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Medical device safety in gastroenterology: FDA recalls of duodenoscopes, 2015-2020 [Meeting Abstract]

Talati, R K; Goodman, A; Pochapin, M B
Introduction: Duodenoscopes are used in more than 500,000 procedures annually in the US as a minimally invasive diagnostic and therapeutic modality for hepatobiliary and pancreatic diseases. Traditionally, these devices have been intended for re-use after undergoing strict cleaning and disinfection protocols to reduce the risk of infection between patients. However, since 2008, several major outbreaks of infections linked to duodenoscopes have resulted in devices recalled from the market. Understanding what occurred in instances of device failure leading to recalls is important to improve the safety and efficacy of these devices.
Method(s): This institution review board-exempt study reviewed the FDA Center for Devices and Radiologic Health database for all duodenoscope-related recall events from November 1, 2002 through December 31, 2020. Market entry data, recall characteristics, and adverse reports were collected for each device.
Result(s): Seventeen class II duodenoscope-related recall events were identified, affecting at least 24,611 units in distribution. 12 out of the 17 (70%) recall events were for duodenoscopes, 3 out of 17 (18%) recalls were for operation manuals, and 2 out of 17 (12%) recalls were for reprocessors. 15 out of 17 recalled devices (88%) had at least 1 documented occurrence of an adverse event at the time of recall. All recall events were approved via the 510k pathway, however postmarket-related issues accounted for 88% of recalls.
Conclusion(s): Given the wide utilization of duodenoscopes in treating pancreaticobiliary diseases, an understanding of their recall events and associated public health impact are important for endoscopists to have a greater awareness of potential safety concerns. Recalls by three duodenoscope manufacturers and one scope reprocessor manufacturer highlight the need for innovation in design and improved post-marketing surveillance mechanisms
EMBASE:636474240
ISSN: 1572-0241
CID: 5084182

A Multicenter Study Evaluating the Risk Factors and Outcomes of Repeat Descemet Stripping Endothelial Keratoplasty

Thompson, Jordan M; Truong, Alexander H; Stern, Hudson D; Djalilian, Ali; Cortina, M Soledad; Tu, Elmer Y; Johnson, Paula; Verdier, David D; Rafol, Lorene; Lubeck, David; Spektor, Tatyana; Jorgensen, Colin; Rubenstein, Jonathan B; Majmudar, Parag A; Talati, Rushi; Basti, Surendra; Feder, Robert; Sugar, Alan; Mian, Shahzad I; Balasubramanian, Neelam; Sandhu, Jasmin; Gaynes, Bruce I; Bouchard, Charles S
PURPOSE/OBJECTIVE:Descemet stripping endothelial keratoplasty (DSEK), currently the most common procedure for managing corneal endothelial dysfunction, may be repeated following DSEK failure from a variety of causes. This multicenter study reports the risk factors and outcomes of repeat DSEK. METHODS:This was an institutional review board-approved multicenter retrospective chart review of patients who underwent repeat DSEK. Twelve surgeons from 5 Midwest academic centers and 3 private practice groups participated. The Eversight Eye Bank provided clinical indication and donor graft data. We also assessed the role of the learning curve by comparing cohorts from the first and second 5-year periods. RESULTS:A total of 121 eyes from 121 patients who underwent repeat DSEK were identified. The average age of the patients was 70 ± 12 years. The most common indication for repeat DSEK was late endothelial graft failure without rejection (58%, N = 63). Average preoperative and 12-month postoperative repeat DSEK corrected distance visual acuities were 20/694 and 20/89, respectively. Visual acuity outcomes, endothelial cell density, and cell loss did not significantly vary between the 2 cohorts. Initial graft rebubble rates for the first and second cohorts were 51% and 25%. The presence of glaucoma, prior glaucoma surgery, or a history of penetrating (full thickness) keratoplasty did not significantly affect visual outcomes. The median, mean, and range of intraocular pressures before repeat DSEK were 15.0, 15.7, and 6 to 37 mm Hg, respectively. Patients with higher intraocular pressures before repeat DSEK had improved postoperative corrected distance visual acuities. CONCLUSIONS:Repeating DSEK improves vision following failed or decompensated DSEK surgery. Higher preoperative repeat DSEK IOPs were associated with improved visual outcomes, and initial graft rebubble rates, which decreased over time, were likely due to surgeon experience.
PMID: 30615600
ISSN: 1536-4798
CID: 4931112

