Bush Signs MDUFMA Reauthorization Bill Into Law

President Bush signed the FDA Amendments Act, H.R. 3580, into law Sept. 27, reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA) and granting the FDA additional authority.
FDA Commissioner Andrew von Eschenbach said in an FDA conference call that the timing of the law’s passage is important as it eliminates the possibility of reductions in the agency work force.
Reauthorization of MDUFMA will provide, in addition to appropriated funds, a revenue of $287 million by October 2012, Randall Lutter, the agency’s deputy commissioner for policy, said.
The reauthorization will ensure that the FDA centers have the resources needed to conduct complex and comprehensive reviews of new devices, von Eschenbach said.

TWO STERILE PROCESSING INDUSTRY GROUPS

American Society for Healthcare Central Service Professionals and the International Association of Healthcare Central Service and Materiel Management, have merged in order to form a single organization. "The newly unified group will create one organization committed to the education and professional development of CS/SP staff," says Virginia Sylvestri, executive director of ASHCSP. "This is an exciting opportunity for ASHCSP and IAHCSMM to improve upon our current high level of service to our membership." The Certification Board for Sterile Processing & Distribution says this merger in no way affects the CBSPD or personnel certified through the CBSPD.

FDA Patient Safety News - Video Available Online and as Podcast

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version:
http://www.fda.gov/psn


-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

Steris Warned After Reports of Flames and Sparks From Cleaning Units

Steris Corporation’s Amsco Sonic Energy Cleaners are misbranded after an inspection revealed user complaints of product-related fires, the FDA said in a warning letter. For example, one complaint said a user “smelled a strong burning odor and observed flames shooting out the back of the unit,” according to the letter, posted last week to the agency’s website.
The letter documented several other complaints, including: “Visible flame coming from the right side of the unit;” Interior wires melted and caught on fire; A unit was sparking and smoking, smelling like something had burned; A switch was smoking and burning. “Can see flames, but can’t get to plug to unplug it;” “Sonic Cleaner caught fire. No injuries and was under control before the fire department arrived;”

A unit caught on fire and a building was evacuated. This was the second unit to catch on fire within a year; A unit caught fire and was damaged beyond repair; and A unit caught fire while not in use. Steris could not be reached for comment by press time.
The letter can be viewed at www.fda.gov/foi/warning_letters/s6461c.pdf.

CDRH Provides Update on Postmarket Transformation

CDRH Provides Update on Postmarket Transformation
Almost a year after the FDA announced its action plan for postmarket transformation at CDRH, the agency is making progress on several “immediate priority actions” identified last November. Don St. Pierre, head of CDRH’s Postmarket Transformation Management Group, said he is receiving updates on these initiatives, some of which will affect devicemakers.

In November 2006, CDRH issued a report recommending work on measures to enhance postmarket surveillance at the center. The report predicted these initiatives would take a number of years to implement. One recommendation was the development of a unique device identification (UDI) system for medical devices, a move that would have “a huge impact on companies,” St. Pierre said.

The agency drafted a concept paper on UDI and held a public meeting on the topic. After collecting comments based on the meeting, the agency has drafted an internal concept paper, which is currently going through internal review. After it completes the review, the FDA will release the concept paper for industry and public comments, he said.

How sterile processing plays central role in success

http://www.hpnonline.com/inside/2007-09/0709-CS-BestPractices.html
Central service/sterile processing and distribution professionals may be vital to hospital performance and patient care quality, but their valuable contributions can be overlooked or not taken seriously until an infection outbreak occurs or a surgeon is rankled.
From cleaning, disinfection and sterilization to customer service, kit/pack assembly, loaner implants, maintenance and repair and quality assurance, CS/SPD could be classified as a "hub" of the organization, as one CS department billed itself.
As a result, Healthcare Purchasing News Senior Editor Rick Dana Barlow consulted with a variety of experts on the provider and supplier sides for anecdotes, tips and tools on best practices in sterile processing – on paper and in practice – as well as with some of the recent years’ winners and finalists in HPN’s annual CS/SPD Department of the Year Award.
What they had to say may be old hat for some or helpful reminders for others, but at the very least their words of wisdom should be educational and enlightening, if not inspiring.

Hospital issues warning to surgical outpatients

http://www.hpnonline.com/#22-2
Leader Hospital (Canada) is notifying outpatients who underwent minor surgical procedures that they should be tested for blood-borne infections after being exposed to improperly sterilized medical equipment. “During the period of Jan. 1 to Aug. 13, the procedures for sterilizing medical instruments may not have been effective according to the standards of the health region,” Dr. Khami Chokani, medical health officer for the Cypress Health Region, said in a prepared statement. “While the risk of acquiring an infection from a potentially inadequately sterilized medical instrument is thought to be low particularly given the minimally invasive nature of the procedures, all patients who have had any minor surgical procedures completed during these time frames are being contacted and advised of the issues, and encouraged to be tested for certain illnesses which patients may have been exposed to.”

Plain soap as effective as antibacterial but without the risk

http://www.hpnonline.com/#17-7
Antibacterial soaps show no health benefits over plain soaps and, in fact, may render some common antibiotics less effective, says a University of Michigan public health professor.
In the first known comprehensive analysis of whether antibacterial soaps work better than plain soaps, Allison Aiello of the U-M School of Public Health and her team found that washing hands with an antibacterial soap was no more effective in preventing infectious illness than plain soap. Moreover, antibacterial soaps at formulations sold to the public do not remove any more bacteria from the hands during washing than plain soaps.