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John Thompson
John Thompson

Pda Cases [2021]



Effective risk management is a new challenge for many drug/biologic companies as they become drug/biologic and combination product manufacturers from traditional drug/biologic manufacturers. In addition, constructing safety assurance cases helps to ensure the completeness and correctness of risk management results and the adequacy of the risk management process. When being proactively developed, safety assurance cases become an effective method to improve risk management effectiveness.




pda cases



Having served for over 30 companies, Fubin has experience with a broad range of medical products including drug delivery combination products, infusion pumps, insulin pumps, on-body injectors, emergency use injectors, mobile medical applications, digital solutions, implantable devices, cardiovascular devices, robotic surgery devices, IVDs, remote monitoring systems, and blood management systems. He is a member of multiple AAMI working groups including infusion devices, combination products, cybersecurity, and software. He also teaches public courses on medical device and combination product risk management, safety assurance cases, cybersecurity, and software reliability.


Management of persistent patent ductus arteriosus (PDA) continues to be a challenging issue. The attitude toward PDA has shifted in the opposite direction during the last 20 years, from advocating an aggressive and early closure toward a call for watchful observation. While persistent PDA may cause challenges in the medical management of preterm neonates secondary to volume overload, pulmonary edema or hemorrhage, hypotension, and impaired tissue perfusion, its contribution toward long-term neonatal morbidities including bronchopulmonary dysplasia (BPD), ROP, NEC, and NDI has not been substantiated. By advocating conservative management, it is clear now that the majority of the PDA cases show spontaneous closure and do not require treatment. However, there has not been agreement regarding what constitutes a hemodynamically significant PDA and when, if any, it should be targeted for treatment. With increasing concern regarding possible associated complications with PDA ligation, a new trend for transcatheter approach to PDA closure is expanding. In this review, we summarize current understanding of the pathophysiology, diagnosis, and management of PDA in preterm infants, and we make some recommendations regarding evidence-based approach.


The Alaska Public Defender Agency is currently hiring for a supervisor to oversee a statewide attorney unit consisting of attorneys mostly located in Anchorage but handling caseloads across multiple jurisdictions. The caseloads of the attorneys in the unit vary and include unclassified and A level felony criminal cases and complex Child in Need of Aid (CINA) cases. The position will be based in Anchorage and be responsible for a caseload. It will supervise several attorneys of varying experience levels and be involved in training new attorneys who join the unit. Experience in rural Alaska and jurisdictions outside of Anchorage is preferred. Salary range is commensurate with experience.


The Alaska Public Defender Agency is currently hiring trial attorneys for its Anchorage, Bethel, Fairbanks, Kenai, Kotzebue, Nome, and Palmer offices. Trial attorneys for the Alaska Public Defender Agency provide court-appointed legal representation to indigent individuals in criminal cases.


The Alaska Public Defender Agency (Agency) is currently recruiting for contract attorneys to provide legal representation to indigent individuals in criminal cases across the state of Alaska. The Agency covers some case related expenses and services in addition to compensation for contractors on either a flat fee or hourly basis.


Applicants for this work must have trial experience and possess outstanding writing and analytical skills and be able to work independently to research and compose legal briefs as well as possess strong oral advocacy skills. Applicants must be admitted to the Alaska bar, possess an active State of Alaska business license, and maintain professional liability insurance to perform contractor work for the Agency. Contractors are expected to handle cases to completion at the trial court level.


The Alaska Public Defender Agency is currently hiring Child in Need of Aid Attorneys (CINA) attorneys for its Anchorage office. These positions typically involve in-state travel to handle cases outside of Anchorage. The Agency has thirteen offices statewide, located in Anchorage, Utqiagvik, Bethel, Dillingham, Fairbanks, Juneau, Kenai, Ketchikan, Kodiak, Kotzebue, Nome, Palmer and Sitka. One aspect of the Agency's mission is to provide constitutionally mandated legal representation to indigent parents in CINA cases appointed by the court. The Agency is more rarely appointed to represent older children in CINA cases. The Agency's Civil attorneys provide legal advice and representation in CINA cases and assist parents or custodians in obtaining needed services for their families.


Sometimes, infants are born with certain heart problems that decrease blood flow from the heart to the lungs or decrease the flow of oxygen-rich blood to the body. In those cases, the PDA actually might help, and the doctor may prescribe medicine to keep the ductus arteriosus open.


