Neurourgeons Beware: Cranial Perforators

Neurourgeons Beware: Cranial Perforators May Fail to Automatically Disengage, FDA Says:

Although certain cranial exercises are designed to automatically shut off after entering the skull (to avoid accidentally drill into the brain), the automatic clutch mechanism may fail to generate a wide range of devices, the Food and Drug Administration US . (FDA) warned Monday.

The FDA said its analysis of currently available data suggest that this "failure to withdraw" is not specific to a manufacturer or the brand of devices, but can be mitigated by proper use, patient considerations, and selection device as instructed. If the manufacturer's instructions are not followed may cause the unit does not work as expected, which could put patients at risk, the FDA says.

From January 2005 to August 2015, the FDA has received more than 300 reports of medical devices (MDR) associated with the use of blows to the head with an automatic clutch mechanism failing to disconnect, resulting in more than 200 injured .

Injury reports describe the drilling of the protective covering of the brain, just below the skull, bleeding, concussion, brain function and brain tissue damage decreased. Results injuries include convulsions, damage to part of the brain responsible for language, prolonged hospitalization delayed / and the need for additional procedures.

FDA asks neurosurgeons:

•     Review and follow the instructions on the device's instructions for use to pierce the skull with an automatic clutch mechanism
•     Use appropriate techniques to drill the skull with automatic clutch mechanism
•     Be careful with a punch head with automatic clutch mechanism if the surgeon
•         Perforated areas of the skull that have variations in the thickness and the bone contours as the posterior fossa.
•         Drill the skull of babies, children or the elderly, due to the change in the consistency and thickness of the skull bone.
•         Drilling the skull of a patient if weak or diseased bones or the possibility of adhesive underlying dura.

Neurosurgeons have also learned to report adverse reactions associated with the use of blows to the head with a system of automatic clutch FDA and the manufacturer.

RAC US Exam Question No 3

Question No 3:

Which of the following states is NOT true with respect to both Investigational New Drug (IND) Applications and Inverstigational Decice Exemptions (IEDs) for significant- risk products?

A. The investigational product must be manufactured in full compliance with CGMP
B. Clinical studies must be reviewed and approved by an Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise.
D. The application must include and environmental impact statement that contains a claim for categorical exclusion or and environmental assessment

Answer: A

RAC US Exam Questions PDF

Regulatory Affairs Certification PDF

(FDA) Center for Food and Drug

(FDA) Center for Food and Drug Administration of the United States for Devices and Radiological Health (CDRH) announced Friday the creation of the Advisory Committee of the participation of the first patients (CAPP) to ensure that the needs and experiences of Patients included in the review of medical devices.

The committee, which will consist of nine members voting, non-voting representative of the industry and a consumer representative without voting rights, will bring together patients, advocacy groups for patients and experts to further discussion device innovation, development, evaluation and access.

Candidates to ECHA:

As for who will be included in the committee, the FDA encourages the public to define a diverse group of candidates with expertise in areas such as:

• Primary care of the patient experience
• Health needs of the patient groups United States
• The work of patients and health professional organizations
• Clinical research
• Methodologies for determining patient preferences
• Methodology results reported for patients
• Communication strategies, benefits, risks, and health outcomes for patients and research subjects.

FDA is asking for nominations for the industry representatives without the right to vote time to be included in a group of people to serve on the committee. Recommended candidates to serve as non-voting representative of the industry can be temporary or self-appointed or designated by an industry organization.

Acting Associate Director of CDRH Centre for Science and strategic partnerships Kathryn O'Callaghan told reporters Friday at a conference that the first meeting will be next year and the committee will be a resource focused on what is happening in the patient community and its prospects.

As for what issues the commission will focus on the first, the FDA requested public comment on the decision. PEAC CDRH can advise on the management, clinical trial design, patient preferences, labeling device, unmet clinical needs and benefit-risk determinations.

"We are entering an era of medicine", "in which patients and their care partners are actively involved in decision making and prioritization of all aspects of health care" patient-centered Nina L. Hunter, Ph.D., and Robert M. Califf, MD, wrote in a blog.

Patient representatives are currently participating in meetings of the Advisory Committee of the FDA, but the agency has never established a committee focused entirely on the patient. And the meetings that need more experience, PEAC may reach the other experts involved in the FDA advisory committees and the National Institutes of Health.

RAC US Exam Question No 2

Question No 2:

FDAs Unified Registration and Listing System?

