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June 01, 2006
Vol. 10 •Issue 6 • Page 26 Industry Watch
An automated system meets the multi-facility point of view for medical reporting and yet allows for decentralized, single facilitymanagement of product alerts and recalls.
How can a health care organization manage the process of medical device, medication and product recalls?
A handful of medical product recalls made headlines over the past year, including recalls for widely prescribed medications such as Celebrex and Paxil, pacemaker devices and IV pumps. Even human tissue was recalled. Overall, thousands of health care products used regularly in hospitals and clinical care delivery are recalled each year. Managing recall alerts through manual, paper-based processes has become increasingly difficult. In reality, the organization often can't effectively manage the process if it's a manual one.
The Risk and Safety Management Alert System (RASMAS), a Web-based recall management system offered by Falls Church, Va.-based Mitretek, last year released 1,960 alerts for products used in health care facilities, ranging from blood, food, pharmaceuticals, medical devices and supplies. Those alerts included 1,685 recalls, 188 bulletins, 60 field corrections and 26 public health notices.
With an average of almost 30 alerts each week, hospitals must be vigilant so that they can act promptly to decrease the number of at-risk days that patients and staff may be exposed to a potentially harmful product. But because this process is typically manual, it can take more than three weeks for a facility to respond and address a product recall; in some cases a facility may miss a recall altogether.
Getting a grasp on recalls
While many organizations have focused on streamlining supply chain ordering and tracking through the use of new software and Internet solutions, the need for technology solutions to manage product recalls has been pushed to the back burner. As a result, many hospitals attempt to get by with labor-intensive processes for identifying recalled products and removing them from the health care delivery setting.
Hospitals typically identify alerts, but recall materials are often dated or even incomplete. Notices sent directly to the hospitals through the purchasing mechanism may be subject to misrouting — further delaying the time to react to a recall. A single individual, usually responsible for other day-to-day activities, typically handles the manual process for entering alerts into aspreadsheet upon receipt, copying them for distribution, physically routing them to the appropriate department and tracking responses. And recreating a paper trail from a dozen sticky notes, mountains of photocopies and hand-scribbled responses is a difficult and daunting task, commonly triggering additional delays. Also, staff turnover, departmental outsourcing and decentralized purchasing further complicate the complexity of recall management.
Shirley Geize, assistant director for purchasing and contracting at Johns Hopkins Health System in Baltimore, explained, "I'd print out 30-page reports, look through them and pick out items that were pertinent."
Release, management of alerts
In contrast, RASMAS, provides centralized recall oversight from a management perspective for alerts spanning across all products used in the health care environment. The application uses knowledge management technology that automatically locates alerts from various known Web sources and parses the information into the appropriate fields. The National RASMAS Center (NRC) clinical staff also performs manual searches for alerts that can affect patients, visitors or staff.
The NRC staff reviews each product alert and assigns it into one of 14 product domains such as biomedical devices, medical supplies, blood or pharmaceutical products. Once released, the system automatically directs the alert to the appropriate coordinator in the health care organization for processing.
Upon release of an alert, the domain coordinator receives a courtesy e-mail, logs into RASMAS to review the alerts and makes assignments where necessary. Staff then remove the product from shelves, quarantine the product for maintenance or perform other actions required to close out an alert. If progress on an alert is delayed, the system automatically sends noticesup the chain of command for assessment of the delay and additional intervention, if necessary. The system generates a complete documentation trail for each alert and an array of reports can be quickly generated for review by hospital management or regulatory/ licensure groups.
Traditionally, hospital materials managers bear the brunt of recall management oversight. But increasing network complexities require those managers to oversee a multi-dimensional, geographically scattered distribution of products. RASMAS is an automated system designed to be flexible enough to meet the multi-facility point of view for reporting and yet allows for decentralized, single facility management of product alerts and recalls.
RASMAS gives staff quick access to the service from any location through a Web connection. While moving from department to department to remove a recalled product, staff can log onto the Internet and document actions that they have taken
The electronic audit trail means managers can keep tabs on recall activities to ensure that patient care areas are being assessed quickly. Another benefit: All of the documentation, files and communication associated with each alert no longer clog up the hospital's e-mail system. Subscribers to the service have continuous access to the most current version of the service without the need for continuous support from the hospital's IT staff.
Hospitals using a manual process can take days to weeks to manage each alert. Automated processes reduce that time to an average of 3 to 5 days. In addition, most health care organizations achieve operational efficiencies of 80 percent, resulting from the time savings in management and administration. An escalation feature that notifies management when action has not been taken on an alert after a specified period of time ensures proactive management of alerts. Immediately accessible reports further reduce labor resources needed to respond to audits.
"Ensuring that recalls are received by the correct individual/ department and handled in an appropriate timeframe is critical toensure the safest care delivery possible for our patients," said Bea Haupt, JD, CPHQ, recall and safety manager at Inova Health System in Falls Church, Va. "RASMAS provides the automated tracking we lacked in our previous process and ensures that proper action has been taken on the alert. Just four months into using the technology, we cut our average alert management time from 20 days to 5. RASMAS is now in place throughout all Inova facilities with average processing time of around 5 to 6 days."
Ms. Magee manages marketing and business operations for RASMAS in Mitretek Healthcare's technology-based services division.
2900 Horizon Drive, King of Prussia, PA 19406 • 800-355-5627
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