The inexorable pressures of limiting costs and optimising patient can lead healthcare providers to find ways to trim their budgets. One “unseen” aspect of treatment provision is the increasing re-use of medical devices designed and sold for single use only (single use medical devices or “SUDs”). This article examines the implications of re-use and outlines the main steps that healthcare providers should take in order to avoid the consequences. SUDs are used in the day to day treatment of patients and include syringes, laparoscopy scissors, surgical blades and catheters. They are devices for the treatment of a single patient during one procedure, and then disposed of appropriately. They are not designed to be reprocessed for multiple use, or multiple patients, which might compromise their sterility and increase the risk of cross contamination, material or mechanical failure.
If healthcare providers (including public hospitals, private clinics and general practice surgeries) choose to reuse SUDs, or purchase reprocessed products from a third party, they must be aware of their potential legal liability.
What is the extent of such liability?
Product Liability Directive
It could include liability to patients under the Product Liability Directive 85/374/EEC (PLD) introduced strict liability for defective products. A product is defective if it is “not as safe as persons generally are entitled to expect”, and the patient can show a causal relationship between his injury and the defect in the product.
This is particularly important as the PLD states that “all the circumstances” are to be taken into account when deciding if a product is “defective” - these include any information provided about the product or its use and encompasses packaging, labelling and warnings. If a product is supplied or used contrary to the manufacturers’ instructions and warnings, the organisation (or in some cases the medial professionals themselves) could be in the firing line for claims under the PLD.
If, for example, a SUD catheter is re-processed and the patient suffers infection as a result, he could pursue a claim against the treating healthcare provider.
General Product Safety Directive
Whilst the Medical and Healthcare Products Agency has responsibility for enforcing standards of medical devices under the Medical Devices Directive (93/42/EEC), the General Product Safety Directive 2001/95/EC (GPSD) may impose additional obligations.
Under the GPSD, producers and distributors must ensure those products for consumer use are “safe” and that products which may “migrate” from professional to consumer use are also “safe”. A reprocessor of an SUD (whether a third party company or a hospital) may be deemed the “producer” under the GPSD and the PLD, particularly if they alter or manipulate the product.
Under the GPSD the producer shall provide “consumers with the relevant information to enable them to assess the risks where such risks are not immediately obvious without adequate warning” and enable the consumer to “take precautions against those risks”.
Breaches of the GPSD can result in a £20,000 penalty or up to 12 months imprisonment if a producer or distributor is prosecuted.
Thus, if a healthcare provider reprocesses an SUD, or purchases reprocessed SUDs and does not provide the patient with the requisite information and warnings, it may be liable to him if injury occurs. For example, if a doctor exposes the patient to a defective reprocessed device, it could be argued that the product is deemed “unsafe”. Consequently, the doctor might be liable to the patient in damages under the PLD and possibly prosecution under the GPSD.
Healthcare providers may also be at risk of liability in negligence under the fault-based common law system. They have a duty to explain the risks and provide adequate warnings to the patient about procedures he is undergoing.
A doctor or nurse may not explain the implications of re-using SUDs, as they themselves may be unaware of the reprocessed SUD. If advised this issue, patients may be unwilling to give consent.
If a healthcare provider provides or supplies a reprocessed SUD to a patient who is unaware that the product is not an original, unused SUD, there may also be a claim in contract if the patient has paid for the device and subsequently suffers injury. Those purchasing SUDs, or reprocessed SUDs from a third party, should ensure their contractual rights are protected, and that they have legal recourse to their supplier if claims arise, for example, because the sterility of the product supplied is compromised.
A report from the Commission to the European Parliament and the Council in 2010 looked at the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC. The report highlighted a number of issues and recommended that health providers should be informed when using reprocessed SUDs. They may be liable in cases of mishandling which affects patient care, e.g. the stiffness of a catheter may be modified by reprocessing.
The manufacturer’s original labelling may remain on an SUD even after reprocessing. The report recommended that labelling requirements of reprocessed SUDs be clarified to reflect liability in cases of product failure and ensure the traceability of reprocessed SUDs.
It also commented that if a user or third party reprocessing service provider develops and validates an SUD reprocessing procedure, they are responsible for the implications of that reprocessing, including any lack of safety or “danger” to the consumer. The report highlighted that the sharing of liability between the user and third party reprocesser is still unclear.
Healthcare providers need to carefully consider their own policies and procedures, in particular to ascertain:
- Are SUDs re-used?
- Are SUDs reprocessed by them?
- Are they purchasing reprocessed SUDs from third parties?
- Is contractual documentation adequate and retained?
- Taking these steps and reviewing their implications are an important aspect of risk management in the current financial climate for all healthcare providers.