Single-use medical devices

Short description: Medical equipment disposed of after one use

The Legislation of Single Use Medical Devices

Quentin Bryce

Long title

* Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)

Enacted by| Quentin Bryce
Enacted| 25 February 2010
Do not reuse symbol. All single-use medical products must contain this symbol for medical specialists to see clearly for health and safety concerns.

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.[1] It is not reusable and, therefore, has a short lifespan and is limited to one patient.[2]

## Contents

* 1 Reasons for single-use only
* 1.1 Design features
* 1.2 Patient Safety and Diminished Functionality
* 2 Different devices
* 3 Legislation
* 3.1 Australia
* 3.2 Canada
* 3.3 United States of America
* 4 Environmental concern
* 4.1 Production
* 4.2 General medical waste
* 4.3 Hazardous medical waste
* 5 Reprocessing SUD (Single-use devices)
* 5.1 History
* 5.2 Risks
* 5.3 Ethics and legalities
* 6 Manufacturing companies
* 6.1 Elcam Medical
* 6.2 Cadence Inc.
* 6.3 Sterling Industries
* 7 Reprocessing companies
* 7.1 Innovative Health
* 7.2 Ascent Healthcare Solutions
* 7.3 ReNu Medical
* 8 References

## 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[3] 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.[4] Additionally, the device could easily absorb chemical residue from disinfectant agents, contributing to the accumulation of chemical burns and chemical reactions in patients.[5] 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.[5] 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.[2] Other examples can include but are not limited to pacemakers, mercury thermometers, and tongue depressors.[6]

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.[7]

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.[6]

Medical waste in the form of syringes.

## 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."[8]

### Canada

Over a quarter of Canada's hospitals reuse single-use medical devices, a rate which resembles that of the United States.[9] 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.[9] 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.[10] 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.[11] 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.[11]

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.[11] 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[11]

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,[11] proposed labels of reprocessed material, description of device makeup, additional necessary data, etc.[11]

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.[11] 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".[11] Third party and healthcare facilities must also follow these labeling regulations, as these facilities must meet the same requirements as the original equipment manufacturers.[11]

## 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.[12]

### General medical 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.[13]

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.[14] 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.[15]

### Hazardous medical waste

Although hazardous medical waste only makes up approximately 15% of all medical waste, it has a significant, observable impact on the health of populations and ecosystems.[16] The improper disposal of hazardous medical waste leads to infectious exposure, contributing to the spread of disease amongst populations. This can be seen explicitly through the improper disposal of biohazardous material (blood, bodily fluids, plasma, etc), release of carcinogens and toxins, and exposure to used sharps, which leads to injury and potential infection.[16] Populations that are directly impacted by hazardous medical waste include healthcare professionals, hospital staff, patients, waste collectors, and the general public as a whole.[17]

Hazardous medical waste also has a significant impact on ecosystems and poses environmental risks. This includes water and soil contamination as a result of the release of toxins and carcinogens and air pollution as a result of current incineration methods of hazardous medical waste. The release of toxic pollutants presents threats to organisms and aquatic life within local ecosystems of landfills where this hazardous medical waste is improperly disposed of, illustrating negative environmental impact.[17]

## Reprocessing SUD (Single-use devices)

Main article: Medicine:Single use medical device reprocessing

### History

The reuse and reprocessing of SUDs have been implemented by hospitals around four decades ago, since the late 1970s for two specific benefits; environmental and economic.[18] Glass and metal were mainly used before this time period and heavily sanitised before reusing on another procedure, but the increasing use of the latest plastic materials and market demand for SUDs, reprocessing was fast approaching. Most SUDs, such as needles, syringes and bandages that are in direct contact with human flesh or blood are single use only by nature, but more complex SUDs, such as pacemakers commonly used in surgical procedures are often reprocessed as an economic benefit for the hospitals.[1]

Most devices that have been categorized as single-use by their manufacturers, have now been reprocessed by third parties, to reuse. All original manufacturers of these devices try and spread the word to prevent potential dangers of infection, failure and danger. Hospitals reprocess SUDs themselves, however, only about 2-3% of SUDS can be reprocessed safely.[19] The global income of third party SUD reprocessing companies are estimated to be $1.054 billion.[19]

The reprocessing company, Innovative Health, has made statements concerning the reasoning behind the single-use definition, including materials involved, technical limitations, and safety. Many companies add the single-use label to increase sales. Although this is so, a small amount of SUDS actually have reusability capacity after controlled sterilization procedures.[20]

### Risks

In many developing countries the reuse and reprocessing of SUDs are simply because of cost restraints and immediate need of these medical devices, but are potentially risk-bounded, as the sterilisation and standards are not yet up to date and could possibly be a hazard for patients. A study done in African countries, reports that 15% to 60% of clinics reuse immunisation needles and syringes without proper disinfecting, resulting in increasingly large cases of unsterilised injections. 55% of North-western China's health care workers reported having used SUDs, resulting in an estimated 135 to 3120 per 100,000 population children in China to have obtained hepatitis B infections through unsafe vaccination practices.[1]

