Steris Corp. settles FDA beef

April 20, 2010 By MedCity News

Steris Corp. (NYSE:STE) settled its beef with the Food & Drug Administration, addressing the “violating device” status of its System 1 liquid chemical sterilizer and setting up a transition plan that will enable U.S. customers — mostly hospitals and surgical centers — to trade in their System 1s for rebates.

The terms of the consent decree resolve a two-year dispute with the FDA, which said Steris had changed the System 1 so much since its 1988 launch that the regulator no longer considered it a device approved for sale. A December 2009 safety alert about System 1 from the FDA had cast the pall of financial uncertainty over the Mentor, Ohio-based firm.

The decree also prohibits Steris from selling liquid chemical sterilization or disinfection products that don’t have FDA clearance, formalizes a transition plan for Steris customers and describes other process and compliance issues, according to a press release. The decree is subject to approval by the U.S. District Court for Northern Ohio.

“We are pleased that our plans for financial assistance and other support we will provide System 1 customers during this transition are now final,” said Walt Rosebrough, the company’s president and CEO, in the release.

“We apologize to our customers for the uncertainty this situation created over the last several months. However, we believe the transition plan will allow healthcare providers the time, financial support and information necessary to make the best possible decisions for patients and caregivers,” Rosebrough said. “We also appreciate the FDA’s efforts to accommodate the needs of health care providers and the patients they serve during this transition.”

Two weeks ago, the FDA cleared the company’s next-generation liquid chemical sterilizing system — the Steris System 1E — after reviewing the company’s marketing application for more than a year. Steris hopes to deliver the first System 1Es by the end of the third quarter.

Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]
Goddard teams with Swab56 on COVID-19 test swabs
Mechanical engineering and industrial design company Goddard announced that it is working with the Swab56 Project to rapidly increase the production of Swab56’s test swabs, which are used in healthcare facilities to test for COVID-19. As news reports have documented, traditional nasopharyngeal swabs are in short supply as healthcare facilities around the world struggle to keep… […]
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases… […]
Sommetrics lands ISO 13485 certification
Sleep apnea treatment device startup Sommetrics announced yesterday that its quality management system has been certified to the ISO 13485:2016 standard. During the audit process required for certification, Sommetrics was also evaluated and found to be in compliance with the standards of the Medical Device Single Audit Program (MDSAP) for Canada. “This is an important… […]