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Fulltext The application study of harmonization code in medical device adverse event reporting

Choi SJ, Choi S, Park S, Nam KC, Jang HJ, Kim JK, et al.

BMC Health Serv Res, 2024 Nov 14;24(1):1402.
PMID: 39543640 DOI: 10.1186/s12913-024-11885-1

BACKGROUND: The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.
METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.
RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.
CONCLUSIONS: We identified the diversification in terminology and code selection for reporting MDAEs.

Matched MeSH terms: Equipment Safety/standards
Fulltext A leadless intracardiac transcatheter pacing system

Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, et al.

N Engl J Med, 2016 Feb 11;374(6):533-41.
PMID: 26551877 DOI: 10.1056/NEJMoa1511643

BACKGROUND: A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.
METHODS: In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies.
RESULTS: The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001).
CONCLUSIONS: In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

Matched MeSH terms: Equipment Safety
A Heart for Travel: Travel Health Considerations for Patients with Heart Disease and Cardiac Devices

Flaherty G, De Freitas S

Ir Med J, 2016 Dec 12;109(10):486.
PMID: 28644591

Cardiovascular disease is the leading cause of death in adult international travellers. Patients living with heart disease should receive specific, individualised pre-travel health advice. The purpose of this article is to provide evidence-based advice to physicians who are consulted by travellers with cardiovascular disease. Fitness-to-travel evaluation will often be conducted by the general practitioner but other medical specialists may also be consulted for advice. Patients with chronic medical conditions should purchase travel health insurance. The general pre-travel health consultation addresses food and water safety, insect and animal bite avoidance, malaria chemoprophylaxis, and travel vaccinations. Patients with devices such as cardiac pacemakers should be familiar with how these may be affected by travel. Cardiac medications may cause adverse effects in cold or hot environments, and specific precautions must be followed by anticoagulated travellers. The physician should be aware of how to access medical care abroad, and of the potential for imported tropical diseases in returned travellers.

Matched MeSH terms: Equipment Safety
The characteristics of vibrotactile perception threshold among shipyard workers in a tropical environment

Tamrin SB, Jamalohdin MN, Ng YG, Maeda S, Ali NA

Ind Health, 2012;50(2):156-63.
PMID: 22293728

The objectives of this study are to determine the prevalence of hand-arm vibration syndrome (HAVS) and the characteristics of the vibrotactile perception threshold (VPT) among users of hand-held vibrating tools working in a tropical environment. A cross sectional study was done among 47 shipyard workers using instruments and a questionnaire to determine HAVS related symptoms. The vibration acceleration magnitude was determined using a Human Vibration Meter (Maestro). A P8 Pallesthesiometer (EMSON-MAT, Poland) was used to determine the VPT of index and little finger at frequencies of 31.5 Hz and 125 Hz. The mean reference threshold shift was determined from the reference threshold shift derived from the VPT value. The results show a moderate prevalence of HAVS (49%) among the shipyard workers. They were exposed to the same high intensity level of HAVS (mean = 4.19 ± 1.94 m/s(2)) from the use of vibrating hand-held tools. The VPT values were found to be higher for both fingers and both frequencies (index, 31.5 Hz = 110.91 ± 7.36 dB, 125 Hz = 117.0 ± 10.25 dB; little, 31.5 Hz = 110.70 ± 6.75 dB, 125 Hz = 117.71 ± 10.25 dB) compared to the normal healthy population with a mean threshold shift of between 9.20 to 10.61 decibels. The frequency of 31.5 Hz had a higher percentage of positive mean reference threshold shift (index finger=93.6%, little finger=100%) compared to 125 Hz (index finger=85.1%, little finger=78.7%). In conclusion, the prevalence of HAVS was lower than those working in a cold environment; however, all workers had a higher mean VPT value compared to the normal population with all those reported as having HAVS showing a positive mean reference threshold shift of VPT value.

Matched MeSH terms: Equipment Safety
Fulltext Safety of thoracic pedicle screw application using the funnel technique in Asians: a cadaveric evaluation

Chan CY, Kwan MK, Saw LB

Eur Spine J, 2010 Jan;19(1):78-84.
PMID: 19763636 DOI: 10.1007/s00586-009-1157-8

The objective of this cadaveric study is to determine the safety and outcome of thoracic pedicle screw placement in Asians using the funnel technique. Pedicle screws have superior biomechanical as well as clinical data when compared to other methods of instrumentation. However, misplacement in the thoracic spine can result in major neurological implications. There is great variability of the thoracic pedicle morphometry between the Western and the Asian population. The feasibility of thoracic pedicle screw insertion in Asians has not been fully elucidated yet. A pre-insertion radiograph was performed and surgeons were blinded to the morphometry of the thoracic pedicles. 240 pedicle screws were inserted in ten Asian cadavers from T1 to T12 using the funnel technique. 5.0 mm screws were used from T1 to T6 while 6.0 mm screws were used from T7 to T12. Perforations were detected by direct visualization via a wide laminectomy. The narrowest pedicles are found between T3 and T6. T5 pedicle width is smallest measuring 4.1 +/- 1.3 mm. There were 24 (10.0%) Grade 1 perforations and only 1 (0.4%) Grade 2 perforation. Grade 2 or worse perforation is considered significant perforation which would threaten the neural structures. There were twice as many lateral and inferior perforations compared to medial perforations. 48.0% of the perforations occurred at T1, T2 and T3 pedicles. Pedicle fracture occurred in 10.4% of pedicles. Intra-operatively, the absence of funnel was found in 24.5% of pedicles. In conclusion, thoracic pedicle screws using 5.0 mm at T1-T6 and 6.0 mm at T7-T12 can be inserted safely in Asian cadavers using the funnel technique despite having smaller thoracic pedicle morphometry.

Matched MeSH terms: Equipment Safety/standards