When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.
 “Now it has flipped,” said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a ‘smart’ catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.
Colone is part of a chorus of industry voices warning that a switch to stricter European rules governing medical devices, due to come into force a year from now, will slow or even halt the release of products in Europe that could transform patients’ lives.
Defenders of the regulations say they will not significantly complicate the process and are vital to prevent problems like rupturing silicone breast implants and debris from all-metal hip implants damaging tissue and bones.
Many patient advocates say the new rules do not go far enough to reform a European system in which a top U.S. official suggested in 2011 patients may be "guinea pigs" here. The comment drew a sharp response from the European Union, which still firmly rejects that characterization.
That transatlantic spat, and the subsequent evolution of medical device certification around the world, are part of a wider global struggle by governments to attract businesses seeking light-touch regulation without scaring off their voters.
The new medical devices rules agreed by the European Union in 2017 will tighten control of devices before they come to market, improve transparency and strengthen surveillance by national authorities, a European Commission spokesperson said.
The new system changes less than some proposals – which envisaged regulation by a public body, along U.S. lines, replacing the existing practice of certification by profit-making private firms.
But players in medical technology – which ranges from surgical implants to scans – say it is too burdensome and is being built too slowly, risking not only hampering innovation but also harming patients by interrupting supplies.
“Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals,” seven European Associations said in a joint statement last week.
All 55,000 devices certified under the old directives have to be re-certified along with other products such as reusable scalpels, nasal saline sprays and dental imaging software.
The industry says there are not enough Notified Bodies – the private firms charged with certifying the safety of devices ranging from bandages to pacemakers, and that manufacturers may have to take products off the market or delay new launches.

Reuters https://tinyurl.com/yyqe7pp3

Almost a decade since sharps legislation was passed in the USA and Europe, compliance still has a way to go to reach mandatory legal requirements in hospitals and even more so in non-hospital locations such as the home. The latter is becoming increasingly important in the drive to increase self-administration and independence in management of chronic diseases. To understand future demand for safety syringes, Owen Mumford, a global industry leader in medical device design and manufacturing, commissioned third-party research into trends and drivers surrounding safety-device take up.

Economic pressures on healthcare efficiency are in fact encouraging greater patient self-administration/homecare. Pre-filled syringes are facilitating this move as they help patients manage treatment and dosage. Another important driver towards regular self-administration is fuelled by new biological therapies and competitive biosimilar markets that are mostly administered via subcutaneous injection. Finally, longer life expectancy, combined with a rise in in obesity, diabetes, cancers and heart disease are also driving the push towards self-administration.

The survey estimates that:
• The global safety syringe market is expe-
riencing a growth rate of 8.96% per year;
• The global pre-filled syringe market is expected to rise to $1.137 billion by 2023;
• Safety-engineered pre-filled syringes dominate the total pre-filled market, with approximately 76% share of the total pre-filled demand in 2023;
• This dominance could suggest that pharmaceutical and biotechnology firms consider safety features to be highly attractive to users and are thus favouring their production as a key element for their combination products.

George I’ons at Owen Mumford comments: “This latest analysis provides a clear view of the factors that are at play in the safety device market, roughly ten years from the introduction of legislation making measures to prevent needle-stick injury mandatory. Although compliance has improved massively in hospital environments there is still some way to go. In addition to this the increasing push to drive patients to manage their conditions at home means that homecare settings are also increasingly coming under scrutiny.

“As a result, market projections are buoyant with safety device demand expected to grow across the world. Pre-filled syringes designed to help patients manage prescription and dosage accuracy are expected to grow with particular strength. Safety-engineered devices comfortably dominate the pre-filled market, indicating that pharmaceutical firms regard safety features as a key differentiator.”
A full copy of the whitepaper – “Safety First!” is available on: https://www.ompharmaservices.com/wp-content/uploads/2019/09/OMPS_WhitePaper_Safety_First.pdf

Ramifications way beyond financial loss and breach of privacy? Equip Global proudly presents Cyber Security for Healthcare – a live online event from 6 – 9 October 2020. This masterclass will emphasize developing effective policies and strategies to counter cyber threats of various kinds, developing an effective security architecture and infrastructure, and improving cyber and cyber physical security risk management
Learning outcome

