Applica Consulting Group

Archive for the ‘Medical Devices’ Category

Recently I interviewed a new patient for a mental health rehabilitation program where I am the attending psychiatrist. “David,” a 20 year-old man, attended an Ivy-league college and achieved a 3.5 grade-point average during his first year. At the end of the otherwise-successful first year, he had a psychotic break. After going without sleep for one week, he was arrested for pursuing a grocery clerk relentlessly around the store and babbling nonsense. Subsequently, David sank into a depression so severe that for many months he could barely shower, dress or even leave his bed. Concentration was difficult and his thoughts were rambling and disconnected. Struggling with distinguishing reality from fantasy, David believed he would never function normally again and consequently made three suicide attempts. Psychiatrists tried multiple different medications in a myriad of combinations, but nothing seemed to help. Finally doctors suggested Electroconvulsive Therapy (ECT), also known as shock therapy.

Unlike many patients who receive ECT, David did not have fast relief from his depression. In the end, he had 29 ECT treatments which he feels had little positive impact on his mood. His assessment of the treatment’s lack of success was substantiated when he made yet another suicide attempt near the end of his ECT treatments.

One of the unfortunate possible side-effects of ECT treatments is memory loss. Usually this loss is limited to the period of time while patients are receiving ECT, but in rare cases it can include events preceding the illness. For most, memory deficits with ECT generally improve over time, but even several months after the procedures, David describes reading his high school journals and feeling as though he is reading about someone else. He feels “really misled” about the severity of memory loss that could occur with the procedure.

There is virtually no other treatment in mental health that raises such fear and passion as ECT, or about which such mythology continues to circulate. Hollywood depictions, such as the ECT treatment Russell Crowe’s character underwent in the film A Beautiful Mind, often include sinister music, painful-appearing seizures in unanaesthetized patients and lobotomy-like after-effects. The few studies of patients’ subjective experiences with ECT indicate that patients have many fears, including personality change or brain damage. The majority, however, describe ECT as an overall positive and sometimes life-saving experience, even in cases like David’s, where side effects occur.

What is ECT, how does it work and why does it remain so important in the armamentarium of psychiatric treatments? Electroconvulsive therapy was first used as a psychiatric treatment in the 1930s, in an age before psychiatric medications were developed and at a time when prognosis for those with mental illness was extremely bleak. In the early 1930s, a European physician named Ladislaus von Maduna noticed that patients with both psychosis and epilepsy had fewer psychotic symptoms after their seizures. Von Maduna used injections of camphor to induce seizures in 26 non-epileptic psychotic patients and was able to show either a reduction or complete remission of their psychosis. Later that decade, the physicians Luigi Bini and Ugo Cerletti began using electric current to initiate the seizures, which caused fewer side effects than the camphor injections. The seizures themselves were physically traumatic, sometimes resulting in broken bones. In the 1940s, the medication curare entered use as a muscle relaxant to stop the muscle contractions so that the brain experienced the electrical events of a seizure, but the body lay peacefully calm. Advances in ECT and anesthesia technique have further minimized side effects and risks.

An ECT procedure is short, taking about 15 to 20 minutes including preparation time. Patients receive IV sedation with an anesthetic agent so they are not awake for the actual procedure. Two electrodes are then attached to the scalp in positions determined by the type of therapy received: unilateral therapy, with both electrodes on the non-dominant–usually right-sided–half of the head generally produces fewer side effects, while bilateral therapy, with electrodes on either side of the head, is more effective for more severe depression. The actual shock lasts little more than one second. Brain wave monitoring allows the doctor to observe the seizure that occurs, and anesthesiologists watch the patient’s blood pressure, breathing and heart rate. A normal course is six to twelve treatments, which may be given as frequently as 48 hours apart. Often patients begin to feel improvement as early as the second or third treatment.

ECT is the most rapid and effective known treatment for mood disorders, both depression and mania. Antidepressant medications relieve symptoms of depression 45 to 60 percent of the time, whereas ECT is effective in 80 percent of depressions. While antidepressant medications may take weeks to start working, ECT can show dramatic effects within days. In highly dangerous mood episodes, those accompanied by psychotic symptoms (hallucinations, delusions, thought disorganization), agitation, refusal to eat or high suicidality, the immediate effects of ECT can be life-saving.

