week 5 responses

310 week 5 Response:

Response needed to each Post! I have listed an example of a “response” in RED. There are four “post” total that need responses.

· Post: Lisa Kaufman posted Nov 17, 2015 1:21 PM

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 of “response”:

Stacey Samuels

Hi Lisa,

 The Medical Device Safety Act is very important especially when dealing with patient who have cardiovascular disease. The Medical Device improves the patients outcome, also has to be effective and safe for all patients. I read that Medtronic held that a patient injured by a poorly designed and labeled medical device (in this case, a heart catheter that exploded and killed the patient) could not sue the device maker.

Post:

· Alex Larson posted Nov 16, 2015 1:41 PM

All,

The law I found interesting was the American College of Surgeons (ACS) statement of practice. This law was brought into effect in hopes of protecting patients when going against the knife. It is estimated that there are roughly 100,000 injuries from surgical errors every year in the United States Healthcare system. The law requires that only physicians that have the appropriate credentials for certain procedures are performing them. Physicians must keep their credentials up to date by completing continuing education and staying proficient in their specialty. Along with this, it allows patients the right to know exactly what their physician is qualified for and the limits attributed to their training.

An interesting case in which this could have helped prevent a death is that of Julie Ribenzer. Julie was undergoing breast augmentation and died when she was given four times the amount of anesthesia that was needed. After further investigation, it was noted that her surgeon was not qualified to perform the operation and the individual who administered her anesthesia has no certified medical training.

 

REFERENCES:

 

(n.d.). Retrieved November 16, 2015, from http://www.hg.org/surgical-errors-law.html

Scope of Practice. (n.d.). Retrieved November 16, 2015, from https://www.facs.org/advocacy/federal/scope

Post:

· Faneshia Walton posted Nov 18, 2015 6:24 PM

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There is no such thing as minor surgery. A surgical error is a preventable mistake during surgery. Although some surgical errors are the direct result of a physician's incompetence, most result from poor preoperative planning or inadequate procedures or work processes. However, all surgeries involve an element of risk. For that reason, it is typical to sign a form before undergoing surgery that states you understand surgery involves certain known risks. This is called “informed consent” Surgical errors go beyond the known risks of surgery. Surgical errors are unexpected.

Surgical Errors Law refers to a subset of Medical Malpractice related to injuries resulting during surgical procedures. The area focuses largely on surgeons failing to give adequate information to the patient or the patient's family to allow for informed consent, performing unnecessary procedures due to negligence or pecuniary interests, performing procedures for which the surgeon is not qualified, performing a procedure on the wrong patient or wrong body part, or other mistakes made during surgery.

References:

http://www.hg.org/surgical-errors-law.html

Post:

· 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).

JC. 18Nov2015. Facts about the Official “Do Not Use” List of Abbreviations. Joint Commision.  http://www.jointcommission.org/topics/patient_safety.aspx