PDA(Patent ductus arteriosus) is a common and clinically important condition which is presented with a number of hemodynamic and respiratory problems such as intraventricular hemorrhage, pulmonary hemorrhage and necrotizing enterocolitis due to increased pulmonary blood flow and stealing from systemic circulation. The incidence of PDA among the infants that were born before the 28th gestational week is as high as 70 %; and spontaneous closure rates in very-low-birth-weight premature neonates(VLBWPN) is around 34 %. The onset, duration, and repeat number of consecutive courses of the prostaglandin synthesis inhibitor medication for PDA closure are still issues of debate. Bed-side PDA closure is a safe surgical procedure in both mature and premature babies. Here we aim to retrospectively present our 26 cases which were less than 28 weeks and 1000 grams that underwent bed-side PDA ligation.


To achieve ductal closure, neonatologists administer several treatment approaches in preterm infants with symptomatic PDA, such as cautious fluid replacement, diuretics, and prostaglandin synthesis inhibitors like ibuprofen and indomethacin. In the cases of contraindications for, or failure of medical treatment, surgical PDA ligation may be performed [3]. Timing of surgical intervention is still an issue of debate. Ko et al. advocate that ligation should be the treatment of choice for symptomatic PDA because of the increased risks brought with indomethacin treatment and prolonged intubation in VLBWPN [4].


One indomethacin course included 0.2 mg/kg indomethacin three times every 12 h. Following a single course of indomethacin, PDA closure was evaluated by echocardiography. The cases without closure were given three additional courses of indomethacin. Side effects of indomethacin were present in 6 cases, which thus did not receive additional indomethacin medication after the first course. Those cases showed one or more of the following conditions: decreased urinary output (30 mg/dl), thrombocytopenia (


The bedside surgery team consisted of one cardiac surgeon, one anesthesiologist, one neonatal intensive care specialist, one scrub nurse, and one circulating nurse. Operations were performed in neonatal incubators with removable side walls and roofs, which was important during the intervention. Head lamps and portable lamps provided the illumination. The room was heated to 37 Co preoperatively, and the head and extremities were covered to reduce heat loss. Following the anesthesia, skin antisepsis was achieved appropriately with iodine solution, and soaking was avoided. The skin was covered with drape and limited left posterolateral thoracotomy was performed. The lungs were retracted anteriorly, and PDA was explored. PDA was ligatured with two 2-0 silk sutures using double ligation transfixion technique. One 8 FR drainage tube was placed in all cases. The ribs were adducted with 2-0 vicryl. The skin was closed separately with 5-0 prolene mattress sutures. No perioperative complication was encountered.


The follow up duration of the patients were between 2 months and 3 years. Medical closure had been tried with one or more courses of ibuprofen of indomethacin in all of the patients. The cases in which either PDA was still open or medical treatment ceased due to complications underwent surgery. No patient was operated without prior medical treatment.


Only single courses of indomethacin were administered to the patients 1, 12, 16, 18, 22, and 26; and early PDA ligation operations were performed. The remaining cases were given three courses of indomethacin. Only PDA diameters are shown here, leaving out other relevant PDA criteria. Except five, no postoperative mortality was observed among the 26 patients that underwent bedside PDA ligation. Causes of mortality were demonstrated on Table 3.


Ibuprofen is as effective as indomethacin in PDA closure, with lower side effects on intestinal, renal, and cerebral blood flow. However, this drug deteriorates the renal functions in premature infants less than 26 weeks more prominently [10]. We chose indomethacin for medical closure of PDA in our study. Upon the side effects encountered, we stopped the medical treatment and performed surgery in 4 of our cases. The most common side effects were thrombocytopenia, necrotizing enterocolitis, and decreased renal functions.


Bedside PDA ligation in the NICU is a safe method for VLBWPN with physiologically significant PDA. According to the results of our study and our clinical experience, early surgical ligation shall be the treatment of choice in VLBWPN with PDA, in order to minimize the possible complications of indomethacin and ibuprofen medications, prolonged intubation, and PDA itself; although, medical closure with these drugs was attempted in all of the cases in our study. In addition, we would like to underline as a conclusion that, whenever appropriate NICU conditions and an experienced team is available, bedside PDA ligation is definitely the best choice for the treatment of whether VLBWPN, or mature neonates, in accordance with the results of our studies and the current literature. 041b061a72


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