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What do you mean by an Adverse Event? / What are the practical goals of this database?

These two questions are very closely related.

The U.S. Department of Health and Human Services defines an adverse event as: An event, preventable or non preventable, that caused harm to a patient as a result of medical care. This includes never events; hospital-acquired conditions; events that required life-sustaining intervention; and events that caused prolonged hospital stays, permanent harm, or death.

By this definition, the practice of acupuncture very rarely involves adverse events. This is one reason that no database has previously been created to track them.

However, the Clean Needle Technique manual contains a list of “adverse events”, both serious and less so, which reflects a much broader definition:

• Bruising and Bleeding
• Needle Site Pain/Sensation
• Fainting
• Failure to Remove Needle
• Stuck Needle
• Aggravation of Symptoms

Rare but serious AEs: pneumothorax, injury to other organs and/or central nervous system, injury to tissue, nerves, and/or blood vessels, infection, and broken needle.

The Current Clean Needle Technique Manual

A major goal of this database is to support a culture of safety in the practice of acupuncture. Part of creating a culture of safety is making it easier and more comfortable for both practitioners and patients to communicate about safety issues. We believe that better, more cooperative communication around even minor “adverse events” can help prevent, and/or improve the management of, adverse events in general

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What kind of adverse events should I report? (How minor is too minor?)

Considering the goal of creating a culture of safety, which includes improving cooperation both among practitioners who are peers and/or colleagues AND improving cooperation between practitioners and patients around safety issues, the working definition of an adverse event is:

• Anything that a patient complains about with regard to treatment, including but not limited to the list of events from the CNT manual.
• Anything that happens in your clinic, related to treatment, that you don’t want to happen again.

Obviously this will involve some judgement calls, and since not everyone will make the same judgement calls, this means our data will not be perfect. However, our data doesn’t have to be perfect in order to contribute to a culture of safety.

For example, bruising and/or bleeding is relatively common in acupuncture. Some patients will be unconcerned when this happens, whereas some patients will be very concerned. Histamine reactions to acupuncture, up to and including hives, are less common, but have a similar dynamic: some patients might be indifferent to major redness and swelling -- if they are accustomed to having hives -- while others will be very worried, even about minor flushing. It is helpful for practitioners to have an idea about how often patients might feel concerned about these kinds of events, regardless of how minor they are, because it helps practitioners know what to expect from their clinical experience, and it also helps them to communicate with patients.

So if a patient states they are concerned about a bruise, regardless of the size of the bruise itself, it’s worth filing a report in our database. Eventually, we’ll have an idea of how often patients are likely to be concerned about bruises -- and that will be valuable in terms of both patients and practitioners knowing what to expect from acupuncture.

Many acupuncturists, especially relatively new practitioners, struggle with knowing how to respond supportively to patients’ concerns. We hope this database will help with that.

Why should I report Adverse Events and Errors?

If you provide acupuncture services, you should anonymously report adverse events and errors because reporting errors is fundamental to preventing errors. Many medical errors are a function of systems and practices as opposed to a failure of individual vigilance, and the only way to improve systems is to gather data about problems from many different perspectives. All healthcare providers have to contend with adverse events and errors; the only way to decrease them across the board is to gather data and analyze it. We encourage you to look at reporting adverse events and errors as simply being a part of the safe practice of acupuncture.

If you are a patient, you should report any acupuncture adverse events and/or errors you have experienced because your information may be able to help prevent similar problems in the future. Your information is valuable to understanding and improving safety practices.

What is an Adverse Event? What is an Error? Are they Different?

An acupuncture adverse event is a negative consequence or injury to a patient because of treatment and not necessarily because of error. Most acupuncture adverse events are minor, such as local bruising or temporary dizziness or nausea (“needle shock”). More serious acupuncture adverse events can include nerve damage or organ puncture.

An acupuncture error is an incorrect action or plan that may or may not cause harm to a patient. A common acupuncture error is failing to remove a needle after treatment, especially if the needle is in an area such as the head and is hidden by hair. In many cases in which an acupuncturist forgets or overlooks a needle, this represents an action in which no harm is caused to the patient. However, there are variants of acupuncture in which needles are intentionally retained permanently (representing a plan), and there have been reports of intentionally retained needles migrating elsewhere in the body and causing harm.

An example of an adverse event combined with an error would be an acupuncturist inserting a needle too deeply in an area too near to the lungs, resulting in a pneumothorax. Awareness of the possibility of organ puncture has resulted in acupuncture safety practices that discourage deep needling in certain areas.

A less serious example of an adverse event combined with an error would be an acupuncturist providing treatment to a patient who reported that they had skipped lunch and were feeling light-headed, and as a result, the patient faints during treatment ("needle shock").