Effects of manufacturing defects on the device failure rate

2013 ◽  
Vol 42 (4) ◽  
pp. 481-495 ◽  
Author(s):  
Kyungmee O. Kim
2019 ◽  
pp. 001857871986765 ◽  
Author(s):  
Jolly Patel ◽  
Rebecca Ann Rainess ◽  
Miranda J. Benfield ◽  
Kate M. L. Rogers ◽  
Donald C. Moore ◽  
...  

Objectives: Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used as primary prophylaxis in patients receiving myelosuppressive chemotherapy regimens that have greater than 20% risk of developing febrile neutropenia (FN). Historically, pegfilgrastim has been administered 24 to 72 hours after chemotherapy, necessitating a return to clinic to receive the provider-administered injection. An alternative option is the pegfilgrastim on-body injector (OBI). With the OBI device, patients have their pegfilgrastim administered 27 hours after receiving chemotherapy while remaining at home, avoiding an additional clinic appointment. Concerns with pegfilgrastim OBI include lack of experience with the device in both the patient and provider, device-related failures, and the success of delivery. This study evaluates pegfilgrastim OBI failure rates through associated patient outcomes among cancer patients receiving chemotherapy requiring G-CSF. Methods: A retrospective electronic chart review was conducted of adult patients with cancer who received chemotherapy and pegfilgrastim OBI from July 1, 2016, to July 31, 2018. The primary objective of this study was the incidence of FN in patients receiving pegfilgrastim OBI. Results: There were no reported cases of hospitalization due to FN in patients who received pegfilgrastim OBI. Dose delays and dosage modifications were not observed in our review. The OBI device failure rate was found to be low (1.92%). Conclusion: The low device failure rate from this study suggests that the OBI is a viable option for administration of pegfilgrastim in patients receiving chemotherapy requiring G-CSF.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2251-2251
Author(s):  
Ali McBride ◽  
Andriy Krendyukov ◽  
Nicola Mathieson ◽  
Kim Campbell ◽  
Sanjeev Balu ◽  
...  

Abstract Introduction: Failure rates ranging from 1.7-3.8% of the pegfilgrastim on-body injector (PEG-OBI) device have been reported (Joshi, Curr Med Res Opin 2017; Stuessy, J Clin Onc 2017; Mahler, Clin J Onc Nurs 2017). Failures may increase the risk of chemotherapy-induced febrile neutropenia (FN) and FN-related hospitalizations (FN-HOSP) beyond the FN and FN-HOSP rates for prophylaxis with single-injection pegfilgrastim (PEG) or daily injections of reference (REF-FIL) or Sandoz filgrastim biosimilar (BIOSIM-FIL). We aimed to estimate for a US panel of 10,000 patients with non-Hodgkin lymphoma (NHL) the total incremental costs of PEG-OBI prophylaxis and incremental FN-HOSP costs at different PEG-OBI failure rates versus (vs) assured prophylaxis administration with PEG, REF-FIL, or BIOSIM-FIL. Methods: Simulation analysis from a US payer perspective of the total incremental prophylaxis costs associated with PEG-OBI failure rates of 1-5% compared to assured prophylaxis administration with PEG, REF-FIL, and BIOSIM-FIL in chemotherapy cycle 1 for a panel of 10,000 NHL patients. Filgrastim daily injection regimens included real-world durations of 5 (Gascón, Support Care Cancer 2016) and 6.5 days (Weycker, Ann Pharmacother 2006) and standard 11 days, all clinician-administered. Differential base rates of FN-HOSP (rate of FN-HOSP without colony-stimulating factor [CSF] minus rate with CSF) in NHL patients was computed for two chemotherapy regimens: 1) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) (Chrischilles, Cancer Control 2002; 13.25% with CSF, 23.28% without), and 2) CHOP or cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) (Osby, Blood 2003; 33.0% with CSF, 50.0% without). Costs (US$) were based on 1Q2018 average selling price for drugs and 2018 Current Procedural Terminology reimbursement for administration. FN-HOSP costs in 2012 of $25,676 per episode for NHL patients (Tai, J Oncol Pract 2017) were adjusted per the Consumer Price Index for Medical Care to $29,938.63 for 2018. Results: Table 1 (Chrischilles; CHOP) and Table 2 (Osby; CHOP/CNOP) present, for PEG-OBI failures rates of 0.01-0.05, the incremental number of patients at risk for FN-HOSP and associated incremental costs; and total incremental costs of PEG-OBI prophylaxis over the costs of assured prophylaxis administration with other CSFs in CTX cycle 1 for a panel of 10,000 NHL patients. Except for one scenario (savings of $72,916 at 0.1 failure rate due to the lower PEG-OBI administration costs), all scenarios showed incremental costs associated with PEG-OBI prophylaxis and failures of the PEG-OBI device (Tables 1 and 2). Per Chrischilles rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $300,284 (at 0.01 failure rate) to $1,501,422 (at 0.05 failure rate). Total incremental costs of PEG-OBI over PEG ranged from $227,369 to $1,128,222. Total incremental costs of PEG-OBI over REF-FIL ranged from $6,794,984 to $28,859,922; and over BIOSIM-FIL from $19,004,984 to $34,409,922. Per the Osby rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $508,957 to $2,544,784. Total incremental costs of PEG-OBI over PEG ranged from $135,757 to $2,171,584; over REF-FIL from $7,003,657 to $29,903,284; and over BIOSIM-FIL from $19,213,657 to $35,453,284. Conclusions: In this simulation of NHL patients treated with CHOP or CNOP, the total incremental costs of PEG-OBI prophylaxis vs assured prophylaxis administration with other CSFs vary as a function of PEG-OBI failure rates, baseline and failure-associated FN-HOSP risk, and the alternative CSF prophylaxis option. Incremental costs of PEG-OBI prophylaxis and failure are lowest vs PEG and highest vs BIOSIM-FIL at real-world duration of 5 days. Disclosures Krendyukov: Sandoz: Employment. Mathieson:Sandoz: Employment. Campbell:Sandoz Inc.: Employment. Balu:Sandoz Inc.: Employment. MacDonald:Sandoz: Consultancy. Abraham:Sandoz: Consultancy.


