ABSTRACT
This round-up of packaging myths provides a reality check on the real world of packaging medical products. Table I shows medical device FDA-assisted recalls due to packaging failures.
Subject(s)
Equipment Failure , Equipment Safety , Equipment and Supplies/standards , Product Packaging/standards , Product Surveillance, Postmarketing , Device Approval/legislation & jurisprudence , Equipment Failure Analysis/methods , Equipment Failure Analysis/standards , Product Packaging/legislation & jurisprudence , Product Packaging/statistics & numerical data , Product Packaging/trends , United States , United States Food and Drug AdministrationABSTRACT
Strength and integrity are the two attributes that must be monitored at the critical point. Strength can effectively be monitored by operating the sealing equipment within the validated control limits. Integrity is another matter entirely. Integrity failures are often random occurrences that must be visible to the trained operator. Yet, this is not true in every instance. Use of precise testing equipment, which exceeds the capabilities of visual testing, is a more effective way to manage the critical control point. New technology to more effectively test the attributes of seal and package integrity at the critical control point is currently under development. Data on its capabilities will shortly be available.
Subject(s)
Equipment Contamination/prevention & control , Equipment Failure Analysis/methods , Equipment Safety/methods , Product Packaging/methods , Safety Management/methods , Sterilization/methods , Equipment and Supplies , Product Surveillance, Postmarketing/methods , Quality ControlABSTRACT
OBJECTIVES: We sought to delineate the angiographic findings, clinical correlates and in-hospital outcomes in patients with cardiogenic shock (CS) complicating acute myocardial infarction. BACKGROUND: Patients with CS complicating acute myocardial infarction carry a grave prognosis. Detailed angiographic findings in a large, prospectively identified cohort of patients with CS are currently lacking. METHODS: We compared the clinical characteristics, angiographic findings, and in-hospital outcomes of 717 patients selected to undergo angiography and 442 not selected, overall and by shock etiology: left or right ventricular failure versus mechanical complications. RESULTS: Patients who underwent angiography had lower baseline risk and a better hemodynamic profile than those who did not. Overall, 15.5% of the patients had significant left main lesions on angiography, and 53.4% had three-vessel disease, with higher rates of both for those with ventricular failure, compared with patients who had mechanical complications. Among patients who underwent angiography, those with ventricular failure had significantly lower in-hospital mortality than patients with mechanical complications (45.2% vs. 57.0%; p = 0.021). Importantly, for patients with ventricular failure, in-hospital mortality also correlated with disease severity: 35.0% for no or single-vessel disease versus 50.8% for three-vessel disease. Furthermore, mortality was associated with the culprit lesion location (78.6% in left main lesion, 69.7% in saphenous vein graft lesions, 42.4% in circumflex lesions, 42.3% in left anterior descending lesions, and 37.4% in right coronary artery lesions), and Thrombolysis In Myocardial Infarction (TIMI) flow grade (46.5% in TIMI 0/1, 49.4% in TIMI 2 and 26% in TIMI 3). CONCLUSIONS: Patients who underwent angiographic study in the SHOCK Trial Registry had a more benign cardiac risk profile, more favorable hemodynamic findings and lower in-hospital mortality than those for whom angiograms were not obtained. Patients with CS caused by ventricular failure had more severe atherosclerosis, and a different distribution of culprit vessel involvement but lower in-hospital mortality, than those with mechanical complications. Overall in-hospital survival correlates with the extent of coronary artery obstructions, location of culprit lesion and baseline coronary TIMI flow grade.
Subject(s)
Coronary Angiography , Registries , Shock, Cardiogenic/diagnostic imaging , Aged , Blood Flow Velocity , Coronary Circulation , Female , Heart Failure/complications , Heart Failure/diagnostic imaging , Heart Failure/physiopathology , Heart Failure/therapy , Hospital Mortality , Humans , Male , Myocardial Infarction/complications , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/physiopathology , Myocardial Infarction/therapy , Myocardial Revascularization , Prospective Studies , Severity of Illness Index , Shock, Cardiogenic/etiology , Shock, Cardiogenic/mortality , Shock, Cardiogenic/therapy , Thrombolytic Therapy , Ventricular Dysfunction, Left/complications , Ventricular Dysfunction, Left/diagnostic imaging , Ventricular Dysfunction, Left/physiopathology , Ventricular Dysfunction, Left/therapyABSTRACT
This review of the important attributes of adhesive systems also assesses the potential benefits of nonadhesive systems, such as peelable films, which are gaining favour as cost-saving alternatives.
Subject(s)
Adhesives , Equipment and Supplies , Product Packaging/methods , Cost-Benefit Analysis , Hot Temperature , Humans , Product Packaging/economicsABSTRACT
This article assesses the materials used for medical device packaging that employs rigid preformed trays. It lists the basic requirements for these materials and summarizes the properties of each that make them useful for specific medical-packaging applications. A cost model illustrates how to properly select materials of similar properties on a cost-per-part basis.
