Monitoring the heart’s mitochondria to predict cardiac arrest?

IMAGE
Credit: Dr. John Kheir, Boston Children’s Hospital & Shutterstock

A new device can assess in real time whether the body’s tissues are receiving enough oxygen and, placed on the heart, can predict cardiac arrest in critically ill heart patients, report researchers at Boston Children’s Hospital and scientists from Cambridge device maker Pendar Technologies. Their study, conducted in animal models, is the cover article in today’s issue of Science Translational Medicine.

 

“With current technologies, we cannot predict when a patient’s heart will stop,” says John Kheir, MD of Boston Children’s Heart Center, who co-led the study. “We can examine heart function on the echocardiogram and measure blood pressure, but until the last second, the heart can compensate quite well for low oxygen conditions. Once cardiac arrest occurs, its consequences can be life-long, even when patients recover.”

The device uses a technology called resonance Raman spectroscopy to measure whether enough oxygen is reaching the mitochondria, the organelles that provide cells with energy. In critically ill patients with compromised circulation or breathing, oxygen delivery is often impaired, making it hard for mitochondria to do their job. This is especially a problem for the heart, which has constant high energy needs.

The current standard for measuring tissue oxygenation, known as mixed venous saturation (SvO2), requires repeated blood draws, adding extra risk in critically ill patients. More importantly, SvO2 cannot tell whether oxygen supply is sufficient to meet the dynamic demands of heart muscle.

“We wanted to create an organ-specific, continuous, reliable readout of how adequately mitochondria are being fed oxygen,” says Kheir. “This is the first demonstration of a device that can monitor mitochondria in living tissues to predict impending organ failure.”

Using light to monitor mitochondria

This technology is the product of a collaboration between the Translational Research Lab in Boston Children’s Heart Center, co-led by Kheir and Brian Polizzotti, PhD, and Pendar Technologies (Cambridge, Mass.). “At the bedside, we saw patients who had a limitation to coronary blood flow, and wanted a device that could provide an early warning sign,” Kheir says.

The team created a metric they call 3RMR that uses light readings generated by resonance Raman spectroscopy to quantify oxygenation and mitochondrial function in real time.

 

Read More: http://snip.ly/bt6o8#https://scienmag.com/monitoring-the-hearts-mitochondria-to-predict-cardiac-arrest-2/

Gauteng Health head office: Sheriff attaches furniture due to non-payment of negligence claim

Gauteng Health head office

Staff at the Gauteng Department of Health provincial head office are without equipment to do their work after the Sheriff of the Court attached two truckloads of furniture on Thursday following a failure by the department to pay court-ordered damages related to a hospital negligence case. By ORATENG LEPODISE.

If you walk into several offices at the provincial health department’s head office at the Bank of Lisbon building in downtown Johannesburg, you are likely to find administrative staff sitting on the floor.

On Thursday the sheriff arrived at the offices and removed two truckloads of furniture from four floors in the building in a bid to force the department to settle payment of a R6.2-million negligence claim awarded against it.

The negligence claim relates to a protracted legal battle between the department and the parents of a child who suffered brain damage during birth at the Pholosong Hospital in December 2009. The seven-year legal battle drew to a close on March 8 with a cost order being awarded against the department.

But it is yet to settle.

“It is a terrible injustice that this case has dragged on for more than seven years, with further suffering for the child and her family, and now the department delays further,” said Jack Bloom, the DA’s Gauteng Shadow MEC for Health.

On Thursday, according to the writ of attachment, the sheriff removed:

• 400 desks;

• 600 chairs
;

• 400 computers;

• 200 filing cabinets
;

• 50 printers
;

• 10 fridges;

• 10 microwaves; and

• three lounge suites

Asked by Daily Maverick to comment on the attachment of its furniture, its impact on the health department staff to do their work and on the department’s failure to pay the negligence claim, department spokesman Prince Hamnca said: “All I am willing to say is that we are concerned that the furniture has been taken from the offices, but that was a court order from the Sheriff.”

“I am appalled that the department has yet again disregarded a court-ordered payment,” said Bloom, while accusing the Gauteng Health MEC, Gwen Ramokgopa, of downplaying the effect of the removal of truckloads of furniture.

An employee at the department and branch secretary of the National Health, Education and Allied Workers Union, Charles Phasa, said the working conditions were “very bad” as everything with any value was taken.

