PART 4 of 5: NPWT, WOUND INFECTIONS, BLEEDING AND INJURY REPORTS and BLOOD PRESSURE DEVICES and INFUSION PUMPS
NPWT, WOUND INFECTIONS, BLEEDING AND INJURY REPORTS
Among its many actions concerning different types of medical devices, the FDA-CDRH will upgrade its Medical Device Home Use Initiative to improve the use of the negative pressure wound therapy systems (NPWT) after releasing an agency safety communication Feb. 24, 2011 to warn healthcare providers, patients and caregivers about the increase in the number of instances of serious complications such as bleeding and wound infection from their use.
The communication comes as the FDA receives reports of six more deaths and 97 injuries for a total of 12 deaths and 174 injury reports since 2007 after releasing its Nov. 13, 2009 guidances titled “Preliminary Public Health Notification” and “Advice for Patients”.
With regard to death and injury reports to the FDA, wound infection took place in more than half the cases with most being linked to maintaining the dressing pieces of the wounds. As a result of the infections, patients had delayed recovery and needed wound treatment, removal of dead tissue and drainage.
Bleeding is the cause of most adverse events and was reported in 12 patients. It occurred in patients who had blood vessel grafts, wound infections, medication for blood clots, and removals of dressings of tissues. Most cases were related to shock, low blood pressure and swelling containing blood, a condition also known as hematoma. Some patients needed more surgery to stop the bleeding, transfusions, admission to the emergency room and hospitalization.
The FDA-CDRH recommends the following for health care providers:
- Choose patients carefully for NPWT contraindicated for wound types and risk factors;
- Assure that patients are monitored;
- Be on guard for life-threatening complications such as bleeding;
- Be aware of complications due to dressing changes;
- Obtain proper training, and;
- Resume NPWT as soon as a patient is transferred to the home or another care facility.
The agency recommends the following for patients and their caregivers:
- Receive adequate training from doctors, nurses or home health care aides;
- Understand the possible complications that may be linked with using the NPWT device;
- Be aware that complications take place, and dressings have to be changed;
- Get NPWT patient instructions from doctors, home healthcare providers, NPWT distributors or the maker’s website, and;
- Talk to the doctors if incapable of managing the NPWT device at home.
NPWT forms a system of care for open wounds by removing fluids and waste material, using negative wound pressure at a wound site and drawing the edges of the wound together.
The systems are made up of a vacuum pump and make a negative pressure environment within a sealed wound. They also include dressing materials to pack and seal the wound; tubing to remove fluids; and a container to collect waste materials that are suctioned out of the wound.
The agency’s Medical Device Home Use Initiative was launched in April 2010 to do the following:
- Establish guidelines for makers of home health care use devices;
- Develop a device labeling repository;
- Partner with accrediting bodies for safe use, including such technology as nanotechnology or health informatics such as electronic health records;
- Improve postmarket supervision, and;
- Boost public awareness and education.
The FDA-CDRH created a 10-month pilot program in the summer of 2010 to help “pre-market” stakeholders such as device makers submit their labeling to the agency for posting to an Internet depository. This resource will help “post-market” stakeholders such as hospitals, medical facilities, home healthcare patients and caregivers find information about the safe use of their devices.
To support its Medical Device Innovation Initiative, FDA-CDRH sought public comment through April 2011 on proposals contained a report about the subject and hosted a meeting for stakeholder feedback March 15, 2011.
The initiative also has post-market supervision through HomeNet, a subset of the FDA’s Medical Device Surveillance Network, an adverse event reporting database linking 350 healthcare entities nationally.
The intended result is that the FDA-CDRH better understands caregivers and home health care workers and their issues and addresses them. The agency will record cases in which devices meant for a healthcare facility are used at home. The FDA-CDRH has already kept an account of safety concerns pertaining to home hemodialysis and is making similar moves for wound therapy devices.
