR). Metformin was administered until conception, even after MPA discontinuation. RESULTS: Of the total patients, 48 (76%) had a body mass index (BMI) ≥25 kg/m² and 43 (68%) showed insulin resistance. Sixty-one patients (97%) achieved CR within 18 months. CR rates at 6, 8–9, and 12 months were 60%, 84%, and 90%, respectively. During a median follow-up period of 57 months (range, 13–115 months), relapse occurred in 8 of 61 patients (13.1%) who had achieved CR. Relapse-free survival (RFS) in all patients at 5 years was 84.8%. Upon univariate analysis, patients with BMI ≥25 kg/m² had significantly better prognoses than did those with BMI <25 kg/m2 (odds ratio=0.19; 95% confidence interval=0.05–0.66; p=0.009). Overall pregnancy and live birth rates per patient were 61% (19/31) and 45% (14/31), respectively. CONCLUSIONS: MPA plus metformin is efficacious in terms of RFS and post treatment conception. Moreover, metformin may be more efficacious for patients with BMI ≥25 kg/m².

Two Cases of Double Orifice Repair for Congenital Mitral Regurgitation / 日本心臓血管外科学会雑誌

We describe two cases of a 9-day-old male and a 5-year-10-month-old female who had congestive heart failure due to severe mitral regurgitation. Preoperative echocardiogram revealed severe mitral regurgitation due to dysplasia of the leaflet, chordae and papillary muscle. Because the leaflet area was not enough for the valve orifice, we performed double orifice repair by suturing the free edge to the corresponding edge of the opposite leaflet. The mitral regurgitation was found to be significantly reduced on postoperative echocardiogram. Double orifice repair is simple and can be performed rapidly. However, although this technique has been performed in adults, it has not been commonly performed in infants. Our results suggest that this procedure can be useful for the congenital mitral regurgitation. Long-term follow-up is needed to confirm the result.

The Usefulness of "kyu" Therapy for Threatened Premature Labor Patients / 日本東洋医学雑誌

Up until the present, the primary treatment for threatened premature labor has been bed rest, with drug therapy as a supplement. However, with drug therapy the problems of side effects and dosage limitations have made it difficult to achieve therapeutic effectiveness. In this paper, the authors report the favorable results obtained in such cases when moxibustion and a microwave emitter were used for stimulation therapy based on Oriental medical theory. Moxibustion was carried out on Shim, Yusen and Saninko (acupuncture points) in cases of threatened premature labor beyond the 24th week. Despite the short duration of treatment, uterine tension was relieved, fetal movement increased, and resistance in the umbilical artery and uterine artery reduced. Similar results were achieved with multiple microwave stimulation treatments; the effects lasted for long periods and were not accompanied by side effects. Thus, the results showed that through the use of moxibustion therapy in conjunction with drug therapy, the dosage could be reduced, and the frequency of side-effect appearance lowered. These results suggest that moxibustion therapy has potential as an effective and safe new treatment for threatened premature labor.

The Effect of Acupuncture Therapy on Abnormal Eye Movement in Wallenberg's Syndrome / 全日本鍼灸学会雑誌

INTRODUCTION<br>There have been very few reports on the effects of acupuncture on abnormal eye movements often seen in patients with central vertigo. Recently we had the opportunity to apply acupuncture to a case of Wallenberg's syndrome, which displays a peculiar nystagmus and vertigo. This case is reported because the effectiveness of acupuncture in improving the eye movement was proved by the electronystagmography (ENG) in collaboration with the Nihon University School of Medicine.<br>CASE REPORT<br>Patient: A 47 year old man. Diagnosis: Wallenberg's syndrome. Chief Complaint: Vertigo. Present Illness: In Nov. 1980, the patient noticed a loss of pain and temperature sense in his right limb, followed by vertigo. He was admitted to the Nihon Univ. Hospital in Dec. 1980. CT-examination of the whole body, a vertebral arteriogram, etc. indicated a circulatory failure in the left lateral area of the medulla oblongata.<br>In Mar. 1981, the patient visited our clinic with the chief complaint of vertigo. Present Condition: He complained of rotary vertigo. The orthostatic test was positive with both opened and closed eyes. A decrease in the pain and temperature sense on the right side of the body, except for the head, was observed.<br>COURSE<br>Acupuncture was applied to the posterior region of the neck, the back, and the lateral of the lower extremity in order to relax the muscles of these parts. After acupuncture the patient reported a decrease in his vertigo. After the twentieth session of acupuncture the symptoms improved to the extent that he could go out alone. After the twenty-second session, he returned to work. Although his vertigo and nystagmus did not completely disappear, an obvious improvement in these symptoms was seen after each session, and this improved condition remained for two or three days. With the ENG recorded before, shortly after, and 30min. after a session of acupuncture therapy, a decrease in abnormal eye movement after the session was confirmed.<br>CONCLUSION<br>Acupuncture therapy was applied to a case of Wallenberg's syndrome.<br>Result:<br>1. A short-term decrease in vertigo was observed.<br>2. A decrease in abnormal eye movement after acupuncture therapy was confirmed by electronystagmography.

MYOFIBROUS ORGANIZATION OF THE M. RECTUS ABDOMINIS FROM 3 SPORTSMEN (WEIGHT-LIFTING, BOXING AND BODY-BUILDING) / 体力科学

The muscle fibers of M. rectus abdominis from 3 sportsmen (Weight-lifting, Boxing and Body-building) were examined histologically and compared with the mean of 22 human control subjects. Following results were obtained.<BR>1. Compared with the M, rectus abdominis of control subjects, the sportsmen's rectus abdominis muscle area was about 4 times the cross-sectional area of muscle belly and the number of muscle fibers per sq, mm, were 1/3 that of the control specimens. The total number and mean size of sportsmen muscle fibers corresponded to the respective maxima of the controls, and the muscle fiber density in sportsmen corresponded to the minimum control value.<BR>2. Comparing the myofibrous organization of 3 specimens, the muscle of the boxer was largest in cross-sectional area, in frequency of muscle fibers with large diameter, and in volume of interstitial connective tissue. It was the smallest of the 3 specimens in the number of muscle fibers per sq. mm. We found that the muscle of the weight-lifter was intermediate in these four categories.