2012 ◽  
Vol 18 (69) ◽  
pp. 237
Author(s):  
فاتن فاروق البدري ◽  
علا علي فرج

تهدف دراسة التوزيعات الإحصائية إلى الحصول على التوصيفات الأفضل لمجموعة المتغيرات والظواهر والتي كل منها يمكن أن يسلك سلوك واحد من هذه التوزيعات. وتعد دراسة عمليات التقدير لمعلمات هذه  التوزيعات من الأمور المهمة والتي لا غنى عنها في دراسة سلوك هذه المتغيرات ونتيجة لذلك جاء هذا البحث محاولة للوصول إلى أفضل طريقة تقدير معلمات توزيع هو واحد من أهم التوزيعات الإحصائية وهو التوزيع الخطي العام لمعدلات الفشل، (Generalized Linear Failure Rate Distribution) وذلك من خلال دراسة الجوانب النظرية بالاعتماد على طرق الاستدلال الإحصائي مثل طريقة الإمكان الأعظم وطريقة المربعات الصغرى وبالإضافة إلى الطريقة المختلطة(طريقة مقترحة) . وتضمن البحث إجراء المقارنات بين طرائق التقدير الثلاثة لمعلمات التوزيع الخطي العام لمعدلات الفشل (GLFRD)، بالاعتماد على مقياسين إحصائيين مهمين هما متوسط مربعات الخطأ (MSE)، ومتوسط الخطأ النسبي المطلق (MAPE)، للحصول على طريقة التقدير الأفضل.


2012 ◽  
Vol 30 (1) ◽  
pp. 119-127
Author(s):  
Henryk Tomaszek ◽  
Ryszard Kaleta ◽  
Mariusz Zieja

The paper is an attempt to describe the forecast on the risk of damages resulting from failures to the means of transport. It has been assumed that the product of the probability of failure (fault) occurrence and measures of effects thereof are to be used to estimate the risk. The below presented dependences that describe the risk of damages have been based on the failure rate. With the available literature as the basis, a preliminary description of the probability of a failure (fault) and the level of losses has been proposed. The paper gives dependences on short- and long-range risk forecasts. To determine the relationship for the probability of a failure (fault), the failure rate has been used.


2018 ◽  
Author(s):  
Wentao Qin ◽  
Scott Donaldson ◽  
Dan Rogers ◽  
Lahcen Boukhanfra ◽  
Julien Thiefain ◽  
...  

Abstract Many semiconductor products are manufactured with mature technologies involving the uses of aluminum (Al) lines and tungsten (W) vias. High resistances of the vias were sometimes observed only after electrical or thermal stress. A layer of Ti oxide was found on such a via. In the wafer processing, the post W chemical mechanical planarization (WCMP) cleaning left residual W oxide on the W plugs. Ti from the overlaying metal line spontaneously reduced the W oxide, through which Ti oxide formed. Compared with W oxide, the Ti oxide has a larger formation enthalpy, and the valence electrons of Ti are more tightly bound to the O ion cores. As a result, the Ti oxide is more resistive than the W oxide. Consequently, the die functioned well in the first test in the fab, but the via resistance increased significantly after a thermal stress, which led to device failure in the second test. The NH4OH concentration was therefore increased to more effectively remove residual W oxide, which solved the problem. The thermal stress had prevented the latent issue from becoming a more costly field failure.


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