Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

Table 5 Recommendations that are provided for healthcare facilities, federal agencies, medical device manufacturers, and healthcare organizations and administrations, to minimize the risk of injury to patients and of legal exposure to healthcare facilities

To healthcare facilities:

Review a previously published set of instructions for reprocessing the Olympus MAJ-855 auxiliary water tube, along with the colonoscope’s auxiliary water channel[10]. Also, review Table 6

Before using an adulterated or misbranded device, or a censured medical device subject to a consent decree and/or CN: (1) consider whether describing it as investigational subject to an approved IDE, the oversight by an IRB and informed patient consent is warranted; and (2) ensure that its use does not contravene the healthcare facility’s policies and procedures (or other documents, including its insurance policies[59])

Ensure that the certification of a censured device’s continued use pursuant to a signed CN (or CT) is lawful and based on sound medical considerations and patient safety

To maintain a consistent standard of patient care, quality, and transparency, consider patient disclosure of a medical error to be the norm, no matter whether the error is an infection-control breach associated with a low risk of infection (Table 3)[1,5,12]

The use of a wet flexible endoscope or surgical instrument to treat patients is not recommended. Prior to their use (and storage), wet, processed flexible endoscopes, such as those processed by the SS1 (or SS1E), may be dried using 70% alcohol followed by forced air

Consider periodically monitoring the microbial quality of the water used to rinse flexible (and rigid) endoscopes following their high-level disinfection or liquid chemical sterilization. Contaminated rinse water will yield contaminated, processed instruments. Failure to monitor the rinse water microbiologically precludes assurances that it does not contain potentially pathogenic microorganisms

Review the history of the SS1’s use, regulation, and discontinuation (Table 4). Also, review the risk assessments provided in Tables 1-3

Review all infection-control product’s labeling claims. Question any processor’s labeling that “guarantees” sterilization (or high-level disinfection)

To regulatory agencies:

Continued attention to the scientifically-sound, active regulation of medical devices with infection-control applications is appreciated. One important aspect of this oversight is the frequent and/or detailed auditing of medical device manufacturers, to ensure, among other considerations, the proper control and documentation of any changes to a medical device’s labeling and design. Also recommended are more frequent and thorough audits by international standard organizations that certify the quality of manufacturers

Continued efforts to ensure that the wording of 510(k) clearances describing a device’s intended use is clear and consistent are encouraged. Cleared labeling claims that detail what the device does achieve, rather than what it does not achieve (e.g., the SS1E’s FDA-cleared liquid chemical sterilization claim), are important to quality and to reducing the risk of confusion, user error, and patient harms

Consider eliminating the oxymoronic and anomalous claim of liquid chemical sterilization and replacing it with a more scientific and consistent claim (e.g., enhanced, ultra, or rapidly sporicidal high-level disinfection)

Also recommended are: (1) the enhanced attention of consent decrees, CNs and CTs to transparency, and patient safety; (2) the definitive clarification by the FDA whether the continued use of an unapproved or otherwise censured device requires an approved IDE; and (3) improved efforts to ensure that the patient’s rights, safety and welfare are protected whenever an unapproved or otherwise censured device is used

To manufacturers:

Adopt more rigorous quality and regulatory standards that prevent the design, manufacture, sale and marketing of potentially unsafe, mislabeled, ineffective, or unapproved medical devices [e.g., those without a 510(k) clearance or PMA]. Do not change or modify the designs (including the labeling and intended uses) of medical devices (e.g., the re-formulation of a high-level disinfectant’s labeling and chemical ingredients) without adequate documentation and control (per the FDA’s Quality System Regulation). Submit to the FDA for its review and clearance substantively modified devices prior to their marketing and sale. Whenever in doubt, conclude that a design change requires a new 510(k) submission

Use caution before including in a reusable surgical instrument’s instructions for use (IFUs) a reprocessing device (e.g., the SS1), that is adulterated, misbranded, or lacks adequate design control, documentation and/or data validating its labeling claims, safety, and compatibility with the surgical instrument’s materials. Otherwise, the FDA may consider the surgical instrument to be itself misbranded

To healthcare organizations:

Consider a more proactive role in the oversight of the safety and effectiveness of infection-control products and of the validity of their labeling claims

Consider publishing guidance to advise a medical facility evaluating whether the continued use of a censured medical device subject to a CN (e.g., the SS1) is legally and medically sound; warrants an approved IDE including informed patient consent; could adversely impact a healthcare facility’s accreditation, certification, or licensing; and requires any corrective or preventative actions or changes in clinical practice

To the VHA:

Notification of patients affected by the infection-control breaches confirmed within the Caribbean in 2009 (Table 2) is recommended[1,3,12], to ensure compliance and consistency with the VHA’s relevant directives and policies vis-a-vis patient notification[14]; a consistent standard of patient care; and a commitment to transparency and quality. In general, consider patient notification to be the norm[5,14]

To patients:

While formal recommendations for patients are not, per se, the focus of this article, some guidance is provided

If an infection is contracted (or other type of patient harm is encountered) during or following a medical procedure, among other considerations:

Verify that the healthcare facility did not use (without the patient’s knowledge) a medical device that had been censured, adulterated, misbranded, described as investigational, or subject to a signed CN and/or CT (e.g., the SS1)

Investigate whether, at the time the patient received medical care or treatment, any known or undisclosed infection-control breaches, lapses, or medical errors were identified by the healthcare facility

Consider contacting the healthcare facility prior to a procedure and ask for the facility to certify its relative risk of infections and other adverse events, compared to other facilities. Ensure that this risk is based on internal data that have been independently validated for accuracy and completeness

Patients potentially affected by one or more of the breaches confirmed within the Caribbean and listed in Table 2 might consider contacting the VHA and requesting being tested to ensure they were not infected with a transmissible disease due to any of these confirmed breaches

These patients may also consider asking the VHA for evidence-based justification for having not notified them of any of these breaches listed in Table 2. The medical literature suggests that these breaches may have posed an increased risk of infection

Consider having a blood test taken before the procedure to demonstrate a negative blood-borne pathogen result. A positive result promptly after the procedure might implicate the procedure as the infection’s cause