The cloud-based platform “teamplay” by Siemens Healthineers, together with its applications teamplay Dose, teamplay Usage, teamplay Protocols, teamplay Images, and teamplay Images Research, has been awarded the European Privacy Seal (EuroPriSe). The European Privacy Seal was first granted to teamplay in 2016, and must be regularly renewed. The privacy seal in its current version relates to the expansions made in recent years to the range of functions the teamplay applications offer, and now specifically checks whether the requirements of the EU General Data Protection Regulation (GDPR) have been satisfied.
From the start, teamplay was developed in accordance with the principle of “Data Protection by Design and Default” and the level of transparency this principle implies. The Privacy Seal confirms that users who utilize teamplay as instructed by Siemens Healthineers can work with the cloud platform and the above applications in full compliance with the GDPR.
With more than 4,000 healthcare institutions connected to teamplay, it is one of the world’s largest cloud-based networks for physicians, medical professionals, and decision-makers in the healthcare industry. Over 18,000 modalities from different vendors deliver data directly to the cloud platform. The teamplay applications for performance management help healthcare providers, for example, support in making rapid, sound decisions based on transparent performance data.
That means it is possible to evaluate the number of imaging examinations just as easily as the radiation dose used in scans, or the capacity utilization of devices, rooms, and resources in a given department, down to individual devices and patient examinations. Teamplay simplifies the reporting process and highlights where workflows need to be adjusted. In addition, users can connect via teamplay, sharing data to obtain comparisons and benchmarks and easily exchanging images and reports. www.siemens-healthineers.com

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