A. FDAs Unified Registration and Listing System
B. FDA Forms 2891 and 2892
C. FDA Forms 2656 and 2657
D. FDA Form 3356

Answer: A

Study Finds Fewer Michigan Women Getting

Study Finds Fewer Michigan Women Getting Minimally Invasive Hysterectomies after FDA Warnin

A new retrospective study found that following calls from the Food and Drug Administration (FDA) to discourage use of the power of fragmentation for laparoscopic hysterectomy or myomectomy for the treatment of women with uterine fibroids, decreased use Grind Michigan, if major complications and readmissions 30 days increased.

Background

Power laparoscopic fragmentation is a minimally invasive method of removing fibroids from the uterus or remove the entire uterus fragmentation into small pieces. In April 2014, the FDA has expressed concern that the technology could spread unsuspected uterine sarcoma in the abdomen and the female pelvis, exacerbating the long-term survival probability.

"For this reason, and because there is no reliable method for predicting whether a woman can have a uterine fibroid sarcoma, the FDA discourages the use of fragmentation of power during laparoscopic hysterectomy or myomectomy for uterine fibroids," the FDA said in its notice.

Results
For the University of Michigan study, recently published in the American Journal of Obstetrics & Gynecology, the researchers analyzed 18,299 hysterectomies during the study period and comparative data of the previous 15 months the FDA warning eight months later.

The researchers noted that in the eight months following safety communication FDA in April 2014, compared with the previous 15 months warning, the use of laparoscopic hysterectomies decreased by 4.1% (p = 0.005) and abdominal and vaginal hysterectomies increased (1.7%, p = 0.112 and 2.4%, p = 0.012, respectively). The main surgical complications of blood transfusion was not significantly increased after the date of the communication from the FDA for safety, from 2.2% to 2.8% (p = 0.015) and hospital readmission rates within 30 days also increased from 3.4% to 4.2% (p = 0.025). But the rate of all major surgical complications or reoperations hospital did not change significantly after the date of notification of the FDA.

"We found that the risk of postoperative complications for women who undergo hysterectomy communication from the FDA, increased," John Harris, MDMSc., Academic Hospital of the Robert Wood Johnson Foundation in the UM Department of Obstetrics and Gynecology in statement. "We do not treat the underlying cause of these changes, but is associated with the communication from the FDA about the fragmentation and the risk of cancer."

The researchers also point out that the study did not examine all the results of all surgical diagnosis of occult cancer rates or fragmentation. The study did not compare if the same patient is more or less likely to receive a more invasive technique.

RAC US Exam Question No 1

Question No 1:

What is Federal Food and Drug Act of 1938?

• Replaced the 1906 act
• Revised the misbranding standard in a way that distinguished food labeling from drug labeling
• Relaxed the standard from "false and fraudulent" to "false and Misleading"
• Introduced premarket review (NDA)
• Prohibited false therapeutic claims for drugs
• Separate law allowed the FTC jurisdiction over drug advertising
• Brought cosmetics and medical devices under FDA's control
• Mandated legally enforceable food standards
• Tolerances for certain poisonous substances were addressed
• Formally authorized factory inspections
• Added injunctions to the enforcement tools

WHO Raises Serious Concerns With Indian TB Drugmaker.

WHO Raises Serious Concerns With Indian TB Drugmaker:

World Health Organization (WHO) inspectors earlier this week sent a letter to discover a series of security problems to a manufacturer of anti-tuberculosis drugs, based in Mumbai.

Who said inspection at the facility Svizera Labs, part of Maneesh Pharmaceuticals, in June 2015 revealed a number of important differences and major WHO standards GMP and the final notification of the menu consists of Concern gaps still are a problem for society.

The list of deficiencies includes the possible manipulation of dissolution testing, lack of pollution controls, oxidized and contaminated packaging lines of drugs, broken seals and black mold in an area cleaning surfaces and inadequate supervision data .

The aforementioned deficiencies are related to prequalified products.
Svizera is one of four contract manufacturers to provide drugs for the Stop TB Partnership, an organization supported by the WHO, according to Reuters. Vinay Sapte Svizera CEO told the media that he disagreed strongly with the content of the report and the independent consultants who visit the plant since the WHO inspection keep up was discovered.

A quality manager Svizera Europe Outsourcing-Pharma.com also said the company disagrees with the decision of the WHO to publish the letter.

The Notice of concern is that more than a dozen manufacturers of medicines from India continue to struggle against data integrity issues.

The data is intended to ensure that products meet predetermined specifications for purity, potency, stability and sterility, among other important markers to determine they are safe and effective medicines. A lack of reliable data, the concern is that these products can not be trusted. FDA and presented several of these companies to import alert, which means that their products entry into the United States refused.