Manufacturer of medical product confirms contamination The Centers for Disease Control and Prevention (CDC) on Monday forwarded the following information regarding a voluntary recall of certain liquid docusate products.
[7/16/16] U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles. In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products. Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose. FDA and CDC will provide additional information when it is available. FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
The FDA’s statement about the voluntary recall is online at here. This information is also linked from the CDC outbreak site: https://www.cdc.gov/hai/outbreaks/b-cepacia/index.html.
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Input is needed on proposed regulations affecting Nevada providers The Nevada Child Care Licensing Section has released proposed changes to several state rules, including changes to the initial training required for new child care workers and child-to-staff ratios. The proposed additions to initial child care employee training are:
Proposed changes to the ratios of children-to-staff can be found at the end of the attached document that includes full language of the applicable section of the Nevada Administrative Code (NAC). The current proposals also include a requirement to document within 24 hours any instance of illness, accident or injury of a child in a facility. Copies of the documentation would need to be given to the child’s parent and retained in the child’s file. The report that must then be filed with the state or local licensing agency must be made within 48 hours under the proposed change. Another proposed change would enable the Child Care Licensing Section to charge and collect a fee from any licensee found in violation of state regulations stemming from a complaint investigation. The fee will be based on the hourly rate established for surveyors of child care facilities. The proposed changes to NAC Chapter 432A must undergo an extensive review and approval process. In the near future, a method of providing feedback on the proposed changes will be released so members of the industry and the public can give their input on the issues.
Public input is needed on changes affecting numerous services for recipients State regulators are asking for public input on new federal regulations regarding such issues as door locks, visiting hours, outside activities and more for Nevadans receiving home and community-based Medicaid services.
A federal program that funds these services for Medicaid recipients has changed some rules, and the state must change its plan accordingly. Under this program, individuals must be offered opportunities to seek employment and engage in community activities in the same manner as everyone else. The federal Centers for Medicare and Medicaid Services (CMS) requires states to solicit public input as part of the changes. To remain part of the program and receive federal funding, the Nevada Division of Health Care Financing and Policy must receive input on its Medicaid State Transition Plan by 5 p.m. on Aug. 12, 2016. Comments must be submitted by one of three methods:
CDC gives guidance for healthcare providers The Nevada Division of Public and Behavioral Health has issued a technical bulletin for healthcare providers to help them recognize the difference between a bacterial colonization and a bacterial infection. Specifically regarding the bacterium Clostridium difficile, the Centers for Disease Control and Prevention (CDC) states, "a patient who is colonized exhibits no clinical symptoms, and tests positive for Clostridium difficile organism and/or its toxin. When a patient is infected, they exhibit clinical symptoms and tests positive for the Clostridium difficile organism and its toxin." The bulletin also discusses prevention of transmission and identification of healthcare-associated infections (HAIs). For more information, see the attached bulletin. |
AuthorThe Bureau of Health Care Quality and Compliance (HCQC) licenses medical and other health facilities, child care facilities and personnel, and medical laboratories and personnel in Nevada. HCQC also conducts compliance surveys and takes complaints. Archives
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