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Medical devices have a $200 billion year market, yet there is a risk with each medical advance, especially in medical devices. Billions of dollars are spent researching and developing new surgical procedures, rehabilitation, technology, and medications. Defective medical devices can cause great harm to patients, and make the conditions worse than the problem they already suffer.
Patients are asking their doctors for newest technologies from genetic testing to specific radiation treatments, and doctors have trouble finding the latest evidence-based information. The only information they get this from the manufacturer.
FDA ROLE
The FDA oversees many products to make sure they're safe for you the patient. The FDA gathers reports of medical device problems and alerts you the public about them. They may require the manufacturer to issue a warning statement, and maybe even a recall of that particular product.
If there is a new indication for an already marketed device, the device must be subject to new investigation.
The FDA regulates more than 100,000 different medical devices from more than 15,000 manufacturers—in addition to receiving several thousand new and supplemental applications each year—and are expected to evaluate and approve these devices without delay. How can they monitor the safety of every device they approve?
Thousands of medical technology applications are submitted each year to the FDA, and less than 100 of them undergo scrutiny required for new drugs. They rely and manufacturers and clinical investigators to initiate recall and failure reports. The FDA is limited in oversight of these new medical technologies. There is a need for an independent review organization to provide transparent objective evaluations.
FDA REVIEW PROCESS
Assessments should require that the information be published or accepted by a peer-reviewed journal. This allows companies to make their trial results available to you the public.
Many medical devices that have proven defective, as: Stryker hip implants, Medtronic defibrillators, and cool mesh hernia patches, have injured countless people. These medical devices have not been subject to the rigorous review process as drug companies have.
A report by the Government accountability office for the five years of 2003 2007, showed 228 medical devices were approved without full review. Scientists were pressured to approve medical devices against their professional judgments.
Nine FDA scientists complained a corrupt review process was putting public health at great risk. These scientists provided a detailed list of laws that the FDA officials have violated. They asked for immediate intervention. They complained that some class 3 devices should be classified as class 2 devices and others should be tested more. Manufactures claim that the FDA is already overly restrictive.
Problems arise when exceptions are made for improvement to devices already on the market. They convince the FDA devices are substantially equivalent to the ones on the market. The FDA acknowledged the problem and said they either have to carry out full reviews on all products, or reclassified some devices at lower risk.
Over two dozen distinct devices escaped close scrutiny: metal hip joints, external defibrillators, and electrodes for pacemakers, all put patients at risk.
FAST TRACK APPROVAL
Medical device companies ask for a fast-track approval, claming their device is similar to other products already on the market. The FDA reviewers however felt, this was a new product that needed more extensive clinical trials to prove its safety and efficacy.
There is a heated internal battle in the FDA agency device division, charging that FDA officials routinely approve for sale high-risk medical devices even though the manufacturers never prove their products are safe or effective.
The FDA normally divides devices into three classes. Class I, are exempt from agency reviews (as reading glasses, tongue depressors). Class 2; get quick reviews (as mercury thermometers). Class 3 devices must be proven through extensive testing that they are safe and effective (as pacemakers, and replacement heart valves).
Annually there are tens of thousands of reports alleging harm from devices. The device industry avoida the FDA,s rigorous oversight of thousands of medical devices every year. Millions of Americans benefit from these devices.
CONGRESS ACTION
Congress is demanding more scientific device evaluations from the FDA. New FDA commissioner, Margaret Hamburg, vowed she would examine the approval process with a comprehensive analysis. Some lawmakers felt that with competent management, enforcement, and more funding to the FDA safety would be improved. The FDA claims they have a lack of resources and increasing technical complex city of these medical devices are to blame for their inability to maintain safety standards.
Congress is trying to change its original intent to allow injured patients to recover for injuries caused by manufacturers of defective medical devices.
The new bill S540 Medical Device Safety Act of 2009 “is being proposed to amend the liability under state and local requirements. A recent 2008 Supreme Court decision in Riegel vs Medtronic, created this uproar. It would reverse the court decision that gave legal immunity to manufacturers of defective medical devices that were approved by the FDA under the premarket approval process.
The Supreme Court ruled that the medical device amendments of 1976 of the Federal Food, Drug, and Cosmetic Act, overrides state law for wrongdoing for which action in damages may be brought.
Congress says they never intended that the FDA approval would give blanket immunity to device manufacturers from liability for injuries caused by their faulty devices. It has resulted in a green light for shoddy practices by manufacturers. Manufactures would not have total immunity from any claims because the FDA approved their device.
FDA ACCUSED
We all know medical devices must have adequate quality and safety and not harm us. The GOA, (Government accountability office), claims the FDA is efficient in protecting us from safety risks
Accusations are made that: the approval process for medical devices need a major overhaul. The GAA has over-reported inadequate post-market surveillance and are not regularly inspecting medical device manufacturing facilities. Preapproval reviews and postapproval monitoring have been inadequate They claim, the FDA is incapable of guaranteeing safe medical devices, and manufactures must be wholly accountable for their products and effectiveness.
Rigorous review processes were not required for all of the most potentially harmful devices, and the agency has a difficult time analyzing that tens of thousands of reports received annually claiming injury from devices.
Recent recalls of defibrillator wires and other devices raised doubts as to the FDA's ability to identify safety problems. The FDA has recalled over 20% of automated external defibrillators.
Formerly, the process-streamlined clearance for products that were deemed, substantially equivalent, if two devices were already on the market. It accelerates innovation and bills on the expanding knowledge.
Now the FDA is tightening the fast track process, (known as 510 K), under new Obama appointed FDA head, Peggy Hamburg, who is reviewing the entire process. Clearance for new devices will now require more indications that in the past. By requiring more evidence for approvals, development costs will increase, making it more difficult for device developers to enter the market with their products.
