FDA Antiseptic sterility report

Sterility of Antiseptic Products:

FDA Investigates, Deliberates on Potential Recommendations

(Infection Control Today, PDF)
FDA investigates Antiseptics Sterility and potential recommendations_Page_01

In light of a number of high-profile recalls of contaminated alcohol prep products in the last several years, the Food and Drug Administration (FDA) is currently weighing whether or not to require sterility of patient skin prep products, specifically items such as alcohol prep pads used for injections, but it is not ruling out other surgical prep products.

On Dec. 12, 2012, the FDA held a hearing to receive expert testimony and public comment on how to address microbial contamination of these patient preoperative skin preparation drug products. It is a step in the ongoing investigational process that the agency is undertaking to determine issues related to sterility impacted by manufacturing processes.

An FDA spokesperson says that the panel members and FDA’s working group have received the submissions from the hearing and have been deliberating. FDA’s working group will be ready to make new recommendations in the coming months. The spokesperson adds that FDA’s working group has been soliciting clinician feedback from the FDA’s federal partners and other public health organizations, and that the agency will be ready to make new recommendations in the coming months.

Currently, patient preoperative skin preparations are not required to be sterile, since bacteria can contaminate these products at the time of manufacture or during product use. But because contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes, the FDA is exploring certain scientific and product-use issues related to patient preoperative skin preparations.

Patient preoperative skin preparations are over-the-counter (OTC) topical antiseptic drug products used to reduce the number of bacteria on the skin prior to medical procedures or injections. Although they are marketed predominantly to healthcare facilities, the use of these products extends beyond the healthcare facility setting.

Distilled water vs. saline soak; tears in wrapped sets; keeping instruments open for cleaning

December 2013 – CS Solutions. More insightful answers to infection control questions from Ray T. Surgical instruments should not be soaked in saline. Saline contains chloride ions which can be very damaging to surgical instruments. These chloride ions are highly caustic and can cause pitting and deterioration to instruments. (See figures 1 and 2.) For support … Read more

Sponsorship for BMXnet 2013 infection control

My company Piercers.com and I are pleased to sponsor a Statim autoclave for sterilization at this year’s event again! I will be there to educate and to learn, as well as to sell infection control equipment and anodizers. The Statim 2000 G4 is on the way, and the new Optim 33TB Blue version for surface disinfection as well. — at Unperfekthaus for the BMXnet … Read more

Researchers Develop Off-Grid Sterilization with Solar Steam

Original article: Researchers Develop Off-Grid Sterilization with Solar Steam.

Copyright 2013 by Virgo Publishing https://www.infectioncontroltoday.com/
Posted on: 07/22/2013

Rice University graduate student Oara Neumann, left, and scientist Naomi Halas are co-authors of a new study about a highly efficient method of turning sunlight into heat. They expect their technology to have an initial impact as an ultra-small-scale system to treat human waste in developing nations without sewer systems or electricity. Photo by Jeff Fitlow/Rice University.

Read more

APP Conference soon!

  CONFERENCE IS ALMOST UPON US! THE CONFERENCE ADVANCED (ONLINE) REGISTRATION WILL SHUT DOWN AT MIDNIGHT ON MAY 17TH, PST ANY CHANGES TO YOUR REGISTRATION SHOULD BE MADE BEFORE THEN (OR WILL HAVE TO WAIT UNTIL WE ARE ONSITE IN LAS VEGAS) BANQUET DINNER SPONSORED BY INDUSTRIAL STRENGTH BODY JEWELRY; ANATOMETAL, INC.; LEROI, INC.; AND KAOS SOFTWEAR THURSDAY JUNE … Read more

Processing Devices

Standards are useful, and guidance based on evidence is often even more so.

Scope

This guidance provides recommendations regarding reuse instructions in labeling for reusable medical devices and the validation of the recommended reprocessing process in the instructions. The recommendations are applicable to the three device reprocessing situations below.

Read more

Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

Read the full textEffects of Non Condensable Gases on Sterilization

Summary:

A gravity displacement (class N) steam sterilization process can not reliably remove gases from hollow or porous items, resulting in areas that do not get sterilized, and the failure of the load. They should not be used for body jewelry, needles, tattoo tubes or textiles.

REVIEW

395 CENTRAL SERVICE Volume 13 2005

ZENTRAL STERILISATION

Effects of Non-Condensable Gases (NCGs) on Steam Sterilisation Processes

U. Kaiser

Keywords

  • steam sterilisation process
  • non-condensable gases (NCGs)
  • process challenge device (PCD)

Introduction

The dangers posed by non-condensable gases (NCGs) in steam sterilisation processes have long been underestimated. Biological indicators, or the best chemical indicators on the market, do not signal the presence of a NCG content of up to 10% in a sterilisation process so long as there is mixing of steam and NCGs in the sterilisation chamber.

Read more

Water quality; staining of sterile packaging; soil detection devices

March 2013 – CS Solutions.

Water quality; staining of sterile packaging; soil detection devices

by Ray Taurasi

Q I work in a small rural hospital in New Hampshire. We only have one OR and one sterilizer and no automated washers. All of our instruments and other reprocessable items are manually cleaned. I have noticed at times, especially during the winter months, our tap water has a cloudy color. Since we use tap water to clean our instruments and to mix with our chemical disinfectants, I was wondering if the water is safe to use or if it can damage our instruments.

A In the winter time in cold regions such as New Hampshire, the water coming into the hospital is extremely colder than the inside temperature and your water may have a milky or cloudy appearance. The reason for this is that cold water holds more oxygen than warmer water does.

Read more

Bravo

Welcome to Bravo! A fractionated vacuum autoclave from SciCan Buy a Bravo now     BRAVO chamber autoclave   Features Fractionated vacuum system 17L or 21L chamber capacity Intelligent closed door drying Integrated datalogger Industry leading cycle times Single use Pull’n Push water system 2 Year warranty The BRAVO fractionated vacuum chamber autoclave continues the … Read more