Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment

FDA, CDC, EPA and OSHA have issued a Public Health Notification on how to avoid hazards when using liquid cleaners and disinfectants on electronic medical equipment. The Notification covers a wide range of equipment, including infusion pumps, ventilators, analgesia pumps, computer workstations and monitoring equipment.

This action was prompted by reports of fires and other equipment damage, as well as burns to healthcare workers, when these types of liquids were used inappropriately on equipment that has unsealed electrical circuits. In many cases, healthcare workers routinely sprayed the equipment with disinfectants or wrapped the housings with disinfectant-soaked towels, causing damage to the circuitry.

The Notification provides a number of recommendations to reduce the risk. Here are some of the highlights:

• Protect equipment from contamination during use, which can help avoid the need for disinfection.

• If equipment becomes contaminated, remove it from use and be sure it's serviced before returning it to use.

• Clean equipment surfaces according to the instructions from both the equipment manufacturer and the chemical manufacturer.


Additional Information:

FDA MedWatch Safety Alert. Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment. November 1, 2007.

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cleaners

Ireland Issues Guideline on Device Reprocessing

Ireland Issues Guideline on Device Reprocessing

Ireland’s Health Service Executive has released a practice guideline on decontamination of reusable invasive medical devices (RIMDs).

The new code of practice sets standards and best practices for facilities operating within Ireland’s public health system.

“Decontamination facilities should be designed, constructed, maintained and controlled to provide effective segregation of clean and dirty activities and to provide an environment that minimizes contamination of clean and disinfected RIMD,” the guideline says.

The seven-part guideline includes sections on recommended practices for central decontamination units, endoscopy units and dental services, as well as an audit prototype for evaluating decontamination procedures.

The guideline, “Code of Practice for Decontamination of Reusable Invasive Medical Devices,” can be viewed at:

www.hse.ie/en/Publications/HSEPublicationsNew/AcuteHospitalReportsGuidelines/#d.en.8696.

Patient and User Burns from Rotary Surgical Handpieces

HPN in their daily news update on 12/13/07 have reported that the FDA has issued an alert about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces, and to recommend specific actions to prevent or minimize the problem. While this notification is directed to dental health professionals, the following information may be useful to all users of electric handpieces.

Patients have been severely burned when poorly maintained electric dental handpieces were used during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage has been done, because the anesthetized patient cannot feel the tissue burning and the handpiece housing insulates the operator from the heated attachment. Although the reported burns have occurred during cutting of tooth and bone, tooth extraction and other dental surgical procedures, overheating could occur during any dental procedure. Note that this problem is not limited to dentistry. Rotary surgical handpieces can cause patient burns during orthopedic procedures, as reported in the July 2003 edition of FDA Patient Safety News.

Please go to this FDA link for more detailed information on this subject.

http://www.fda.gov/cdrh/psn/show17-burns.html

AORN Specialty Assembly for SP/MM News

The AORN Specialty Assembly for SP/MM has released a statement titled "Dancing with the Stars" on their web page concerning how this group interacts with other organizations. Hospital professionals can go to the AORN homepage (www.aorn.org) to view the statementor click on the link below to read the statement.

http://www.cpdguy.net/index.php?s=100&PHPSESSID=a56aee61bcfb545a50adbe75ed709f37

FDA and New Requirements for Tracking Medical Devices

Tracking Requirements Relaxed Under FDAAA
Medical devicemakers will be subject to fewer tracking requirements under H.R. 3580, the FDA Amendments Act (FDAAA).

Previously, devicemakers were required to track certain higher-risk devices even if the FDA did not issue a specific order to track a device. Under the new law, tracking will apply only if the FDA issues an order, according to a revised guidance document.

The agency may require tracking for a Class II or III device:

That is a life-sustaining or life-supporting device used outside a device user facility;
That is intended to be implanted in the human body for more than one year; or
Whose failure would be reasonably likely to have serious adverse health consequences.

Tracking methods are subject to FDA inspection, which may include a review of the tracking system and verification of information requirements. Medical device tracking is intended to ensure that manufacturers can promptly identify product distribution information and remove a device from the market in the event of a recall.

This information was posted on the FDA Daily News itmes;Vol.4,No.221,Friday,Nov.9, 2007


http://www.fda.gov

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