Acupuncture needles

The line between alternative and complementary medicine may shift over time. An example of this, involving a medical device, is acupuncture. At one time in the USA, acupuncture was viewed as an alternative practice, but it is now used as a complementary treatment. Acupuncture is part of a tradition of ancient Chinese healing practice that inserts needles at specified acupuncture points to redirect and reposition the flow of energy (see Figure 21.1). This practice is used to relieve pain, such as migraine pain or

Ancient Japan And Medicine

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Figure 21.1 Engraving of moxabustion acupuncture being performed, Japan, 1863-1864. Reproduced with permission from the Science Museum/Science and Society Library

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Figure 21.1 Engraving of moxabustion acupuncture being performed, Japan, 1863-1864. Reproduced with permission from the Science Museum/Science and Society Library

Table 21.2 Acupuncture was until recently considered an alternative medicine. The FDA has now cleared numerous products and brands for use in acupuncture

Product

Year first cleared

Number cleared to date

Acupuncture needle

1996

66

Acupuncture point locator

1978

3

Electro-acupuncture stimulator

1979

7

menstrual pain, or to treat chronic medical conditions, such as arthritis or asthma. It is now recommended or prescribed by some MDs or DOs for their patients who have, for instance, nausea from chemotherapy or chronic pain. Auricular acupuncture is also used in conjunction with conventional practices in detoxification programs and in addiction treatment. Table 21.2 shows approved or cleared medical devices that are used in acupuncture, based on searching the public 510(k) database [8]. The acupuncture needle is now defined in regulations as a hospital and general personal use device:

An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture.

The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment [9].

Another acupuncture device, the electro-acupuncture stimulator, is defined as a prescription device (meaning that it must be prescribed by an MD or DO).

In the 1970s, acupuncture needles were 'investigational'devicesintheUSAandcould not be legally sold. In April of 1996, the FDA announced that it had reclassified the acupuncture needle from Class III, a category usually requiring clinical studies to establish safety and effectiveness, to Class II, a category which involves less stringent controls by FDA but requires good manufacturing and proper labeling (see Chapter 2 for a more complete description).

This change was largely based on a workshop held by the Office of Alternative Medicine (now NCCAM) in 1994 to investigate the current state of knowledge on the safety and effectiveness of acupuncture needles [1]. After the workshop, petitioners filed with the FDA to reclassify acupuncture needles. The FDA agreed to this change, although they did not agree that there was adequate clinical information to recommend approval for any of the proposed indications. This change made it possible to consider acupuncture needles under Section 510(k). Data from the workshop supported use of acupuncture needles for a number of indications, including acute and chronic pain, nausea and vomiting, and substance abuse.

The acupuncture needles used in human body acupuncture are generally 0.2-0.5 mm in thickness. The length of the needle shaft varies considerably, according to therapeutic indications and practitioners' styles; 20-40 mm long needles are commonly used, but longer needles are often selected by practitioners trained in traditional Chinese acupuncture practice. There are also hair-thin Japanese needles used by practitioners. Veterinarian use requires longer and larger needles for treating large animals, as commonly seen in equestrian use.

In addition to the commonly used types of body needle described above, other types of needle are also used. Among them are press tacks, intradermal needles, and stud needles used for body acupuncture, finger acupuncture, and auricular acupuncture. These are often short needles intended to be left in place for varying lengths of time. Patients may be instructed to self-simulate the needles according to a schedule set forth by the practitioner or according to the patient's own symptoms.

Aside from the above standard body and ear acupuncture needles, there are a variety of related devices in acupuncture practice. Moxibustion (or Moxa) is the burning of dried fiber herbs to deliver heat stimulation, often wrapped around the needle handle after acupuncture needle insertion.

The electrical acupuncture point detector is a device used for accurately locating acupuncture points by measuring the electrical resistance of the skin, assuming that acupuncture points have a lower electrical resistance. The value of acupuncture point detectors is debated, even among acupuncture practitioners. The electrical acupuncture simulator is used to deliver electricity to stimulate acupuncture points once the acupuncture needles are inserted. The current and frequency can be selected by the acupuncture practitioners according to therapeutic indications. Clinical evidence is lacking regarding whether electrically stimulated acupuncture is more effective than manual acupuncture.

Other devices are used with acupuncture for cupping, which is thought to eliminate stagnation and improve the flow of vital energy. The practitioner creates suction in the cup (most often by lighting a flame in the cup) and applies the cup to the body. The skin rises under the cup vacuum force and often results in a local bruising. Currently the FDA registered general medical devices list includes acupuncture point locators, cupping sets, and various acupuncture needles.

Although today's acupuncture needles are made mostly of steel, one may find traditional practitioners using gold or silver needles. These metals are considered by some to have special therapeutic indications and properties. Re-usable acupuncture needles impose serious public health concerns; note, for instance, an outbreak of acupuncture-associated hepatitis B [10]. Because of increased awareness of the risk of communicable diseases, most practitioners in the USA now use disposable needles.

