Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD

2015 ◽  
2009 ◽  
Vol 43 (6) ◽  
pp. 489-497
Author(s):  
Carol M. Lampe ◽  
Joyce M. Hansen ◽  
Therese M. Rymer ◽  
Harold Sargent

Abstract Product recalls due to non-sterility occurred between 1993 and 1994 among manufacturers that were sterilizing cotton products sourced from China using ethylene oxide (EO). The primary contaminant was identified as a pyrophilous mold from the class Discomycetes, Pyronema domesticum. Multiple references suggest this organism has special needs for reproducing and maintaining the two assumed resistant stages of this organism (ascospores and sclerotia). Sterilization resistance studies were performed using a China-sourced cotton product that was naturally contaminated with P. domesticum. These studies showed the organisms to have: 1) a low resistance to moist heat sterilization at 250°F (121°C); 2) a resistance to radiation no greater than that predicted by the bioburden-based resistance model (i.e., Population C) used for dose determination Method 1 described in ANSI/AAMI/ISO 11137-2:2006—Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose; and 3) a high resistance to EO processing.


1999 ◽  
Vol 27 (2) ◽  
pp. 203-203
Author(s):  
Kendra Carlson

The Supreme Court of California held, in Delaney v. Baker, 82 Cal. Rptr. 2d 610 (1999), that the heightened remedies available under the Elder Abuse Act (Act), Cal. Welf. & Inst. Code, §§ 15657,15657.2 (West 1998), apply to health care providers who engage in reckless neglect of an elder adult. The court interpreted two sections of the Act: (1) section 15657, which provides for enhanced remedies for reckless neglect; and (2) section 15657.2, which limits recovery for actions based on “professional negligence.” The court held that reckless neglect is distinct from professional negligence and therefore the restrictions on remedies against health care providers for professional negligence are inapplicable.Kay Delaney sued Meadowood, a skilled nursing facility (SNF), after a resident, her mother, died. Evidence at trial indicated that Rose Wallien, the decedent, was left lying in her own urine and feces for extended periods of time and had stage I11 and IV pressure sores on her ankles, feet, and buttocks at the time of her death.


1996 ◽  
Vol 24 (3) ◽  
pp. 274-275
Author(s):  
O. Lawrence ◽  
J.D. Gostin

In the summer of 1979, a group of experts on law, medicine, and ethics assembled in Siracusa, Sicily, under the auspices of the International Commission of Jurists and the International Institute of Higher Studies in Criminal Science, to draft guidelines on the rights of persons with mental illness. Sitting across the table from me was a quiet, proud man of distinctive intelligence, William J. Curran, Frances Glessner Lee Professor of Legal Medicine at Harvard University. Professor Curran was one of the principal drafters of those guidelines. Many years later in 1991, after several subsequent re-drafts by United Nations (U.N.) Rapporteur Erica-Irene Daes, the text was adopted by the U.N. General Assembly as the Principles for the Protection of Persons with Mental Illness and for the Improvement of Mental Health Care. This was the kind of remarkable achievement in the field of law and medicine that Professor Curran repeated throughout his distinguished career.


1988 ◽  
Vol 52 (11) ◽  
pp. 637-642 ◽  
Author(s):  
TA Dolan ◽  
CR Corey ◽  
HE Freeman

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