Healthcare Technology Management Professionals Are Influential for Device Safety and Reliability

Healthcare technology management professionals play a key role in the medical device environment. By sharing their insights and expertise on medical devices issues with the US Food and Drug Administration, healthcare technology management professionals help the agency resolve medical device safety concerns and help improve patient safety. This article presents two real-world case study examples in which medical device reports containing critical healthcare technology management input were submitted to the US Food and Drug Administration's MedSun (Medical Product Safety Network) reporting program and helped contribute to 2 recalls. The details in the reports, provided by the hospital reporting team, offer a unique perspective for identifying the device concern and greatly contribute to the investigation and resolution of the reported device safety issue.

Section: Discussionmentioning

confidence: 99%

The Role of Healthcare Technology Management Professionals in Adverse Event Reporting

Ferreira

Waheed

2023

“…Healthcare technology managers can provide the FDA with extremely valuable information about their communications with manufacturers and whether any corrective actions previously taken have been effective at resolving the issue. 8 MedSun reports detailing the work of HTMs have directly contributed to recall classifications as well as other regulatory actions in the past. 4,8 One of FDA's key levers in working with manufacturers on addressing medical device concerns is to encourage and rely upon diligent medical device reporting from user facilities.…”

Section: Discussionmentioning

confidence: 99%

The Importance of Medical Device Reporting by Health Technology Managers Before and After Recalls Are Posted

Brown

2023

The Food and Drug Administration (FDA) performs postmarket surveillance of medical devices as part of its mission to ensure that devices remain safe and effective while they are on the market. Medical device reporting by manufacturers, user facilities, and the public plays an important role in the agency identifying and resolving medical device safety signals. User facilities are defined as a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility and do not include physician's offices. The Safe Medical Devices Act requires user facilities to report medical-device–related deaths to the FDA and the device manufacturer, to report device-related serious injuries to the manufacturer, and to submit an annual summary of all device reports to the FDA. If the manufacturer is unknown for a serious injury report, the user facility then submits the report to the FDA. Healthcare technology managers in user facilities use their expertise to recognize, communicate, and evaluate medical device concerns. This article highlights the importance of identifying and reporting medical device issues to the FDA to ensure continued safety and effectiveness of devices on the market.

“…FDA has previously published articles discussing voluntary reportable event case studies that have ranged from patient falls from beds, electronic thermometer inaccuracies, and a variety of home-use device failures. 1,5,6 Each of these articles further expands on ways for HTM professionals to take preventative measures to mitigate risk with these devices, best practices for reporting events, and the resulting outcomes that improved patient safety. The more feedback FDA receives on how medical devices are performing in the real world, the more rapidly and effectively the Agency can work with manufacturers to improve products and address patient safety concerns.…”

Section: Voluntary Reportable Eventsmentioning

confidence: 99%

“…The Agency uses these critical report elements to make informed decisions when interacting with manufacturers and communicating safety information to the public. 1…”

Section: Medwatchmentioning

confidence: 99%

“…Because of their responsibilities with setting up, maintaining, and repairing a range of medical devices used throughout hospital departments, healthcare technology management (HTM) professionals are in a distinct position to first observe and, subsequently, report device-related adverse events and concerns, which can be critical in notifying FDA of new safety signals or an increase in known risks. 1 Only after the details surrounding the device event or concern have been identified and reported can FDA use the information to inform solutions through follow-up with the device manufacturer or identify other mechanisms (eg, safety communications or recalls) to resolve problems resulting in risk mitigation to both patients and healthcare providers. However, in order to improve patient safety through reporting medical device events and concerns to FDA, you must first understand what to report and where to report.…”

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confidence: 99%

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Reporting Medical Device Events

Zhuang

Kuo

2021

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating medical devices, radiation-emitting electronic devices, drugs, biologics, food, tobacco, and cosmetics. After a product reaches the market, the Agency continues to evaluate a product's safety by monitoring adverse events. FDA's Center for Devices and Radiological Health facilitates reporting of medical device events and complaints by manufacturers, importers, healthcare facilities, and the general public to help FDA identify potential safety signals and/or improve medical device performance. FDA has established 2 reporting mechanisms (1) reporting through the public MedWatch system and (2) direct user facility collaboration via the MedSun program.Does this scenario sound familiar to you? You are meeting your responsibilities to keep a fleet of medical devices properly maintained and functioning well to be used on the hospital floor, but despite your best efforts, the devices seem to keep failing, all in a similar way. How do you report the malfunctions and stop this problem from continuing, or worse-from impacting delivery of safe and timely patient care?Reporting of adverse events helps to ensure the continued safety of medical devices and other products regulated by the Food and Drug Administration (FDA) once they are introduced into the US market. When problems with FDAregulated products occur, FDA wants to know about them because timely reporting by consumers, health professionals, and manufacturers allows the Agency and manufacturers to take prompt action to mitigate the problem. Because of their responsibilities with setting up, maintaining, and repairing a range of medical devices used throughout hospital departments, healthcare technology management (HTM) professionals are in a distinct position to first observe and, subsequently, report device-related adverse events and concerns, which can be critical in notifying FDA of new safety signals or an increase in known risks. 1 Only after the details surrounding the device event or concern have been identified and reported can FDA use the information to inform solutions through follow-up with the device manufacturer or identify other mechanisms (eg, safety communications or recalls) to resolve problems resulting in risk mitigation to both patients and healthcare providers. However, in order to improve patient safety through reporting medical device events and concerns to FDA, you must first understand what to report and where to report. So far, we have covered the "Why?" of reporting medical device events. This article aims to help HTM professionals get from observation to action by explaining regulatory reporting requirements at a high level, as well as the who, what, when, where, and how to report medical device events and concerns related to device safety, efficacy, or reliability, to FDA. What Events Should Be Reported?An adverse event is any undesirable experience associated with the use of a medical product in a patient. 2 FDA is interested in receiving repor...