### Ethics and legalities

A national survey was performed by Canadian Agency for Drugs and Technologies in Health (CADTH) of acute care facilities in Canada in 2008, establishing that 28% of responding hospitals reprocess SUDs, but the larger amount of 42%, was done more through bigger hospitals and academic centres. They found that of the hospitals recorded, in-house reprocessing was done by 85%, resulting in 40% not having written policy approving their practice. Since the development of policies, legal issues, risks awareness and standards having to be met, many hospitals have relied heavily on third party reprocessing companies, who specialise in reprocessing, making it more convenient and assessable for them. This process includes the shipping of infected SUDs, the reprocessors sterilising and disinfecting them and then being shipped back. In many cases the hospitals would receive unknown SUDs and not their own ones.[21]

The economical ethics of not using a product more than once, if it is certainly capable to do so, could be viewed as unethical, as most of the time, manufacturers label these devices as single use and could arguably do so to increase sales and revenue, by hospitals constantly bulk buying, instead of focusing on patient safety as a priority.[18]

The primary goal for the ethical reprocessing of SUDs is to protect the communal health, resulting in the patient's health being put first and to ensure the reprocessing of the devices is done ethically, cost efficiently and safely with an outcome of the reused SUD to be considered as an effective brand new product with least amount of risk.[22]

## Manufacturing companies

### Elcam Medical

A world class producer of disposable medical devices and components for the OEM market, and a provider of innovative solutions for specialised flow control needs.[23]

### Cadence Inc.

A single use medical device manufacturer catering for the OEM market. Their headquarters are in Staunton, Virginia.[24][25]

### Sterling Industries

Sterling Industries is a medical device contract manufacturer that assists medical device OEMs and scale-up companies with the production of their single-use medical devices.[26]

## Reprocessing companies

### Innovative Health

A reprocessing company, which specializes in the safe remanufacturing of SUDs, specifically Electrophysiology devices. The company is focused in efforts of making cardiology SUDS more sustainable, and the company is located in Scottsdale, Arizona.[27]

### Ascent Healthcare Solutions

A multi-million-dollar company formed by two corporations merging in 2005; Vanguard Medical Concepts and Alliance Medical Corporation. Ascent has facilities in two locations where the reprocessing of medical devices is done, Phoenix, Arizona and Lakeland in Florida. It is transported and delivered across various states in North America, providing its services to 1800 hospitals and purchasing organisations. They specialise and offer devices in the cardiovascular, orthopaedics, gastroenterology, and general surgery industries complying to the FDA's 510(k) and Quality System Regulation requirements. Their staff base includes more than 900 employees.[28]

### ReNu Medical

The 100% green FDA-registered medical reprocessing company was founded in 2000 in Everett, Washington.[29] They focus on supplying chain saving and waste elimination, providing instant solutions to rising healthcare prices. They specialise in DVT Garments, Pulse Oximeter Probes and many other SUDs to hospitals and clinics nationwide.[30]