Firms marketing acupuncture needles in the USA are now required to obtain pre-market clearance from FDA through the premarket notification (510k) process. Manufacturers are required to label the needles for single use only, restrict their use to qualified practitioners as determined by the states, and provide information about device material biocompatibility and sterility. Foreign manufacturers must meet the same premarket clearance and manufacturing quality requirements as US manufacturers.

Although there are no available data demonstrating the safety effects of this reclassification, with acupuncture needles marketed as a single-use, sterile product, to be used only by qualified acupuncture practitioners; together with the acupuncture profession's emphasis on clean needle technique in training, written examination, and a requirement for licensure throughout the USA, acupuncture patients may now donate blood without a 12 month deferral (if the needle sterilization procedure cannot be verified, then the donor should be deferred for 12 months).

A recent review on the effectiveness of acupuncture concluded that, despite the difficulties and methodological constraints in conducting high-quality acupuncture clinical trials, a general international agreement has emerged that acupuncture appears to be effective for postoperative dental pain, postoperative nausea and vomiting, and chemotherapy-related nausea and vomiting [11]. For numerous other conditions, the evidence is considered promising, but rigorous research is still needed to add to the body of evidence. For conditions such as asthma, drug addiction, and certain pain conditions, the evidence is considered inconclusive and difficult to interpret. The review also concludes that acupuncture is a relatively safe procedure, although it is not free from serious adverse events.

Regardless of the evidence on the effectiveness of acupuncture practice, the increasing popularity of acupuncture worldwide has resulted in a growing literature on adverse events associated with acupuncture, including case reports on communicable diseases such as hepatitis, and mechanical trauma from needle placement, such as pneumothorax and spinal cord injury. There were also reported fatalities from infections. A common cause of adverse events was due to needle breakage [12-15].

The best evidence in supporting the safety of acupuncture practice thus far has come from prospective studies relying on both practitioner and patient reports [13,16,17], supporting the assertion that 'acupuncture is safe in competent hands'; but more studies are expected to add to the international evidence base. A recent study estimated severe underreporting of acupuncture-associated serious adverse events, and suggested a means of verifying the accuracy of the reported serious adverse event rate and correcting it to the statistically expected rate [18].

A recent review pooled information from computerized databases, previous reviews of case reports, population surveys, and prospective surveys of acupuncture practice to indicate the range of significant adverse events associated with acupuncture [19]. In this review, a total of 715 adverse events were included. Reports of adverse events were classified by the author as 'primary' if written by a clinician who dealt with the case, and as 'secondary' if written by another author, e.g. from retrospective studies which were considered to be more likely to subject to recall bias and which might include double reporting. Trauma accounted for 90 primary reports and 186 secondary reports; the most common were pneumothorax and injury to the central nervous system. Infection accounted for 204 primary reports and 91 secondary reports. Over 60% of these cases were hepatitis B. The next most common infection was of the external ear, as a complication of auricular acupuncture. The 144 miscellaneous events comprised mainly seizures and drowsiness judged severe enough to cause a traffic hazard. There were 12 primary reports of deaths. In addition, this review also pooled from 12 prospective studies which surveyed more than a million treatments; the risk of a serious adverse event with acupuncture was estimated to be 0.05 per 10 000 treatments, and 0.55 per 10 000 individual patients. The review thus concluded that the risk of serious events occurring in association with acupuncture is low and below that of many common medical treatments.

In addition to safety concerns associated with acupuncture needles themselves, there are also concerns about their potential interactions with other medical devices. For example, with the growing and common use of magnetic resonance imaging (MRI), patients with embedded auricular needles should be forewarned about the interactions with the large field magnet and safety concerns. Also, localized argyria and often invisible metallic remnants from prior acupuncture treatment may pose potential risk from heating and localized tissue injuries when patients undergo MR scanning.

Other types of device interactions include the interaction of electro-acupuncture with other medical devices powered by electricity. Acupuncture practitioners often avoid using electro-acupuncture across the thorax because of the theoretical risk of interfering with the heart's conduction system. One case report described electromagnetic interference from low-frequency acupuncture on a pacemaker [20]. Therefore, caution should be exercised when using electro-acupuncture on patients with any electrically powered medical devices.

As previously stated, surveillance or epidemiologic studies on 'alternative and complementary' devices are usually absent. Surveillance or epidemiologic studies for acupuncture needles are feasible, and could be helpful in reducing future serious injuries and improving the safety of acupuncture practice. The current acupuncture professional education and licensure does not have an emphasis on adverse events reporting. It is important for the public and acupuncture professionals to know that, with their involvement in the surveillance or epidemiologic studies, the benefits of these devices and the types of adverse events and full spectrum of device issues associated with these products can be better analyzed and understood by healthcare providers and patients.

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