Problems with memory and confusion immediately following the procedure are the major side effects that can accompany ECT. Confusion can be frightening for patients and their families, but is short-lived. During this time patients may not be aware of where they are or may not recognize people familiar to them. Confusion generally resolves over a period between 30 minutes to a few hours. Memory loss is generally limited to events in the weeks immediately surrounding the procedures, but can be more extensive in some individuals. Memory effects can be either loss of memory for events preceding the procedure (retrograde amnesia), or difficulty storing new information (anterograde amnesia). Changes in ECT technique over the past one or two decades have reduced the severity of memory loss. Memory effects usually improve with distance from the ECT procedures, resolving six to eight weeks after treatment in many cases. Because of anterograde amnesia during the treatment process, it is not uncommon for patients to retain some gaps in memory for the period of active ECT treatment. Factors that are associated with more severe memory effects are bilateral ECT treatment, a larger number of treatments and high-dose ECT (as opposed to a titration method, where the patient receives the lowest dose needed to produce a seizure). Studies have shown that the extent of memory loss is unrelated to the benefits of ECT, and improvement in mood is not due to forgetting one’s problems.

Many patients considering ECT also fear they will suffer irreversible brain damage. More vocal opponents of ECT have compared it to minor head trauma and have claimed that ECT causes brain atrophy, cerebral bleeding, edema (brain swelling) and neuron death similar to prolonged epileptic seizures. In general, these claims are based on early, uncontrolled and methodologically flawed studies. We now know that major depression itself is associated with structural brain abnormalities on MRI scans. Newer studies that have examined brain structure both before and after ECT have shown no changes or brain swelling from the procedure. Reliable studies from both humans and primates have identified that neuron death in epilepsy occurs only with prolonged uninterrupted seizures (more than 20 minutes) and is mainly a result of low oxygen. In contrast, seizures during ECT treatment last less than three minutes, and the patient is well-oxygenated by mask the entire time. ECT does not raise levels in the bloodstream of chemicals that are markers for brain trauma. The preponderance of evidence from a large number of well-designed studies with modern research techniques has found no evidence of structural brain damage from ECT.

Despite the many theories and observations, the exact mechanisms for how ECT works are not precisely understood. Some of the brain effects recently noted with ECT are similar to the effects found over longer periods of time with antidepressant medications and even with non-medication treatments such as psychotherapy. For instance, recent research has shown that ECT increases a growth factor called brain-derived neurotrophic factor (BDNF), a chemical that is responsible for maintaining cell growth in the hippocampus–a brain area involved in mood and memory. Studies have shown that in depression, levels of BDNF decrease and the cells lining the hippocampus begin to thin out. There is also evidence that as individuals begin to respond to antidepressant therapies–whether pharmacological, psychotherapeutic, or perhaps just exercise–BDNF increases and hippocampal cells return to their pre-depression state.

While ECT is currently the most effective known treatment for an episode of depression, particularly depression with psychotic symptoms, its effects are temporary. After a successful course of ECT treatment, individuals can often maintain their remission from depression with medication, even if medication was not successful in bringing them out of the depression originally. Others find that no alternative treatment works for them except ECT. For these individuals ECT can be continued in less frequent “maintenance” sessions (given, for example, once a month), often with concurrent use of medication. Some critics have equated ECT’s lack of permanence with lack of effectiveness, but this criticism misses the point. Depression is a chronic illness, in the same way diabetes and heart disease are chronic illnesses. When one stops treatment for any chronic illness the symptoms will return.

For those who fail to respond to medications alone, new treatments for severe depression may soon be available as alternatives to ECT. A procedure called repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses applied to the scalp to stimulate underlying brain structures. Intermediate research results of rTMS are showing similar results to ECT for non-psychotic depression. Advantages of rTMS are that is does not produce seizures or cognitive side effects and does not require anesthesia. Studies are underway to determine the best locations and intensities for the magnetic pulses, and if rTMS is effective for other conditions treated with ECT, such as mania.

Depression is the leading cause of days missed from employment. It is also one of the major risk factors for suicide (studies show that one in six patients with depression commits suicide). When an illness itself is debilitating, evaluation of any treatment must consider the risks of not treating the illness as well as the risks of treatment. Unfortunately, depression often interferes with individuals’ ability to absorb, understand and remember the information presented to them, so weighing alternatives can be difficult. Those considering ECT should request written information about the risks and benefits. If possible, a friend or family member should be present to hear the explanations and help weigh the alternatives.

