In high-reliability industries such as health care, the quality of a device’s service and repair can literally mean the difference between life and death. With the need to assure patient safety, members of AAMI’s Supportability Task Force – which includes representatives from original equipment manufacturers (OEMs) and healthcare technology management (HTM) professionals – are focusing on developing competency guidelines for servicing and maintaining medical equipment.
“The serviceability and supportability of medical devices have been tricky issues for both HTM professionals and OEMs for years,” said Patrick Bernat, AAMI’s director of HTM. “During last November’s AAMI Forum on the Supportability of Healthcare Technology, participants agreed that competency verification could go a long way toward tearing down the walls that have separated the two sides. They felt that developing mutually agreed upon criteria to evaluate and measure competency for working on various types of equipment could be the key to establishing the trust and confidence needed to move the conversation forward.”
This effort comes at a time when the Food and Drug Administration (FDA) is asking questions about the third-party service and repair of medical devices, due in part to OEM fears that repairs by unqualified personnel are putting patient safety at risk.
Many working in hospitals see a bias on the part of OEMs against hospital HTM departments, but these professionals agree that the two sides can find common ground by talking about competencies.
“The only way to alleviate perceptions on the part of vendors that parties other than the OEM may not be qualified to safely and effectively service and maintain their products is to look at how HTM professionals and OEMs can come to terms on competencies and expectations,” said Mike Capuano, manager of the biomedical technology department at Hamilton Health Sciences in Ontario, Canada.
The task force is not looking to build these competencies from the ground up, but instead leverage an existing or modified certification process.
“It’s important that OEMs, especially those not involved with the task force, have something universal to recognize,” Capuano said. “When health care organizations purchase equipment, having these credentials up front will hasten the process and provide more success in acquiring the support needed to repair devices in-house. This will allow health care institutions to maintain the highest level of patient safety and capitalize on the cost-effectiveness HTM professionals can bring to the bedside.”
The group is also working to create a template for service-level agreements and developing data points that will eventually be included in a dashboard for the C-suite.
AAMI’s eSubscription Service Expands
In the fast-paced world of technology, it seems like almost everything is available at your fingertips – the latest news, television shows, music, and even transportation. To keep up with what healthcare technology professionals and the medical device industry need to ensure conformity and compliance in this on-demand world, AAMI moved its complete collection of standards to a web-based platform last fall.
In addition, this service now includes specialized subsets, such as standards collections focusing on sterilization, dialysis, or human factors, instead of providing them on a CD. AAMI is also preparing to offer some individual standards via the eSubscription service.
One of the main benefits of the eSubscription service, according to Sonia Dorfman, a librarian at NeuroPace Inc. – an implantable device company in Mountain View, California – is the search function. Using a keyword search of the title or full text, you can much more easily find the exact standard and page you need.
“The CD-Complete Collection used to be so difficult to search,” Dorfman said. “But with the online version, people can more easily find what they are looking for. When people ask me for a standard, I just have to point them to the platform, and they are able to get what they need.”
For organizations such as NeuroPace that have acquired a multiuser license, it is also more convenient for employees to access standards. Instead of passing around a hard copy or a CD, staff members are able to get what they need, when they need it, wherever they are.
“The access is so much easier,” Dorfman said. “As many people who need to look at a standard are able to, even if they are not at their desks.”
Joseph Bremner, AAMI’s director of marketing, said the move to the eSubscription service was driven by AAMI’s commitment to offer the best experience possible for professionals who purchase and use its standards.
To learn more about AAMI’s eSubscription service or to view a demonstration, visit www.aami.org/esubscription.
Just Two Chances Left to Get ACI Certified in 2016
A central concern for many hospitals and companies is having a workforce that’s both knowledgeable and skilled in the safe application of biomedical equipment. Certification demonstrates that successful applicants have the knowledge to ensure a safe and reliable health care environment. It also demonstrates to employers a significant commitment to career and competence.
AAMI’s Credentials Institute (ACI) maintains certification programs for biomedical equipment technicians (CBET), laboratory equipment specialists (CLES), radiology equipment specialists (CRES), healthcare technology managers (CHTM), and quality system managers (CQSM). With more than 4,000 people certified worldwide, the ACI seal of approval has become a commanding credential in the healthcare technology field.
There are two exam windows left in 2016: Sept. 9-17 (registration due by Aug. 9; late registration by Aug. 23) and Dec. 2-10 (registration due by Nov. 4; late registration by Nov. 18).
For more information, about the exams and eligibility requirements, visit www.aami.org/certification or reach out to an ACI representative with questions at email@example.com.
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