Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications

 

 

Using any medical device brings with it an element of risk at the clinical level, where risk represents the probability of occurrence of harm and the consequences of that harm (severity). While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. 

 

Such risks are foremost about injury to the patient and to the user and other persons, with the need to consider risk across the medical device life cycle. Other associated risks may be to the environment or with any data collected. The various risks are set out in ISO 14971.

It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk to patients and users posed by these devices. This article assesses the common risk areas that require assessment.

Tim Sandle has published a new article, see:  https://www.outsourcedpharma.com/doc/risk-factors-to-consider-when-selecting-medical-devices-for-pharmaceutical-applications-0001 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

The IoT Improves Medical Connectivity During the Pandemic

                                                                Image by Frp17580 - Public Domain, https://commons.wikimedia.org/w/index.php?curid=5244864

Emily Newton is the Editor-in-Chief of Revolutionized Magazine, an online publication discussing the latest news in science and technology. She has over four years experience covering stories in the science, technology and industrial sectors.

 

To say it’s been an unusual year for the medical industry would be an understatement. The COVID-19 pandemic has presented health care organizations with their greatest challenge in recent memory, and yet, this has spurred some remarkable innovations. No trend exemplifies this phenomenon as much as medical device connectivity.

 

The internet of things (IoT) is not necessarily a new technological trend, but its adoption in medicine skyrocketed amid the pandemic. Experts now expect the global medical IoT market to be worth $446.52 billion by 2028, compared to just $71.84 billion in 2020. Already, medical connectivity has reached new heights across the healthcare industry.

 

Here’s how the IoT has improved medical connectivity amid the COVID-19 pandemic.

 

Telemedicine

 

Perhaps the most recognizable application of the medical IoT to accelerate amid COVID is telemedicine. While just 43% of health centers were capable of providing telehealth services in 2019, 95% reported using them during the pandemic. Remote patient care is now more accessible than ever, painting a bright picture of the future.

 

If a similar health crisis should arise in the future, more hospitals will have the resources necessary to provide telehealth care. As a result, they can prevent overcrowding, which plagued many hospitals early in the pandemic. This increased connectivity can also save money for both medical organizations and their patients.

 

The healthcare industry generates $165 billion in waste every year. Eliminating unnecessary hospital visits through these now more accessible telemedicine services will reduce this waste. Patients will also save money by avoiding high hospital fees from unneeded visits.

 

Vaccine Supply Chain Visibility

 

Another way in which medical device connectivity expanded in the pandemic was through supply chain tracking. As vaccines began to roll out to the public, many health care systems used the IoT to track them through the supply chain. These connected logistics networks helped ensure timely, safe vaccine deliveries.

 

Historically, as many as 39% of vaccine doses go to waste in some areas due to supply chain issues. Given the severity of COVID-19 and the extreme storage needs of its vaccines, minimizing that figure was critical. IoT location and temperature sensors proved to be the answer.

 

These devices provided real-time visibility into vaccine shipments’ status, enabling faster responses to developing situations. If, for example, a refrigeration system broke, supply chain managers and drivers would know immediately. They could then deliver the shipment to a closer facility, ensuring the vaccines don’t go to waste.

 

Equipment Tracking

 

As medical IoT adoption grew, more hospitals used it to keep track of valuable equipment. Hospitals became crowded at the height of the pandemic, often making it a challenge to stay organized and efficient. IoT tracking technologies emerged as an ideal solution, as they can show staff exactly where a piece of equipment is in real-time.

 

Ventilators, for example, saw skyrocketing demand amid COVID-19, but hospitals often had a limited supply. With IoT-based inventory systems, nurses and doctors could locate any available ventilators immediately. They could then give patients the treatment they need sooner, potentially saving lives.

 

This increased connectivity can continue to provide value outside of the pandemic. Considering how between 8% and 17% of health care workers have latex allergies, hospitals could use IoT inventory tracking to keep track of non-latex PPE. These workers could then find the equipment they need faster, maintaining efficiency while avoiding potential health issues.

 

Outbreak Tracing

 

The ever-expanding medical IoT saw use outside of hospitals and their supply chains, too. IoT connectivity in workplaces, public areas, and other environments provided medical researchers with data to trace COVID-19 outbreaks. This visibility provided more relevant and informative insights into how the virus spread than judging it by hospital visits.

 

South Korea was one of the first countries to use IoT networks, including people’s phones, to enable in-depth, accurate contact tracing. When the solution led to a significant improvement in COVID cases and deaths, many other nations followed suit. Now that this level of connectivity is more widespread, medical authorities could use it to fight future disease outbreaks.

 

IoT devices are ideal for outbreak tracing since they can provide a wealth of information without disrupting everyday life. The remote communication features in the devices people use every day can transmit the data medical researchers need. As this connectivity expands, the world’s health care systems can keep a closer eye on emerging medical threats.

 

The Medical IoT Is Changing the Face of Modern Medicine

 

Medical device connectivity may predate the pandemic, but it reached new heights amid COVID-19. The extremes many health care organizations faced drove them to accelerate IoT adoption to the point where these technologies are now standard. The medical IoT is now inseparable from the healthcare industry.

 

These advancements played a crucial role in fighting the pandemic, and now that they’re widespread, they can help prevent future crises, too. As IoT adoption in health care keeps expanding, medical organizations become better equipped to tackle unforeseen challenges.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

New standard for ventilators

News from ISO: When the COVID-19 pandemic took hold, so too did the demand for ventilators. With patient safety at its heart, ISO’s committee for respiratory devices rapidly got to work on a new standard to support the manufacture of new, high-quality medical equipment that could help.

 

Now, as publication of this standard draws near, we talk to two experts about the role of this and other related standards in the current crisis and what difference they could make.

 

 

See: ISO/DIS 80601-2-90 Medical electrical equipment — Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment.

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Preparing for ISO 13485:2016

The new ISO 13485 revision is here and, for medical device manufacturers, this is significant news.

ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including:

• Overview of the update to the new standard
• Breakdown of what has changed in each section
• Guidelines on how to prepare for the new standard
• Deadline for recertification
• Requirements for recertification
• Considerations for timing the update and recertfication

With this, Emergo has issued a white paper, which introduces the standard. It can be accessed here.

Posted by Dr. Tim Sandle

ISO 13485:2016 – new medical devices standard

ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.

With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and even in vitro diagnostic reagents.

Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

For more details, see: ISO.



 Posted by Dr. Tim Sandle

Cleaning duodenoscopes

In an effort to cut down on the risk of superbug infections tied to a medical device used in hospitals, Olympus America has issued new protocols for cleaning duodenoscopes, which have been implicated in several recent outbreaks, The Washington Post has reported.

The issue is that Carbapenem-resistant Enterobacteriaceae (CRE) have infected at least seven patients—two of whom died—at California’s Ronald Reagan UCLA Medical Center in recent months. Another 179 patients were possibly exposed, and health officials suspect contaminated endoscopes are to blame.

This, the manufacturer of the type of medical scope linked to the spread of deadly bacterial infections issued detailed new cleaning instructions for the devices, urging hospitals to implement the procedures “as soon as possible.”

Posted by Tim Sandle