Category: Vascular Access

FDA Scrutinizes Medical Device Companies

Posted on by Greg Dennis

Anybody involved in the medical device industry can’t help but notice how much bigger a presence the FDA is these days.

Within the past month, the agency has taken two notable actions with regard to vascular access and infection control — areas of particular concern to clinicians and companies, including several of our coalition partners and client companies.

Most recently, the FDA has issued a recall of certain Huber needles used for vascular access. The needles, the agency said, could produce cores — slivers of silicone — when they penetrate a vascular access port. That could lead to infection and other complications. More info at http://tinyurl.com/2v4k9kw.

Even more significantly, earlier this month the agency notified virtually every maker of needleless IV connectors that they would have to do major post-market studies to determine if their positive-pressure needleless IV connectors were associated with an increased risk of potentially deadly catheter related bloodstream infections (CRBSI).

Interestingly, it appears that the only maker of needleless IV connectors NOT affected by the recall was RyMed Technologies, which makes only neutral-pressure (AKA zero-displacement) connectors. (Full disclosure: RyMed is one of our clients.)

More about that FDA action on connectors at http://tinyurl.com/3az47ko.

And of course, beyond these actions, every regulatory person in the medical device industry has a story to tell about increased FDA scrutiny of device applications for marketing clearance.

Medical Errors and Reducing Bloodstream Infections

Posted on by Greg Dennis

If anyone doubted that medical errors carry a hefty price tag — beyond the obvious suffering of patients and their families – that doubt has been removed by a new study.

The Wall Street Journal Health Blog notes that medical errors and associated problems cost the US economy $19.5 billion in 2008, according to a study released today. The study, commissioned by the Society of Actuaries and carried out by the actuarial and consulting firm Milliman, is based on insurance claims data. The report estimates the errors caused more than 2,500 avoidable deaths and over 10 million lost days of work.

The number of avoidable deaths seems awfully low, considering that catheter-related bloodstream infections alone account for an estimated 30,000 deaths among U.S. patients each year. Presumably methodology differences account for the underestimate of CRBSI. Medical errors covered by the study included bed sores, post-op infections and implant or device complications.

Increasingly in our PR practice, we see the need for technology to address medical errors. Sometimes these errors are simple and avoidable – such as the failure to properly clean needleless IV connectors, which can be overcome by the use of Excelsior Medical’s SwabCap device. SwabCap replaces alcohol swabs for cleaning connectors (also known as luer access devices) — making it much easier for nurses to comply with cleaning protocols demanded by the Joint Commission. The device adds the extra safety measure of protecting IV connectors for up to 96 hours, in the pathogen-laden atmosphere of hospital rooms.

The WAND Continues to Draw a Crowd

Posted on by Greg Dennis

Among the most crowded booths at the recent annual meeting of the Association for Vascular Access was that of Access Scientific, makers of The WAND, which enables the Accelerated Seldinger Technique. This faster and safer means of placing central line catheters is expected to be available late this year, from Access Scientific.

Nurses often lined up two rows deep to see The WAND demonstrated by Dr. Steve Bierman, the Access CEO, and by VP Bill Bold. The WAND is designed to eliminate many of the risks associated with the widely used Modified Seldinger Technique. Risks of MST include accidental needlesticks, bleeding, contamination, embolism, and loss of cannulation.

Also at AVA, Access Scientific and Teleflex teamed to provide the first Nurse Certificate Program in the Accelerated Seldinger Technique.

Continue reading “The WAND Continues to Draw a Crowd” →

Joint Commission Will Require Catheter Valve Disinfection

Posted on by Greg Dennis

The Joint Commission will require hospitals to have a standardized protocol to disinfect catheter luer access valves, starting January 2010. In the face of that new dictum, what’s a hospital to do?

A panel pondering that question – and featuring three national vascular access experts — drew more than 100 nurses at the recent annual meeting of the Association for Vascular Access. Panelists were:

• Lynn Hadaway, M.Ed., RNC, CRNI, infusion therapy expert
• Gregory Schears, MD, Mayo Clinic
• Kelly Fugate, ND, RN, Joint Commission

The panel’s focus: Preventing Intraluminal Contamination from CRBSI’s: Complying with New Guidelines from the Joint Commission & SHEA Compendium.” The event was sponsored by Excelsior Medical, makers of the SwabCap disinfection cap for luer access valves, and moderated by Greg Dennis, of Dowling & Dennis Public Relations.

Dr. Schears led off by outlining the seriousness of catheter-related bloodstream infections, which are all too common despite years of effort aimed at eradicating these potential killers. He said it was a “logical extension” of infection control efforts to cover and disinfect valves with a cap.

Lynn Hadaway outlined a variety of studies on the issue, while Kelly Fugate explained why the Joint Commission has new National Patient Safety Goals that include the disinfection protocol requirement,..

For more on SwabCap, go to http://www.Excelsiormedical.com. Excelsior Medical is a client of Dowling & Dennis Public Relations.

Excelsior, Novian Added as New Clients

Posted on by Greg Dennis

We’re happy to report that even in the economic downturn, we’ve added two new clients:

* Excelsior Medical is a leading maker of prefilled catheter flush syringes. The company is also launching an exciting new technology called SwabCap™. This product promises to pioneer more effective prevention of potentially deadly catheter-related bloodstream infections.

SwabCap provides passive, verifiable disinfection of the top and threads of luer access valves. These valves are a critical part of providing IV medication and nutrition. Both the Joint Commission and SHEA/IDSA Compendium have new guidelines calling for hospitals to have a specific disinfection protocol– meaning Excelsior expects strong demand for SwabCap as part of the company’s focus on preventing intra-luminal contamination of catheters. http://www.ExcelsiorMedical.com

*Novian Health makes the Novilase™ laser ablation device to treat fibroadenomas of the breast. These non-cancerous lumps are a troubling breast health problem for many women. Novilase provides a minimally invasive alternative to surgical lumpectomy, with no scarring and less infection risk. Novilase is FDA-cleared for treating fibroadenomas. http://novianhealth.com

WAND Weaves Magic at INS

Posted on by Greg Dennis

With more than 400 million catheters placed in U.S. hospitals each year, vascular access and infusion nursing are increasingly important in healthcare. Nowhere is that more obvious than at the Infusion Nurses Society annual meeting, which Greg recently attended.

Hot news from INS? One star of the show was The WAND, the all-in-one safety introducer for vascular access, from Access Scientific. While the first iteration of The WAND will be used by interventional radiologists and cardiologists, the big buzz at INS was about the coming PICC WAND and Power WAND.

These new devices will bring the safe, faster Accelerated Seldinger Technique to placement of peripherally inserted central catheters (PICCs) and extended-dwell peripheral IVs. Virtually every nurse who saw the devices demonstrated at INS came away saying she wanted to be sure her facility got The WAND.

Another star of the show was the fast-growing Excelsior Medical. Excelsior is already the biggest maker of  prefilled catheter flush syringes – a vital component in reducing deadly bloodstream infections. The company has just launched the SwabCap, an innovative luer access valve disinfection cap, which could become part of the new standard of care in catheter safety – especially when Excelsior combines the SwabCap with its flush syringes in one nifty device.

Also making an impression at INS for their expanding product lines were Medcomp and AngioDynamics, and PICC Excellence and Nancy Moureau for their expertise and leading educational programs.