Medical Device Daily National Editor

Most of the major diseases have received a special day – or month.

Until now, there has been none for one of the large but unacknowledged disease threats – at least not seen or understood much by the public.

But that will change with today's announcement by the MRSA Survivors Network (Chicago). The organization has set Oct. 2 of this year as the first "World MRSA Day" to be commemorated yearly on that date, as well as October as yearly "MRSA Awareness Month."

The organization called MRSA – methicillin resistant Staphylococcus aureus – a worldwide pandemic-type of epidemic, noting that it was first discovered on Oct. 2, 1960, by Patricia Jevons, a UK microbiologist.

The organization wants to spread public awareness of the MRSA threat – and the many lives lost as a result – while underlining the fact that this infection is preventable.

Another consequence of the effort is likely to highlight the larger threat of hospital-acquired infections (HAIs), and drive new opportunities by both drug and device developers.

Pharmaceuticals are always in the spotlight concerning their unhappy downsides – the reports of adverse side effects, even stand-up comic jokes about drug side effects (or the warning on a sleep aid box that you should not take this medication and drive because it might make you drowsy.) And increasing these days is the data concerning HAIs and the new drive by the Centers for Medicare & Medicaid Services to refuse payment for treatment of those infections considered preventable?

But less often reported is the cause of these infections – or the most frequently associated culprit: the use of devices.

The U.S Department of Health and Human Services (HHS) recently released an action plan to prevent these types of infections, in the process providing a dire portrait of their presence and impact on the healthcare system. In that report, the HHS says that HAIs occur "in all settings of care" and that they are "associated with a variety of causes, including (but not limited to) the use of medical devices, such as catheters and ventilators, complications following a surgical procedure, transmission between patients and healthcare workers, or the result of antibiotic over-use."

Except for the over-use of antibiotics, all of these other circumstances relate to device use.

The HHS action plan says that HAIs are among the top 10 leading causes of death in the U.S., and they accounted for "an estimated 1.7 million infections and 99,000 associated deaths in 2002. In hospitals, they are a significant cause of morbidity and mortality." Additionally, the occurrence of MRSA infections has more than tripled since 2000 and have increased nearly ten-fold since 1995.

And three-quarters of MRSA infections were associated with device use: infections at surgery sites; in the bloodstream associated with central line use; ventilator-associated pneumonia; and catheter-associated urinary tract infections.

Urinary tract infections comprise the highest percentage of HAIs (34%), followed by surgical site infections (17%), bloodstream infections (14%), and pneumonia (13%).

Not understating the case, the HHS characterizes the cost of treating HAIs as "staggering," nearly $20 billion a year, and the overall charges to Medicare for MRSA infections (not all of the HAI-preventable type) at $2.5 billion in 2005.

Clearly, if CMS follows through on its plan to withhold payment for preventable HAIs, the costs to hospitals will be in the many millions of dollars, and all of these circumstances suggest huge opportunities for new device systems to avoid these infections or effectively battle them - and of course for continued use of more effective pharmaceuticals.

The effort also provides large opportunities for researchers, since the HHS action plan calls for the discovery of new approaches and strategies for reducing these infections. In particular, it points to new efforts in healthcare information technology (see sidebar, above).

The report says that though there are numerous systems and databases used to collect collect HAI-related data across HHS, but the Government Accountability Office has told the HHS that it needs greater consistency and compatibility of the data to enhance the information provided, including national estimates of the major types of HAIs.

This offers new opportunities for HIT providers and database developers.

Especially important, the HHS said, is the "need to avoid gaps in data for age groups and other population groups. The feasibility of use of various systems must also be carefully evaluated and used to inform research.

One of the first projects for the Interagency Working Group on HAIs, developed by HHS, will be the creation of an inventory of HAI data and database resources to guide preliminary analysis and decision-making for near-term data integration projects to guide the integration of multiple databases.

HHS said that its first initiatives, defined as a "Tier One" effort, will concentrate on six areas within the acute care hospital setting. Four account for about three-quarters of HAIs:

• Surgical site infections.

• Central line-associated bloodstream infections.

• Ventilator-associated pneumonia.

• Catheter-associated urinary tract infections.

Two other organisms – Clostridium difficile and MRSA – are among these priorities because impacting resource use and inpatient treatment.

Included in the HHS initiative is the development of an action plan offering five-year targets for prevention and the identification of "metrics and systems" to assess progress towards these targets.