In David’s situation, he has noticed other improvements from the ECT that have allowed him to return to normal functioning. ECT eliminated his psychosis (his disorganization and delusions) when medication was unable to do so. Also, while he subjectively remained depressed during ECT, his functioning in terms of being able to take care of himself (get out of bed, remember the day and date, attend some activities, etc.) did improve. Furthermore, since his ECT treatments, David has been able to respond to antidepressant medication.
When asked recently, David indicated he did not regret having ECT, despite the serious side effects he has experienced. “You would have to see my journals from back then,” David says. “I don’t think people knew how crazy I was. If I hadn’t had the ECT, I would still be psychotic. I wouldn’t be on medication that worked and I wouldn’t be going back to school.”

Offset presses are getting faster, cleaner and more efficient and the same is true of the cleaning chemicals used on them. Sadly though, where a printer may be happy to spend extra money to get every imaginable bell and whistle to improve the efficiency of a new press, when it comes to the consumables the purchasing decision can still be driven by price alone. But as Yarn national sheetfed manager Steven Haig says: “You don’t buy a RollsRoyce and then put two-star petrol in it.”

Washes are used to clean ink and other contaminants off blankets and rollers. Most blanket/roller washes are based on hydrocarbon solvents, and the blend of solvents is balanced for the speed of drying. The higher the volatile organic content (VOC) the faster the product will dry and the quicker the makeready. The downside is that washes with a higher VOC have a lower flashpoint.

VOCs are a hot topic right now. According to Haig: “There’s been a big drive to comply to the UK Health and Safety Executive solvent substitution scheme.” The scheme is voluntary at the moment but it’s been hovering around for a while and it’s only a matter of time before it becomes legislation. The Solvent Substitution Scheme’s aim is to introduce solvents that have a flashpoint above 55°C.

One of the biggest changes in the roller and blanket wash market in recent years has been the proliferation of automatic wash systems. The vast majority of presses use them and although they can reduce the amount of wash used and increase efficiency, as a rule the chemistry – more highly refined solvents or solvent substitutes with lower VOCs – comes at a premium. But lower or VOC-free products have the bene- fit of not only being safer for the user and compatible with auto-wash systems, but also better for the environment, as they have fewer, or even no, aromatic hydrocarbons.

It can be very important to make sure that you are using chemicals that are approved by the press manufacturer, especially for the state-of-the-art presses where using the wrong chemicals can not only damage the machine, but possibly invalidate your warranty. The manufacturers of solvents submit their products to Fogra and upon meeting the criteria the products are issued with a pass certificate, stating that the chemicals are suitable for use with the press’ auto-wash system. Details of approved products are available from the press maker, chemical manufacturer or Fogra itself (www.fogra.org).

One interesting development in terms of reducing the cost of wash chemicals, while at the same time becoming more eco-friendly is the Technotrans Ecoclean. It recycles the solvents from your presses so that once cleaned they only require a 5% virgin solvent solution to be added before being re-used on the press.

Manufactured low-cost solvents that use ketones or acetones tend to be more aggressive and, although cheaper initially, they can end up costing more in the long run in terms of reduced blanket and roller life. Some chemical manufacturers reduce the costs of their products further by using reclaimed solvents, but here product quality and safety is a contentious issue. Reclaimed chemicals may reduce the manufacturing costs of the wash but data is rarely available on the product’s origin or sometimes even its composition, which makes it hard to guarantee its quality or safety.

Plate cleaners differ from washes in that they’re generally still applied by hand and are sold in far smaller containers. They’re used to remove ink and other contaminants from the plate before storage or recycling. A good plate cleaner will help to repair surface scratch damage inevitably picked up by the plate during its transport around a shop floor.

When sourcing wipes, look for softness, absorbency and linting capacity. Virtually all wipes are now disposable, the launderable wipe is very nearly extinct. There has also been a definite shift away from wipes impregnated with a cleaning solution. In fact, no manufacturers we contacted offered impregnated wipes. With the vast choice of plate, blanket and roller washes now available, all with their own specialist applications, it no longer makes sense to pre-impregnate the wipes.

Insulin pump therapy, also known as the Continuous Subcutaneous Insulin Infusion (CSII), is more expensive way to counteract Type 1 Diabetes, rather than the conventional syringe or pen therapy. In countries where insulin pumps are not subsidized, they may be difficult to afford. If this applies to patients, they may ask their diabetes team whether they might be eligible for any grants or other financial help from local organizations or national charities (Hanas 2003, p. 160). This is more convenient for children or working individuals with Type 1 Diabetes because it delivers intensive insulin therapy that is considerably more stable to absorb, it lowers the risk of nocturnal and activity-related hypoglycemia, and it enhances the lifestyle of patients to become more flexible.

Continue reading “Insulin Pump to Assist Patients with Type 1 Diabetes” »