CDC Publishes Latest Emergency Department Summar for 2005

ED-sign

FierceHealthIT notes a new CDC study on ED overcrowding – it’s getting worse.

Emergency department visits hit a new high in 2005, with more than 115 million visits, says new research from the CDC. That’s a jump of five million visits over the previous year, and a substantial 20 percent increase over 10 years.

Over the same time period, the number of hospital EDs decreased more than 9 percent from 4,176 to 3,795, the CDC says. More than half of these patients (62.8 percent) were referred to a physician or clinic
for follow-up after their visit, suggesting their needs weren’t critical.

The 32 page report is fuel for the American College of Emergency Physicians lobbying efforts to get congress to, “create a commission to study the ED overcrowding problem. Under the terms of the ACEP-backed bill, hospitals would have to report to HHS on how many patients are boarded in the ED, and how long they’re boarded.” [Patient "boarding" is the practice of placing patients in hallways, usually in the ED, where they wait for an inpatient room to become available. Patients commonly wait for hours, and sometimes more than a day, on a stretcher parked in a hallway.]

Ambulance diversion data is tracked by hospitals, regional and state hospital associations, and sometimes the state. This data is not available to the public or most state health agencies. Given how bad ED diversion is, I’m not surprised hospitals want to keep this data private – especially the worst offenders. Data on patient boarding is tracked less often by hospitals and to my knowledge, is not tracked across hospitals by associations.

Public reporting of both diversions and boarding would provide an important customer service metric and patient safety indicator and should be available to prospective patients. It is too bad that such a requirement must be forced on the industry by government.

You can download your own copy of the CDC report here (pdf).

Share
Read More

More Hospitals Lift Cell Phone Bans

cell-phones

According to a survey by CHIME, more hospitals are reducing restrictions on cell phones.

Twenty-three
percent of the 185 survey respondents reported their organization has
lifted all restrictions on mobile phone use, up 5.5% from a similar
survey conducted by the Ann Arbor, Mich.-based organization in 2004.
Only 11 respondents, or 6%, indicated that cell phone use is entirely
prohibited at their hospitals.

Sixty-nine percent of respondents reported mobile phone use is
restricted only in certain areas, such as the emergency department or
intensive care unit. And 39% indicated their organization has or will
install technology to enhance cell phone signals.

Respondents, however, also reported that some problems have arisen
as a result of increased use of mobile phones in their hospitals. For
example, some say privacy and noise pollution concerns are compelling
them to continue some mobile phone restrictions. Further, some
respondents indicated their organization has specific bans on camera
phones in patient areas.

As I noted on the Biomed Listserv this week, RF interference is a fact of life and cell phones are but one contributor. Regarding RF interference risk, cell phone's will never be proven to be perfectly safe – but then neither will hair dryers, florescent light ballasts, microwaves, and elevator motors. The key is risk management.

Sadly there's no link to the actual report on CHIME's web site. (You'd think they could have found a corporate sponsor for the study, and then published it in support of their advocacy for effective use of IT in health care and as a service to the industry – that is why CHIME exists, isn't it?)

Share
Read More

Medical Device User Interface Design Issues

Robert North, PhD, chief scientist of Human Centered Strategies, and participant in the AAMI committee that is updating the human
interaction standards, highlights the impact of user interface design on medical device safety. In speaking for the FDA (?), he notes correctly that the, “FDA views errors during human interaction with a device as seriously as
any mechanical, electrical, software, or chemical errors that may make
a device cause patient harm.” From the MD&DI story:

To understand the effect of regulation on the design-research and
early concept-testing phases, the overall process that FDA requires
must first be understood. This process is succinctly described on FDA’s
Web site [here]. It cites AAMI/ANSI HE74-2001, “Human Factors Design Process for Medical Devices.” It further states the following:

