Thursday, January 8, 2009

Are Emergency Departments of Philippine hospitals designed, managed, and supported in ways that ensure patient safety?

* Are there sufficient spaces for the delivery of care?
* Did the number of patients exceed ED capacity to provide safe care?
* How long after being contacted did specialty consultation for critically ill
patients arrive?
* How long did it take ED patients requiring admission to the ICU to
be transferred from the ED to the ICU?
* How many, if any, of the people in the ED, have been trained in emergency
medicine?

advisory regarding Ching M. Alano concerning BPA-free feeding bottles
The following allegations were published in what was identified as said Alano's column in the January 6, 2008 issue of the Philippine Star newspaper:

". . . you can purchase BPA-free feeding bottles (4 or 8 oz.)
at SM branches."

What is the basis, if any, for the allegation that said bottles are BPA-free?

Hospira Issues Voluntary Recall
of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label
http://www.fda.gov/oc/po/firmrecalls/hospira12_08.html
FOR IMMEDIATE RELEASE -- LAKE FOREST, Ill., Dec. 8, 2008 -- Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a . . . voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.


New Report Recommends Strategies To Reduce Medical Resident Fatigue-related Errors and Improve Training
http://www.ahrq.gov/news/press/pr2008/iomrespr.htm


Press Release Date: December 2, 2008

Fatigued medical residents need protected sleep periods and increased supervision of work hour limits to improve patient safety and the training environment, according to a new Institute of Medicine (IOM) report funded by the Department of Health & Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ).

The study confirms that scientific evidence shows acute and chronically fatigued residents are more likely to make mistakes.

The IOM committee recommends several changes to the existing 80-hour-per-week limit on work hours, including protected sleep periods for residents. The IOM recommends a change to require residents who complete a 30-hour shift to only treat patients for up to 16 hours. They must then have a five-hour protected sleep period between 10 p.m. and 8 a.m., during which time other non-sleeping residents or additional staff members could take over patient care.

"The Institute of Medicine study provides the clear evidence to prove what we have long-believed is true—fatigue increases the chance for human error," said AHRQ Director Carolyn M. Clancy, M.D. "Most importantly, this report provides solid recommendations that can improve patient safety, as well as increase the quality of the resident training experience."

Other recommendations in the report, Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, include:

* Increased supervision of work hours. Lack of adherence to limits is common and often underreported. The IOM report recommends periodic independent reviews and strengthened protections for residents and others who report a lack of adherence to current work hour restrictions.
* Stronger moonlighting restrictions. Current ACGME rules only count internal moonlighting (additional paid health care work at same health care facility) against the 80-hour weekly limit. The IOM report recommends internal and external moonlighting count against the 80-hour weekly limit, because moonlighting outside residency training affects strategically designed periods for rest and sleep, which could reduce residents' readiness for their primary duties.
* Guaranteed days off to permit adequate recovery after working long shifts. The IOM committee said residents should receive a 24-hour break from duty each week, with one 48-hour break per month, for a total of five days off per month.
* Reasonable on-call periods. The IOM committee said residents should be on call in the hospital no more than every third night.
* Safe transportation provided by hospitals to residents who are too fatigued to drive home. AHRQ-funded research shows that residents more than double their risk of driving accidents when they drive home after working extended shifts.
* Increased resident training on better communication during handovers. Handovers, when clinicians transition care responsibility to other health care providers, are likely to increase with shorter resident shifts. In some cases, multiple handovers could add to the risk for adverse events unless a structured team approach is used.
* Increased involvement of residents in patient safety activities and adverse event reporting.



Questions to ask local hospitals:

Does said hospital have a centralized system for collecting reports of adverse events? reporting system?
Does said hospital fully distribute adverse event summary reports?
Does said hospital encourage reporting by a range of hospital staff, and distribute timely summary reports that are reviewed by senior-level staff?
Are said reports used to develop event reduction strategies.
Has said hospital established “supportive environments” that allow anonymous reporting.
Does said hospital have broad staff involvement in reporting adverse events?

FDA Drug Approval Reports
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

FDA Radiological Health Program
http://www.fda.gov/cdrh/radhealth/

Radiation-Emitting Products
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Products and Procedures

* A-Z List
* Medical Imaging
X-Rays, CT (Computed Tomography), Fluoroscopy, Mammography...
* Other Medical & Surgical Products
Surgical Lasers, Ultrasound Therapy...
* Consumer & Business Products
Cell Phones, Laser Light Shows...

Radiation Dose Reduction

* Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
* Focusing in on Dose Reduction: The FDA Perspective
* New England Journal of Medicine (NEJM) Article, "Computed Tomography (CT) - An Increasing Source of Radiation Exposure"
* American College of Radiology Appropriateness Criteria®

News & Highlights

* Electronic Submission of Diagnostic X-ray Reports of Assembly (January 6, 2009)
* CeSub Electronic Submissions Software Updated (January 5, 2009)
* Available in CeSub: Microwave Oven Radiation Safety (Product) Report, Television Radiation Safety (Product) Report (September 5, 2008)


Regulated Industry

* Getting Your Product to Market (FAQs)
* Products Subject to Performance Standards
* Laws, Regulations and Performance Standards
* Radiation-Emitting Electronic Product Codes
* Reports and Recordkeeping
* CeSub Electronic Submission Program
* Industry Guidance
* Imports & Exports

Radiation Safety

* Report a Problem
* Electromagnetic Compatibility (EMC)
* Nationwide Evaluation of X-Ray Trends (NEXT)

FDA's Role in Radiation Protection

* Radiological Health Program
o New Directions
o Questions and Answers
* Mammography Program

Other Resources

Updated January 7, 2009


Department of Trade and Industry received warning letter
regarding Sun Cellular Shop

The Department of Trade and Industry - National Capital Region received warning letter regarding Sun Cellular Shop. Evidence is a letter bearing what was identified as bearing the the letterhead of the Department of Trade and Industry Legal Affairs Center and titled "1st Indorsement December 23, 2008 and addressed to the Shop Manager, Sun Cellular Shop, Robinsons Place Ermita. Said letter contained the following words:

"Respectfully forwarded to THE SHOP MANAGER,
Sun Cellular Shop, Robinsons Place Ermita . . . the
herein attached warning-letter of . . . M. Silva . . .
as the subject matter is within your area of concern."

Said letter bore the name "Asst. Sec. MA THERESA "Angel" L. Pelayo-Ty
National Capital Region/Regional Operations Group".

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image of registry return receipt of letter addressed to Makati councilor J. J. Binay

image of registry return receipt of letter addressed to Makati councilor J. J. Binay