Serious and fatal diseases such as pancreatic cancer, Parkinson's disease and diabetes may eventually be treated using stem cells from breast milk following a remarkable discovery at the University of Western Australia.

The Food and Drug Administration has proposed regulation of some medical applications that run on smartphones and other mobile computing devices that could affect the operations of other medical devices already under its governance.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm#3

Tim Lozier, marketing manager at Farmingdale, NY-based EtQ, says his company has developed an FDA-compliance software solution that is Web-based but with offline capability. Modules include change management, calibration and maintenance, corrective and preventive actions, and employee training. In the case of adverse events, Lozier says, the software filters out the most critical events first.

The importance of monitoring lab equipment has led Raritan, NJ-based Ortho Clinical Diagnostics to develop a 24/7 remote monitoring system for its own product lines, says Susan Kadri, vice president of transfusion medicine, worldwide. Using a broadband Internet connection, data exchanged is securely encrypted via a VPN. "We know when something will go wrong, then schedule maintenance time," she says.

Reducing errors to ensure patient safety is as much a part of giving blood as it is prescribing and administering standard medications. A major trend today, says Lori Giannetta, director of operations for Trumbull, CT-based Korchek Technologies, is the use of bar codes on blood bags and patient wristbands. With and increasing number of procedures moving to the point of care, Giannetta says her company has developed both a wired and wireless hand-held device for use at the bedside before a transfusion begins. Not only does the device match the patient with the blood product, but it also documents any and all adverse events. "But we are taking it one step further," she says. "The scanning also allows vital signs to be captured at the bedside."

Advancing automation

by Richard R. Rogoski

MDDS Rule
In the Federal Register of February 15, 2011(76 FR 8637), the FDA issued a final rule to reclassify MDDS from Class III (subject to premarket approval) to Class I (subject to general controls).
Devices that were not in commercial distribution prior to May 28, 1976, are generally referred to as post-amendment devices, and are classified by operation of law under section 513(f) of the Food Drug and Cosmetic Act (21 U.S.C. 360c(f)) as Class III devices.

JCAHO’s Positive Response to Critical Issues: Patient and Specimen Identification Errors

The July 2002 issue of OUTCRY Magazine is dedicated to medical errors. Many of its articles are about the search for solutions to medical errors, based on our ongoing study of error prevention in health care institutions. What people on the outside of health care do not realize is, there are many systemic problems associated with the continuation of medical errors. Problems within the system and problems outside the system are impeding the quality of care. Based on research study to date, evidence indicates that even though known best practices are presented to health care professionals, health care organizations have not been eager to incorporate these known practices into their daily procedures to help improve the quality of patient care. This is similar to the observation made in our ongoing national campaign and research on medical errors. Our study, like others, encountered many types of resistance to solutions implementation and other ideas to improve the quality of care. From our study, it is evident that solutions can neither be engineered from the bottom (front-line workers) nor starting from the middle (technical managers). Such attempts will not be as successful. The best solution is for the initiation of coherent effort to be championed and fired-up by the hospital CEO and the hospital medical director.

Women who can't breast-feed are turning to the internet and getting breast milk from mothers who have a surplus, but the government is warning new moms that breast milk sharing may not be such a good idea.

In November, the Food and Drug Administration issued a warning against feeding babies breast milk acquired directly from individuals or through the internet saying that in such cases "the donor is unlikely to have been adequately screened for infectious disease or contamination risk" and that "it is not likely that the human milk has been collected, processed, tested or stored in a way that reduces possible safety risks to the baby."

The actuarial consulting firm Milliman has published an excellent report detailing the economic cost of medical errors. An excellent source guide to learn more about how much medical errors affect our economy and the cost of health care...this report also tracks medical error frequency and value by ICD-9 code...and has great value to physicians, practice managers, and those charged with the improvement of the quality of care.

Medical errors and the problems they can cause — including bed sores, post-op infections and implant or device complications — cost the U.S. economy $19.5 billion in 2008, according to a study released today. (That’s enough to buy almost 1.3 billion copies of The Checklist Manifesto, Atul Gawande’s bestseller on reducing such errors via the lowly checklist.)By Katherine Hobson

We extend our sincere thanks to more than 3,800 readers who participated in our survey regarding the definition of a near miss! ISMP agrees with the vast majority of respondents (88%) who defined a near miss as an error that happened but did not reach the patient. These errors are captured and corrected before reaching the patient, either through chance or purposefully designed system controls that have been put in place. Thus, reporting near misses can help to evaluate whether capture opportunities are functioning poorly—if they are fortuitous—or functioning well—if they are part of the system design, consistently implemented, and routinely effective.

The US Health and Human Services Department's released today the final rule on "meaningful use" of an Electronic Health Record (EHR).

The rule clarifies the requirements physicians must satisfy to earn financial incentives for automating and connecting their practices under the HITECH Act, part of the American Recovery and Reinvestment Act (ARRA) of 2009. The final rule was accompanied by a second rule setting standards, implementation specifications, and certification criteria for EHR technology in an effort to help physicians ensure their purchases will deliver the value the rule is designed to drive.

http://www.ofr.gov/OFRUpload/OFRData/2010-17210_PI.pdf