This standard serves as a guideline for integrating human factors
engineering into the product design and development process necessary
to satisfy the FDA Quality Systems—Design Control requirement to ensure
that the needs of the user are appropriately defined, verified and
validated. Any declaration of conformance to this standard with respect
to establishing a manufacturer’s standard design and development
process adequate to meet the needs of the user should be accompanied by
the following documentation at a minimum:

  1. Description of the process to be followed in defining the user needs to establish the device-user interface design input.
  2. Description
    of the process to be followed in verifying that the user needs as
    defined by the design input is addressed by the design output.
  3. Description
    of the process to be followed in validating that the final design
    functions in a way as to met the intended users needs.
  4. Description
    of the risk analysis process to be followed in identifying and
    assessing reasonably foreseeable risks associated with intended use.

All of these FDA requirements affect how a medical manufacturer
would structure and document design research and early concept work.

After the Improving Patient Safety through Medical Device Interoperability and High Confidence Software workshop last week in Boston, it was clear that the importance of this area grows considerably as connectivity and interoperability is added to medical devices. This, combined with the rather sorry state of embedded system software development – in both requirements gathering and product development processes – I suspect the FDA will be increasing their scrutiny in this area.

Share
Read More

Tyco Spin Off Covidien Signals Acquisitions

Nellcor-SpO2-monitor-wireless

The Tyco International spin off of their medical division was completed a couple weeks ago. The new company, Covidien has about $10 billion in sales. With a stable of mature health care technology, Covidien is looking to acquisitions to fuel growth.

It is now investing aggressively in research and development in its
core devices business and would consider acquisitions in the $60
million to $250 million range, [Richard] Meelia [president and CEO of Covidien] said, as it looks to expand its
offerings of surgical, respiratory and energy-based devices.

It expects ultimately to boost R&D spending in devices to 5
percent to 6 percent of sales from 2.7 percent today, Meelia said.

Like many mature medical device vendors, the company “which makes surgical instruments, ventilators and syringes, struggled
with sluggish revenue growth and declining profitability due to
underinvestment.”

Many medical device vendors face the challenges of mature undifferentiated core technologies (and resulting products) and changing market requirements that demand workflow automation beyond the operation of the medical device itself. For example, there has been a market need for a patient worn wireless SpO2 monitor (Covidien's Nellcor product line) for years, yet the company chose to milk the cash cow of sensors and disposables rather than investing in next generation products. Ditto for ventilators, where the transition of ventilated patients from critical care units to general wards has created new surveillance and alarm notification requirements. It is also notable that Covidien's medical devices do not provide connectivity (sorry, serial ports don't count).

Perhaps Covidien will acquire a software company to develop a common connectivity platform for all their devices. Such a strategy would not likely generate incremental revenue, but could certainly drive medium and long term organic growth in their existing product lines. Pictured right is a Nellcor SpO2 monitor made “portable” with the addition of a wireless radio wart.

Share
Read More

Vocera Names Zollars New Chair and CEO

Vocera has named Robert J. Zollars as their new Chairman and CEO. Like many health care executives, Zollars got his start at American Home Products, before moving to Baxter. From the press release:

Most recently, he served as President and CEO of Wound Care Solutions,
the leading operator of outsourced chronic wound care centers serving
275 hospital customers nationwide. Before joining Wound Care Solutions,
he was Chairman and CEO of Neoforma, Inc. (NASDAQ: NEOF), a leading
provider of supply chain services to more than 1,200 hospitals and 465
supplier customers. Prior to his tenure at Neoforma, Inc., he was
Executive Vice President for Cardinal Health, Inc., a $75 billion
healthcare products and services company, where he was responsible for
five wholly owned subsidiaries, including Pyxis Corporation, Medicine
Shoppe, Owen Healthcare, Cardinal International, and Cardinal’s
Information Technology business.

Vocera has successfully competed in health care against a a number of much bigger competitors. Their unique offering has gotten good adoption, but they will have to continue to innovate to maintain their market position, let alone grow. It will be interesting to see what direction Zollars takes the company.

Share
Read More