Bundled Payments Initiative Participation and Retention [Comment]

Kahvecioglu, Daver; Ogbue, Christine; Talati, Rushi K
PMID: 29800170
ISSN: 1538-3598
CID: 4931102

Major FDA medical device recalls in ophthalmology from 2003 to 2015

Talati, Rushi K; Gupta, Ankur S; Xu, Shuai; Ghobadi, Comeron W
OBJECTIVE:To assess recent high-risk ophthalmic medical device recalls. METHODS:The publicly available Food and Drug Administration Center for Devices and Radiological Health database was mined for Class I (high-risk) ophthalmic device recalls from January 1, 2003 to December 31, 2015. The number of Class I ophthalmic device recalls was quantified. Additionally, recall characteristics and market entry data were determined for each device. RESULTS:Twelve Class I ophthalmic device recall events were identified, collectively affecting over 68 million units in distribution. A median of 147,491 units (range 20 to 57,252,581) were recalled per event. 9 out of 12 recalls (75%) had at least one documented occurrence of an adverse event to a patient. Pre-market related issues accounted for one device recall (8%), post-market related issues accounted for nine device recalls (75%), and two device recalls (17%) were indeterminate. 510(k) clearance was the most common pathway to market, accounting for 50% of Class I recalls. Three devices were approved through pre-market approval (PMA) pathway, two devices were exempt from review, and one device failed to register with the FDA. CONCLUSION:Class I recalls surrounding ophthalmology are relatively infrequent compared to other medical specialties. However, given the impact of Class I recalls in the field, ophthalmologists have an impetus to advocate for stronger device regulation particularly in the context of post-marketing surveillance.
PMID: 29631834
ISSN: 1715-3360
CID: 4931092

Retroprosthetic Membrane Formation in Boston Keratoprosthesis: A Case-Control-Matched Comparison of Titanium Versus PMMA Backplate

Talati, Rushi K; Hallak, Joelle A; Karas, Faris I; de la Cruz, Jose; Cortina, M Soledad
PURPOSE/OBJECTIVE:Retroprosthetic membrane (RPM) formation is the most common complication after Boston type 1 keratoprosthesis (KPro) implantation. It affects visual acuity and can predispose to corneal melt. Two KPro backplate materials are available: titanium and polymethyl methacrylate (PMMA). This study investigates the influence of the KPro backplate material on visually significant RPM formation. METHODS:A retrospective case-control-matched study involving 40 patients; 20 eyes implanted with a titanium backplate KPro were case-matched with 20 eyes implanted with a PMMA backplate KPro between 2007 and 2015 with 1-year minimum follow-up. RESULTS:The mean follow-up duration was 28.1 ± 8.9 and 53.6 ± 24.3 months in the titanium and PMMA groups, respectively. At 12 months postoperatively, 7 eyes with titanium and 6 eyes with PMMA backplates developed a visually significant RPM. By the end of the study, a total of 11 eyes with titanium and 9 eyes with PMMA KPros developed a visually significant RPM. There was no statistically significant difference between both groups. Three of 11 eyes with titanium KPros that had a visually significant RPM required surgical membranectomy, whereas all eyes with PMMA KPros were successfully treated with the yttrium-aluminum-garnet laser. Recurrence of RPMs was found in 7/11 eyes in the titanium group and 2/9 eyes in the PMMA group with no statistical significance. CONCLUSIONS:Titanium backplate KPros do not significantly reduce RPM formation compared with PMMA backplate KPros in a case-control-matched setting. A larger prospective study is warranted to evaluate comparative long-term performance and guide newer designs.
PMID: 29140862
ISSN: 1536-4798
CID: 4931082