## References

1. ↑ 1.0 1.1 1.2 Shuman, Emily K.; Chenoweth, Carol E. (March 2012). "Reuse of Medical Devices: Implications for Infection Control". Infectious Disease Clinics of North America 26 (1): 165–172. doi:10.1016/j.idc.2011.09.010. PMID 22284382.
2. ↑ 2.0 2.1 "What are disposable devices?" (in en-US). 2016-08-08. https://www.medicaldesignandoutsourcing.com/what-are-disposable-devices/.
3. ↑ Gillespie, E. (October 2016). "ACIPC Single-use devices Position Statement". http://www.acipc.org.au/wp-content/uploads/2017/06/Single-Use-Items.pdf.
4. ↑ Popp, Walter; Rasslan, Ossama; Unahalekhaka, Akeau; Brenner, Pola; Fischnaller, Edith; Fathy, Maha; Goldman, Carol; Gillespie, Elizabeth (July 2010). "What is the use? An international look at reuse of single-use medical devices". International Journal of Hygiene and Environmental Health 213 (4): 302–307. doi:10.1016/j.ijheh.2010.04.003. PMID 20471316. Bibcode: 2010IJHEH.213..302P.
5. ↑ 5.0 5.1 "Single Use Items". 2013-09-25. https://www.isopharm.co.uk/dental/single-use-items.
6. ↑ 6.0 6.1 "Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process | U.S. GAO" (in en). https://www.gao.gov/products/gao-09-190.
7. ↑ Wilson, Brian (April 2011). "If it's Reusable Why not Reuse it? The Reuse of Single Use Medical Devices". Dalhousie Law Journal 34 (1): 229–258. https://digitalcommons.schulichlaw.dal.ca/dlj/vol34/iss1/9/.
8. ↑ "Position Statement - Single-use devices". http://www.acipc.org.au/wp-content/uploads/2017/06/Single-Use-Items.pdf.
9. ↑ 9.0 9.1 Collier, R. (9 August 2011). "Reprocessing single-use devices: an international perspective". Canadian Medical Association Journal 183 (11): 1244. doi:10.1503/cmaj.109-3906. PMID 21727228.
10. ↑ Spurgeon, David (8 September 2001). "Single use equipment is used up to 20 times, says report". BMJ 323 (7312): 532. doi:10.1136/bmj.323.7312.532d. ProQuest 1777599775.
11. ↑ 11.0 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 Health, Center for Devices and Radiological (2024-08-01). "Reprocessing Single-Use Medical Devices: Information for Health Care Facilities" (in en). https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-single-use-medical-devices-information-health-care-facilities.
12. ↑ Greene, Jeremy; Skolnik, Caroline L; Merritt, Maria W (October 2022). "How medicine becomes trash: disposability in health care". The Lancet 400 (10360): 1298–1299. doi:10.1016/S0140-6736(22)01941-9.
13. ↑ Health, Center for Devices and Radiological (2024-08-01). "Reprocessed Single-Use Devices: Frequently Asked Questions" (in en). FDA. https://www.fda.gov/medical-devices/reprocessing-single-use-medical-devices-information-health-care-facilities/reprocessed-single-use-devices-frequently-asked-questions.
14. ↑ Unger, Scott R; Hottle, Troy A; Hobbs, Shakira R; Thiel, Cassandra L; Campion, Nicole; Bilec, Melissa M; Landis, Amy E (October 2017). "Do single-use medical devices containing biopolymers reduce the environmental impacts of surgical procedures compared with their plastic equivalents?". Journal of Health Services Research & Policy 22 (4): 218–225. doi:10.1177/1355819617705683. PMID 28530129.
15. ↑ Yao, Zhuang; Seong, Hyeon Jeong; Jang, Yu-Sin (2022-09-01). "Environmental toxicity and decomposition of polyethylene". Ecotoxicology and Environmental Safety 242. doi:10.1016/j.ecoenv.2022.113933. ISSN 0147-6513. PMID 35930840. Bibcode: 2022EcoES.24213933Y. https://www.sciencedirect.com/science/article/pii/S0147651322007734.
16. ↑ 16.0 16.1 Janik-Karpinska, Edyta; Brancaleoni, Rachele; Niemcewicz, Marcin; Wojtas, Wiktor; Foco, Maurizio; Podogrocki, Marcin; Bijak, Michal (2023-01-13). "Healthcare Waste—A Serious Problem for Global Health" (in en). Healthcare 11 (2): 242. doi:10.3390/healthcare11020242. ISSN 2227-9032. PMID 36673610.
17. ↑ 17.0 17.1 "Health-care waste" (in en). https://www.who.int/news-room/fact-sheets/detail/health-care-waste#:~:text=Health-care waste contains potentially,health facilities into the environment..
18. ↑ 18.0 18.1 Grantcharov, Peter; Ahmed, Shushmita; Wac, Katarzyna; Rivas, Homero (March 2019). "Reprocessing and reuse of single-use medical devices: perceptions and concerns of relevant stakeholders toward current practices". International Journal of Evidence-Based Healthcare 17 (1): 53–57. doi:10.1097/XEB.0000000000000146. PMID 29847410.
19. ↑ 19.0 19.1 Jacobs, Philip; Akpinar, Ilke (November 2018). "Single-use medical devices: economic issues". Heart Asia 10 (2). doi:10.1136/heartasia-2018-011034. PMID 30556542.
20. ↑ Garder, Elliot (2018-10-31). "Breaking point: should we be reusing more medical devices?" (in en-GB). https://www.medicaldevice-network.com/features/breaking-point-reusing-medical-devices/.
21. ↑ Larose, Emily (23 July 2013). "Legal Implications of Single-Use Medical Device Reprocessing". Healthcare Quarterly 16 (3): 48–52. doi:10.12927/hcq.2013.23499. ProQuest 1463070622. PMID 24034777.
22. ↑ Hernandez, Antonio (2020). "Single-use medical devices reuse and reprocessing". Clinical Engineering Handbook. pp. 276–279. doi:10.1016/B978-0-12-813467-2.00043-2. ISBN 978-0-12-813467-2.
23. ↑ "History". https://www.elcam-medical.com/history.
24. ↑ "Cadence's history | Cadence Inc". https://www.cadenceinc.com/about/our-history.
25. ↑ "Cadence, Inc. Competitors and Products in the Medical Device Directory". https://www.medicaldevicedirectory.com/company/554438/cadence-inc.
26. ↑ "Medical Device Contract Manufacturing" (in en-US). https://www.sterlingindustries.com/.
27. ↑ admin. "Innovative Health – Medical Device Reprocessing" (in en-US). https://innovative-health.com/.
28. ↑ "Stryker Pays $525M for Ascent Healthcare Solutions | HealthLeaders Media". https://www.healthleadersmedia.com/strategy/stryker-pays-525m-ascent-healthcare-solutions.
29. ↑ "ReNu Medical, Inc.: Private Company Information - Bloomberg". https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapid=21994849.
30. ↑ "ReNu Medical Releases the Results of a Perfect Inspection by FDA" (in en). 2010-09-16. https://www.businesswire.com/news/home/20100916005164/en/ReNu-Medical-Releases-Results-Perfect-Inspection-FDA.

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