Single-use medical devices include any type of medical equipment, instrument, or apparatus that is disposed of after a single-use in a medical facility. The Food and Drug Administration (FDA) defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. It is not reusable and, therefore, has a short lifespan and is limited to one patient.
There are countless types of single use medical devices, ranging from external, such as plastic gumboots, gloves and bandages merely used to assist a patient to more complex and internal devices, consisting of sharp blades, needles and tubes. Both these devices are single-use due to their in contact with radioactivity, blood, infection, disease or human tissue and must therefore be terminated. Each country has its own strict legislation regarding medical waste and the reprocessing of medical devices in hospitals and clinics.
Reasons for single-use only
There are multiple reasons why single-use devices are disposed of after using, which include:
Design features The device may be manufactured a certain way, making it impossible to properly sterilize, decontaminate, and disinfect. This aspect of medical devices could possibly inflict harm on a patient if reused, causing cross-contamination to occur if the medical devices were used for different patients.
Patient Safety and Diminished Functionality There could be excessive bacteria left over on the device, even after sterilizing, which could spark reactions and be hazardous. The cross contamination of this bacteria could contribute to the spread of HIV and Hepatitis B or C when unsterilized needles are reused to give injections. Additionally, the device could easily absorb chemical residue from disinfectant agents, contributing to the accumulation of chemical burns and chemical reactions in patients. The device might not be able to reach its supposed level of functionality after being reused or remanufactured, causing the devices' medium to become weak and impractical. This could decrease the effectiveness of the medical device when performing its clinical function, putting patients at risk for inadequate treatment and other harmful effects.
Different devices
Single-use devices stretch over a large area of the medical industry. Different devices are used in every region of the world and also every area of the hospital.
First world countries would have access to a larger range of devices than third world countries, who struggle to even get in contact with medicinal products. Examples include: Hypodermic needles, syringes, applicators, bandages and wraps, drug tests, exam gowns, face masks, gloves, suction catheters, and surgical sponges. Other examples can include but are not limited to pacemakers, mercury thermometers, and tongue depressors.
Some examples of single use devices that can be reprocessed are ventilator circuits, biopsy forceps, blades and drill bits, vaginal speculums, breast pump kits, clamps and ET tubes.
Different medicinal devices have different regulations regarding patient risk, classified as Class |, Class ||, or Class ||| with an increasing risk as the classes increase in value. Examples of the devices classified in each class include:
Class |: tongue depressors, elastic bandages, etc. Class ||: electrocardiographs, mercury thermometers, and bone drills Class |||: pacemakers, replacement heart valves, etc.
Legislation Each country has their own strict legislation on single use medical devices. They all feature similar overall ideas, that focus on putting a patient's health and safety first, with clear emphasis on sterilization.
Australia "Medical devices are defined as follows by the Therapeutic Goods Act 1989 : a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
i. diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii. diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap;
iii. investigation, replacement or modification of the anatomy or of a physiological process;
iv. control of conception;
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
b. an accessory to such an instrument, apparatus, appliance, material or other article.
The Therapeutic Goods (Medical Devices) 2007 Regulations require a healthcare facility that reprocesses single-use devices to be licensed as a manufacturer. A healthcare facility that reprocesses single use devices would be considered to be a manufacturer under the Act and thus would be required to conform to the regulation and be subject to audit to ensure compliance."
Canada Over a quarter of Canada's hospitals reuse single-use medical devices, a rate which resembles that of the United States. However, Canada has no national regulations regarding single-use medical devices, as all regulations that exist remain at the provisional level and are simply suggestions for compliance implemented by organizations such as Health Canada as well as The Canadian Patient Institute. Regulations may be imposed, but it is often up to the hospital or regional health authorities to implement regulation regarding single-use medical devices.
Only about 10% (43/422) of Canadian Hospitals included in a study undertaken by the Canadian Hospital Epidemiological Committee and Health Canada have in-hospital "reuse" committees and regulations regarding the safe reuse of single-use medical devices. The lack of regulation in Canadian Hospitals, therefore, leads to the excessive reuse of single-use medical devices, compromising patient health and safety.
