At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.
June 7, 2018 | Health systems face numerous challenges in their efforts to improve population health. What makes a comprehensive strategy, and where do health care systems start?
Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.
Learn about Scotland’s 10-year effort to apply quality improvement on a national scale to improve patient safety, including an in-depth review of the successful Scottish Patient Safety Programme, and further QI efforts that spread across Scotland into new social policy areas such as children’s services, education, and justice.
This article contains information about the partership between Agência Nacional de Saúde Suplementar (ANS) and IHI in creating the Appropriate Childbirth Project, which aims to encourage normal childbirth and raise awareness among future mothers and the entire obstetric care network about cesareans without clinical indication.
The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.
Through the process of delving more deeply into the topic of fostering joy in work and reducing burnout, IHI has discovered four lessons from the field of community organizing that are readily applicable to nurture joy in the health care workforce.
Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.
The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.
This case study provides an overview of the Poverty Outcomes and Improvement Network Team (POINT) initiative, a multiyear regional effort to reduce poverty in Northeast Wisconsin by teaching nonprofit organizations how to use quality improvement methods and tools to improve the services they provide to those in the community living in poverty.
Commentary from IHI faculty member Kirsten Meisinger is included in this Modern Healthcare article on team-based care.
This article includes a video interview with Barbara Balik on addressing burnout and finding joy in work.
This article includes new research on end-of-life care from the Massachusetts Coalition for Serious Illness Care and includes commentary from Maureen Bisognano, co-chair of the Coalition .
The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.
This article discusses one hospital's success in reducing hospital aquired infections with the help of using IHI's methodologies and programs.
Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.
Six ways for health care staff to help counteract negative emotions of cancer patients are offered in this article, which may improve outcomes in cancer care.
The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.
This article contains an interview with Barbara Balik that centers on the main causes of burnout.