week 5 310 discussion

Example:

· The Medical Device Safety Act (MDSA)

I found this “ACT/LAW” very much and advocate for the patient….The Medical Device Safety Act (MDSA) was implemented in 2009. This law will restore patients’ ability to hold medical device manufacturers accountable for injuries caused by defective medical devices. Medical devices range from catheters, implantable defibrillators, pacemaker wires and artificial heart valves.

“Although, the bill replies to a 2008 Supreme Court decision, Riegel v. Medtronic.” That case held that a medical device manufacturer usually cannot be sued by injured patients if the Food and Drug Administration (FDA) approved the device for marketing through its premarket approval (PMA) process.

This bill has two important goals;

               ▪Improved Recall Processes: This bill has implantation to have the Government Accountability Office (GAO) to improve the handling on the FDA’s recall of defective devices. The GAO will require the FDA to assess and revaluate each device that falls under the unsafe device and expedite the recalls once the “problem” is discovered.

▪ Enhance Post-Market Surveillance Tools: “This legislation would improve FDA’s ability to conduct post-market surveillance for 510(k) cleared devices by allowing FDA to require the collection of post-market data as a condition of approval.” “The authority would mirror the post-market studies that can be required as a condition of a Pre-Market Approval (PMA) for highest risk devices. Under this legislation, the FDA could require conditions of clearance for 510(k) cleared devices that may have safety concerns. If FDA found a device substantially equivalent to a predicate for a higher-risk device, FDA could clear the device for market through 510(k) but require companies to conduct clinical studies and collect and report more complete data”.

Background

FDA’s oversight of medical devices has landed the agency on GAO’s “high-risk list”.2 GAO cites its concerns about FDA’s post-market surveillance of medical devices as a key reason for being on this list.

http://www.citizen.org/documents/Pass_MDSA.pdf

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

Example:

· Allen Beach posted Nov 18, 2015 1:26 PM

One of the many standards and policies I have personally encountered while working in health care, is the "Do Not Use List" of abbreviations. This list is utilized by many organizations but is a primary concern for Joint Commission, a non-profit organization providing certification and accreditation to health care facilities. This list is comprised of commonly used abbreviations that pose a potential risk to patients and medical staff alike. Abbreviations such as MS are barred from use as they could be read as either morphine sulfate or magnesium sulfate. Another item found on the list is trailing or leading "0's" in decimals as the decimal can often be missed, turning 1.0mg into 10mg (JC, 2015).