The FDA is now scrutinizing certain applications more severely. Device makers will now have an increased tax on their device devices to the tune of $40 billion over 10 years.
The 510 process did not require lengthy clinical trials, and allowed device makers to get their products to market quickly. Many companies have been using the process too often for complex products that required more testing for safety and efficacy. These multiple reviews now will certainly result in fewer medical devices entering the marketplace.
Zimmer holdings, the largest maker of hip and knee replacements, had recently some product issues with replacement hip cups. Surgeons reported the cups were loosening and repeated surgery was necessary. Zimmer now has included two new hip parts to help the company improve its market but they too will have to be approved with new intense scrutiny.
HAZARDS OF OTHER DEVICES USED TODAY
The Emergency Care Research Institute (now called the ECRI Institute), an international non-profit organization dedicated to improving patient safety and care listed the top 10 hazards currently related to medical devices. The list is based on the experience of its expert technicians, who investigate and consult on device-related incidents
ALARM HAZARDS
Devices must limit false or excessive alarms, the volume must be loud enough to be heard, and visible indicators must be seen. The staff must know why it's appropriate and meaningful. Problems tend to occur in pulse oximetry monitors and ventilators.
ACCIDENTAL NEEDLE STICK INJURIES
There must be good disposable techniques that are effective, and disposals must offer good protection.
CONTRAST MEDIA INJECTORS
Contrast media is injected into the vessels with power contrast media injectors. There is a risk of injecting error resulting in fatal air embolisms. There should be standard protocols defining who does tube checks rather than assuming someone else will do them. Those who prepared the injectors must be trained and disposable items must be labeled. A second clinician must verify that the injection tubing is tightly free and that there is no contrast media outside of the tubing that could interfere with error detection. Before injection clinicians should inspect the tubing and injector for possible air bubbles
FOREIGN BODIES LEFT IN PATIENTS
During surgery, sponges may end clamps may be left hidden by body tissues. Catheter tips or foresaw jobs breakaway and fragments are left because the doctor fails to notice them missing. Often the decision is made to leave it because it is too risky for retrieval. Such retention can lead to serious infection or damage to the surrounding tissue. If the patient has a future MRI, the retained metal can heat or migrate resulting in Burns.
Devices should be visually inspected as soon as they are removed from the patient and it should be systems to locate retained surgical sponges before a procedure is completed. Devices should be visually inspected before they are used to see if they were damaged, and should be looked at immediately after they are removed.
SURGICAL ELEMENTS
Electrical devices and lasers can stay hot for some time after they are used and must be discarded safely. Accidents are more likely if there is supplemental oxygen being used. Drinks must be arranged to prevent the pooling of oxygen. The amount of oxygen use must be kept to a minimum. Towels and electrical must be kept as far away as possible from the ignition source. Alcohol-based preparations must be decorated before electoral surgeries started. And sponges must be moistened to reduce their flammability. Electrical cables and oxygen hoses should be inspected regularly be forced surgery.
ANESTHESIA EQUIPMENT PROBLEMS
Breathing circuits are mis-connected, ventilators are leaking, and empty gas cylinders are used. All devices and accessories used in anesthesia, as manual resuscitators and scavenging equipment, must be inspected. A checklist should be used prior to every anesthetic being given.
MEDICAL DEVICE DISPLAY SYSTEMS
Some displays are ambiguous or counter intuitive and may result in false readings resulting in treatment decisions being made on this false information. Device displays that may pose a real risk report of confusion should be assessed and pre purchased trials should be done.
CT RADIATION OVERDOSES
CT radiation doses CT scans may be responsible for about 6000 additional cancers a year. The patient should not be unnecessarily exposed to high dose levels. The benefits of a CT scan must outweigh the radiation risk. Guidelines should be regularly reviewed especially for children CT scans. Protocols should minimize doses, and monitoring should be part of quality control and equipment maintenance. Referring doctors should have access to this information.
MRI BURNS
MRI burns are a common hazard. Cables crossing each other, conductive cables that are looped, exposed symmetry sensors are placed too close to the radiofrequency coils, blankets and sheets are used rather than manufacture supplied padding, all can cause poor magnetic contacting. Sensors, tables, and MRI accessories (as RF coils and cables), should be checked for breaks in insulation. Headphones and video goggles used, must be checked for signs of damage. Heating can still occur during MRI's high scan, and the patient should be told to shout if they feel heat during the scan.
Fiber optic light sources, retractors, and headlamps, can all cause burns at the end of the cable or if the scope is placed on a patient without shutting off the light source. Cable connections can be heated if the cable is too large for the light post on the connecting device. Light sources must be turned off, or placed in a standby mode, before removing the cables from the light source. Minimum output should be used when performing procedures. All light sources must have safety features, such as power up and standby modes, or any variable output settings.
COMMENTARY
Because the FDA approves a medical device does not guarantee its safety. In 2006, 650 recall actions were initiated involving 1550 products.
Under today’s rules, a negligent device manufacturer is not accountable for the costs incurred when a patient as a faulty medical device removed or replaced. The patient or Medicare is responsible for all the costs. A provision in the device amendments of 1976 authorized the FDA to make a manufacturer pay the replacement of a faulty device.
If this safety act passes, medical devices will be more costly and less accessible and there will be less innovation. Experts and scientists of the FDA now decide the safety and effectiveness of medical devices. A jury of laypersons is not qualified to decide the effectiveness of these devices.
If state courts effectively review and regulate medical devices, it would allow the states to set their own standards for safety and effectiveness. Chaos would result. This bill will result in needless delays in patient access to essential medical technologies, ultimate higher health care costs, and again provide more income for the poor trial lawyers.
Visit www.drneedles.com for more commentaries on controversial medical issues. Your comments are always appreciated.
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