To help prevent adverse events related to the improper use of replacement parts in healthcare technology, AAMI’s Supportability Task Force has compiled two checklists regarding the proper development, selection, and use of replacement parts. One checklist is geared toward healthcare technology management (HTM) professionals, while the other is aimed at manufacturers.
Replacement Parts Checklist — HTM
• Is the part an exact replacement from the manufacturer of the device, or from the manufacturer of the part?
• If it is not, are the specifications identical?
• Does the part affect the accuracy of the device?
• Does the parts provider offer a warranty at least equal to the manufacturer?
• Does the parts provider fully test each part before making it available?
• Does the parts provider have ISO or another type of quality certification?
• If the parts provider isn’t the manufacturer, does the provider have a relationship with the manufacturer?
• Is the parts provider financially sound and likely to be around for a while?
• If you send a device out for repair, how do you verify the quality of the repair when it comes back?
• Does the parts provider offer a wide selection of quality parts or is it a niche provider?
• If you have used third-party parts and require manufacturer assistance, will the manufacturer require you to replace those parts with its parts before doing any work?
Replacement Parts Checklist — Manufacturer
• Are there restrictions on what cannot be serviced by the customer?
• Are those restrictions clear?
• For items that cannot be serviced by the customer, is there an explanation as to why? For example, is a special calibration fixture or test setup required? Without an explanation, the repair personnel cannot defend to management why OEMs must make certain repairs when, at first glance, those repairs appear to be able to be performed in-house or by a third party.
• Consider providing drawings that indicate what components/subassemblies are and are not user-replaceable.
• For restricted components/subassemblies that are likely to be serviced, consider labeling them as “not user replaceable” and providing an explanation in the service manual.
• Consider tamper-evident seals for access to restricted components.
• When a device is returned for repair, inspect it to determine if unauthorized repairs were made. For example, does the batch/lot number of a critical part match the DMR record of when it was originally assembled? Are the calibration parameters the same as they were originally? If not, these are signs that the device might have had unauthorized work performed.
Post-Summit Report Aims to Make Risk Management Everybody’s Business
There is wide recognition that caring for patients can be a risky business. Currently, the compelling need for greater responsibility and accountability in managing risk does not match the reality in health care delivery. A post-summit report from AAMI and the U.S. Food and Drug Administration (FDA) aims to identify the barriers and priority actions for strengthening the discipline and practice of risk management for healthcare technology.
The report, “Making Risk Management Everybody’s Business: Priority Issues from the 2015 AAMI/FDA Risk Management Summit,” includes broad, multidisciplinary perspectives from device manufacturers; health care delivery organizations; regulators; standards development organizations; patient safety organizations; clinicians; safety, risk, and quality management professionals; healthcare technology management professionals; and systems engineers who attended the summit this past September.
Their discussions yielded the following clarion themes:
1. Recognize that everyone in health care is a risk manager.
2. Develop shared understanding of the risks — and benefits — of healthcare technology.
3. Adapt systems engineering principles, practices, and tools for risk management.
4. Engage in a total life cycle approach to risk management, which is required to effectively manage risk.
5. Create new practical tools to continue advancing the field of risk management for healthcare technology.
To download the complimentary report, visit www.aami.org/risk_management_summit_report.
Foundation Report Makes Case for Continuous Monitoring of Patients Receiving Opioids
The AAMI Foundation has released a compendium that describes the serious risks faced by patients receiving opioids and the potentially life-saving benefits of continuous electronic monitoring (CEM). The report, “Opioid Safety & Patient Monitoring: Conference Compendium,” includes diverse perspectives from stakeholders who attended the kick-off meeting for the National Coalition to Promote Continuous Monitoring of Patients on Opioids.
Continuous respiratory data and other vital sign information from electronic monitors can identify subtle changes in respiration, detect trends, and provide clinicians with actionable information that is not readily apparent from a two- or four-hour spot check of vital signs.
“CEM isn’t the only answer, but it’s a fundamental part of any meaningful solution,” said Marilyn Neder Flack, senior vice president of patient safety initiatives at AAMI and executive director of the AAMI Foundation. “Many hospitals are saving lives by integrating technology as a tool to support the work of clinicians.”
In addition to issuing a call to action, the compendium outlines the strategies eight hospitals have used to make the business case for and implement continuous patient monitoring, as well as provides insights from experts at the Westchester Medical Center in New York, the ECRI Institute, and the San Diego Patient Safety Council in California.
New Podcast Covers Culture of Safety
What does it take to develop and support a culture of safety in hospitals and other health care facilities? A complimentary new podcast from AAMI answers that question with insights from experts who stress that changing a culture starts with changing behaviors. “Safety is not automatic in health care,” one guest notes.
This AAMI podcast, along with more than a dozen others, is available at www.aami.org/newsviews/podcasts.
For more information, please visit www.aami.org.