Cutaneous burn caused by radiofrequency ablation probe during shoulder arthroscopy [Case Report]

Talati, Rushi K; Dein, Eric J; Huri, Gazi; McFarland, Edward G
It is common in shoulder surgery to perform an arthroscopic acromioplasty for patients with varying degrees of rotator cuff disease. One method for helping the surgeon stay oriented to the location of the arthroscopic instruments during this procedure is to place spinal needles into the subacromial space to demarcate bony landmarks. It is also common during arthroscopic partial acromioplasty to use an electrocautery device for hemostasis and tissue ablation. Although many complications of using an electrothermal device have been described, this is the first published report of a skin burn from direct contact of the device with the spinal needle used for demarcation during acromioplasty. We report this case to highlight the need to take precautions to prevent the metal needles used in arthroscopic surgery from overheating by contact with an ablation device.
PMID: 25658085
ISSN: 1934-3418
CID: 4931072

Femoral component rotation in total knee arthroplasty: an MRI-based evaluation of our options

Patel, Anay R; Talati, Rushi K; Yaffe, Mark A; McCoy, Brett W; Stulberg, S David
Proper femoral component rotation is crucial in successful total knee arthroplasty. Rotation using anatomic landmarks has traditionally referenced the transepicondylar axis (TEA), Whiteside's Line (WSL), or posterior condylar axis (PCA). TEA is thought to best approximate the flexion-axis of the knee, however WSL or PCA are common surrogates in the operating room. This study evaluated 560 knees using MRI-based planning software to assess the relationship of WSL and PCA to the TEA and determine if the relationships were influenced by pre-operative coronal deformity. Results showed the WSL-TEA relationship has more variability than PCA-TEA and that the PCA is more internally rotated in females and valgus knees. Axis options and historical assumptions about axis relationships may need to be reassessed as imaging technology advances.
PMID: 24746490
ISSN: 1532-8406
CID: 4931062

Prokineticin 2 is an endangering mediator of cerebral ischemic injury

Cheng, Michelle Y; Lee, Alex G; Culbertson, Collin; Sun, Guohua; Talati, Rushi K; Manley, Nathan C; Li, Xiaohan; Zhao, Heng; Lyons, David M; Zhou, Qun-Yong; Steinberg, Gary K; Sapolsky, Robert M
Stroke causes brain dysfunction and neuron death, and the lack of effective therapies heightens the need for new therapeutic targets. Here we identify prokineticin 2 (PK2) as a mediator for cerebral ischemic injury. PK2 is a bioactive peptide initially discovered as a regulator of gastrointestinal motility. Multiple biological roles for PK2 have been discovered, including circadian rhythms, angiogenesis, and neurogenesis. However, the role of PK2 in neuropathology is unknown. Using primary cortical cultures, we found that PK2 mRNA is up-regulated by several pathological stressors, including hypoxia, reactive oxygen species, and excitotoxic glutamate. Glutamate-induced PK2 expression is dependent on NMDA receptor activation and extracellular calcium. Enriched neuronal culture studies revealed that neurons are the principal source of glutamate-induced PK2. Using in vivo models of stroke, we found that PK2 mRNA is induced in the ischemic cortex and striatum. Central delivery of PK2 worsens infarct volume, whereas PK2 receptor antagonist decreases infarct volume and central inflammation while improving functional outcome. Direct central inhibition of PK2 using RNAi also reduces infarct volume. These findings indicate that PK2 can be activated by pathological stimuli such as hypoxia-ischemia and excitotoxic glutamate and identify PK2 as a deleterious mediator for cerebral ischemia.
PMCID:3325724
PMID: 22431614
ISSN: 1091-6490
CID: 4931052