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

Yoon C, Nam KC, Lee YK, Kang Y, Choi SJ, Shin HM, et al.

J Korean Med Sci, 2019 Oct 14;34(39):e255.
PMID: 31602825 DOI: 10.3346/jkms.2019.34.e255

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.

Matched MeSH terms: Corneal Ulcer/etiology
Fulltext Some experiences in ophthalmology

Lowther AH

Journal of the Malaya Branch of the British Medical Association, 1938;2(3):144-64.

Matched MeSH terms: Corneal Ulcer
Fulltext Enterococcus faecalis Endophthalmitis: Clinical Settings, Antibiotic Susceptibility, and Management Outcomes

Chen KJ, Lai CC, Chen HC, Chong YJ, Sun MH, Chen YP, et al.

Microorganisms, 2021 Apr 24;9(5).
PMID: 33923356 DOI: 10.3390/microorganisms9050918

Enterococcus faecalis is known to cause severe acute endophthalmitis and often leads to poor visual outcomes in most ophthalmic infections. This retrospective study is to report the clinical settings, antimicrobial susceptibility patterns, and visual outcome of E. faecalis endophthalmitis at a tertiary referral institution in Taoyuan, Taiwan. E. faecalis endophthalmitis was diagnosed in 37 eyes of 37 patients. Post-cataract surgery was the most common cause (n = 27, 73%), followed by bleb-associated (n = 3, 8%), endogenous (n = 2, 5%), corneal ulcer-related (n = 2, 5%), post-vitrectomy (n = 1, 3%), post-pterygium excision (n = 1, 3%), and trauma (n = 1, 3%). Visual acuities upon presentation ranged from counting fingers to no light perception. Pars plana vitrectomy with intravitreal antibiotics were performed in 23 eyes (76%) as primary or secondary treatment. All isolates (37/37, 100%) were sensitive to vancomycin, penicillin, ampicillin, and teicoplanin. Six of 22 eyes (27%) were resistant to high-level gentamicin (minimum inhibitory concentration > 500 mg/L). Final visual acuities were better than 20/400 in 11 eyes (30%), 5/200 to hand motions in 4 eyes (11%), and light perception to no light perception in 22 eyes (59%). Three eyes were treated with evisceration. Compared with non-cataract subgroups, the post-cataract subgroup showed a significant difference of better visual prognosis (p = 0.016).

Matched MeSH terms: Corneal Ulcer
Fulltext Corneal laceration caused by river crab

Vinuthinee N, Azreen-Redzal A, Juanarita J, Zunaina E

Clin Ophthalmol, 2015;9:203-6.
PMID: 25678769 DOI: 10.2147/OPTH.S74548

A 5-year-old boy presented with right eye pain associated with tearing and photophobia of 1-day duration. He gave a history of playing with a river crab when suddenly the crab clamped his fingers. He attempted to fling the crab off, but the crab flew and hit his right eye. Ocular examination revealed a right eye corneal ulcer with clumps of fibrin located beneath the corneal ulcer and 1.6 mm level of hypopyon. At presentation, the Seidel test was negative, with a deep anterior chamber. Culture from the corneal scrapping specimen grew Citrobacter diversus and Proteus vulgaris, and the boy was treated with topical gentamicin and ceftazidime eyedrops. Fibrin clumps beneath the corneal ulcer subsequently dislodged, and revealed a full-thickness corneal laceration wound with a positive Seidel test and shallow anterior chamber. The patient underwent emergency corneal toileting and suturing. Postoperatively, he was treated with oral ciprofloxacin 250 mg 12-hourly for 1 week, topical gentamicin, ceftazidime, and dexamethasone eyedrops for 4 weeks. Right eye vision improved to 6/9 and 6/6 with pinhole at the 2-week follow-up following corneal suture removal.

Matched MeSH terms: Corneal Ulcer
Fulltext Atypical contact lens related corneal ulcer caused by pasteurella multocida

Fatin Hanisah, F., Umi Kalthum, M. N., Rona Asnida, N., Jemaima, C. H.

Journal of Surgical Academia, 2018;8(1):43-46.
MyJurnal

A 55-year-old healthy lady with history of regular contact lens (CL) use presented with 10 days history of
progressive left eye blurring of vision, redness and pain. There was good CL hygiene practiced with no history of
swimming, trauma or contact with domestic pets. Left eye vision was hand movement and right eye was 1/60,
pinhole 6/18. On the left eye, there was a central, oval-shaped corneal infiltrate with an overlying large epithelial
defect and stromal oedema, with significant anterior chamber cells and fibrin. B-mode ultrasound showed no vitritis.
Intensive topical benzylpenicillin 10000iu/ml and topical gentamycin 1.4% hourly, homatropine 2% three times
daily, oral doxycycline and oral ascorbic acid were started. The gram stain results showed gram positive cocci
growth. Her ulcer improved with the treatment and preservative-free dexamethasone 0.1% once daily was
commenced to reduce inflammation and scarring. Interestingly, culture was reported as Pasteurella maltocida, a
gram negative bacilli sensitive to penicillin, and so treatment was continued until the ulcer completely healed. She
had central corneal scarring with best corrected vision of 6/24 in the left eye but was not keen on further surgery to
improve her vision. Although it has not been previously reported, Pasteurella multocida can cause CL related
corneal ulcer with severe anterior chamber inflammation. This diagnosis should be considered even if there is trivial
contact or no history of exposure to domestic animals.