United States of America Legislation regarding single-use medical devices in the United States is regulated and enforced by the FDA and mostly resides in the reprocessing of single-use medical devices. Despite previous problems with the reprocessing of single-use medical devices, or SUDs, during the 1970s in an effort to save money and prevent the accumulation of medical waste, legislation has been amended since this period to regulate device manufacturers, third part reprocessors, and hospitals that reprocess SUDs. In this way, these companies are regulated the same way as original equipment manufacturers in order to promote patient safety and effectiveness of the single-use medical devices.
The FD&C Act, enacted by the U.S. Food and Drug Association (FDA), is the preliminary form of legislation that is responsible for maintaining regulation regarding the reprocessing of single-use medical devices within the United States. This act and its amendments ensure reprocessed single-use medical devices continue to comply with FDA requirements after each instance of reprocessing as well as reprocessed single-use medical devices present reprocessing validation testing upon submission to the FDA. This act exists in 3 classes:
Class | and Class || Reprocessed SUDs:
In accordance with section 501(o) within the FD&C Act, reprocessors of Class | and Class || SUDS must submit to the FDA appropriate testing and evaluation data up to the maximum number of times a single-use medical device can be reprocessed, including the following criteria:
Cleaning Disinfection Sterilization Functional Performance with included rationale of maximum reprocessing capacity Class ||| Reprocessed SUDs:
In accordance with section 501(c)(2)(A) within the FD&C Act, reprocessors of Class ||| single-use medical devices must submit a premarket report to the FDA that includes but is not limited to the following information: device name, registration number, actions taken to comply to performance standards stated in section 512 of the FD&C Act, proposed labels of reprocessed material, description of device makeup, additional necessary data, etc.
Labeling and Postmarket Requirements:
Reprocessed single-use medical devices must be labeled accordingly and include the fact that they are reprocessed and the company responsible for the reprocessing in the label. This section of the FD&C Act, section 502(v), also states that any reprocessed SUD that does not include this label will be considered "misbranded". Third party and healthcare facilities must also follow these labeling regulations, as these facilities must meet the same requirements as the original equipment manufacturers.
Environmental concern
Production The production element of single-use devices is very simple. There are multiple large manufacturing companies, that produce these medical devices, shipping them world wide to different hospitals, clinics and academic centers. The different processes, such as planning, building, producing, packaging and shipping all happen in this step of the process and is done by the manufacturers or 'third-party' companies. The devices are only received by the consumers after all aspects of the product are in perfect condition. The consumers (hospitals, clinics etc.) do not take a part in the production process, nor in the disposal or reproduction process. This is all done by 'third-party' organizations. Production of single-use medical devices leads to excessive pollution due to the plastic composition both within the device and its packaging, which is increased due to the single-use nature of the medical devices. Since these devices are only used once, more must be made, causing single-use medical devices to be the cause of 80% of the healthcare industry's carbon footprint through the devices' production, transportation, use, and disposal.
General medical waste Plastics have been the main material used in single use devices since the 1960s, where raw materials, such as glass, rubber, metal and woven textiles were in practice before. The modern production of poly-vinyls, polycarbonates and polystyrenes have substituted these previously used materials and have dominated the disposable healthcare market ever since. The main reason for this forward driven use of plastics, was because of economic reasons, as it was cheaper and more efficiently manufactured. This drastic change in materials used in the healthcare industry positively under held the increasing need for medical procedures with a growing globally population, resulting in fundamental changes in the legislation and producing that governed medical device manufacturing, use and disposal or waste.
The single use medical devices phenomenon has only recently occurred, as these previous medical products would undergo sterilization and disinfecting onsite and be reused, but following the substitution of petroleum-based plastics, these devices would be received, used and then disposed of, which increases the quantities of medical waste enormously over the past decades globally. The production of SUDs has set trends universally in the medical industry, making it impossible to rely on any other source of device.
According to a study analyzing the reprocessing capacity of single-use medical devices, most of these devices had a percentage of polyethylene in their contents, ranging from 7%-88% for individual devices and 52% for the accumulated average. Polyethylene is a common plastic that, when improperly disposed or recycled of, leads to polyethylene pollution and decreased soil absorption capacity, promoting larger implications such as the harm of organisms within the soil as well as reduced diversity of soil microbes.
Hazardous medical waste