For years in the medical device industry we have discussed alerts and alarms and their implications for medical devices. In many cases, the two terms are used interchangeably. While there has been confusion, there has been no clear definition or at least a standard, defined term for the distinction between the two. Many companies, especially the Electronic Medical Record companies use the term alert and feel this will enable them to be shielded from regulatory oversight. In looking at the context of the EMR, that is understandable since this is historical data, often minutes delayed from actual occurrence.
We also have paging companies (now mostly using smart phone technology) who continue to send messaging and provide messaging solutions to enable better communication between caregivers, and between caregivers and patients. But, many of these still say they provide alerts, not alarms. This may be true and this is not necessarily a bad thing, just maybe limiting and/or misleading.
FDA has published a guidance on changes to existing software policies as a result of the 21st Century Cures Act (Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, Sept. 27, 2019). In this guidance, FDA clarifies possible ambiguities from the draft guidance documents regarding software functions that they consider a medical device [emphasis mine].
"Section 520(o)(1)(D) of the FD&C Act does not capture software functions intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays, because these functions involve analysis or interpretation of laboratory test or other device data and results. For example, if a software function is intended to prioritize patients in an Intensive Care Unit based on their clinical status, then this function is intended to interpret or analyze device data, results, and findings and is, therefore, not excluded from the definition of device under section 520(o)(1)(D) of the FD&C Act. Similarly, software functions that analyze medical device data in order to provide a notification or flag (e.g., that a parameter is out of range) are not excluded from the definition of device under subsection (D)). The examples included in the draft of this guidance that described alarms, alerts, or flags have been removed from this guidance, because they are not excluded from the definition of device under subsection (D). These functions are addressed in section 520(o)(1)(E) of the FD&C Act, the regulation of which will be described in a separate guidance document."
Adding complication to the issue is the use of the term “alarm”. The standard does not use the term as a noun. There is an ALARM CONDITION and an ALARM SIGNAL. And, clinicians refer to the term alarm as a noun. In context, a clinician will explain the patient is “in alarm” meaning the patient has entered an ALARM CONDITION and the ALARM SYSTEM is generating an ALARM SIGNAL. (See my previous post “A Common Ground Begins with Common Language")
In the statement from FDA, they intend to focus on alarms or alerts that are intended to notify a caregiver to take immediate clinical action. So by that definition, an alert and an alarm have the same implications if they are intended for the caregiver to take clinical action to avoid harm to the patient.
So, what are the differences between the two? The ANSI/AAMI/IEC alarms committee (ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012 MEDICAL ELECTRICAL EQUIPMENT – Part 1-8: General requirements for basic safety and essential performance – collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) was asked in their upcoming update to define the term alert to help industry clarify the difference. Keep in mind alarm condition has been a defined term. Alert has been used in other standards but has not been a defined term, and the definition the committee developed, while not finalized did not generate additional comments.
Here are the definitions (including ALARM SIGNAL):
ALARM CONDITION
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS SITUATION exists for which OPERATOR awareness or response is required
NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
ALARM SIGNAL
type of signal generated by the ALARM SYSTEM to indicate the presence (or occurrence) of an ALARM CONDITION
ALERT
ALERT SIGNAL
INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT providing contextual awareness that is intended to improve the clinical workflow or understanding of the PATIENT condition, but the awareness is not related to providing RISK CONTROL
EXAMPLE 1 A notification that it is time to draw the next blood sample.
EXAMPLE 2 A battery status notification that replacement will be needed in a day.
EXAMPLE 3 A notification that it is time to bathe the PATIENT.
The committee, which had representation from industry, regulatory bodies, and clinical caregivers intended to define these such that an ALARM CONDITION differs from an ALERT by indicating the potential for patient harm and need for operator intervention. An ALERT SIGNAL is a signal that provides notification of a condition to caregivers but is not requiring action that changes the clinical workflow or indicates harm.
So, as for the question “When is an Alert and Alarm?”, the answer is simply, it’s not! No matter what companies call it, if it requires immediate clinical intervention or action, it is an indication of a hazardous situation with potential harm to the patient and the indication is an ALARM SIGNAL resulting from an ALARM CONDITION.
For a company that is providing ‘Clinical Communications’ to message a caregiver with an ‘alert’ that comes from a patient monitor or other medical device indicating the need for the caregiver to take clinical action and to not have that device regulated by FDA is misleading. Some companies, when asked about FDA compliance have stated “we aren’t ready to talk about that.” Companies that do comply with FDA oversight, that provide alarm notification, typically target acute care settings. At issue is that we are seeing more companies entering this market without any oversight. They call it “alert messaging” and are not concerned about regulatory compliance.
This lack of regulatory compliance can save a lot of expense for these companies. However, what happens when there is an issue? Regulatory oversight by FDA and other global notified bodies helps to ensure the company has a Quality Management System and their products are developed and manufactured based on risk hazard analysis. In doing so, products that are placed on the market have undergone a more rigid set of checks and balances during the design and manufacturing process and if an issue does arise, they must address it both from a corrective and preventive point of view.
If you are looking at a clinical communications tool for your hospital, ask if the products will be providing alarm information and if so, do they have FDA clearance to market. Make sure the company can back up their claims, and if necessary, ask them for the evidence of their FDA clearance.