Matched MeSH terms: Corneal Ulcer
Fulltext Conjunctiva Necrosis Following Subconjunctival Amphotericin B Injection in Fungal Keratitis

Han Shu T, Hussein A, Kursiah MR

Cureus, 2019 Sep 05;11(9):e5580.
PMID: 31695999 DOI: 10.7759/cureus.5580

A 30-year-old Bangladeshi gentleman presented with history of sand entering his left eye and was diagnosed as having fungal keratitis by private ophthalmologist. He was treated with three doses of conventional subconjunctival amphotericin B injections (1.5 mg of amphotericin B and 1.2 mg of deoxycholate) over the inferior bulbar conjunctiva and topical antibiotics. Subsequently, he developed conjunctival necrosis over the site of injections and there was no clinical improvement of the keratitis. He was then treated with intensive antifungal and antibiotics eye drops. Debridement of epithelial plug was done and he was given intracameral amphotericin B injection. There was gradual improvement observed then with conjunctival epithelialization. The conjunctival tissue was completely healed after three months along with the corneal ulcer. Subconjunctival injection of Amphotericin B (AMB) may be considered as an adjunct therapy in severe fungal keratitis to address the issue of compliance. Close monitoring is needed due to its known complication of scleritis, scleral thinning and conjunctival necrosis. Liposomal AMB which is known to cause less toxicity given via subconjunctival injection in human subjects needs to be further studied.

Matched MeSH terms: Corneal Ulcer
Ocular tuberculosis in Hospital Universiti Sains Malaysia - A case series

Shahidatul-Adha M, Zunaina E, Liza-Sharmini AT, Wan-Hazabbah WH, Shatriah I, Mohtar I, et al.

Ann Med Surg (Lond), 2017 Dec;24:25-30.
PMID: 29062482 DOI: 10.1016/j.amsu.2017.10.003

INTRODUCTION: Ocular tuberculosis (TB) encompasses a broad spectrum of clinical manifestations affecting different structures of the eye. It is caused by Mycobacterium tuberculosis, a great ancient organism that induces various types of diseases and unfavorable outcomes if unrecognized and not well treated.
PURPOSE: To report the clinical profile of 34 ocular TB cases observed during 6 years period in Hospital Universiti Sains Malaysia (HUSM).
METHOD: A retrospective review of medical records from 34 patients diagnosed with ocular TB in HUSM from January 2011 until December 2016.
RESULTS: The mean age was 43 ± 14.6 years old. Both male and female affected in about 1:1 ratio. The majority of subjects were local Malays (91.2%). Risk factors included previous contact with pulmonary TB patients (38.2%), and patients with underlying diabetes mellitus (26.5%). Most patients showed normal chest radiography (79.4%). However they had positive Mantoux test (94.1%) and raised erythrocyte sedimentation rate (ESR) value (58.8%). Uveitis was the most common ocular manifestation of ocular TB (70.6%) while the rare ocular manifestations included optic perineuritis and optic neuritis, orbital apex syndrome, orbital cellulitis, sclerokeratitis, corneal ulcer and conjunctival abscess. All patients responded well to anti-TB treatment, but visual outcome was variable.
CONCLUSIONS: This review shows the diverse entity of ocular TB spectrum in an endemic area. Good clinical response to anti-tuberculous therapy supported the presumed diagnosis of ocular TB in majority of the cases.

Matched MeSH terms: Corneal Ulcer
Burkholderia cepacia: a rare cause of bacterial keratitis

Ibrahim M, Yap JY

BMJ Case Rep, 2018 Apr 25;2018.
PMID: 29695396 DOI: 10.1136/bcr-2018-224552

We describe the first clinical case of Burkholderia cepacia keratitis registered in Southeast Asia. A man in his mid-70s with underlying poorly controlled diabetes mellitus came with complaints of painful red left eye for 4 days. This was accompanied with photophobia and blurring of vision after being injured by a wooden particle while cutting grass. Slit-lamp examination showed a paracentral anterior corneal stromal infiltrates with overlying epithelial defect. Culture of the corneal smear isolated B. cepacia that was sensitive to ceftazidime, meropenem and bactrim (trimethorprim and sulfomethoxazole). Topical ceftazidime was given intensively to the patient and the infection resolved after 6 weeks of treatment.

Matched MeSH terms: Corneal Ulcer