The Cost of Quality Failures - An FDA Response

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PharmTech Talk » The Cost of Quality Failures:

"One response from FDA and industry is to better quantify the costs of quality failures: lost revenue, lost jobs, damaged reputations and, in some cases, loss of the company, Woodcock said. FDA also is looking closer at the root causes of failures, which may reflect management inattention, deliberate company decisions to defer investment in modern production facilities, or corporate disregard for the quality department. Companies take calculated risks with such approaches, she said, and should consider whether the savings are worth the cost to the firm. “We need the business side to become convinced that a commitment to quality can avoid costly failures.”"

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• FDA Warning Letters in 2011 Mostly Focused on Batch Failures (drughealth.blogspot.com)

How Human Factors Lead to Medical Device Adverse Events

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A nicely written article on "Human Factors."

How Human Factors Lead to Medical Device Adverse Events « QD Syringe Systems™:

"The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device."

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You might also be interested in:
The Human Factors Program at FDA

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FDA Updates MAPP On Human Research

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Updated October 27, 2022

The original links broke.

You can still learn more at:

CDER Manual of Policies & Procedures | MAPP - FDA.gov

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This FDA Manual of Policies and Procedures (MAPP) establishes the policies and procedures that employees in the Center for Drug Evaluation and Research (CDER) must follow when submitting human subject research for review to FDA’s Institutional Review Board (IRB), the Research Involving Human Subjects Committee (RIHSC), in the Office of Science and Health Coordination (OSHC) within the Office of the Commissioner. These procedures must be followed, and written RIHSC approval or exemption obtained, before initiating any research involving human subjects. This MAPP also establishes policies and procedures pertaining to responsibilities for study conduct and oversight.

This MAPP is a revision of an earlier MAPP originally numbered 4112.6. The MAPP’s change in number reflects the establishment of the Office of Translational Sciences (OTS) within CDER.

Additional FDA Resources:

• 45 CFR part 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Office of the Secretary, HHS, April 18, 1979 (the Belmont Report) http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
• "Federal-wide Assurance of Protection for Human Subjects," OHRP, HHS http://www.hhs.gov/ohrp/assurances/assurances_index.html
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (http://privacyruleandresearch.nih.gov/pr_02.asp)
• Information Sheet Guidances - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

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Integrating Human Factors Engineering Into Medical Devices (video)

Checkout this free video, Integrating Human Factors Engineering Into Medical Devices. Human factors is the science and the methods used to make devices easier and safer to use. The FDA has a patient safety mission of distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. The FDA works with manufacturers to help ensure the application of Human Factors engineering to the design of new products. It also helps device users through identification and investigation of use-related errors. This is a nice primer and video lesson on all things about human factors.

   

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Wow - FDA OKs Stem Cell Trial - This is a red letter day!

I'm thrilled to see some momentum gaining in this potentially rich area of clinical research. The U.S. Food and Drug Administration has granted clearance for Geron Corp. to begin trials for the world's first study of a human embryonic stem cell-based therapy for people. Geron said it will begin a Phase I multicenter trial designed to establish the safety of its treatment, currently referred to as "GRNOPC1," in patients with complete Grade A subacute thoracic spinal cord injuries. Read more details in this Medical News Today article, US Approves First Trial Of Embryonic Stem Cells.

I'm of the opinion that stem cell research has been stifled for way too long, and it's good to see the appearance of these studies. What's your opinion?

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FDA QSR Human Factors Reqs - Intro

Updated April 17, 2019

The links in the original post broke.

You might also be interested in:
Human Factors and Medical Devices on FDA.gov

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OK, now I get it. I understand this topic quite a bit better after reading Human Factors MD's "FDA Human Factors Requirements." This is applicable for medical devices that need to follow the FDA's regulations on Do It By Design: An Introduction to Human Factors in Medical Devices and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Even better, the folks at Human Factor's MD, cite section 820.30 of the QSR, in paragraphs c, f, and g, and walk us through the meaning and application of those paragraphs. Did you find it helpful too? These three paragraphs cover . . .

• design input
• design verification
• design validation

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