• Understand the different types of cyber security breaches that can occur including browser-based attacks, phishing attacks, malware, ransomware attacks, data breaches, DDOs attacks amongst others and how you can combat them
• Improve Security Architecture Design & Implementation
• Gain insights on cyber security for connected medical devices
• Learn how to ensure your security infrastructure is strengthened

Join us for our 4-day case-study-driven and practical cyber security for healthcare masterclass. Learn from the expert trainer how you can develop a fool proof and effective cyber security strategy that protects your organization, operations, your patients’ privacy and public security whilst ensuring your healthcare services and patients’ health are not compromised.
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Philips and B. Braun,  a player in regional anesthesia and pain management, recently announced the launch of Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking in regional anesthesia. Available on the latest version of the B. Braun and Philips Xperius ultrasound system, Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body. The introduction is part of a multi-year strategic alliance between Philips and B. Braun to innovate in ultrasound-guided regional anesthesia, a rapidly growing alternative to general anesthesia.
Accurate needle placement is critical to the success of regional anesthesia procedures, such as peripheral nerve blocks, both in terms of effective pain relief and the avoidance of unintended nerve and vessel punctures or collateral damage to surrounding tissue. While real-time ultrasound imaging has proved to be a valuable tool for needle guidance, failure to optimally visualize the needle tip remains a challenge for both novice and experienced anesthetists. Currently, 10-20% of all peripheral nerve blocks are ineffective on the first attempt. By simplifying alignment between the needle and ultrasound probe, Onvision reduces the effort needed to interpret the ultrasound image. This allows the anesthesiologist to more confidently guide the tip of the needle to its target.
“Regional anesthesia is a rapidly growing alternative to general anesthesia and has the potential to improve patient outcomes as well as increase workflow efficiency in the hospital,” said Bert van Meurs, Chief Business Leader, Image Guided Therapy at Royal Philips. “By combining B. Braun’s expertise in needle design with Philips’ capabilities in real-time image guidance, we’ve created a solution to one of the biggest challenges in regional anesthesia – accurate positioning of the needle tip in the body. Our alliance with B. Braun is a strong example of our commitment to partner with industry leaders to grow our footprint in the therapy market.”
“Our customers want intuitive solutions that allow them to focus on the patient rather than the technology, so they can achieve the best outcomes. As demand for regional anesthesia grows, improved efficiency can also help reduce the pressure of an increasing workload,” said Dr. Meinrad Lugan, Member of the Board for the Hospital Care Division at B. Braun. “Onvision is a perfect example of what can be achieved through shared expertise to meet the evolving needs of our customers, bringing regional anesthesia to more patients in more hospitals worldwide.”
Together, B. Braun’s Stimuplex Onvision needles and Philips’ Onvision needle tip tracking technology indicate the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of better than 3mm. A sensitive micro-sensor placed on the needle, combined with advanced signal processing and visualization techniques on the Xperius system, indicate the real-time location of the needle tip in relation to the 2D ultrasound viewing plane. The solution provides greater flexibility in needle trajectory and can reduce procedure times. The increased confidence and predictability offered by Xperius and Onvision will empower more anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia.
Regional anesthesia or analgesia involves the injection of an anesthetic in the proximity of a nerve, targeting areas of a patient’s body that are subject to surgical intervention. Regional anesthesia can have significant advantages over general anesthesia for both patients and hospitals. Patients undergoing regional anesthesia typically benefit from reduced opioid consumption and fewer side-effects, such as nausea. Moreover, regional anesthesia may lead to faster post-surgical recovery, allowing patients to ambulate or leave the hospital sooner, which benefits both patients and hospitals.
Together, Xperius and Onvision form an integrated point-of-care solution for supporting current and future needs in regional anesthesia. They are co-branded and sold via B. Braun’s global sales network, with Philips providing installation and service. Xperius is part of Philips’ portfolio of point-of-care ultrasound systems, which offers clinicians the ability to diagnose and care for their patients in any work environment. www.philips.com