Device Reuse or Misuse? Statistics by Country

Device Reuse or Misuse? Statistics by Country

One reason single-use medical devices were developed was to eliminate the possibility of infection due to reuse and to increase standards of care. However, reuse of single-use medical devices is regrettably common in most countries, including the United States.

Why this is Important

After patient safety concerns, a key question for medical device manufacturers is liability when medical devices are reprocessed and reused. For example, the World Health Organization (WHO) estimates that unsafe injections due to reuse cause an estimated 1.3 million early deaths and an annual burden of $535 million in direct medical costs.1 According to the WHO report, unsafe injection practices are a powerful engine to transmit blood-borne pathogens, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
 

What Devices are Reused and Where?

According to a recent study, medical devices that are commonly reused in emerging markets are urinary catheters, tubes, gloves, drains, syringes, needles and indwelling venous cannula.2 In developed countries, reprocessing of single-use devices more frequently is limited to expensive or highly specialized products. In either case, the driver of reuse in is cost savings. In the developed world, a new argument is based on the model of sustainable development, which is founded on the belief that reprocessing is a more efficient use of resources and the management of medical waste. It is unclear if sustainable development includes the costs of medico-legal and patient health risks.The question is who, besides the patient or clinician, bears that risk?

European Statistics on Reuse

Reuse is reported in all European countries except France, where reuse of medical devices is illegal.3 Reuse is limited in the United Kingdom, where guidance has been issued detailing potential risks and consequences of reuse.4 Other than that, reprocessing of single-use devices may be undertaken in nearly all European countries, and mostly without quality standards.5

U.S. & Canada

In the United States, reuse of single-use medical devices is reported at 25 percent of hospitals and many are reported to reprocess single-use devices with third party reprocessors.9 An article in The Wall Street Journal reports that the dollar value of U.S. reprocessed single use medical devices is approximately $150 million.10

Who is Liable for Adverse Events?

There is no clear answer. Device reprocessors claim that their reprocessed devices are safe, recycled and reduce medical waste. One study from the U.S. government found no evidence that reprocessed single-use devices create an elevated health risk for patients.12 However, the study hedged its claim by stating that there is “insufficient research “to draw definitive conclusions about the safety of reprocessed single-use devices as compared to similar original devices.” And Tara Federici, vice president of Technology and Regulatory affairs for the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed), said:“Single-use devices are designed and manufactured for just asingle use in a single patient and are intended to be disposed ofpermanently after use.”13

She added that medical devices have characteristics that make them extremely difficult to effectively clean and re-sterilize. Inaccessible areas on the devices, according to Federici, create barriers to cleaning and allow for the collection of organic matter, such as blood, feces and respiratory secretions.

Device reuse will continue, and probably escalate in the emerging device markets and now, in the constrained economic environments of the Western world. Understanding the drivers and trends will continue to be a critical variable in the forecasting and design of medical devices.

Author’s note: Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria. Send your questions to [email protected].

References:

1. www.who.int/mediacentre/factsheets/fs231/en/

2. Popp, et. al. International Journal of Hygiene and Environmental Health 213 (2010) 302–307

3. www.eucomed.org/key-themes/patients-safety/reuse-of-single-use-devices

4. www.cnwl.nhs.uk/…/Single%20Use%20Medical%20Devices%20Policy.doc

5. European Commission, 2008b. European Commission: synthesis document. Outcome of the first public consultation on the reprocessing of medical devices. Brussels.

6. Ischinger, T.A., et.al., 2002. Wiederverwendung von medizinischen Einwegprodukten nach qualitatsgesicherter Wiederaufbereitung: ein Modell zur Kostendampfung? Z. Kardiol. 91, 889–898.

7. El Mundo, 2005. Material medico, se usa pero no se tira. September 17.

8. Christensen, M., Meyer, M., Jensen, O.B., 1999. Reuse of single-use sterile medical devices in Danish hospitals decreased after report discouraged it. Eurosurvaillance 4, 101–102.

9. Quirk, M., 2002. Most US hospitals avoid reuse of single-use devices. Lancet Infect. Dis. 2, 714.

10. www.online.wsj.com/article/SB120588469924246975.html

11. Polisena, J., Hailey, D., Moulton, K., Noorani, H.Z., Jacobs, P., Ries, N., Normadin, S., Gardam, M., 2008. Reprocessing and reuse of single-use medical devices: a national survey of Canadian acute-care hospitals. Infect. Control Hosp. Epidemiol. 29, 437–439.

12. www.gao.gov/new.items/d08147.pdf

13. www.lvrj.com/news/doctor-s-ad-defends-reuse-of-single-use-devices-118759284.html

Maria Shepherd, founder of Data Decision Group, has 20 years of leadership experience in medical device and life-sciences marketing in small startups and top-tier companies. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd can be reached at (617) 548-9892 or at [email protected] or www.ddecisiongroup.com.