Infusion Delivery Systems and Safety



Infusion Delivery Systems and Safety


Sharon M. Weinstein





FROM IDEA TO INCEPTION

As technology has continued to keep pace with advances in medical science, the delivery of patient care has improved, and more sophisticated devices and innovative equipment have become available for administering infusion therapy. Many of these product concepts have evolved as a result of focus groups or nursing input; those in the field, regardless of the setting in which care is delivered, know what is needed, and nurses are willing to share those concepts. Those who design and manufacture devices do so with outcomes in mind; they are our partners and colleagues.



Nurses, as gatekeepers, play an active role in making product selections that are appropriate for the patient across the continuum of infusion care. Nurses rely on best manufacturing processes, product information, the existing evidence base, and clinical research in making recommendations. As an advocate for patient safety, the nurse responsible for infusion care understands the role of safety and the need to ensure safe use of medical devices and equipment.

Equipment used to deliver infusion therapy is regulated by the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). The organization is a huge asset to the process of care delivery. Its roles are outlined in Box 12-1. Simply stated, a medical device is an instrument, apparatus, implement, machine, implant, or other similar article recognized in the official National Formulary of the United States Pharmacopoeia intended for use in diagnosis or treatment.


Government Regulations

Before any device may be sold in the United States, it must have FDA approval. Class I devices have nominal risk and include catheter stabilization devices, tape, pressure infusors, and IV poles. Class II devices have a moderate degree of risk and include solution containers, catheters, vessel dilators, introducers, guidewires, and stylet wires. Class III devices are more invasive and carry the greatest amount of risk. Within this category, we find cardiac pacemakers, replacement heart valves, and other surgical devices.

The classification is consistent with the level of review; for example, class I devices must demonstrate “general controls” including proper labeling, adherence to good manufacturing processes (GMP), and adequate packaging/storage.


INSTITUTE OF MEDICINE AND POSTMARKET SURVEILLANCE

In the hallmark report entitled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” published in July 2011, the Institute of Medicine recommended that the FDA develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze, and act on medical device postmarket performance information. The FDA’s postmarket surveillance system specifications are listed in Box 12-2.

Once the device has been introduced and used in the clinical setting, postmarket surveillance begins. The system, known as medical device reporting (MDR), involves the
manufacturers, institutions, and professionals and is aimed at reducing possible adverse effects. Specifically, medical device postmarket surveillance should




  • Provide timely, accurate, systematic, and prioritized assessments of the benefits and risks of medical devices throughout their marketed life using high-quality, standardized, structured, electronic health-related data


  • Identify potential safety signals in near real time from a variety of privacy-protected data sources


  • Facilitate the clearance and approval of new devices or new uses for existing devices


A companion to the Institute of Medicine’s 1999 Report, To Err is Human, is Keeping Patients Safe: Transforming the Work Environment of Nurses (Institute of Medicine, 2004). This report identifies solutions to problems in hospital, nursing home, and other health care organization work environments that threaten patient safety through their effect on nursing care. The report’s findings and recommendations address the related issues of management practices, workforce capability, work design, and organizational safety culture. Actions needed from the federal and state governments and from coalitions of parties involved in shaping the work environments of nurses also are specified.


Medical Product Safety Network (MedSun)

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the CDRH. MedSun works collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. Once a problem is identified, MedSun researchers work with each facility’s representatives to clarify and understand the problem. Reports and lessons learned are shared with the clinical
community and the public, without facility and patient identification, so that clinicians nationwide may take necessary preventive actions.

The Safe Medical Devices Act defines “user facilities” as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. By monitoring reports about problems and concerns before a more serious event occurs, the FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death (FDA, 2013).


Nongovernmental Organizations

Nongovernmental agencies play a key role in ensuring safety through oversight and creation of product standards. Appropriate use of devices is critical in ensuring patient safety; the nurse plays an important role in utilizing good technique. Professional nursing societies, such as the Infusion Nurses Society (INS), often provide feedback to manufacturers to initiate change as needed. Nongovernmental organizations (NGOs) and their contact information are listed in Box 12-3.


Jun 19, 2016 | Posted by in NURSING | Comments Off on Infusion Delivery Systems and Safety

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