The agency is working with the Community Health Accreditation Program and the Joint Commission of Accredited Healthcare Organizations (JCAHO), which examines and accredits healthcare facilities and programs, to enforce home health agency accreditation criteria for medical device safe use.
BLOOD PRESSURE DEVICES
Another example of a category of medical device that is increasingly gaining a presence in private homes of the chronically ill and recuperating is the blood pressure device. More BP machines are making their way into home health care for such reasons as “white-coat” hypertension.
Namely, research has found that a person’s blood pressure can be high when measured in a physician’s office as a psychological or emotional reaction to the nature of conversations held with the doctor, the institutional environment or atmosphere on the part of that patient.
In the instance of “white-coat” hypertension, the accuracy of the BP reading of an office machine is compromised, researchers say. To avoid such inaccuracy, more self-monitoring of BP at home using automated devices is being used to assess BP for technical use.
Researchers say home health care BP devices are most effective in early detection and treatment of hypertension when their readings are accurate, their measurements can be replicated and senior patients and family caregivers have enough information to use them properly and safely. Before the FDA created and identified regulations for noninvasive blood pressure (NIBP) monitors and aside from the “white-coat” hypertension phenomenon, many BP monitors were discovered to be inaccurate and lacking in adequate instructions for use.
They say that the accurate measurement is essential to determine risk and to guide treatment. Researchers explain that there is increasing evidence that self-measured BP readings taken at home can often predict future cardiovascular events and are useful for monitoring the effects of hypertension treatment.
An automated home BP monitor can cost as low as $20, contains manual inflation units and may feature printers and USB ports. The monitors are regulated to have the same performance standards in home health care as they do in hospitals or other formal health care settings.
Federal agencies in the United States are not the only entities to have expressed concerns and craft policy on the development, re-design, training and proper use of BP machines. As early as 1987, the Arlington, Va. nonprofit Association for the Advancement of Medical Instrumentation (AAMI)’s sphygmomanometer committee (SPIO), the British Hypertension Society and the European Society of Hypertension developed standards that led to an increase in the number of home use BP devices with validated accuracy.
A sphygmomanometer measures arterial pressure and reports values in millimeters of mercury through devices that do not use mercury. Like a BP machine, it operates with an inflatable cuff to restrict blood flow. It is often used with a medical stethoscope.
Specifically, the AAMI-SPIO committee standards specify safety, labeling and performance requirements designed to protect patients and family caregivers. While they need not do so, manufacturers designing and testing their products and who must meet AAMI requirements and the standards of world bodies the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) typically label their packages to indicate compliance.
Packaging for the home health care BP monitors must provide the following details: identification of the appropriate range of arm circumferences on which the enclosed cuff component of the machine can be used; the operating and storage temperature and humidity ranges; and battery use requirements.
AAMI has created a new home healthcare committee called Medical Devices and Systems in Home Care Applications to tackle key issues, which complements the FDA’s Medical Device Home Use Initiative. The standard will raise the bar for home healthcare devices for safety of construction and installation, electromagnetic isolation, and safety when in use. Already, the FDA has joined with the AAMI and the IEC to develop a general standard IEC 60601-1-11 for medical electrical equipment and medical electrical systems intended for home health care.
Johnson says that User Centric is a member of AAMI and works with the other members to advance safety in medical technology. As a member of AAMI, company consultants attend meetings and participate in discussions about standards, guidance, and best practices for the testing and development of medical devices.
“We now see medical device making efforts to comply with the guidelines created by the FDA,” he says. “We see their behavior shifting. There is more training and much greater focus is being placed on formative and summative testing to incorporate human factors into the product design process.
Additionally, the ISO-IEC regulation titled 60601 contains language that dictates other requirements for home health care equipment under IEC 60601-1-11:2010.14. In particular, IEC 80601-2-30:2009 provides guidance for major non-electrical safety issues to address problems in the pneumatic system of a special class of BP machines known as automated sphygmomanometers.
