With devices undergoing numerous cycles of repair over the course of their life cycle, there is a risk that some equipment may be used beyond its certified useful life. To continue using aging devices is to risk equipment malfunction, which may lead to – among other things – major budgetary discrepancies. Medical institutions must therefore weigh the conflicting interests of safety and economy in deciding if and when to perform device updates.
Tsukuba Medical Center Hospital(TMCH), operated by the Tsukuba Medical Center Foundation,is located in the southern region of Ibaraki prefecture in Japan. It opened in 1985 and has 453 beds. Not only a public interest incorporated foundation but a community-based health care provider, the hospital practices “patient-centered medical care in coordination and cooperation with the local community.”It acts both as a center for emergency care and as a regional oncology hospital.
TMCH hospital director in April 2011 founded the Medical Equipment Materials Unit, a functionality-oriented organization that supports safe and effective management of medical equipment. With a medical device safety manager at its helm, the unit was one of the first in Japan to link care workers, the hospital’s purchasing department and clinical engineers in addition to doctors and nurses. Hideaki Kamijyou is a clinical engineer working in device management for the Medical Equipment Materials Unit.
A clinical engineer by training, Kamijyou’s primary purview is equipment management, including the inspection and preventative maintenance of portable medical equipment, responding to device failure, investigating defect history, communicating repair requests to manufacturers, making backup plans and providing safety training for hospital staff. He is also responsible for quality improvement and total optimization measures.
One of the medical devices of primary concern is an external infusion pump. The hospital has many of these devices, and patients often walk around the facility with them in tow.
These infusion pumps are of course used under the watchful eyes of staff, but should anything abnormal occur the facility is equipped with an alarm that will sound, shutting the malfunctioning pump off. However, if an abnormality were detected on the ward, the offending device would immediately be replaced with another, triggering a repair inspection request. Such requests are often triggered accidentally when the external infusion pumps fall, are dropped, or are taken into a high magnetic field environment such as an MRI radiology lab. User error problems can be prevented with analysis of error factors, repeated training, awareness education and communication across the hospital. Although inspections which aim at preventive maintenance are performed on a regular basis, there are still many minor problems that occur, such as cracking or contamination, that do not generate errors. As such, this device remains one of the most difficult to manage.
“Patients have the right to be treated with devices that ensure the same level of safety as when they were first purchased,” Kamijyou says.