One Liners Issue 19 - October 2002

DEVICES LABELLED "SINGLE USE ONLY"
Some medical devices labelled for "single use only" are reused often because of a lack of understanding of why such a label has been applied. The reuse of such devices can however affect the safety, performance and effectiveness of the devices, exposing staff and patients to unnecessary risk. Such reuse also has legal implications.

The aim of this edition therefore is to detail briefly some of the incidents that have occurred as a result of this practice.

Devices designed for "single use" must not be reused under any circumstances
(Controls Assurance Standard on devices: criteria 12)

Endless?
MDA has received a number of reports of cardiac catheters whose tips have broken off in the patient, with serious consequences. These cases occurred where the catheters had been resterilised and reused.

• Such catheters may be made of a materials which embrittles on repeat sterilization or have design features such as long or narrow lumens, acute angles, coils or specialist surface coatings that could prevent effective cleaning.

Re-entry Bradycardia
MDA has become aware of instances where external pacemakers' extensions/adapter leads packaged as "single use" (sterile and non-sterile) have been reused. Manufacturers have advised that sterilization or reuse may lead to material degradation.

• This degradation can result in poor connections between the lead and pacemaker and a potential for fatal bradycardia or asystole.

Once is Enough
MDA has received reports of inadvertent guidewire advancement used with trauma/orthopaedic guided cannulated screw systems. In one case this resulted in a fatal incident where a cannulated drill became jammed over a screw guidewire which then advanced into the pelvis damaging the iliac vein.

• In the case of guidewires marked "for single use only", reuse increases the risk of employing a damaged guidewire with possible fatal consequences (Safety Notice SN2001(14)).

Make a Clean Breast of it!
MDA are aware of the practice of breast implants being used as sizers for measuring the size of implants needed to produce a good cosmetic result.

• Some breast implants do not withstand cleaning, decontamination and sterilization processes, resulting in a potential for cross infection and material degradation. Several different models of breast implant sizers, both reusable and single use, are available.

Don't get Pseud!
"Single use" pressure domes, used to cover the pressure transducers in the urodymnamic systems for assessing bladder pressure. Several cases have been reported to MDA where they have been reused resulting in a number of patients becoming contaminated with Pseudomonus aeruginosa and in one case developing sever septicaemia.

• These devices and the catheters linking the transducers to the patient must be used for one procedure only (Safety Notice SN2000(09)).

Speculation?
MDA are aware of "single use" vaginal speculae being reused after "decontamination" by glutaraldehyde.

• Apart from the fact that single use speculae may not withstand the cleaning and sterilisation process necessary for effective decontamination to prevent cross infection, glutaraldehyde may be absorbed by certain plastics and leach out during subsequent use, resulting in chemical burns or a risk of sensitisation of the patient or user.

Published by the Medical Devices Agency - an executive agency of the Department of Health. We investigate problems arising from the use or misuse of medical devices when health or safety have been put at risk. If you would like to discuss or report an incident or request any of the publications referred to above, contact us on 020 7972 8123 (medical), 8128 (nursing) or e-mail address: clin@medical-devices.gov.uk