Specifically, malfunction problems in the inflation cycle of the BP machine include a high target inflation pressure for the intended population, too long an inflated period or too rapid a repetition rate for a long period of time.
Additionally, an inflated cuff of a BP machine could fail to deflate during a determination when the device is turned off or loses power. Any one of these conditions could create injury to an aging patient, which could occur undetected if the devices are used in a private home. FDA standards provide details of how the device works under single-problem conditions to alleviate the chance of a mishap involving a patient, including a senior.
The FDA rule allows for a disruption of a specific automatic mode useful for the measurement of blood pressure at home or in a doctor’s office. Recommendations for the diagnosis of hypertension include at least two determinations to be taken every minute and the average of those determinations that must be taken as the patient’s blood pressure, including a senior. The allowance is due to the increased use of home BP monitors. The period between measurements, as directed by the manufacturers, may be from several second to minutes.
As with all devices, automated sphygmomanometers must meet electromagnetic compatibility requirements. Testing instructions and toleration for error for the device are contained in one rule. Validation methods and accuracy are also in the FDA regulation.
A BP monitor will be exposed to external pressures. As a result, it must be strong enough to absorb vibration, shock, bumps and drops in daily use. The FDA standard governing this takes a private home or hospital setting into account. Testing requirements vary based on whether the BP monitor is handheld or mobile. Many are handheld devices. After testing, the device must continue to meet all safety and performance standards.
INFUSION PUMPS
Additionally, the FDA-CDRH is creating an initiative for pump manufactures, will ease device improvements and educate users to address the safety problems associated with external infusion pumps. Infusion pumps are connected to control, accuracy and precision in drug delivery in diminishing medication errors and assisting with patient care.
The pumps are medical devices used to delivery fluids such as nutrients and medications such as antibiotics, chemotherapy drugs and pain relievers into a patient’s body in limited amounts. Examples include large volume, patient-controlled analgesia (PCAs) or pain-relieving pumps, elastomeric, syringe, enteral or gastrointestinal and insulin pumps used in all health care settings and for home health care.
The FDA has found problems, potentially leading to over- or under- infusion, missed treatments or delayed therapy. To address them, the agency has drafted a guidance to infusion pump premarket notification; sent a letter to pump manufacturers April 23, 2010; held a workshop on May 25-26, 2010 on a generic pump project; held presentations in October 2010 on such subjects as leadership on the proper use of the pumps by the most influential healthcare providers, standardization of user interfaces, drug libraries and filling data gaps on incidents; and created a website to report adverse events.
Infusion pumps in a hospital setting might undergo testing or preventive maintenance annually, with the staff cleaning it between uses. As a result, a hospital BMET might see the pumps on campus once a year.
The efforts have paid off, industry leaders say. Use of the pumps has been found to improve overall health. Research states that more frequent treatments with infusion pumps decrease medications and enable patients to feel mentally sharper and to gain weight, enhancing the patients’ sense of well-being.
Continue reading Part 5 next week…
Vladimire Herard is a freelance writer in Chicago. She was a health writer and online publication freelancer for the Guidance Channel, Longtermcare.com and States News Service for five years. For Community Development Publications, a publication chain in Silver Spring, Md., Ms. Herard wrote and edited newsletter articles about senior health and housing (Housing the Elderly Report and Aging News Alert); substance abuse prevention and treatment funding (Substance Abuse Funding Newsletter); health care financing (Inside HCFA); and food and product safety issues (Inside FDA) for four years. She has written articles about public education reform, county affairs, crime and community development for the Chicago Defender daily newspaper, the Syracuse Post-Standard and Syracuse Herald-American daily newspapers in New York state and the Pride of Syracuse monthly newspaper in New York state for five years. A print journalist for 18 years, Ms. Herard holds a master’s degree in newspaper from Syracuse University and a bachelor degree in liberal arts from Loyola University in Chicago.