“This is not something new. Every year the sheriff comes in and the department waits until the 11th hour to negotiate some sort of way to cover their payments, but this time around it is just too much,” Phasa said.

According to Phasa the department has urged its workers to be patient while it attempted to address the issue.

The health department finds itself in a pool of debt which includes outstanding payments to suppliers and medical negligence cases and in May this year faced a R10.9-billion funding gap as budgeted funds were all taken up by salaries, accumulated debt and payments for negligence.

Medical negligence claims have increased significantly in recent years. From just over R8-million paid out by the Gauteng Department of Health in 2010/11, almost R154-million was paid out by the same department in 2013/14. Contingent liabilities for medical malpractice (money that the department would have to pay should all medical negligence claimants be successful in their claims) in 2016 in Gauteng sat at over R13-billion.

Bloom said the Gauteng Provincial Government was being destabilised by the endless financial woes of the Health Department, which faces a potential medico-legal liability of more than R13-billion and owes large sums to suppliers as well.

“Delays in payment also add to the costs as a 10.5% penalty interest is charged – in this case, this amounts to more than R300,000,” Bloom said. DM

Photo: Gauteng premier David Makhura speaks at a Gauteng township economy revitalisation summit in Soweto, Tuesday, 7 October 2014. Picture: Werner Beukes/SAPA

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Quality by Design using Design of Experiments 2017

The Q8, which is the ICH guidance document on pharmaceutical development, requires a drug product to meet its intended product performance as well as the needs of patients. A drug product is encouraged to adapt a systematic approach for pharmaceutical development in accordance with the steps defined by Quality by Design (QbD) principles, even though the strategy may vary from company to company or from product to product.

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System. Some of these are:

o  Process design

o  Qualification

o  Continued process verification

o  Risk management

o  Validation.

Laxity in implementation is no longer an option

Despite the issuance of guidance on implementation of these requirements; many companies have not yet implemented QbD into their Quality Systems. This will change soon, though. Regulatory agencies have been taking a serious view of non-implementation of these requirements.

The ways in which reviewers will begin to enforce the requirements from these guidance documents have been spelt out in the manual the Chemistry, Manufacturing, and Controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) released on policies and procedures (MAPP).

The zeal with which the regulatory agencies will enforce compliance with the requirements of the QbD requirements has been emphasized also by the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, who detailed the concept and reiterated the importance of using a QbD approach to pharmaceutical development in a paper he co-authored in The American Association of Pharmaceutical Scientists in May 2014.

Understand the ways of implementing QbD

In the light of the fact that a drug product can no longer afford to relax in its adherence to steps defined by Quality by Design (QbD) principles to adapting a systematic approach for pharmaceutical development; a meaningful and educative two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will show the ways of doing this.

At this seminar, Heath Rushing, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director. To gain complete insight into how to implement QbD, please register for this seminar by visiting Quality by Design using Design of Experiments. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Complete learning on QbD using DoE

The core purpose of this session is to demonstrate how to integrate those QbD principles into a pharmaceutical Quality System. Towards this end, Heath will focus on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DoE).

He will also take up the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability for detailed description. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.

A systematic understanding of the process

A QbD approach for pharmaceutical development studies should include a systematic understanding of the process. It should then use this understanding to establish a control strategy as part of a comprehensive quality risk management program. This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical Quality Attributes (CQAs). Heath will discuss these in depth.

Despite the thrust of this seminar on the use of DoE for QbD; it will integrate multiple aspects of QbD. An understanding of the relevant applied statistics will be offered, which will help participants understand how statistics can be used to help in two foundational requirements of QbD: A) Setting specifications, and B) Analyzing measurement systems.

Important tools for facilitating understanding

This seminar will also offer tools to participants, which will help them to derive value out of their designed experiments. Generating and analyzing both screening and response surface designs for QbD studies, the ways of using this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability are among the other constituents of this course. This course uses the point-and-click interface of JMP software for analyses.

Heath will cover the following areas at this seminar:

o  Implement QbD principles from discovery through product discontinuation

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Utilize risk management tools to identify and prioritize potential Critical Process Parameters

o  Identify Critical Process Parameters and develop a functional relationship between those process parameters and your Critical-to-Quality Attributes (CQAs)

o  Establish your design space

o  Develop a control plan as part of a risk management strategy

o  Ensure your process is in (statistical) control and capable.